Patents And Intellectual Property Blog

Apotex Succeeds In Getting A NOC Despite Itself.

2011-02-28T11:10:00.000-05:00

A recent Federal Court decision highlighted the differences in prohibition proceedings under the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations) and impeachment actions under the Patent Act. It is yet another example of how every case is to be determined on the specific evidence adduced before the Court.

In Eli Lilly Canada Inc. v. Apotex Inc, the Court dismissed Eli Lilly's application under the NOC Regulations for an order prohibiting the Minister of Health (the Minister) from issuing a notice of compliance (NOC) to Apotex in respect of the medicine atomoxetine until after the expiry of the '735 Patent. However, the dismissal was based on mootness alone, as the Court would have allowed the application had it not invalidated the '735 Patent entirely in a related impeachment action brought by Novopharm.

Proceedings under the NOC Regulations vs. Actions under the Patent Act

In Canada, in order for a generic manufacturer to get approval to market a generic version of an existing drug product, it must file an abbreviated new drug submission (ANDS) with Health Canada demonstrating that its product is bioequivalent to the innovator's previously approved drug product. If the Minister of Health (the Minister) is satisfied with the submission, she must issue a NOC allowing the generic drug to be marketed, but only if the generic manufacturer has first "jumped the hurdles" of the NOC Regulations.

In particular, the Minister is prohibited from issuing a NOC to a generic manufacturer, even if it has satisfied Health Canada as to the safety and efficacy of its drug, until the generic has addressed all of the patents listed against the innovator's drug product under the NOC Regulations.

With respect to each patent listed on this "patent register", the generic must either accept that a NOC will not issue for its drug until the patent expires, or, if it seeks to enter the market before the patent expires, it must allege that the patent is not valid or that no product, use, dosage form or formulation claim of the patent will be infringed by the making, constructing, using or selling of its generic drug. Such allegations must be contained in a notice of allegation (NOA), which is served on the innovator, and includes a detailed statement of the legal and factual basis for the allegations. NOAs are required to be very detailed and are often well over 100 pages in length.

The innovator may apply to a Court within 45 days after being served with a NOA for an Order prohibiting the Minister from issuing a NOC until after the expiration of the patent(s) that are the subject of the NOA. This effectively freezes Ministerial action for 24 months unless the application is disposed of by the Court earlier. Such applications are supposed to be summary in nature, as they proceed by way of affidavits and out-of-court cross-examinations, and hearings occur by way of lawyers presenting the evidence to a single judge of the Court.

The innovator has the burden of proving that each of the generic's allegations of invalidity and non-infringement are not justified on a balance of probabilities. If the innovator does not meet its burden, the application is dismissed and the Minister is free to issue a NOC to the generic for its drug product. If the innovator successfully argues that the generic's allegations are not justified, then the Minister is prohibited from issuing a NOC until the latest expiry date of the patents at issue.

What is particularly interesting about this procedure is that (because of the supposed "summary nature" of such applications) the innovator's remedies under the NOC Regulations are in addition to its usual remedies for patent infringement under the Patent Act. In other words, a final decision on an application under the NOC Regulations does not prevent a subsequent action for infringement under the Patent Act, and the doctrine of res judicata does not apply. Thus, the innovator is free (if its application was dismissed under the NOC Regulations) to effectively re-litigate the patent(s) at issue, meaning that the innovator gets a second "kick at the can" regarding the issues of infringement and validity. Similarly, a generic is free to commence an action under the Patent Act seeking impeachment of the patent(s) and/or a declaration of non-infringement even if the prohibition application was allowed.

Unlike applications under the NOC Regulations, final determinations as to validity of a patent in the course of an action under the Patent Act are in rem, meaning the decision is applicable to the patent itself rather than just the parties in the litigation. Moreover, unlike applications under the NOC Regulations, actions under the Patent Act are subject to the full array of legal procedures, including documentary and oral discovery, expert reports, and live fact and expert witnesses before the Court. This generally means that much more significant evidence is placed before the Court in the trial of an action.

Novopharm's action against Eli Lilly to impeach the '735 Patent

As previously reported, Novopharm was successful in impeaching the '735 Patent, which claimed the use of the medicine atomoxetine for treating attention deficit hyperactivity disorder (ADHD) in three of its manifestations among all age groups (children, adolescents and adults). In particular, the judge accepted the evidence of Novopharm's experts going to the significant limitations of a study relied upon by Eli Lilly to establish utility. The study's most critical shortcomings were related to its small sample size, the potential for imperfect patient blinding, and the limited study duration.

The Court found that the study's reported results failed to demonstrate the critical utility of atomoxetine to treat ADHD in adults or children, and that utility had therefore not been demonstrated. Moreover, the Court found that the alleged invention in the '735 Patent was also not soundly predicted on the basis that the patent failed to disclose reference to the findings in the study in the patent disclosure.

Although the two cases were heard back-to-back by the same Federal Court judge, the decision in Novopharm's action was released before a decision was rendered in the Apotex application (discussed below).

Eli Lilly's application against Apotex under the NOC Regulations

Apotex had alleged in its NOA that the disclosure of the '735 Patent failed to provide any information, data or test results purporting to show that the administration of atomoxetine was safe and effective in the sense that treatment of ADHD would result. Apotex further alleged that the first clinical trials or experiments assessing the safety and efficacy of atomoxetine for treating ADHD were not conducted until after the filing of the priority application. As a result, Apotex asserted that any results or data obtained from those trials could not have formed a sufficient factual basis or sound line of reasoning upon which a sound prediction could be made of the safety and efficacy of atomoxetine for treating ADHD. Alternatively, if the trials were sufficient for these purposes, Apotex alleged that Eli Lilly failed to disclose the results and data from those trials and experiments in the '735 Patent. Eli Lilly answered the NOA with a notice of application that alleged that it had established by virtue of studies that atomoxetine was useful for the treatment of ADHD (i.e. that it had demonstrated utility).

When it came to presenting evidence, Apotex only framed its case around the issue of sound prediction and failed to provide any evidence contesting Eli Lilly's assertions of demonstrated utility. Eli Lilly responded by producing the study report that was the subject of the Novopharm action. Apotex elected not to challenge this evidence on matters of substance. In particular, Apotex chose not to seek to file reply evidence or to cross-examine Eli Lilly's witnesses to challenge the study's reliability or sufficiency. The only evidence that Apotex put forward in response to the study was that the study and its data were not referenced in the '735 Patent. Apotex asserted that this was enough to put the issue of utility into play.

The Court, however, disagreed.

Where a patentee relies on demonstrated utility, its disclosure obligation is limited to the provision of a full description of the invention and the means to work it. It is only where the patentee relies upon a sound prediction of utility that it is required to disclose in the patent both the factual data on which the prediction is based and the line of reasoning to support it. Therefore, because Eli Lilly was relying upon an assertion of demonstrated utility, it was under no obligation to disclose the study or its findings in the '735 Patent.

As a result, Apotex's evidence, which simply pointed to the absence of proper disclosure in the '735 Patent, was not even capable of rebutting the statutory presumption of validity. As stated by the Court:
I am accordingly bound on this record to reject Apotex's allegation of inutility because it has failed to satisfy its initial evidentiary burden ... For this issue, the statutory presumption of validity prevails.

This is, of course, a surprising result in the face of my earlier finding in Novopharm Limited v. Eli Lilly and Company, 2010 FC 915, that the MGH Study was not sufficient to demonstrate utility. But in that case the issue was addressed by the parties on the strength of considerable evidence that went to the merits of the MGH Study. Here, Apotex took a different approach and elected not to meet Lilly's assertion of demonstrated utility head-on. In the result, its allegation of inutility fails.

In the result, the Court would have allowed Eli Lilly's application to prohibit the Minister from issuing a NOC to Apotex since Apotex's allegations were not justified. However, because of the intervening determination that the '735 Patent was invalid in the Novopharm action (an in rem decision), Eli Lilly's application against Apotex was dismissed on the basis of mootness. Apotex was therefore still able to receive a NOC to market its generic version of atomoxetine.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com/
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Unpredictable but Not Surprising - The Federal Court of Canada Clarifies the Application of the Obvious-to-Try Test

2011-02-25T11:10:00.000-05:00

On August 3, 2010, the Federal Court released reasons in Novo Nordisk Canada Inc. et al. v. Cobalt Pharmaceuticals Inc. et al. (2010 FC 746; "Novo Nordisk")) finding Cobalt's allegation of obviousness justified with respect to Canadian Patent No. 2,111,851. The patent covers repaglinide (an (S) enantiomer), its use for the treatment of Type 2 Diabetes, and processes to make it.

Novo Nordisk is an important case both from legal development and commercial perspectives. The Federal Court has made clear that scientific knowledge evolved after 1987, the date considered by the Supreme Court of Canada ("SCC") in Sanofi and that by 1991 it was the state of the art to separate and test enantiomers of racemic potential drugs. This decision refines the obvious-to-try test set out by the SCC and suggests a review of all enantiomer patents applied for in or after 1991.

The Decision in a Nutshell

The patent involved in this proceeding (the "851 Patent") essentially covers the enantiomer repaglinide. Repaglinide is sold under the brand name GLUCONORM".

Enantiomers are mirror image molecules that cannot be superimposed on each other (think of right and left hands). They are normally synthesized together, as a "racemate", and one cannot know how each of the two enantiomers comprising the racemate (denoted (S) and (R)) will act in the body until it has actually been made and tested. Activity and toxicity can be different as between the racemate, the (S) enantiomer and the (R) enantiomer.

Unlike other recent cases, the racemate comprising repaglinide was never approved or marketed as a drug product, although the racemate had been identified in a previous "genus" patent covering numerous compounds, as well as a patent covering new solid forms of the racemate.

Nonetheless, Cobalt alleged repaglinide to be obvious, and the 851 Patent to be invalid on this and other grounds. The Court agreed and found the 851 Patent obvious to try.

This is only the second decision known to the author in which the Court found allegations of invalidity of an enantiomer patent justified.

Refining the Obvious-to-Try Test

In the Sanofi case, the SCC dealt with an enantiomer patent and in that context, set out the obvious to try analysis applied by the Court to repaglinide in this case. The obvious to try factors include asking whether it is more or less self-evident that what is being tried (i.e. the invention) ought to work.

In answering this question, the SCC stated:

As I have observed earlier, Shore J. found that the skilled person would not know, before separating this particular racemate into its isomers and then testing the separated isomers, that the properties of the dextro-rotatory isomer [(R) enantiomer] would be different from the properties of the racemate or the levo-rotatory [(S) enantiomer] isomer (para. 81). Similarly, he found that the person skilled in the art would not know before trying the different salts in combination with the dextro-rotatory isomer what the bisulfate salt's beneficial properties would be (para. 82).

Just because there are known methods of separating a racemate into its isomers does not mean that a person skilled in the art would necessarily apply them. The fact that there are such known methods of separation will be of no account if the evidence does not prove that it was more or less self-evident to try them. It is true that at the relevant time there was evidence that a skilled person would know that the properties of a racemate and its isomers might be different. However, a possibility of finding the invention is not enough. The invention must be self-evident from the prior art and common general knowledge in order to satisfy the "obvious to try" test. That is not the evidence in this case.

At its broadest, this holding would mean that – in the case of an enantiomer or other selection patent – the discovery of advantageous properties could be the foundation of a valid patent, as long as the properties were not predictable in the particular selection of compounds. Given that routinely-identified properties (such as toxicity, solubility, pharmacokinetic profile, etc.) are often unpredictable, it was unclear how this holding would be reconciled with previous jurisprudence suggesting that routine testing may not qualify as an inventive step.

Novo Nordisk addresses this seeming tension by clarifying that unpredictable but unsurprising properties are not necessarily a bar to a finding of obviousness.

The Court found that an enantiomer claim can be obvious even if the enantiomer's advantages were unknown. In addition, the Court held that it was impossible to predict what the differences in the pharmacokinetic profiles of enantiomers would be before actually separating and testing them. Nevertheless, as of 1991, it was known that these differences could well exist, and that it was, therefore, important to test for them.

The Court held Cobalt's allegation of obviousness justified even though the Court found that there was no clear preference for one enantiomer or the other expressed in the prior art, and that the advantages of the (S) enantiomer were not previously identified. The basis of this finding was that pharmacokinetic properties that differ between enantiomers would inevitably have been discovered as a result of testing that was a routine part of the state of the art in 1991.

The Evolution of Enantiomer Science

In addition to refining the obvious to try test, this decision should make all patentees ask the question: "Are enantiomers patentable after 1991?"

In Sanofi, the SCC found that as of 1987 there was little motivation to pursue enantiomers. The relevant date in Novo Nordisk is in 1991. The Federal Court found it clear on the evidence that by 1991:

• the world had evolved and it was now the state of the art to separate and test enantiomers;
• techniques for separating racemates into their isomers were generally known; and
• testing enantiomers for differences in pharmacokinetic properties was a routine matter.

The evidence in this case included the fact of an enantiomer policy approved in 1989 by Dr. Karl Thomae GmbH – the patent owner – which confirmed that "A forced move towards the development of enantiomer-pure active substances results out of the necessity to minimize development time and costs, as well as in order to comply with the current state of the art. The development of racemates will thus only still be justifiable in exceptional circumstances".

This decision also highlights the importance of strong evidence of how drug development was actually undertaken at the relevant time.

The Court specifically contrasted the evidence presented by Cobalt in this case to that presented in the recent Lundbeck case, where the evidence was found to be "appallingly thin".

References:

1. Sanofi-Synthelabo Canada Inc. v. Apotex Inc., 2008 SCC 61.
2. Cobalt asserted a number of grounds of invalidity, though only the anticipation, obviousness and void pursuant to s. 53 of the Patent Act were dealt with by the Court, and only the obviousness ground was successful.
3. The first decision was with respect to the drug levofloxacin. Despite allegations of invalidity being found justified in the context of a NOC proceeding, the enantiomer patent was upheld as valid at trial and appeal.
4. Lundbeck Canada Inc. v. Canada (Minister of Health), 2009 FC 146.

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Federal Court Of Appeal Refuses A Patent To A Compound Already The Subject Matter Of Product-By-Process Patent.

2011-02-21T11:10:00.000-05:00

On October 20, the Federal Court of Appeal put an end to the disparity in the jurisprudence surrounding whether a patentee could obtain a patent to a medicine subsequent to obtaining a patent to a process for producing the medicine by dismissing Bayer's appeal in the case of Bayer Schering Pharma Aktiengesellschaft v. The Attorney General of Canada. The case stems from May 2008, when the Commissioner of Patents refused to grant Bayer a patent to a pharmaceutical compound per se because a previous patent had already been issued to it for the same compound when made by a particular process (product-by-process patent). After Bayer's appeal to the Federal Court was dismissed, it appealed to the Federal Court of Appeal.

Bayer argued that "obviousness-type" double-patenting didn't apply to the situation at hand. However, the Federal Court of Appeal disagreed and dismissed the appeal, stating that:
[T]here is nothing inventive or "patentably distinct" in a claim for a product that is the subject of a previous process-dependent patent. On the other hand, a process-dependent patent may be granted, even though a patent has already been issued for the product itself, if the process claimed and described for making the product exhibits inventive ingenuity.

... Consequently, the Commissioner correctly denied the Application on the ground of "obviousness" double patenting because the patent would have disclosed no new invention. For her to have granted a patent for the compound would have improperly "evergreened" the parent patent, now expired, by creating a second monopoly in the use of the compound running from the date when the Application was approved.

This decision puts an end to any disparity in the jurisprudence, as the Federal Court of Appeal effectively overruled the decision in Aventis Pharma Inc. v. Mayne Pharma (Canada) Inc., 2005 FC 1183, 42 C.P.R. (4th) 481, rev'd. on other grounds, 2008 FCA 21, 380 N.R. 35.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Trade-Driven Changes Coming to Canadian Patent and Data Protection Laws? Canada-European Union Trade Negotiations

2011-02-18T11:10:00.000-05:00

Canada and the European Union (EU) are negotiating an intellectual property (IP) agreement, as part of a broader free trade agreement, which may have great impact in the pharmaceutical and related industries. The Comprehensive Economic and Trade Agreement (CETA) is potentially the most important Canadian IP treaty since the North American Free Trade Agreement (NAFTA).

Negotiations for trade deals differ from lobbying legislators, and results in areas such as data protection or patent term extension that could not be reached by legislation may be reached through treaty. The Canadian government, and perhaps the EU, are still open to submissions, and interested parties should consider communicating their interests before negotiators' positions crystallize. American companies should also consider whether the CETA will bolster their European competitors' legal and strategic position in Canada at their expense.

Intellectual Property and the Trade Negotiation Context

Different results from legislative change? Canada and the EU have been working towards the CETA since 2008. Preparatory documents clearly show both governments' intent that IP will be addressed in the final agreement.

The EU's initial negotiating position strongly supports its international pharmaceutical industry—primarily by requesting data protection and patent term extension—and has implications for the medical device and food industries as well. Generally, the Europeans are requesting that Canada adopt European standards.

Calls for Canada to adopt patent term extension and enhanced data protection, including pressure from the United States and Europe, are hardly new. So what is different this time? Why might this process result in substantive change where past efforts have failed?

First, treaty negotiation is different from domestic lawmaking. Domestic legislative change is often marked by interest groups competing to negotiate trade-offs in respect of a specific issue through government officials or interested legislators. In the trade context, states are negotiating over a broad range of issues through trade officials.

Put simply, Canada could trade an agreement on IP that satisfies European interests in return for agreement in a separate area that advances Canadian interests. Also, trade officials may give a particular subject area less weight than the officials directly responsible for that area—i.e., a trade official may regard patent and pharmaceutical regulation as simply one area among many that he has to balance, while an official responsible for drug approval may regard pharmaceutical regulation as of fundamental importance.

Interest groups still play a key role in the trade context by affecting—maybe even determining—what a state regards as its self-interest. In the past, industry representatives have sometimes been at the table with the trade officials during negotiations. However, the groups that influence a state's trade interests may be different from those that influence specific domestic issues. Years of building credibility, trust and influence with patent or pharmaceutical policy officials might be of little benefit when the key decisionmakers are trade officials. Trade officials' perceptions of domestic interests may differ from decisionmakers with responsibility for specific fields, and trade officials may be less influenced by interest groups perceived as "foreign."

Second, this is a negotiation with the EU. The EU is much larger and more influential than other countries with which Canada has recently negotiated free trade agreements.

If past behavior is a guide, the EU will aggressively pursue the interests of its international pharmaceutical industry, and has the negotiating clout to move Canada towards its positions. For its part, Canada seems intent on securing a deal "deeper and broader" than NAFTA, and may be willing to make significant concessions to reach agreement.

Third, it is 2010. Europe will be seeking concessions taking the present system as the baseline for comparison. A concession by Canada that may have been politically unacceptable in the Canada-U.S. Free Trade Agreement (CUSFTA) and NAFTA negotiations in the late 1980's and early 1990's may now be just one of many topics to be negotiated.

What's on the Table— the Initial Negotiating Positions

A review of the draft chapter on IP reveals that the EU is interested in addressing the entire range of IP topics, from copyright, patents, trademarks and designs to standards for enforcement and border controls, while Canada has minimal demands. The following are the topics on the table of the greatest interest to the food and drug industry.

1) Data protection
This is likely to be a contentious topic, and is one of the few areas where Canada has submitted alternative drafting language to accompany the European proposals.

Canada's data protection regime was amended in 2006 to provide for effective data protection for innovative drugs—"a drug containing a new medicinal ingredient not previously approved in a drug by Health Canada and not a variation of a previously approved drug." The regime gives eight years of exclusivity, and for the first six years a generic is prevented from filing an abbreviated submission—" 6 plus 2" years of exclusivity.

The EU position is that data protection should apply to "data submitted for the purpose of obtaining an authorization to put a pharmaceutical product on the market." In other words, the EU position would eliminate the innovative drugs qualification, and grant data protection widely. Canada, in contrast, would limit data protection to "new chemical entities" where the origination of such data "involves considerable effort."

The EU also wants to extend Canada's data protection regime to 8+2 years rather than the present 6+2. Data protection is to be extended to 11 years if the holder of the basic authorization obtains another authorization for new therapeutic indications of significant clinical benefit compared to existing therapies.

The Canadian position is that data protection should be a minimum of five years, and that "subject to this provision, there shall be no limitation on any Party to implement abbreviated approval procedures ... on the basis of bioequivalence and bioavailability studies." This would write into treaty a 1999 ruling of the Federal Court of Appeal allowing Health Canada to grant marketing approval for generics based on bioavailability and biosimilarity comparisons to the brand name drug within the data protection period as long as it does not explicitly "rely" on the protected data.

2) Patent term extension – supplementary protection certificates

Canada does not have patent term extension, whether tied to delays in granting patents or for delays in granting authorization for the marketing of pharmaceuticals.
Unsurprisingly, the EU would like Canada to implement patent term extension, tied to marketing authorization, through the granting of "Supplementary Protection Certificates." Canada has suggested no relevant language.

Whatever one thinks of patent term extension, the proposed European mechanism seems unrealistic—an extension for "the period that elapses between the filing of the application for a patent and the first authorization to place the product" on the market minus five years (to a maximum of five years). This seems ill-suited for the Canadian context, where there have been cases where the marketing approval comes after the expiration of the first relevant patent. Without the addition of a mechanism to reflect the diligence of the patentee in pursuing marketing authorization, the proposed language seems to be a free pass for applicants to dawdle.

3) Right of Appeal for Innovative Pharmaceutical Companies from Patented Medicines (Notice of Compliance) Proceedings

Canada has a patent linkage mechanism similar to the United States', where marketing authorization (a "Notice of Compliance" or NOC) is linked to relevant patents owned by the brand name company. Unlike in the United States, in Canada the proceeding to oppose the issue of an NOC is an application rather than an action, and a loss by the brand name company results in the immediate and irrevocable issuance of the NOC. As a result, while a generic company can always appeal from an NOC proceeding, a brand company effectively cannot appeal—the NOC irrevocably issues upon a loss, and further proceedings are moot.

The European proposal would oblige Canada to "ensure that the patent holders and the manufacturers of generic medicines are treated in a fair and equitable way, including regarding their respective rights of appeal." Assuming this means that patent holders should have an effective appeal route, it implies that Canada modify its NOC procedures to either delay the issue of an NOC until all rights of appeal are exhausted or allow an NOC to be revoked if a decision favourable to the generic applicant is overturned on appeal.

4) Data Protection and Patent Term Extension for Plant Protection Products

The leaked EU negotiating position also seeks data protection and patent term extension for "plant protection products," a European term for active substances and preparations that protect plants or plant products against harmful organisms.

If a test or study report is necessary for the marketing authorization of the plant protection product, the EU would like a 10-year period of data protection to apply, starting at the date of first authorization in Canada, to be extended to 13 years for "low risk" plant protection products. Canada's position is to grant data protection for agricultural chemical products identically to pharmaceuticals. The EU and Canada's positions on patent term extension are identical to that for pharmaceuticals.

5) Avoidance of Duplicative Testing

The EU proposals require rules to prevent duplicate safety or efficacy testing on vertebrate animals. Any applicant intending to perform such tests is required to verify that such tests have not already been performed, and if they have "the new applicant and the holder ... of the relevant authorizations shall make every effort to ensure that they share tests..." If no agreement is reached, the new applicant is still entitled to use the test data, but the holder of the authorization is entitled to "a fair share of the costs incurred by him."

6) Border Measures

An irritant in Canadian relations with the United States and Europe is Canadian border measures—measures designed to catch infringing goods at the border before they enter the stream of commerce. The EU is proposing language that would allow customs officials to detain goods suspected of infringing an IP right, either further to an application by a right-holder or on the customs authority's own initiative, even if such goods are merely in passage to another jurisdiction. For example, a drug or active ingredient brought ashore in Vancouver before shipping to the United States could be seized as potentially violating Canadian patent laws even if the product clearly does not infringe any United States law.

7) Right of Information

Rights-holders are often unable to trace counterfeit goods to their source or to detect where the goods have passed in commerce. The EU is proposing a "right of information" which is new to Canada and would provide a valuable new tool for rights-holders seeking to eliminate counterfeit goods.

This right would be applied against a person (a) who was found to be in possession of infringing goods or using infringing services or providing services used in infringing activities, or (b) a person indicated by a person under (a) to be involved in the production, manufacture or distribution of the goods or services. It obliges such a person to provide information on producers, manufacturers, distributors and previous holders of the goods or services as well as the intended wholesalers and retailers, and to disclose information on quantities and prices.

6) Geographical Indications

The EU proposes language to bolster protection for geographical indications― legal protections for marks that link products to a specific location of origin, such as Parma for ham or Champagne for sparkling wine. This is one of the few sections of the draft chapter that reveals sharp differences between the Canadian and European positions, with both parties submitting substantive language. The Canadian position is terse, affirming the parties' obligations under Trade- Related aspects of Intellectual Property Rights (TRIPs) Agreement and creating lists of European and Canadian products entitled to protection under geographical indications. The European position is several pages long, obliging the signatories to provide effective protection for geographical indications (including sections on rights of use, scope of protection and enforcement), and would establish an institution―a "joint committee"―to monitor compliance, share information and "intensifying their cooperation and dialogue on geographical indications."

7) A New Intellectual Property Institution

Finally, the EU has suggested the creation of a new institution (separate from that proposed under geographical indications) with a view to "supporting implementation of the commitments and obligations undertaken under" the IP chapter.

With no details provided, this is clearly subject to further negotiation. However, international institutions designed to monitor compliance, exchange information and promote ongoing dialogue have played a critical role in shaping the development of laws, regulations and international cooperation. Such an institution has the potential for driving IP developments long into the future.

Implications, and Spillover to the United States

In the longer term, an EU/Canada free trade agreement may raise an interest in the United States to come to the table to protect American interests. For example, investor protection mechanisms in CETA could lead to American companies being disadvantaged in Canada compared to their European counterparts. The usual solution is either to conclude an EU/Canada/United States agreement or to amend NAFTA to reflect the contents of the CETA.

Negotiations are ongoing with the next round set for July 12–16, 2011. Although discussions are reported to be going surprisingly well, government officials have indicated that they are still interested in feedback from concerned parties, and public scrutiny and criticism of the agreement is just beginning to occur. Companies in the pharmaceutical, food and related industries should monitor developments, consider communicating their interests to responsible officials and be prepared to take advantage of anticipated legal changes if the negotiations progress towards a conclusion.

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Federal Court of Appeal Upholds Data Protection Regulations

2011-02-12T11:10:00.001-05:00

On December 9, 2010 the Federal Court of Appeal dismissed the appeals brought by Apotex Inc. and the Canadian Generic Pharmaceutical Association challenging the validity of the Data Protection Regulations (referred to as DPR in the decision). These regulations implement Canada's obligations under the North American Free Trade Agreement (NAFTA) and the World Trade Organization's Agreement on Trade-related Aspects of Intellectual Property (TRIPS). Eli Lilly Canada Inc., and Canada's Research-Based Pharmaceutical Companies had intervened in the proceedings at the Federal Court, and were respondents in the appeal.

The appellants, in two separate proceedings, heard together at the Federal Court level, had challenged the Data Protection Regulations on a number of grounds, shortly after they came into force in 2006. The Federal Court decision, released on July 17, 2009, held that the regulations were valid as being within the regulatory authority under which they were created. The Federal Court also found that the regulations were within the constitutional authority of the federal government, as they fell within the federal Government's federal trade and commerce power. However, the Federal Court did not find that the regulations fell under the federal criminal law power.

In writing for the Federal Court of Appeal, Mr. Justice Nadon held that the Data Protection Regulations were properly within the authority of the Governor in Council, and were in clear accord with the enabling provision of the Food and Drugs Act. The Court held that "It is clear that the data which article 1711 of NAFTA and paragraph 3 of article 39 of TRIPS seek to protect is precisely the type of data in regard to which the DPR offers market protection, i.e. the data found in an innovator's NDS for an innovative drug." The regulations were held to be properly delegated by Parliament to the Governor in Council and held to be intra vires the Governor in Council.

In considering the constitutional issues, the Court of Appeal considered the purpose of the Data Protection Regulations, stating, at paragraph 114, that, "The true purpose of the DPR is not to balance the commercial interests of innovators and generic drug manufacturers, but rather to ensure that Canadians have reasonable access, at reasonable prices, to new safe and effective drugs. In other words, the Regulations as a whole encourage the research and development of new medicines that save lives, prevent diseases, heal and cure, and improve the health of Canadians, who can only benefit from the discovery and development of new medicines after the information and data generated in extensive pre-clinical and clinical trials demonstrate the "innovative drug's" safety and efficacy to the satisfaction of the Minister."

In commenting on the purpose further, at paragraph 117, the Court held that, "The pith and substance of the DPR is to implement article 1711 of NAFTA and paragraph 3 of article 39 of TRIPS so as to encourage the development of new drugs, a valid public health and safety purpose." In considering the constitutionality of the regulations, the Court held that their enactment was a valid exercise of the federal criminal law power contained in subsection 91(27) of the Constitution Act. Having found the regulations valid under the criminal law power the court held that it need not consider whether the regulations may also be upheld under another head of federal power such as trade and commerce. The Court also commented that the Data Protection Regulations do not encroach on matters of provincial jurisdiction, since the provinces have no role whatsoever to play with respect to the approval of the safety and effectiveness of new drugs.

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New Chinese Patent Law: What Does It Mean For Life Sciences Companies ?

2011-02-06T11:10:00.001-05:00

After more than three years of preparation work, the revised PRC Patent Law ("New Patent Law") was finally promulgated on 27 December 2008 and entered into force on 1 October 2009.
As a major emerging economy, China is striving to become an innovative country while facing major concerns such as accessibility to and affordability of medicines. The New Patent Law reflects this dilemma and thus the implementation difficulties are foreseeable.

Changes to the patent regime that will mostly affect life sciences companies are genetic resources based patent, compulsory licence, parallel import and bolar exception. This article describes and comments these significant changes.

Genetic resources

The New Patent Law has introduced for the first time a compliance requirement and a disclosure obligation for the application of patents based on genetic resources.

Firstly, Article 5 provides that no patent shall be granted if an invention is based on genetic resources obtained or used in violation of any laws or administrative regulations.

Where Article 27.2 of the TRIPS Agreement only provides that "Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality (...)", Article 5 sets out a general reference to "laws and regulations", which could seem to imply future more detailed laws and regulations on this matter.

Secondly, Article 26 of the New Patent Law requires the applicant to disclose and explain the direct and original source of the genetic resource. If the applicant is not able to disclose the original source, the applicant must provide the reasons.

This obligation is in line with and in advance of an international trend of introducing such disclosure obligations. For example, the Swiss patent law of 2008 includes such a disclosure obligation. In addition, 110 WTO members, including China, had proposed in the Doha negotiations in July 2008, to consider including a disclosure obligation in the TRIPS Agreement. The disclosure obligation is welcome at a same time for a better transparency in the access and benefit sharing of genetic resources, according to the Convention on Biological Diversity and the Bonn Guidelines on Access and Benefit Sharing. It is also believed that this disclosure obligation will improve the patent examiners' work.

However, Article 26 triggers many questions as to its implementation. How will the "direct source" and "original source" be defined? Which reasons would be acceptable for not disclosing the original source? Such questions may lead to implementation uncertainties and life sciences companies need to keep a close eye on them to ensure these requirements are complied with before they apply for a patent.

Compulsory licence

In addition to the circumstances of national emergency, extraordinary state of affairs, public interest or major technical progress of prominent economic significance based on a patent, which were already foreseen in the former patent law, the New Patent Law adds new grounds under which the Patent Office may grant a compulsory licence for patents.

Firstly, Article 48 provides that a compulsory licence may be granted when:
• a patentee fails to exploit or fully exploit his patent without any justifiable reason within 3 years of the patent grant date or 4 years of the patent application date.
• the patentee has been exploiting the patent rights in a monopolizing manner.
It is noted that the wording of Article 48 is vague which renders its application uncertain. At very least, definitions of "failure to exploit", "justifiable reason" or "monopolizing behavior" need to be provided to avoid any detrimental effects to patent holders.

Secondly, Article 50 provides that for reasons of public health policy, the Patent Office has the right to grant Chinese companies licences for patented medicines to be manufactured and exported to countries or regions with which the PRC has concluded related international treaties.
This provision implements the Decision of the Amendment of the TRIPS Agreement (2005) ratified by China on 28 November 2007, which reads that "the obligations of an exporting Member under Article 31(f) [according to which a compulsory licence shall only be granted for the supply of the domestic market of a Member] shall not apply with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) (...)".

Parallel import

The New Patent Law explicitly confirms that parallel import is not considered to be a patent infringement.

Article 69 of the New Patent Law provides that the use, offer for sale, sale and importation of patented products or products made from a patented method, which have been sold by the patent right holder or the entity or individual authorized by the patent right holder, shall not be considered as patent infringement.

Until the adoption of the New Patent Law, Chinese law did not contain such a provision. Without any legal basis, Chinese courts could inconsistently allow or condemn parallel import practices.
This provision provides clarification but is likely to further more affect the pricing of patented medicine made by foreign invested companies in China, because domestic companies have the right to import the products directly from another country where the price is more competitive.

Bolar exception

The Bolar exception has also been incorporated into the New Patent Law. Article 69 (5) provides that the manufacture, use and import of patented medicine or medical devices by someone other than the patent holder shall not be considered to be a patent infringement if such manufacture, use or import is solely for the purpose of obtaining administrative approval for the pharmaceuticals or medical device.

Unlike the EU Bolar exception clause, which literally limits the purpose of the Bolar exception to an abridged application process for generics, the Chinese Bolar exception may be applicable for new drugs.

Besides, it should be noted that China's drug approving authority, the SFDA, currently regulates that the applicant of a generic of a patented drug can only be accepted two years prior to the expiration of the patent. With this provision, the application of Bolar exception in China seems subject to a time limit.

The New Patent Law brings clarity to the former patent regime, but many terms which have been used remain to be defined.

As major emerging economies, China is striving to become an innovative country while facing major concerns such as accessibility to and affordability of medicines. The New Patent Law reflects this dilemma and thus the implementation difficulties are foreseeable.

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China Clarifies Principles and Rules of Patent Protection.

2011-02-03T11:10:00.000-05:00

New legislation was promulgated recently following the recent revision of the PRC Patent Law ("New Patent Law"). "Matching rules" will affect the initiative of patent right holders in patent infringement actions in China. More litigation is expected to be initiated by inventors in civil and labour disputes. Foreign invested companies have to negotiate their contract with their employees to mitigate the risk of litigation.

These new legislation includes the Interpretation on the Application of Law Concerning Several Issues in Handling Patent Infringement Disputes ("Interpretation") (effective on 1 January 2010) published by the Supreme People's Court, and more importantly, the revisions of the Rules for the Implementation of the Patent Law of PRC ("Implementation Rules") (effective on 1 February 2010).

I shall briefly present the Interpretation and the Implementation Rules and analyse the new elements they brought to the PRC patent regime.

1. Interpretation

Most of the guidelines in the Interpretation have already been widely implemented in practice in the past. The Supreme People's Court officially adopted these guidelines as judicial interpretation to support the implementation of the New Patent Law.

1.1 Guideline for damage calculation

Matching rules are adopted in damage calculation. The Interpretation expressly limits the "gains from infringement" to such extent as solely originated from the activities that infringe the rights of the patent right holder, suggesting a dichotomy between the infringer's gains from the infringing products and compensation amount.

1.2 Guideline for claim determination

According to Article 59 of the New Patent Law, the content of the claim determines the scope of protection of patent rights related to inventions or utility model. The Interpretation provides for the following rules:
(i) Free will of the patent right holder
The court shall allow the patent right holder to make changes to his claim(s) before the conclusion of the court debate of the first instance.
In addition, the patent right holder may also request to determine the scope of protection of patent rights based on a subordinate claim.
(ii) Doctrine of estoppels
If, during the course of examination or invalidation procedure, a patent applicant or patent owner abandons a technical solution by amending the claim or specifications or by making statement, the court will not uphold its allegation of rights on the abandoned technical solution into the scope of protection of patent.

1.3 Guideline for infringement determination

According to the Interpretation, the principle of literal infringement and doctrine of equivalence are respected.

The court shall examine all the technical features defined in the claim(s) asserted by the patent right holder in order to judge whether the disputed technical solution falls into the scope of patent. If such technical solution lacks one or several technical features as defined in the claim, or includes one or several technical features that are neither identical nor equivalent to that defined in the claim, it shall not constitute an infringement.

1.4 Indirect infringement

The Interpretation provides for the rules of indirect infringement which is not stipulated in the New Patent Law.

The use of a patented product as a component for the manufacture of another product as well as the sale of such manufactured product is considered as use of patent and constitutes patent infringement. However, for an industrial design, the manufacture of another product by using such industrial design product as one of the component will not be considered as infringement if such use is only limited to the technical function of such product instead of its industrial design.

Joint infringement may be constituted if the party which sells such patented product without authorisation of the patent right holder as well as the party which manufactures another product by using such patented product has jointly planned for such infringement.

2. The Implementation Rules

The revised Implementation Rules provide for detailed explanations and specifications to smooth the implementation of the New Patent Law.

The following key rules need to be taken into account:

2.1 Inventor or designer financial reward

The former implementing rules of the Patent Law provided that an inventor or designer of a stated owned enterprise was entitled to obtain financial reward for the patent of the technology or design that he or she had invented or made during the performance of his/her duty. However, no detailed rules were stipulated for other companies than state owned enterprises.

The new Implementing Rules extend the above provision to any type of companies, including private companies.

Unless otherwise agreed or excluded in the underlying contract (employment or services contract) or internal regulations of the company, the company shall financially reward the inventor or designer at least as follows:
• announcement: at least 3,000 RMB (invention) and at least 1,000 RMB (utility model or industrial design)
• exploitation of the patent: at least 2% of the annual operating margin (invention or utility model) or 0.2% of the annual operating margin (industrial design)
• licence: at least 10% of the royalties

2.2 Genetic resources

The New Patent Law has introduced a disclosure obligation for the application of patents based on genetic resources.

The Implementation Rules define, in Article 26, the following two important terms regarding the genetic resources stipulated in the New Patent Law:

• Genetic resources mean the materials obtained from human body, animal, plants or microbes, etc, which contain genetic functions and which have actual or potential value.
• Invention relying on genetic resource means an invention that utilises the genetic functions of genetic resources.

Moreover, the Implementation Rules specify that when a patent application is made for an invention relying on genetic resources, the applicant shall expressly disclose this issue in the application documents and shall fill out a specific form provided by the patent administration authority.

However, the Implementation Rules fail to clarify issues such as the definition of "direct source" and "original source" mentioned in the New Patent Law.

2.3 Compulsory licence

The New Patent Law stipulates situations which allow the patent authority to grant a compulsory licence:

• a patent right holder fails to exploit or fully exploit his patent without any justified reason within 3 years of the patent grant date or 4 years of the patent application date; or
• the patent right holder has been exploiting the patent rights in a monopolising manner.
According to the Implementation Rules, failure to fully exploit a patent would happen in the event the patent right holder or licensee's methods or scale of exploiting the patent cannot fulfil the need of such patent in China.

The New Patent Law provides that for public health purpose, the patent authority has the right to grant Chinese companies the licence to manufacture patented medicine and/or export them to countries or regions, with which China has concluded related international treaties. The Implementation Rules use the definition of pharmaceutical products in the TRIPS Agreement to define "patented medicine". The definition of "patented medicine" include necessary active ingredients and diagnosis kits to be used for making such patented medicine.

The main consequence of the above clarifications on compulsory licence is probably to give the Chinese government further bargaining power prior or during negotiation with the patent right holder on the exploitation of its rights and to encourage generic companies to apply for grant of a compulsory licence.

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Patent Filing and Protection in China

2011-01-31T11:10:00.000-05:00

As one of the largest filers of PCT national stage applications in the world, inovia often observes firsthand global trends occurring in the foreign filing industry. One noteworthy development in the past decade is the emergence of China as both a major source and destination for patent applications. For instance, China was the top national stage entry country in 2009 among our clients, surpassing Europe for the first time in our history.

Why File in China?

This is a common question we field from our clients. After all, applicants have historically associated China (and by extention perhaps other BRIC countries) with lax IP law enforcement, and many wonder whether patent protection there is worth the expense of its pursuit.

To aid in changing this global perception, China passed the Third Amendment to Chinese Patent law, effective October 1, 2009. The Third Amendment significantly strengthens protection of patent rights, including increasing infringement penalties, granting officials the authority to conduct investigations and patent infringement raids, and establishing an evidence preservation system. These new laws, along with the recognition of China as a commercial and industrial behemoth, help explain the surge of applicants seeking patent protection in China, even during these troubling economic times.

Increased Patent Applications Originating from China

Increased awareness of the need for IP protection and an environment fostering innovation will also designate China as a leading source of patent applications. In 2008, the top PCT patent filer worldwide was Huawei Technologies, a Chinese telecommunications company, with 1,737 applications. The next year, they were surpassed by another Chinese telecommunications manufacturer, ZTE Corporation, which filed 1,164 applications. Coincidentally, the one millionth PCT application was one filed by a Chinese corporation. Needless to say, we expect China's PCT momentum will only continue for the coming years.

China's IP Goals for 2010

I have previously blogged about the emergence of China as a leader in patent filings.

Recently, 28 members of the Ministerial Joint Meeting on National Intellectual Property enacted the 2010 National Intellectual Property Rights (IPR) Strategy Implementation Plan. Serving as a guide for China's IP protection program, the 2010 Implementation Plan focuses on the following objectives:

• Elevating IPR creation capability
• Spurring IPR transformation and utilization
• Quickening IPR legal system construction
• Raising IPR law enforcement levels
• Enhancing IPR administrative management
• Exploiting IPR agency service
• Strengthening IPR talent construction
• Boosting IPR cultural building
• Enlarging IPR foreign exchange cooperation

Further details regarding the 2010 Implementation Plan can be found on the China IPR website.

On a related note, April 1, 2010 marked the 25th year since the birth of the Chinese Patent Law. In those 25 years, the Chinese Intellectual Property Office has received 5.95 million applications and granted over 3.17 million patents.

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The 2011 drug patent ‘cliff’: The Evolution of IP valuation.

2011-01-20T07:36:00.004-05:00

On the pharmaceutical front, many companies are diversifying their portfolios in anticipation of waves of patents ready to expire beginning in 2011.

In today’s global economy, there is an increasing convergence of intellectual property and finance. Wall Street is grappling with how, exactly, to recognise the true value of a firm’s intellectual property, even as an increasing share of the market involves intangible assets. Companies are also realising that simply accumulating patents does not necessarily increase their firms’ value, but it is how those patents are used that can attract capital.

Meanwhile, to combat global efforts to contain healthcare costs and massive numbers of upcoming patent expiries, a deflated economy and other market pressures, more drug companies are looking to diversify their portfolios to stay in the black.

Drug Diversification-

On the pharmaceutical front, many companies are diversifying their portfolios in anticipation of waves of patents ready to expire beginning in 2011.

The 2011 “patent cliff” is expected to erode $78 billion in global sales from brand drugs made by companies such as Merck, Teva and Mylan with patents set to expire anywhere from 2010 to 2014. Another $32 billion will be lost from continued erosion of already expired brands. Other factors expected to limit sales include price cuts, reimbursement restrictions, healthcare reforms and growing regulatory pressure to contain costs.

Consultants report that 57 percent of 2008 global pharmaceutical sales will be going off-patent within the next here years, and 75 percent within the next five. A majority of the top industry CEOs interviewed believe diversification – acquiring generic and consumer health companies, for example – is a way out of the crisis facing the industry after a prolonged focus on strategies focused on patent-protected, high-margin products.

To cope with these expected losses, drug companies are considering measures such as manufacturing more generic drugs and/or vaccines and focusing on more specialty care areas. Some companies also hope to make strides in specialist secondary care via the production of biologic therapies in the United States and Europe that could treat diseases such as rheumatoid arthritis and Alzheimer’s. Biologics are expected to grow by $41 billion between 2009 and 2014.

Novartis, for example, plans to cut costs and further diversify its portfolio as it prepares for patent losses on some of its most popular drugs: Diovan for hypertension; cancer drug Gleevec; and hypertension drug Lotrel. The Swiss company has 142 pharmaceutical projects in the pipeline and plans on bringing to market more biosimilars – similar versions of branded biologic drugs that can be sold at lower costs – via its generic division, Sandoz. It also will produce more generic drugs, eye care products, vaccines and diagnostic products. And it plans to strengthen its commercial position in rapidly growing markets in China, Russia, Brazil and India.

“Novartis remains committed to the core strategy of focused diversification in high-growth healthcare segments” as reported in company sources. Meanwhile, German drug company Bayer is cutting costs and jobs to redirect finances toward investments in developing and marketing pesticides and genetically modified seeds and focus more on emerging markets in Asia. US-based Merck’s growth strategy includes new and mature products, including branded generics and other products through local and regional partnerships or acquisitions.

In 2012, its patents for asthma treatment Singulair and two other drugs expire, with patents for popular drugs such as Propecia, Nasonez, Zetia/Vytorin, and the NuvaRing delivery system set to expire by 2018. But a spokesman stated that the company is “uniquely positioned to outperform the broader healthcare market and create value” because of its broader portfolio of medicines and vaccines, greater geographic footprint in key markets, its strong late-stage pipeline and research organisation, and an efficient customer-centred commercial model.

IP Investment Trends

Many investors are also looking to firms that have well-positioned IP in their portfolio, instead of those that simply accumulate patents. The IP needs to be clear of any risk of infringing on someone else’s product, and it needs to be able to be enforced. Accumulated patents must also be assembled in a logical way that creates something bigger that has the potential to open up new markets.

“A firm and its management which take the time … effort and care to develop strong patents” by working with patent agents/ attorneys, technologists and investing in strong legal filings, signals that the firm is likely a good investment. Patent counsellors work with clients to help them design or improve business processes relating to their IP using patent analytics and database systems.

Particularly in the area of clean technology, there is currently a tendency for investors to be wary of weak IP positions – a view many also take when it comes investing in high-margin biotechnology businesses. Around $13.6 billion in venture capital dollars has been invested in the last five years.

“If you don’t have IP to keep everyone away, then you have nothing” and “You have to have 100 percent assurance … you can stake out your territory” and enforce a patent if necessary. This is particularly important in high-cost industries. “It’s not a question of whether the economy is good or bad, it’s a question of, ‘if I’m going to put $1 million in that company, are there going to be returns?”

There is a distinct relationship between IP and success in capital markets. Companies with solid patent portfolios that managed them well instead of just filing for patents – a process which can be very costly, particularly if the patent does not fit well into a firm’s broader business strategy – were most successful in attracting investment.

There are three key questions an IP holder should ask when determining how to use his or her IP-

• How good and useful is the underlying invention
• How well has that invention been captured in legal documents and is the patent itself strong enough to ward off potential infringers; and
• What is your strategy for extracting the value of the patent.
• If a company is assembling many patents, how do you build them in a way that they have the most value?

My observation, being in this field for over a decade is that “The above cited basic techniques have really just been developed over the last few years”. Those techniques – used to assess the strategic value of a firm’s IP – are now being used by some companies during mergers and acquisitions (M&A) screening.

Firms are looking at who has the best IP, how it is managed and how it fits strategically with what the firm does. Those in charge of M&A are essentially including IP earlier in their due diligence process when considering taking over or merging with other companies than they have done historically.

Technology & services – like that offered by Innoworks Canada Limited (URL www.Innoworksltd.com ) – is increasingly enabling more efficient IP screening processes. These assessments are growing in importance nowadays, so much of a company’s value or market capitalization is not in tangible assets.

Firms have “historically taken the view of intellectual property towards the end of process if at all and what we see is that an increasing number of companies do, is move that perspective or data point forward in the process, rather than looking at just market share and values.”

Meanwhile, Wall Street is still grappling with how exactly to valuate intellectual property, particularly when it comes to the growing market of intangible IP. Current US accounting rules do not allow firms to record their patents and intangible IP on their accounting statements until that company is involved in an acquisition transaction with another firm. Yet the cash and intangibles asset categories are increasing on companies’ balance sheets as tangibles like equipment and real estate are decreasing, particularly in today’s sour global economy.

There’s a different perspective these days on where the value is in the business and with intangible assets representing about 81 percent of the S&P 500 market in 2009, according published reports, that is a large percentage of unaccounted for value.

Meanwhile, the Intellectual Property Exchange International (IPXI) – the first financial marketplace for the trading of patent rights – is scheduled to begin operating at the beginning of next year. The IPXI will work similar to an emissions trading cap and trade system, but without a ceiling of patent rights allowed to be exchanged. IPXI leaders have been in talks with some of the largest IP owners in the world on the design of the system.

Patent Trolls

Patent trolls – companies or individuals that buy up patents not to use them to innovate but for the sole purpose of enforcing them, also called “non-practising entities (NPEs)” – have traditionally been considered a costly nuisance to technology companies like Microsoft, Apple, Google, Verizon Wireless, but now, some also are perfecting the business model of patent enforcement – and it seems to be paying off. NPEs are essentially monetising their assets – the patents – without any accompanying innovation. Instead, they attempt to force perceived infringing companies into licensing agreements.

As of April 2010, there were over 325 NPEs identified. Since 1985, NPEs have been involved in litigation with nearly 4,500 different operating companies in more than 3,100 actions; nearly 75 percent of the lawsuits were filed since 2003 alone and some have been successfully into negotiating $ 612 million in settlement.

I look at these NPEs … as a catalyst for the marketplace but believe them to be relatively small and expect them to remain relatively small. They are high-profile examples of the value of individual patent rights. Plus, NPE actions bring more attention to the prospective value of the IP portfolio of those companies being pursued. It’s bringing some recognition to IP as a valuable asset.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

By, Dr.Shruti Bhat, specialist with Hitech Formulations and Life science Patent Expert.

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United Kingdom: Patent Box

2010-12-31T11:05:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data.

a. The Chancellor, Alistair Darling, announced in the Pre-Budget Report on 9 December 2009 that he plans to introduce a so-called "patent box" which would give a favourable tax treatment to income derived from patents.

b. This new regime is part of a drive to make the UK more attractive to high-tech companies. It is hoped that the patent box will encourage these companies to locate their research and development ("R&D") functions in the UK to take advantage of the change which will be introduced in April 2013.

c. A new 10% corporation rate will be applied to patent income from April 2013. It appears that the new tax rate will apply to income derived from patents which have been granted after the new legislation comes into force. The Government believes that the new tax rate, when taken alongside the UK's relatively low main corporation tax rate and other innovation-focused tax reliefs (i.e. the R&D tax credits regime) will ensure that the UK remains an attractive location for high-tech companies.

d. The Government has stated that the patent box has a necessarily narrow scope so that it is focused on areas where the UK has competitive strengths. Therefore only patents are included in the regime, rather than any further intellectual property rights. This is in contrast to a number of other jurisdictions (e.g. Switzerland, the Netherlands, Belgium) which have introduced similar proposals.

e. The Government discussed issues surrounding tax and innovation at the Business-Government Forum on Tax and Globalisation in June and October 2009. HM Treasury has also published communications with forum members (http://www.hm-treasury.gov.uk/tax_and_innovation.htm ).

Benefits for companies-

a. GlaxoSmithKline ("GSK") has just announced that it plans to create 1,000 new jobs in the UK and has cited the new patent box tax rate as a driving factor behind the decision. GSK believes that the patent box will transform the potential of the UK to attract new investment in the life sciences sector.

b. Commentators, such as the Bio Industry Association, have said that the patent box will be a real incentive for companies to exploit intellectual property in the UK which has been developed in the UK.

c. The Government believes that the patent box will strengthen the incentive for investors to invest in innovative industries. If the patent box is successful in attracting new business to the UK, this could result in a much needed boost and may assist in tackling the UK's budget deficit.

d. With the UK bringing in higher tax rates in areas such as income tax, and with VAT having reverted back to 17.5%, a lower corporation tax rate for specific income will be seen as a positive step.

e. It is thought that the patent box will encourage new growth in the bio sciences sector and other industries that rely on intellectual property, and patents in particular. The Chancellor has stated that he wants to encourage growth in these areas and to take advantage of the innovation and ingenuity which we have in the UK.

Future plans

The Government has said that it will consult widely with business on the design of the patent box which will enable relevant legislation to be included in the Finance Bill 2011. The UK software industry in particular may wish to make a case for extending the patent box to include other intellectual property rights, given the difficulties in obtaining patent protection for software in Europe.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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United Kingdom: Deadline for Filing of Divisional Patent Applications

2010-12-30T11:05:00.000-05:00

Counter-Generics Strategies to Defend Patents Require Flexibility

2010-12-28T11:05:00.000-05:00

According to the new study, Countering Generic and Biosimilar Threats: Near-Term and Long-Term Strategies, Top 10 pharmaceutical companies attempt an average of 5.4 counter-generics tactics per brand. The next 15 top drug companies average five specific counter-generics approaches per brand, and the remainder of the industry's Top 50 companies attempt 4.2 strategies. Smaller drug companies outside the Top 50 employ fewer strategies per product on average.

The ability to deploy more brand-preservation strategies helps larger companies fend off generic competitors. "Companies need to plan and allow time for a diverse range of counter-generics strategies," said Jason Richardson, president of Cutting Edge Information.

"Brand leaders need to make these considerations while there is still sufficient time before market exclusivity ends to be thoughtful," he said.

Defense Strategies Must Include Short and Long Views-

Efforts to extend patent protection do not always deliver hoped-for results, as extensions rely on trial success and regulatory approval. Shorter-term strategies such as pricing, counter-promotions and patent litigation may require less time and money, but they only delay revenue erosion for a relatively brief period of time.

"The direction of a successful lifecycle management strategy is often driven by its market and competitive landscape," said Ryan McGuire, author of the study (http://www.cuttingedgeinfo.com/counter-generics ).

"Small companies don't often have the blockbusters in their portfolio that generic companies most frequently target. Therefore, only a few tactics may suit a small company's brand team as it approaches patent expiration."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Translates innovative concepts to PROFITS.
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New Zealand: Prior Art Searching: The Importance Of Due Diligence In R&D Processes

2010-12-26T11:05:00.000-05:00

Comvita was granted a $1m set-off from the $2m amount owed to WL under the agreement. Justice Harrison commented that with hindsight Comvita had not taken the necessary steps to protect itself in terms of conducting its own preliminary due diligence.

This need to conduct thorough prior art searching will become more critical in the future because of changes to patent laws that will take effect once the new Patents Bill is enacted in early-mid 2011. The Bill will make significant changes designed to provide greater conformity with aspects of the Australian and United Kingdom patents legislation.

One of the significant changes proposed in the Bill is that the standard of "local novelty" in determining what is relevant prior art for assessing patentability will be replaced with an "absolute novelty" standard. Whereas currently the novelty of an invention is determined by what is known (published or used) in New Zealand prior to the priority date of a patent application, under the Bill the novelty threshold will be widened to what is known worldwide prior to the priority date.

A further proposed change of the Patents Bill is that examination of a patent application will include a consideration of inventive step and usefulness, as well as novelty. Currently examination is conducted on the basis of novelty only, but the claims of an accepted patent have to be inventive for the patent to be valid. Whereas novelty is determined by whether the proposed invention has at least one new feature over similar technology, inventive step is assessed on whether the proposed invention is an obvious modification of known technology, even if novel. This higher inventive step threshold will make examination more rigorous and therefore place greater emphasis on carrying out due diligence prior to filing a patent application.

Preliminary searching conducted in-house using one or more of the online patent office databases is strongly recommended before committing to more exhaustive commercial searching conducted by a patent attorney. The time and cost spent understanding the prior art may prevent you from conducting redundant R&D and/or proceeding with patent filings where protection will not ultimately be obtained, or protection obtained is weak or unenforceable and therefore of little commercial value.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Mexican Supreme Court Decides on Broad Interpretation of Linkage Regulations.

2010-12-24T11:05:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data.

Back in 2003, Mexico enacted linkage regulations to avoid the granting of marketing authorizations in violation of patent rights. The system created by these regulations is far less elaborate than the one set forth by the Hatch-Waxman act in the U.S., as there is no extension/term restoration, and there is no possibility for Paragraph IV-type applications. This system was intended to be simple: two provisions were added to the health and IP law regulations establishing that the Mexican Patent Office (IMPI) is bound to publish a specific gazette every six months, listing those patents in force that cover allopathic drugs. The regulatory authority (COFEPRIS) has to observe the patents listed in this gazette, request information from IMPI if necessary, and deny applications for marketing authorizations which would invade patent rights.

Nevertheless, controversy arose from the moment the provisions were enacted. IMPI immediately stated that the linkage benefit would only be applicable to patents covering active ingredients per se, and therefore formulation patents were not to be listed nor observed by COFEPRIS. Thus, the first gazette was published including only active ingredient patents.

R&D Pharma companies decided to challenge this criteria through individual constitutional actions before Mexican District Courts, arguing that a correct interpretation of linkage provisions should cause for all pharmaceutical product patents to be published. Most courts agreed on this, resulting in over 40 decisions in favor of patent holders over a period of six years. The vast majority of these cases were handled by the Mexican IP Firm Olivares & Cia.

As two Circuit Courts issued opposing decisions, indicating that the linkage system was indeed limited only to active ingredient patents, the case was brought to the attention of the Mexican Supreme Court, which recently made its decision public.

In a closely contested 3-2 decision, the Supreme Court determined that product patents, including those covering pharmaceutical formulations are to be included in the Gazette. The Court also made reference to the co-related obligation by COFEPRIS to observe these patents.

Even though this decision is only mandatory for Courts, and not for administrative authorities, we expect that both IMPI and COFEPRIS will observe it, which is a step in the right direction for a strong IP system in Mexico.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Mexican Patent office excludes formulation patents from Link gazette-

2010-12-23T11:05:00.001-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data.

The Mexican Trademark and Patent Office (IMPI) made available through its website the new edition of the Linkage Gazette (Mexican health and IP law regulations require IMPI to publish a gazette every six months listing patents in force that cover allopathic drugs). Regrettably, IMPI decided to exclude formulation patents, limiting the inclusion criteria to compound patents. There are formulation patents included in the list derived from individual Court orders in litigation proceedings where the non-inclusion of specific formulation patents in the Gazette was contested.

The current non-inclusion of formulation patents disregards a petition by the Pharmaceutical Association of R&D companies (AMIIF), and does not follow the jurisprudence of the Mexican Supreme Court ruling that formulation patents are to be included in the Linkage Gazette (see "Mexican Supreme Court Decides on Broad Interpretation of Linkage Regulations").

Legally, as an administrative authority, IMPI is not bound to follow judicial precedents; nevertheless, there is broad dissatisfaction with the political decision taken by IMPI regarding the denial to include formulation patents in the Linkage Gazette, since following the Supreme Court's criterion would have avoided further litigation from patent holders.

The non-inclusion of valuable formulation patents can be contested within the next fifteen working days. Any litigation proceeding at this point will benefit from Supreme Court precedent, which is mandatory for District and Circuit Courts and provides guidelines to decide these cases.

Of course, inclusion of formulation patents in the Linkage Gazette provides grounds to prevent or challenge marketing authorizations granted to third parties in violation of formulation patents which in many cases have expiration dates beyond the initial compound patent.

Additionally, inclusion of formulation patents is pivotal, as the formulation of drugs is reviewed by the Regulatory Authority (COFEPRIS) upon studying applications for marketing authorizations. Since safety and efficacy of a drug reviewed by COFEPRIS is not limited to compounds, there is no rationale to limit the linkage regulation to compound patents by the linked authorities (IMPI and COFEPRIS), particularly when the highest Court in México has decided that formulation patents for allopathic medicines including an identified compound should be included in the Gazette.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Is ‘hybrid model' a good long-term strategy for drug-makers?

2010-12-21T11:05:00.000-05:00

Company heads will have to “manage” their hybrid models against the backdrop of the optimism that the market reveals in terms of innovative products driving growth, said Mr Sameer Savkur, IMS Managing Director, in India.

Generic medicines are not covered by patents, while innovative drugs enjoy patent-protection, or market exclusivity for 20 years. The next five years will see $ 94 billion impact from the loss of exclusivity, and a $ 89 billion impact from new launches. The next five years will see reduced impact of $ 66 billion due to loss of exclusivity, and an increase of $ 271 billion from the new products launched in the previous five years, the study said.

In the Indian market, the hybrid model is illustrated by Japanese innovative drug-maker Daiichi Sankyo's acquisition of generic drug company Ranbaxy or the more recent acquisition of Piramal Healthcare's domestic formulations business by Abbott.

Optimistic-

Giving a “more optimistic than expected” outlook – the IMS study projects that the pharmaceutical industry is headed to clock $ 1 trillion in 2020, on the back of a renewed pipeline and growth in the pharma-emerging markets, among other things. The study also shows a healthy pipeline of products across 41 focus categories including oncology, diabetes and HIV, a contrast to the gloomy picture that industry often paints.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Drug Manufacturers -- How Will Expiring Drug Patents Affect Companies in the Healthcare Sector

2010-12-20T11:05:00.000-05:00

Big pharma kisses its blockbuster years goodbye.

2010-12-18T22:45:00.002-05:00

In 2009 Lipitor topped the best-selling prescription drug charts, generating $5.7bn in sales in the US and an additional $5.7bn outside the US. These revenues ultimately come from the drug's active ingredient, atorvastatin.

Lipitor is what is known in the industry as a classic "blockbuster drug". The problem for Pfizer is that next year the patent to exclusively produce and sell Lipitor expires. This "coming off-patent" process will allow other companies to produce and sell generic copies of Lipitor, and it will take a hatchet to Pfizer's revenue stream from the drug.

Pfizer's pharmaceutical peers Sanofi-aventis and Bristol-Myers Squibb are facing a similar "generic erosion" of their widely used anti-clotting drug Plavix which comes off-patent next year.

But the real issue for the sector is that Lipitor and Plavix mark the start of a coming avalanche of expiring patents of blockbuster drugs over the next few years, known colloquially as the "patent cliff".

Some estimate that, over the next five years, drugs currently generating $142bn in sales annually will lose patent protection. The investment management firm AXA Framlington, meanwhile, has said that the leading pharmaceutical companies will lose between 14 per cent and 41 per cent of their existing revenues because of patent expiries.

And, despite record levels of investment in research and development by the big pharmaceutical companies, there appear to be few similar blockbuster drugs in the pipeline to plug the gaping revenue hole.

At a time when the world's population is getting bigger, older, and more likely to take prescription drugs, it seems counter-intuitive that the $518bn pharmaceutical sector could be entering an era of declining revenues and profits, however, it is a real possibility. The sector is preoccupied with its own evolution; and, as this analysis shows, the challenges, and potential risks and rewards, are immense.

Is the 'patent cliff' hype?

The "patent cliff" is the chief challenge facing the industry, although some companies will be affected more than others. Patents can sometimes be extended by making slight changes to the chemical composition, for example – a process called "ever-greening".

However, some analysts argue that the search for new blockbuster drugs is not good value for money. PricewaterhouseCoopers (PwC), in its report Pharma 2020: The Vision, says that industry leaders' revenues "have come at a very high price". It notes that between 1985 and 2000 the industry's market value increased 85-fold, outpacing the stock market as a whole. But in the six years to 30 March 2007 the FTSE global pharmaceuticals index rose just 1.3 per cent, while the Dow Jones World Index rose by 34.9 per cent. Additionally, it says that only five of the top companies worldwide generate more than 10 per cent of their revenues from products launched since 2001. "Even allowing for inflation, the industry is investing twice as much in R&D as it was a decade ago to produce two-fifths of the new medicines it then produced," it says.

Where will all the new drugs come from?

"The number of new medicines is at an all-time low and is as low as it has been since the Second World War," says Professor Clive Page, chairman of Verona Pharma.

The small biotech company is working on three drugs that alleviate symptoms of hayfever and chronic respiratory diseases, and is emblematic of the new breed of companies providing the innovation and stream of drugs that will feed the big pharma companies' supply chain.

Smaller start-up companies have lower costs, smaller teams, more efficient working processes, high scientific expertise and the ability to recognise and produce new molecular entities that could become tomorrow's breakthrough drugs. But it is the big pharma companies that have the financial might to buy or license new drugs and take them through the often expensive second and third phases of testing, with the aim of producing a viable commercial drug at the end.

Kevin Johnson, chief executive of PanGenetics, which last November sold an experimental drug for the treatment of chronic pain for $170m to Abbott Laboratories, says: "In my view, it is easier to develop a drug in a small company, at least in the early stages. From there the balance of power shifts; when you get to the later stages of testing the big companies are the right ones to do that. It is about playing to relative strengths".

Can the small companies provide these drugs?

Securing finance is difficult for any start-up business and particularly tricky in the field of science. Experimental drugs, by their nature, are risky and can fail; scientific discovery can be lengthy, expensive and difficult to explain to a financial backer looking for returns on equity and financial performance. The sector has also had a bad reputation for promising more than it can deliver.

This is why Francesco De Rubertis, a partner at the venture capitalist Index Ventures, says the developing division of labour between the big pharma companies and the biotech sector, and emerging collaborations with big academic institutions, should be encouraged. "A new equilibrium has to be reached. We are not there yet but in the long term I am optimistic," he says.

Said Darwazah, chief executive of the FTSE 250 pharmaceutical company Hikma, says the changing nature of the business is not surprising: "Why should a scientist work for £100,000 a year in a big pharmaceutical company when he can set up on his own, do exactly the same work, create a new product and sell it for £100m?"

Smaller companies also tend to be more businesslike about killing projects that don't work, says Professor Page. "In small companies, people don't have pet projects that they keep throwing money at."

Is finding new blockbuster drugs the only option for big pharma?

Discovering new drugs is not the only answer for the sector as there are new frontiers opening in emerging markets such as China, Turkey, the Middle East and North Africa.

Tim Edwards, chief executive of Cellzome, which is producing chemical proteomics technology that identifies new drugs to treat inflammatory diseases, comments: "The emerging markets could produce revenue which could be equal to the revenue streams lost from drugs coming off patent."

Kevin Johnson of PanGenetics adds: "One half of the merger and acquisition dollars that have gone into acquiring companies has been in the emerging markets sector."

Many companies that previously focused on branded products are also looking to tap into the growing generic drugs market by setting up their own generic-drug producing and licensing arms.

Regulatory environment-

Regulatory bodies and the large consumers of drugs, such as the NHS and health maintenance organisations in the US, are playing an increasing role in influencing the actions of pharmaceutical companies. As budgets are cut and healthcare reform gets under way many are buying or recommending only drugs that have a proven record and are cost-effective.

It is a contentious issue which was played out again last week as the storm continued over Roche's new bowel cancer drug, Avastin. The UK's healthcare cost agency – the National Institute for Health and Clinical Excellence (Nice) – has rejected the drug again, saying it is too expensive despite the manufacturers having offered new terms. Andrew Dillon, chief executive of Nice, said: "We have to be confident that the benefits justify the considerable cost of this drug."

Steve Arlington, a partner at PwC, says the "payer agenda" is "much more powerful now than ever before". He says the industry has to participate in the debate on healthcare funding and demonstrate the value of its products.

So is it all doom and gloom?

At $518bn, the size of the pharmaceutical industry is still significant; it could grow to between $800bn and $1.3trn by 2020.

Global census figures suggest that future consumer demand could be strong. The United Nations projects that the world's population will grow from 6.5 billion in 2005 to 7.6 billion by 2020. Of that, around 719.4 million, or 9.4 per cent, will be 65 or older – up from 477.4 million two years ago.

The "grey factor" boosts the need for medicines dramatically, with the UK Department of Health stating that four in five people aged over 75 take at least one prescription product, while more than a third take four drugs or more.

PwC says that diseases once more usually associated with developed countries – such as hypertension (high blood pressure) and diabetes – are also increasing in developing markets. It says that in 2004 there were 639 million people in the developing world with hypertension, a figure that is forecast to reach one billion by 2025.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com/
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Translates innovative concepts to PROFITS.
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IP Australia Tightens Rules for Divisional Applications

2010-11-18T23:14:00.002-05:00

IP Australia, in line with reviews in other jurisdictions, is seeking to address concerns around certainty of patent rights arising from the filing of divisional applications, particularly where divisional applications are filed with identical or substantially identical claims to those originally filed in the parent application(s).

IP Australia is addressing this problem through changes to 'case management' practice rather than any legislative changes. Effective October 1, 2010, the following practice will be implemented in stages:

• Requests for examination of all divisional applications will be expedited by early issuance of examination directions.

• Where grounds for objection exist, a first adverse examination report will issue in the normal way.

• However, where a ground of objection is substantially identical to a ground previously raised in relation to the parent application and not addressed by substantial amendment or written submissions, the report will, in addition, give notice to the applicant that if no response is filed within two months of the report overcoming the ground of objection, the Commissioner will consider whether to direct amendment of the application or proceed to refuse the application.

• If a response overcoming the objection is not filed within that period, IP Australia will contact the applicant or their attorney and discuss the case before setting the matter for hearing according to established practice. Where the matter is the subject of a hearing, the hearing officer will consider all grounds of objection whether raised previously or not. Where a ground is capable of rectification a reasonable period for the applicant to overcome that ground will be provided. An appeal to the Federal Court of the hearing officer's decision is available under existing legislation.

This last change is expected not to affect divisional applications considered to be in respect of "genuine" different further inventions.

As there have been no legislative changes, the two-month deadline does not override the normal twenty-one month period available for obtaining acceptance of a divisional patent application. However, the new expedited approach to prosecution will force applicants to resolve any outstanding issues more quickly.

The changes will have a number of practical implications for patent applicants. It will be more difficult to delay prosecution by re-filing an application as a divisional application. Further, the strategy of filing divisional applications in order to reserve options in relation to activities of potential infringing competitors will now be severely curtailed - though alternative strategies are available and should be discussed with your patent attorney. On the positive side, applicants wishing to expedite the prosecution of their application may find the filing of a divisional application attractive. Finally, applicants will need to be aware of the potential for a hearing before IP Australia and the additional costs involved should the objections that are raised during prosecution not be resolved.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Australia: Not All Patent Protection Is Equal - Beware IP-Related Scams

2010-11-14T23:28:00.004-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design.

Shruti brings to you some highlights from current pharmaceutical and clinical research news, views and data.

Recently, there has been an increase in so-called "scams" involving apparent IP-related companies sending misleading letters to applicants and owners of IP rights in an attempt to extract money from those persons. A number of official intellectual property organisations, including the World Intellectual Property Organisation (WIPO), have recognised this issue and distributed warnings against these scams.

Often these scam letters take the appearance of invoices requesting the applicant/owner to pay for services that are essentially worthless. Examples include offers or invoices for registering patents or trade marks in international registers and offers for patent and trade mark monitoring services.

These companies obtain their targets' details from official registers where details of their patent, trade mark or application are published, often together with the applicant/owners personal details. The companies use e-mails, fake websites, faxes and telephone numbers to give the appearance of a legitimate IP-related organisation.

In a recent example, late last year, a Florida-based company had been found to have violated the state's Deceptive and Unfair Trade Practices Act by sending misleading invoices requesting payment for essentially worthless IP-related services. This company, trading as "Federated Institute for Patent and Trademark Registry", was found to have distributed misleading invoices to patent and trade mark applicants, including applicants of international Patent Cooperation

Treaty patent applications:

This victory is a small step towards combating this deceptive practice. However, recently, WIPO has witnessed a rise in the number of IP related scams. IP Australia has also advised that they occasionally receive notification of similar instances.

To combat this issue, if you are an owner or applicant of a patent or trade mark, you should question correspondence from unfamiliar organisations offering services such as those mentioned above. Typically, the only organisations sending IP-related correspondence to applicants/owners of IP rights should be their legal representatives such as patent or trade mark attorneys, the official intellectual property offices such as WIPO and IP Australia, and Computer Patent Annuities (CPA), which is an organisation involved in managing renewal fees for patents and patent applications.

If you are unsure of the origin or intention of a certain piece of correspondence, particularly if that correspondence requests money, you should contact us to ascertain the legitimacy of the party concerned.

IP Australia and WIPO have issued lists of companies reported to have distributed unsolicited communications. The WIPO list also includes examples of the misleading correspondence sent by each listed organisation. These lists can be found at the following addresses.

http://www.ipaustralia.gov.au/factsheets/unsolicited_ip.shtml
http://www.wipo.int/pct/en/warning/pct_warning.htm

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Italy: Disclosing Generics Applications : AIFA Heading For Greater Transparency?

2010-11-11T23:59:00.004-05:00

The Italian Medicines Agency (AIFA) has issued new guidelines on its future policy on the disclosure of generics (Gxs) applications.

AIFA stated that "further to consultations with Italian and European institutions, as well as the industry and the Italian courts" (presumably the Italian administrative courts where cases were recently brought by leading pharmaceutical companies), AIFA has decided to change the procedure whereby AIFA will process patent holders' requests for information on Marketing Authorisation (MA) applications filed by generics manufacturers.

Further, AIFA will publish a list of all the active substances for which MA applications have been filed in accordance with Article 10(1) and 10(3) of Directive 2001/83/EC. According to AIFA, publishing that list will meet the requirements of the Italian Freedom of Information Act (Law 241/1990), according to which affected third parties are entitled to be informed of any administrative procedure being commenced.

AIFA has decided that it will not authorise the disclosure of Gxs files to patent holders before the completion of the regulatory procedure, unless exceptional circumstances require otherwise. In particular, for medicinals that are not reimbursed by the National Health Service, such disclosures will be authorised only once the opinion of the Scientific Commission has been submitted. In terms of medicinals that are reimbursed, disclosures will be authorised once price negotiations have been completed. In essence, this will mean that disclosure of Gxs files will be authorised at the very end of the regulatory process, i.e. just before Gxs MAs are published in the Official Gazette.

AIFA has gone on to confirm that it will be adhering to recent case law by the Supreme Administrative Court whereby it judged that the existence of patent rights is irrelevant in terms of including approved Gxs in the reimbursement list.

The List of Active Substances :

AIFA did not clarify whether the list of active substances for which article 10 (1) or 10 (3) MA applications are filed will include just the active substances or the names of the actual generics manufacturers filing the MA applications as well.

The first list for new MA applications filed for September 2010 was published online on 7 October: http://www.agenziafarmaco.it/it/content/lista-sostanze-attive . The list indicates the relevant active substances, the type of procedure (national, mutual recognition or centralised/decentralised) and the number of MA applications filed for each active substance. The identity of the Gxs manufacturers is not revealed.

What will this mean?

In the past, AIFA's reaction to requests made by right holders (under the Freedom of Information Act) for the disclosure of Gxs applications was to send the relevant generics manufacturer a letter asking if it objected to such request. A copy of such letter was also sent to the patent holder and the right holder was thus officially informed of the identity of the Gxs manufacturer filing the MA application.

Under the new procedure – assuming that AIFA will not include the names of the Gxs manufacturers in the next lists – it may become increasingly harder for right holders to be officially informed of who is filing Gxs applications. As a result, the new AIFA procedure may well be seen to be breaching the Freedom of Information Act.

On a more positive note, since 7 October 2010, patent holders are able to monitor MA submissions by active substances in Italy using an online tool.

Apotex Vs Astra Zeneca : Court Finds AstraZeneca Patent To Esomeprazole (NEXIUM) Invalid For Lack Of Sound Prediction And Obviousness.

2010-09-15T08:54:00.003-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data.

This was an application brought by AstraZeneca under the provisions of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex for 20 and 40 mg esomeprazole magnesium tablets until after the expiry of Canadian Patent No. 2,139,653 (the '653 patent). If successful on the application, this would have prevented Apotex from marketing a generic version of NEXIUM in Canada for treating conditions wherein a reduction of gastric acid secretion is required until May 27, 2014. Apotex, on the other hand, sought early market entry by arguing that the '653 patent was invalid for lack of sound prediction, anticipation (or lack of novelty), and obviousness.

The '653 patent relates to an improved process for preparing highly optically pure esomeprazole, one of the enantiomers of the racemate omeprazole, that is stable against racemisation (i.e. recombination). Claim 8 was the claim at issue and could be read as claiming a salt (e.g. magnesium) of esomeprazole having an optical purity of 99.8% or greater. There was no provision as to utility (or use of the invention) in claim 8. This was an important fact, as the Court noted that where the invention relates to a new compound, utility does not need to be included in the claim, so long as it is described in the description portion of the patent. On the other hand, when the patent relates to a new use for an old, known compound, that new use must be set out in the claims. In this case, claim 8 was not directed to a new compound; it was directed to a previously known compound having a particular purity.

Moreover, utility of the compound was simply described in the description of the patent as follows:

It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole.

However, nowhere in the patent, whether in the Examples or otherwise, was any information given to the person skilled in the art as to whether, in fact, the highly pure esomeprazole salt does give an improved therapeutic profile such as a lower degree of interindividual variation. Moreover, there was no evidence from any witness to say that there was anything in the disclosure of the '653 patent that would inform a person skilled in the art that the purified esomeprazole salt would fulfill this promise. As a result, there was a clear question as to whether the invention had a basis for a "sound prediction" as to utility.

The requirements for sound prediction are well established:

There must be a factual basis for the prediction.
The inventors must have as of the date of the patent application an articulable and sound line of reasoning from which the desired result can be inferred from the factual basis and
There must be proper disclosure.

The facts of the present case did not show that as of the priority date, May 1993, or even the Canadian filing date, May 1994, that the inventors had either a factual basis for a prediction that an esomeprazole salt of a particular purity would have the utility indicated in the patent, nor did they have an articulable and sound line of reasoning for inferring such a result. In addition, clearly there was no proper disclosure in the patent in that respect. As a result, the patent was invalid for a lack of sound prediction.

As to anticipation, the question was, given that prior art German patent application DE 40 35 455 A1 (DE '455) described a process for separating the enantiomers of omeprazole (and salts) into "optically pure" fractions, did the description, particularly Examples 5 and 6 (incorporating Examples 1 and 2) "enable" what was claimed in claim 8 of the '653 patent, a purity of 99.8% (ee) or greater? In this respect, the Court found that to practice DE '455 "would at best only occasionally result in a product with the purity level stipulated in claim 8." On this basis, there was no enablement such as would support an allegation of anticipation.

As to obviousness, the Court was satisfied on the evidence that, as of the claim date, May 1993, it was known that omeprazole could be separated into its enantiomers (+) and (-), that they would be useful, just as omeprazole was, in treating gastric problems, and that they could be processed in salt form with a salt such as magnesium. A purity of 95.6% (ee) for esomeprazole had been reported as having been achieved in the prior art, and such technique could have been used to increase that purity to 99.8% (ee) if desired. In the result, the '653 patent was also found to be invalid for obviousness.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Patent Abstracts for Canadian patent filings must be made available in both official languages i.e. English and French.

2010-08-14T09:12:00.002-04:00

Frédéric Picard brought an application in the Federal Court under subsection 77(1) of the Official Languages Act (Act) against the Canadian Intellectual Property Office and the Commissioner of Patents claiming that patents and patent applications must be bilingual to meet the requirements of the legislation. He sought an order requiring the Patent Office to make certain parts of patents and patent applications available in both official languages and a declaration of invalidity of all patents available in one official language only, to be suspended to allow the Patent Office to make the invalidated patent applications and patents available in both languages.

Justice Tremblay-Lamer found that the Patent Office had not met the requirements under section 44 of the Act relating to the duty of all federal institutions to take positive measures to foster "the full recognition and use of both English and French in Canadian society." She concluded that "the fact that patents exist only in one official language deprives Canadian who do not speak that language of information that is important in both legal and scientific terms." In considering the appropriate remedy for this violation, she acknowledged the cost associated with translating all patents and applications.

The Federal Court therefore ordered that the Commissioner must at least "make available an unofficial translation of the abstract of all patents he issues" to be in compliance with the Act. While the Court was not prepared to require that all aspects of the patent be translated, abstracts will have to be prepared in both official languages.

More at http://decisions.fct-cf.gc.ca/en/2010/2010fc86/2010fc86.html

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Eli Lilly Canada v. Novopharm Ltd : Canadian Patent Act contains no reference to invalidate selection patents –

2010-07-30T04:08:00.006-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current pharmaceutical and clinical research updates, patent news, views and data.

Lilly sued Novopharm for infringement under Canadian Patent No. 2,041,113, a selection patent for the compound olanzapine (sold under the brand name Zyprexa), owned by Lilly. Olanzapine is used to treat schizophrenia. Novopharm argued that the ’113 Patent is invalid. A Federal Court judge (the trial judge) agreed with Novopharm and dismissed Lilly’s action. The Federal Court of Appeal reversed.

On appeal, the question raised by the parties was: Do the conditions for a valid selection patent constitute an independent basis upon which to attack the validity of a patent?

Lilly already obtained Canadian Patent No. 1,075,687, a genus patent described by the court as covering “approximately 15 trillion compounds predicted to be useful in the treatment of mild anxiety and certain kinds of psychotic conditions, such as schizophrenia and acute mania. The ’687 Patent expired 15 years ago. The ’687 Patent encompassed, but did not disclose, olanzapine. The trial judge concluded that olanzapine fell within the “most preferred” compounds. The ’687 Patent specifically disclosed flumezapine, ethyl flumezapine and ethyl olanzapine.

Further research was conducted on some of the ’687 Patent’s compounds, one of which was olanzapine. In 1989, clinical trials began with patients. Lilly decided to file the ’113 Patent, which characterizes olanzapine as a selection from the class of the ’687 Patent. The patent for olanzapine was filed in Canada on April 24, 1991 and the ’113 Patent issued July 14, 1998.

In the reasons for judgment, the trial judge identified the ’113 Patent’s stated advantages over both the ’687 Patent and other antipsychotic drugs, including lower incidence of liver enzyme elevations compared to flumezapine; lower CPK levels than flumezapine; lower ESP liability than flumezapine; and no increase in cholesterol compared to ethyl olanzapine.

The trial judge reasoned that if these advantages amounted to a substantial advantage secured by the drug (or a substantial disadvantage avoided in comparison with the genus patent), if they were known or predicted at the time of filing, and if they were adequately disclosed, the ’113 Patent would be a valid selection patent. The trial judge concluded that there was insufficient evidence of the advantages identified by the ’113 Patent. Specifically, the trial judge determined: the stated advantages were not substantial and peculiar; a person skilled in the art (POSITA) would not be able to appreciate any inventive difference between the ’687 Patent and the ’113 Patent; the test for sound prediction was not met; Lilly had very little idea about what olanzapine’s effect was likely to be; and the ’113 Patent did not meet the requirements for adequate disclosure.

Although not restricted to chemical patents, selection patents more commonly arise in that context. Simply stated, the originating (or genus) patent typically refers, in general terms, to a group of products or processes from all of which a particular result (or results) may be obtained or predicted. If a property, quality or use in relation to one or more members of the genus is subsequently discovered, that discovery may be an invention giving rise to a valid selection patent.

As explained in Pfizer and Sanofi, selection patents exist to encourage researchers to further use their inventive skills so as to discover new advantages for compounds within the known class. A selection patent can be claimed for a selection from a class of thousands or for a selection of one out of two.

In Sanofi, the characteristics of a valid selection patent are described as follows:

1. There must be a substantial advantage to be secured or disadvantage to be avoided by the use of the selected members;
2. The whole of the selected members (subject to “a few exceptions here and there”) possess the advantage in question;
3. The selection must be in respect of a quality of a special character peculiar to the selected group. If further research revealed a small number of unselected compounds possessing the same advantage, that would not invalidate the selection patent. However, if research showed that a larger number of unselected compounds possessed the same advantage, the quality of the compound claimed in the selection patent would not be of a special character.

Lilly argued that the trial judge erred by creating an “illegitimate amalgam by merging the doctrine of sound prediction of utility with obviousness and sufficiency and in the process required Lilly to provide proof of the inventive step (i.e. the advantages) in the disclosure.” In Lilly’s view, the “selection” issue goes to the question of obviousness and is properly addressed as part of that inquiry. The Federal Court of Appeal felt likewise:

In my view, a challenge directed to a determination that the conditions for a selection patent have not been met does not constitute an independent basis upon which to attack the validity of a patent. Rather, the conditions for a valid selection patent serve to characterize the patent and accordingly inform the analysis for the grounds of validity set out in the Act – novelty, obviousness, sufficiency and utility. In short, a selection patent is vulnerable to attack on any of the grounds set out in the Act. Notably, the Act contains no reference to invalid selection.

On consideration, I think it would be unwise to endeavour to state in definite language all the conditions on which a selection patent must depend; for after all a selection patent does not in its nature differ from any other patent and is open to attack on the usual grounds of want of subject-matter, want of utility, want of novelty and so forth.

Application to this Case:
I have concluded earlier that a determination that the conditions for a selection patent have not been met does not constitute an independent basis upon which to attack a patent’s validity. A selection patent is the same as any other patent. Its validity is vulnerable to attack on any of the grounds set out in the Act. It necessarily follows that the trial judge erred in determining the validity of the ’113 Patent on the basis that he did. That is not to say, however, that his analysis is not relevant to the issue of utility, or other grounds of validity.

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Apotex Vs Pfizer in Lipitor Patent Challenge: An interesting case study.

2010-07-29T07:21:00.005-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design.

Shruti brings to you some highlights from current pharmaceutical and clinical research news, views and data.

The litigation between Pfizer and Apotex over Apotex's ANDA for a generic version of Lipitor (atorvastatin calcium) presents the fairly typical scenario of a later ANDA filer (Apotex) trying to trigger the 180-day exclusivity of the first filer (in this case, Ranbaxy).

Pfizer and Ranbaxy settled their Lipitor ANDA litigation in 2008, agreeing that Ranbaxy would not market its generic version of Lipitor until November 30, 2011. Later ANDA filers like Apotex, therefore, must wait until at least mid-2012 to launch their own generic Lipitor--unless one of them triggers Ranbaxy's exclusivity earlier. In order to do so, the later filer must obtain a final decision of non-infringement or invalidity of the Lipitor patents. But this isn't easy to do if the patent owner doesn't sue the later filer: the later filer must obtain a declaratory judgment, which requires establishing declaratory judgment jurisdiction.

In this case, Pfizer listed six patents in the Orange Book for Lipitor. Apotex filed a Paragraph III certification on U.S. Patent No.4,681,893 (expiring March 2010) and Paragraph IV certifications on the other five. Pfizer sued Apotex on only two of the five challenged patents. In its Answer, Apotex filed declaratory judgment counterclaims of non-infringement and invalidity of all five challenged patents, as it must have in order to trigger Ranbaxy's exclusivity. Pfizer then filed a motion to dismiss Apotex's counterclaims with respect to the three patents that Pfizer did not assert against Apotex (the "Unasserted Patents"), on the grounds that they did not present a "case" or "controversy" as required by Article III of the Constitution. In an Opinion and Order filed June 30, the district court denied Pfizer's motion, allowing Apotex's declaratory judgment counterclaims--and its attempt to trigger Ranbaxy's exclusivity--to proceed.

In its motion to dismiss, Pfizer argued that Apotex lacked standing to assert its counterclaims. To establish standing, a plaintiff must demonstrate (1) an injury-in-fact, (2) that is fairly traceable to the defendant's conduct, and (3) that can be redressed by the court. Apotex alleged two injuries-in-fact: first, by not suing on the Unasserted Patents while reserving the right to do so in the future, Pfizer created uncertainty as to Apotex's legal rights under its ANDA; second, by refusing to litigate all of its patents and settling its litigation with Ranbaxy, Pfizer erected a barrier to FDA approval of Apotex's product, thereby barring Apotex from entering the market. Pfizer countered that Apotex's alleged injuries were "not sufficiently imminent in light of Apotex's Paragraph III certification to the '893 patent, which prevents the FDA from approving Apotex's ANDA until the '893 patent expires."

Siding with Apotex, the court found that the facts of this case were more like those in Teva v. Novartis (where the Federal Circuit held that the "threat of litigation" on unasserted patents and the "legal undertainty" caused when a patent holder sues an ANDA filer on some but not all of Orange Book-listed patents create a justiciable controversy) and Caraco v. Forest (where the Federal Circuit held that blocking a generic drug company from selling a non-infringing product presents a justiciable controversy) than in Janssen v. Apotex (in which the Federal Circuit found no justiciable controversy because Apotex had stipulated to infringement and validity of one of the Orange Book-listed patents).

On July 14, Pfizer filed a motion for reconsideration of the district court's June 30 decision. In addition, today Pfizer filed a second motion to dismiss, arguing that the circumstances have changed in two important ways since the court's June 30 decision: first, "in light of the Court's decision Pfizer has now given Apotex a covenant not to sue on the Formulation Patents (two of the three Unasserted Patents) and thus there is no possibility of a future lawsuit on these patents"; and second, "also in light of the Court's decision, Pfizer has brought a counter-counterclaim against Apotex on (the third Unasserted Patent, U.S. Patent No. 5,969,156), which expires, including pediatric exclusivity, in January 2017, after the expiration of the Formulation Patents and after the November 30, 2011 date that Ranbaxy may enter the market under its settlement with Pfizer."

According to Pfizer, "the earlier-expiring Formulation Patents and the Ranbaxy settlement with its November 30, 2011 license date cannot prevent Apotex from overcoming Ranbaxy's 180-day exclusivity rights unless and until Apotex prevails on the '156 patent." Thus, Pfizer argues that any alleged injury to Apotex is "based solely on the possibility that the '156 patent is not infringed or is invalid" and "such a speculative injury is 'conjectural' and 'hypothetical', and does not rise the level of 'concrete and actual or imminent'," as required to be justiciable.

Of course, the longer the case lasts, the less likely Apotex is to obtain the declaratory judgment that it seeks, get the judgment affirmed by the Federal Circuit, and trigger Ranbaxy's exclusivity. Pfizer might simply run out the clock.

http://www.istockanalyst.com/article/viewarticle/articleid/4335245

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US Supreme Court Hedges Its Bets On Business Methods- Canadian Businesses, beware !

2010-07-09T06:34:00.005-04:00

Blessing of ‘Business Patents’ in US will affect you. The US Supreme Court recently issued its long-awaited decision in the case of Bilski v Kappos which is considered to be one of the most anticipated patent decisions of recent time.

The case involved a patent application for a method of hedging risk in commodities trading. The application was rejected in the first instance by the patent examiner as the invention was a business method which did not relate to any specific apparatus. It was therefore considered to be an abstract idea which is not patentable under US law. The case was then appealed all the way to the Supreme Court.

The main issue for the Supreme Court was whether a patent could be issued for an invention which was a business method. The Court rejected the lower court's ruling that the patent was invalid because it didn't meet the "machine or information" test, meaning that a process must be associated with a machine or must physically transform a product to qualify for a patent. It found that whilst the test was a useful tool, it was too narrow and should not form the sole test as it excluded all business methods. The focus should instead be on whether a claim is "directed to an abstract idea".

The Court's Opinion
The Court's opinion was written by Justice Kennedy and joined by Chief Justice Roberts and Justices Scalia (in part), Thomas, and Alito.

The Court held that Section 101 precluded the broad contention that the term "process" categorically excludes business methods. The Court reasoned, in part, that federal law explicitly contemplates the existence of at least some business method patents (e.g., Section 273 of Title 35 of the U.S. Code).

• The Court characterized the machine-or-transformation test as a "useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under [Section] 101."

• The Court held that the machine-or-transformation test is not the sole criterion for determining the patentability of an invention in the "Information Age." It is not clear, however, that many patentable processes lie beyond the reach of this test.

• The Court noted that even if a particular business method fits the statutory definition of a patent-eligible "process," that does not mean an application claiming the method should be granted. Any claimed invention must also be novel (Section 102), non-obvious (Section 103), and fully and particularly described (Section 112). The Court explained: "These limitations serve a critical role in adjusting the tension, ever present in patent law, between stimulating innovation by protecting inventors and impeding progress by granting patents when not justified by the statutory design."

The Concurrences
• Justices Breyer, Sotomayor and Ginsburg joined a concurring opinion, authored by Justice Stevens, that methods of doing business are not patentable "processes" under Section 101. They based their decision on their belief that methods of doing business fall outside of the subject matter that has historically received protection under U.S. patent law.

• Justice Breyer, joined by Justice Scalia, also wrote separately to highlight the "substantial agreement among many Members of the Court" on certain fundamental issues of patent law raised by the Bilski case. He highlighted four points:

(1) that although the text of Section 101 is broad, it is not without limit;
(2) that the machine-or-transformation test is a "useful and important clue" that has repeatedly helped the Court determine what is a patentable process;
(3) that the machine-or-transformation test has never been the sole test; and
(4) that it is by no means true that anything that produces a "useful, concrete, and tangible result" is patentable.

Although the Court stated that it would be possible to obtain a patent for a business method in some circumstances, it concluded that a patent should not be awarded to the petitioners in this case as the hedging method for which they were seeking a patent was an abstract idea.

The Court failed to commit itself to further guidance in respect of what business methods would be patentable and expressed the view that "the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles" but "nothing in this opinion should be read to take a position on where that balance ought to be struck".

Whilst this decision means that the door has been left open for innovation and new technologies, the ruling means a lack of clarity on precisely what types of business methods would meet the criteria for protection under patent laws.

Businesses affected: Computer and other business-related inventions.

The long-simmering debate over the scope of patentability of "business methods," computer software, and other enterprise-related innovations remains unresolved, at least in the United States - which both directly and indirectly dominates the North American market. The effects of Bilski and other cases will be felt north of the border in a number of ways.

Canadians and others who do business in the United States, or who do business with Americans via the Internet, regardless of location, are advised to revisit the effects of US patents on their customers and markets. Those who seek patents in Canada - including those who do business solely in Canada - should be aware of the possible impact on Canadian patent law as well.

Importantly, both offensive and defensive US patent strategies must be considered by Canadians.

Doing Business in the US
In the United States, there remains considerable doubt as to whether a broad range of enterprise-related innovation is protectable. In Bilski, America's highest court did not rule out possible expansive interpretation of the categories of included subject matter. Specifically, the court stated that the patent act "precludes the broad contention that the term 'process' categorically excludes business methods." The only exceptions to patentability, the Court stressed, are the exceptions of "laws of nature, physical phenomena, and abstract ideas."

While these three exceptions do impose limits on patentable subject matter in the US, a very broad range of the types of innovation generally considered most valuable to businesses - computers, software, and other business-related inventions - remains patentable. It is expected that U.S. courts and the Patent Office will continue to apply the machine or transformation test, but US courts, at both the appellate and Supreme Court levels, have persistently declined to find that computer or software implementations of business-related processes are not patentable.

In its lower-level review of the Bilski case, the US Court of Appeals for the Federal Circuit, which oversees patent cases in the US, commented that:

We... reject calls for categorical exclusions beyond those for fundamental principles already identified by the Supreme Court. We rejected just such an exclusion in State Street, noting that the so-called "business method exception" was unlawful and that business method claims (and indeed all process claims) are "subject to the same legal requirements for patentability as applied to any other process or method." We reaffirm this conclusion...

Therefore... we decline to adopt a broad exclusion over software or any other such category of subject matter beyond the exclusion of claims drawn to fundamental principles set forth by the Supreme Court.

These findings were echoed by the Supreme Court in its review of the case. The future of computer- and other business-related patents in the US seems secure, at least with respect to those that can meet the machine or transformation test.

Doing Business with Americans via the Internet
Those who do business with Americans via the Internet should consider both offensive and defensive effects of US patents on their business, regardless of their location. Taken together with decisions like that in the NTP case several years ago, the Bilski decision will ensure that US patents related to e-commerce, communications, and other types of networked or distributed processing continue to have impact far beyond the territorial limits of the United States.

The Effect on Canadian Patent Law
The Bilski decision may spill over into Canada in other ways as well: the Canadian Intellectual Property Office (CIPO) has been rejecting computer systems and other enterprise-related patent applications as "unpatentable subject matter." While some patent applicants, as well as other observers, have questioned CIPO's decision to reject such applications as broadly as they have, CIPO has based its rationale partly on the lower-court US ruling in Bilski. Some observers are eager to see what effect the US Supreme Court's ruling in Bilski might have on CIPO's thinking - or that of the courts, as the Amazon One-Click6 case works its way through Canadian federal court system.

Canadians be warned: For most businesses, merged North American markets are inseparable. US patents will affect your business, even if based only in Canada.

As a result of Bilski, the correct strategy for Canadian businesses continues to be to seek protection for software related inventions and processes in the US.

Looking Forward
What does this mean for you? Without a bright-line test, the Supreme Court's decision in Bilski will only encourage more debate as to whether specific business methods are patentable. While the entire court agreed that Bilski was not entitled to a patent here, the Court's opinion requires the lower courts to decide the issue of patentability on a case-by-case basis. The decision makes clear that the machine-or-transformation test is not the only test for deciding whether an invention is a patent-eligible "process." Nonetheless, the justices were unanimous in the view that the "machine or transformation" test will remain an important tool for determining the patentability of claimed business method inventions in the future.

What this means to you?
Holders of existing business method patents can breathe a sigh of relief. By not foreclosing the patent-eligibility of all business methods and rejecting the exclusivity of the machine-or-transformation test, the Supreme Court has given existing business method patents new life. Going forward, the Patent Office must now consider how to adapt. The machine-or-transformation test remains important, and processes that meet this test are likely to be deemed patentable, provided other statutory criteria (e.g., for novelty and non-obviousness) are satisfied. However, the machine-or-transformation test is not the exclusive test for patent-eligibility, and some business methods that do not meet this test could be patent-eligible, if not too abstract.

While abstract ideas, laws of nature, and mathematical formulae are not patent-eligible, as noted by the Supreme Court, "an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection." Indeed, the inventors in Bilski have themselves promised to go back to the Patent Office seeking the allowance of revised claims. The Federal Circuit will likely revisit the scope of patent eligibility very soon, as the Supreme Court vacated and remanded two cases (Classen Immunotherapies Inc. v. Biogen Idec and Mayo Collaborative Services v. Prometheus Laboratories) in light of Bilski.

References
1. For additional details concerning the Bilski case, please link to our recent circular: http://www.ogilvyrenault.com/en/resourceCentre_10445.htm

2. Bilski et al. v. Kappos, US Sup. Ct., Slip Opinion No. 08-964 (28 June 2010).

3. Indeed, in Bilski the Court affirmed the rejection of claims drawn very broadly toward the protection of methods of hedging risks in commodities markets. The rejected claims, however, were so broad that they could have been infringed by individuals passing cash among amongst themselves in a living room.

4. In Re Bilski et al., US Court of Appeals for the Federal Circuit, Slip Opinion No. 2007-1130, at 21 and note 23.

5. See Respondent's Memorandum of Fact and Law in Amazon.com, Inc. v. Attorney General, Fed. Court file T-1476-09, at 27. CIPO's reliance on Bilski has itself been questioned.

6. Fed. Court file T-1476-09.

7.http://www.mondaq.com/article.asp?articleid=104790&email_access=onhttp://www.mondaq.com/article.asp?articleid=104790&email_access=on

8. http://www.mondaq.com/unitedstates/article.asp?articleid=104664&email_access=on

9. http://www.mondaq.com/unitedstates/article.asp?articleid=104818&email_access=on

United Arab Emirates: Major Changes To UAE IP Laws Announced

2010-05-15T00:47:00.004-04:00

Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moieties, brings to you some highlights from current pharmaceutical and clinical research news, views and data.

The UAE government has announced proposals to introduce major amendments to the IP regime in the UAE. These proposed changes will have an impact across three areas:

• Confidential Information – Introducing, for the first time, a mechanism for protecting confidential information through the civil courts;

• Patent And Design Protection – Introducing numerous improvements to the current regime, including, clarifying the test to be applied for assessing what constitutes a patentable invention and extending the term of protection for registered designs; and

• Integrated Circuits – Introducing, for the first time, protection for layout designs for integrated circuits.

These changes have been proposed by way of amendments to the UAE's existing Patents, Industrial Drawings and Designs Law (No. 31 of 2006) (the "Patent Law").

Confidential Information :

The biggest impact of the amendments is likely to be in relation to the protection of confidential information.

The proposed amendments will for the first time:
1. enable rights in confidential information to be enforced by way of an injunction;
2. allow parties to non-disclosure agreements to enforce their rights by way of an injunction;
3. provide a claim for damages in the event of unauthorised disclosure of confidential information;
4. clearly define what constitutes protectable confidential information (broadly defined as information which is (i) confidential, (ii) has commercial value, and (iii) is subject to reasonable steps to maintain confidentiality); and
5. provide specific protection for test data required for regulatory approvals for pharmaceutical and agricultural chemical products.

Patents

The proposed amendments:
1. clarify the basic standards of patentability, which were not expressly stated in previous versions of the Patent Law. The Patent Law will apply the following tests for patentability of inventions in the UAE:
a. novelty is to be judged on an absolute, worldwide basis;
b. inventiveness is to be judged by reference to what is obvious to the ordinary person skilled in the art; and
c. the question of whether an invention is capable of industrial application is to be interpreted broadly, so as to include all types of industry, including handicrafts; and
2. remove the requirement that an Arabic translation of a patent application must be submitted at the time of filing. This is very positive news for patentees and practitioners alike because of the very real risks which arise when translations of highly technical patents are prepared at the last minute before the filing of priority applications.

The deadline for filing Arabic translations has not yet been fixed but, if it matches the timetable for the submission of other supporting documents, then it is likely to be 90 days after filing.

These amendments are welcomed, although some clarification is required and further changes are desirable, such as:
1. allowing decisions of the Patent Office on the examination of patents to be appealed to the courts;
2. clarifying which of the two filing languages (Arabic and English) takes priority when it comes to enforcement;
3. clarifying how GCC patents are to be enforced in the UAE;
4. clarifying the deadlines for the payment of annuities (the current Patent Law creates a good deal of confusion between the deadline for paying annuities for international filings and the deadline for paying annuities for national phase, priority filings);
5. providing a mechanism for lapsed patents to be restored, in certain limited circumstances where the patentee is not at fault; and
6. clarifying an existing provision which excludes infringement by manufacturers whose use of an invention predates the filing or priority date for the patent application. It is hard to make sense of this provision in its current form as the prior use of an invention would appear to destroy novelty, rendering the invention unpatentable.

Designs

The proposed amendments:
1. increase the term of protection for designs from 10 to 15 years; and
2. clarify the basic standards of registerability, which were not expressly stated in previous versions of the Patent Law. The Patent Law will require novelty to be judged on an absolute, worldwide basis.

Similar to the position in relation to patents, this is welcomed although some additional clarification and further changes would also be beneficial.

For example, the provision which excludes infringement by users of a design whose use predates the filing or priority date for the application should be removed. It is hard to make sense of this provision as such prior use would appear to destroy novelty, rendering the design unregisterable.

Integrated Circuits

The proposed amendments will for the first time introduce protection in the UAE for the layout designs for integrated circuits. The amendments envisage:
1. a regime under which layout designs for integrated circuits can be registered with the Patent Office (although it is unclear as to whether there will be any examination process);
2. a two year priority period (from the date of first commercial exploitation); and
3. a 10 year term of protection.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
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Selection patents new business challenges:

2010-03-08T12:03:00.005-05:00

Dr. Shruti Bhat, Generics & Specialty Pharmaceuticals Expert.

In their quest for new and more potent drugs, pharmaceutical companies look to their scientists for inspiration. Once a discovery is made, there is often a rush to patent as much of the discovery as it allows and then some. Patent practitioners seek to protect new compounds by filing patent applications in which, once granted, broad genus claims protect not only the compounds actually made by the scientists, but also other compounds of similar chemical structure, which, if they are made, would be predicted to have similar properties. This type of broad claiming generally rewards the discovery of a hitherto unknown class of compounds identified by a common chemical structure and can protect many hundreds of thousands of compounds. However, available human and financial resources often limit the number of compounds claimed that can actually be made and tested. Given that the Patent Act confers on an inventor the right to a monopoly for 20 years, where should the line be drawn in terms of extending claim protection beyond the initial discovery?

Should there be a bar against ‘new’ discoveries that may be hiding somewhere in the broad genus claim, which the scientists may have overlooked in their initial discovery? The Patent Act and now the courts say no, if the discovery is new and provides unexpected advantages over the initial discovery. Canadian pharmaceutical companies and those looking to protect their valuable pharmaceutical discoveries in Canada use so-called selection patents to protect their inventions when they discover a surprising and unexpected advantage of a selected compound, often a drug, over a claimed genus of compounds from which the selected compound was chosen. It is well-established law in Canada that if the selected compound is new and has properties of an unforeseen nature, then the inventive character is met. The Supreme Court has now confirmed that a selection patent does not differ in its nature from any other patent and that it is consequently compatible with the Patent Act.

The Supreme Court case centred on Sanofi-Aventis’s earlier patent, which disclosed a genus covering more than 250,000 possible compounds that were useful for inhibiting platelet aggregation. One compound, a racemic mixture of two enantiomers, dextro-rotatory clopidriogel and levo-rotatory clopidriogel, was of particular interest to Sanofi-Aventis. Sanofi-Aventis discovered that when separated from the racemic mixture, the dextro-rotatory enantiomer had a higher therapeutic effect and lower toxicity when compared to the levo-rotatory enantiomer, and it was granted a later selection patent based on this discovery. Apotex attacked Sanofi-Aventis’s selection patent on three fronts – anticipation, obviousness and double patenting (or ‘evergreening’) – but failed on all three.

Anticipation and obviousness:
One of the fundamental canons of patent law is that prior public disclosure of an invention for which a patent is sought will effectively bar the patent applicant from obtaining a valid patent for the invention. The Supreme Court affirmed a two-step approach to establish whether a prior publication, such as a patent, patent application or scientific article, is so-called ‘prior art’, which destroys the newness or novelty of the invention. The approach requires separate consideration of ‘prior disclosure’ and ‘enablement’, both of which, if proven, establish that the prior art anticipates the invention. In the context of selection patents, if, when reading the genus claim in the prior patent, a person skilled in the art does not discover the special advantages of the selection, there is no anticipation by way of prior disclosure. No trial and error is allowed. Similarly, if the person skilled in the art must perform the invention with undue burden, then there is no anticipation by way of enablement. Skilled readers of the patent should be able to arrive at the invention the first time they try it and each time thereafter, with limited trial and error. In this case there was no anticipation because Sanofi-Aventis’s former patent did not reveal which enantiomer was more active, even if it was known that one enantiomer was often more active than another. Since anticipation requires both prior disclosure and enablement, it was unnecessary for the Supreme Court to consider the second issue of enablement. Even if the methods of separation of enantiomers were known, the Sanofi-Aventis inventors had to spend several months of research to identify the active enantiomer and its advantages. Therefore, the Supreme Court found that the prior disclosure was not enabling.

Historically, the Canadian courts have relied on rather strict language to decide the issue of obviousness and whether a notional skilled person, in light of the state of the art and common general knowledge, would have been led directly and without difficulty to the solution taught by the patent. In addition, the courts have routinely rejected an ‘obvious to try’ criterion.

Interestingly, the Supreme Court compared current Canadian attitudes towards the question of obviousness with those of the United Kingdom and the United States, where a stringent ‘obvious to try’ approach is the current state of the law. In addressing the obviousness issue in Sanofi-Aventis, the Supreme Court examined the circumstances under which it might be appropriate to use the ‘obvious to try’ criterion. The court concluded that for an invention to be obvious instead of it being merely obvious to try, it must also be “more or less self evident to try to obtain the invention. Mere possibility that something might turn up is not enough”.

The Supreme Court found that Apotex failed to establish that the selected dextro-rotatory isomer was obvious to try from the 250,000 other possibilities in the earlier genus patent because it was not self-evident from the prior art and common general knowledge. In particular, there was no evidence that a person skilled in the art would have known which of the established separation techniques would work to separate the racemic mixture.

Double patenting:
The Patent Act provides for “one invention per patent”. Apotex argued that selection patents extend the lifetime of the original genus patent by allowing so-called ‘evergreening’, or double patenting. The Supreme Court rejected this and pointed out that third parties can obtain selection patents, and that they encourage innovation by identifying hitherto unknown and useful properties in the original genus. In a double-patenting challenge, the focus is on the claims of the two patents rather than on the disclosure, and because the claims of the genus patent are broader than those of the selection patent, there cannot be double patenting.

Licensing issues:
A pharmaceutical company has many choices when establishing a research programme which aims to produce a drug. One is to carry out its own basic research and development, which can put an enormous strain on human and financial capital. Another is to inlicense or out-license technologies which it can use to develop a drug. In fact, the content and the substance of the Sanofi-Aventis decision will have an impact on both these scenarios. From now on, and in view of the decision, rights owners of genus patents should carefully review their agreements to verify whether the possibility of a selection patent is covered by the terms and conditions contained therein. In doing so, they will have to judge if any action needs to be taken with respect to the existence, or possible existence, of a selection patent. Indeed, the Sanofi-Aventis decision will certainly affect the way in which genus patents are managed and licence agreements are drafted around them.

From a business and licensing perspective, this decision raises many important questions related to the rights effectively granted or obtained under a research agreement related to a genus patent, under a licence agreement or even under the assignment of a genus patent. It also raises questions with respect to what constitutes an improvement and the issue of infringement. Therefore, anyone responsible for drafting, implementing or managing agreements dealing with the grant of rights on a genus patent should be conversant with the impact this decision may have on its business and projects. It is very important that all such agreements be reviewed to consider and address the impact that a selection may have in light of the rights granted on the genus patent. It should also be underlined that one of the main effects of this decision can be foreseen in situations where there is no contractual relationship between the owner of the genus patent and the inventor of the selection. In fact, the Sanofi-Aventis decision points out that no control can be exercised over any third party wishing to patent a selection, with the exception that in order for the third party to exploit the selection patent, it must enter into an agreement with the owner of the genus patent. The interested parties should evaluate whether it is advantageous either to negotiate with another party to reach an agreement for the exploitation of the selection patent or to wait until the protection afforded by the genus patent has expired to be able to exploit its selection freely.

Moreover, important considerations should be taken into account upstream of any licensing activity – that is, at patent prosecution stage. The Sanofi-Aventis decision will affect how and when a patent related to a group of compounds should be prosecuted. Research and development departments must assess at an early stage whether they foresee a selection and whether such a selection is easy to achieve. This assessment will likely influence the scope of the claims and when a patent application is to be drafted and filed. Accordingly, this decision will add to the issues which need to be considered when a technology is to be developed and commercialised.

Conclusion:
The pharmaceutical selection patent landscape has changed in Canada, most likely for the better. Provided that the drug selected from the previous broad patent satisfies the basic canons of patent law, the courts will look favourably on claims to such. Even before the Sanofi-Aventis decision, the lower courts in Canada heard a number of earlier selection patent cases and concluded that sufficient representative testing is required to establish a valid selection patent. Although it remains to be seen what exactly is meant by this term, clearly the more comparative data the patentee includes in an application for a selection patent and the more the patentee articulates the selection’s advantages over the previous genus, the stronger the argument will be for a proper patentable selection.

This requirement has obvious implications for research managers because in order to satisfy the valid claim to a selection, more bench work will be needed to produce the required representative testing for inclusion in an application for a selection patent. This additional work may delay filing a patent application and require the extension of internal timelines, but it is worth it, especially since the business goal is to discover an all-important blockbuster drug. The Sanofi-Aventis decision will no doubt pave the way for more selection patents in Canada. In the meantime, with the affirmation of the two-part test for anticipation, the apparent softening of the historically strict test for obviousness and the requirement for “sufficient representative testing”, we can expect selection patents and applications for selection patents to be scrutinised for compliance with this decision. Finally, parties that deal with a selection patent will now have to consider which strategy they develop around prosecuting and exploiting genus and selection patents.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

Australian Innovation Patent Advantage - Ignore it at Your Potential Peril

2010-02-25T22:39:00.003-05:00

Patent Expert, Dr. Shruti Bhat

The facts:

The Australian patent system has a unique beast called the "innovation patent". Under the Australian patent system it is possible to obtain both standard patents and innovation patents. Under the innovation patent system, while the term is only eight years, there is no test for obviousness, but rather a test for "innovative step". Further, in certain circumstances, it is possible to file innovation patents from standard patents and vice versa.

The lack of an obviousness test provides a great opportunity for patentees to take advantage of our innovation patent as a powerful strategic property in its own right and/or to maximise their advantage during litigation. Such was the case in Dura-Post (Aust) Pty Ltd v Delnorth Pty Ltd [2009] FCAFC 81, where the Full Federal Court recently decided to uphold a trial judge's decision that an innovation patent was not subject to an obviousness test, but rather to the substantially weaker "innovative step" test being something peculiar to Australian jurisprudence.

In the Dura-Post case, relating to the simple subject matter of elastically-deformable road-side posts, the patentee had filed multiple divisional innovation patents from a standard patent and successfully sued on the innovation patents. The successful innovation patent claims each defined a new, but arguably non-inventive, combination of known features. However, the Court concluded, based on evidence, that in each case the claimed difference over the prior art, while small, did provide a substantial or "real" contribution to the working of the invention and as such passed the threshold test.

The implications and recommendations:

The absence of an obviousness test allows applicants to potentially obtain protection for more marginal developments and/or obtain broader rights for an invention in Australia than would be possible in nearly all other jurisdictions. As such, we would encourage potential applicants to consider innovation patents as an adjunct to a standard patent application in order to obtain a fast-to-grant right with potentially broader claims. They should also be considered as an adjunct or alternative for developments that would normally at best be protected via the useful, but limited, registered designs regime. Importantly, many applicants are already doing this. It is undoubtedly preferable to be the holder of innovation patents in your particular IP space, than trying to operate around competitors' rights which may prove to be unexpectedly broad and difficult to successfully challenge.

Innovation patents proceed to "grant" with only basic formalities review. They need not be examined substantively unless and until the patentee wishes to establish enforceable rights. In this way, they can be both powerful and flexible, as it is clear from this latest case that minor points of distinction disclosed within the specification may be sufficient to establish patentable rights.

For the same reasons, it is difficult to accurately predict the potential scope of granted but unexamined innovation patents of third parties. This arguably provides an added incentive for applicants to attempt to dominate particular market sectors through innovation patents.

However, it is worth noting that the innovation patent regime appears to be at odds with one of IP Australia's stated goals, of aligning Australian patentability standards with those of other major jurisdictions such as Europe and the US. Such policy considerations may give rise to a substantive review or revision of the regime in due course, although any resultant changes would almost certainly not have retrospective effect.

Meanwhile, based on the law as it presently stands, a good option is to take full advantage of the significant strategic and commercial benefits that innovation patents currently provide. Your competitors may already be doing just that!

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Practical Considerations And Strategies In Drafting U.S. Patent Applications-

2010-02-22T19:49:00.000-05:00

United States patent law probably ranks as one of the most sophisticated and complex bodies of law in the world. Under the U.S. patent law, a patent not only serves as a technical disclosure for an invention to be protected, but also defines the boundaries of exclusive rights granted by the U.S. government to protect the invention. As a legal document, a U.S. patent is subjected to legal interpretation and strict scrutiny of the U.S. court system. As more Chinese companies start pursuing patent protection in the United States, they should be aware of general strategies and considerations when preparing U.S. patent applications or, more particularly, specifications and claims of the U.S. patent applications.

Importance of Carefully Drafted Specifications and Claims-

Many people, including patent attorneys, often pay more attention to drafting claims than drafting specifications. In reality, however, the specification is as important as, if not more important than, the claims. To take just one example, the claims can be amended during the prosecution to redefine the scope of patent protection. But the specification can rarely be changed during prosecution, which means the applicant only gets one opportunity to explain how the invention works.

In the world of patent litigation, specifications and claims always go hand-in-hand. A carefully drafted specification is particularly important when the federal district judge interprets the patent claims, for the claims must be read in light of the specification. In Phillips v. AWH Corp.,the Federal Circuit, recently clarified the role of the specification when a federal district judge seeks to ascertain the proper scope of patent claims.

In Phillips, the Federal Circuit held that "the specification 'is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.'"That is, a carefully drafted specification can resolve a dispute over claim terms without resort to any extrinsic evidence. A good strategy for a patent applicant is thus to take advantage of Phillips and assume more control over claim construction in any future litigation by carefully drafting the specification.

Of course, carefully drafted claims are also essential for any patent protection because the claims directly set the scope and boundaries of the patent rights. A careless mistake, no matter how small or innocent, may have the biggest impact on the outcome of a patent litigation.

For example, in Chef America, Inc. v. Lamb-Weston, Inc.,Chef America tried to protect a cooking step for heating a dough at a certain temperature inside an oven. But Chef America drafted the claim to read "heating the . . . dough to a temperature in the range of about 400 degrees F. to 850 degrees F." The Federal Circuit reasoned that "to" is not "at" and, thus, the claim required the dough (not the oven) to be heated to the specified temperature. The Court then ruled that the claim was not infringed. In fact, under the Court's claim construction, this claim could not possibly be infringed unless one wanted to make burned dough.

Another example shows the importance of carefully choosing alternative language when drafting claims. In Kustom Signals, Inc. v. Applied Concepts, Inc., Kustom Signals added the limitation "selecting either a greatest magnitude or highest frequency search" to the claim during prosecution and later sued Applied Concepts for patent infringement. But Applied Concept's device searched both magnitude and frequency. The Federal Circuit reasoned that "or" is not "and/or" and the claim only covered a choice between either one of two alternatives, not both. The Court then affirmed a ruling of noninfringement by Applied Concept's device. The outcome was indeed unfortunate for Kustom Signal, but it could have avoided the problem by carefully drafting the claim to read, for example, "selecting at least one of a greatest magnitude search and a highest frequency search."

Drafting the Specification-

Astute drafters of U.S. patent applications always follow a list of "do's and don'ts." Details of the complexities, ways of drafting US patents and case studies of successes with USPTO are available as a Technical White paper delivered free to your email box. To register, contact us.

http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Canada: The Patent Pendulum

2010-01-18T19:26:00.000-05:00

In the past 12 months, two significant decisions (one in Canada, the other in the United States) have the potential to dramatically recalibrate the scope of patent protection for so-called "business methods" (and possibly "software inventions" as well). These cases may herald a backward swing of the patent law pendulum towards less protection for business methods.

In Canada, the Canadian Patent Appeal Board rejected a patent application of Amazon.com Inc. for its novel "one-click" online product ordering system. In the US, the Court of Appeals for the Federal Circuit in the Bilski case has narrowed extensively the ambit of patent protection in a decision involving a commodities-hedging system.

The Bilski decision is under appeal to the US Supreme Court, and the Amazon decision is also being appealed to the Federal Court of Canada. This is welcome, because each decision is unsatisfactory. But the importance of their ultimate respective determinations cannot be underestimated. Therefore it is worth taking stock, even at this interim stage, of the issues presented by them — and of what exactly is at stake in what will be their final judicial resolutions.

Importance of Patents
Before going into the two decisions, just a reminder of why patents are so incredibly important: in essence, it is because they afford the strongest form of intellectual property (IP) protection. While copyrights and trade secrets are useful as far as they go, they actually do not go that far because they protect only against copying. For example, independent creation is always a full defence to a copyright or trade secret claim.

By contrast, independent creation (subject to some nitty-gritty nuances) is generally not a defence in a patent claim. That is, you can never successfully be sued under copyright/ trade secret law for ripping off someone else's software if you never had access to it; but you certainly can be sued for infringing a third party's patent even if you know nothing about it. Therefore, for the duration of the patent (roughly 20 years), the patent holder can assert an effective monopoly on the invention it covers (and presumably charge monopoly profits on its sale or licensing for such time period). Patents, in a word, are incredibly valuable IP assets.

Hurdles to Patenting
Not surprisingly, given their significant value, the government agency that issues patents — in Canada, the Canadian Patent Office (CPO) — does not hand them out willy-nilly, but only very carefully and selectively, applying the patentability criteria with rigour and discipline. By contrast, copyright arises automatically, as does trade secret protection so long as you take appropriate steps to keep secret your proprietary information.

In general terms, the invention for which you desire to be issued a patent must be new and inventive. In terms of novelty, essentially this means that no one, anywhere in the world, can have disclosed or used something similar to what you want patented. And even if you satisfy this requirement, then your invention must not be obvious — it has to embody some degree of inventive spark that an average technical person in your space would not have come up with (in short, there has to be some creative ingenuity buttressing your invention).

In addition, your invention must come within one of the categories of patentable subject matter permitted by the Patent Act; namely, it has to be a "new and useful art, process, machine, manufacture or composition of matter." It was this latter requirement that was found to be missing in the Amazon case.

Amazon's One-Click Invention
To understand the genius behind Amazon's "One-Click" online ordering invention, you have to cast back your mind to the mid-1990s, and the infancy of business-to-consumer e-commerce. Unlike today (when Amazon is a leading online retailer — or "e-tailer"), back then, Amazon was one of many struggling new online businesses, each trying to set themselves apart from the others in a new, crowded and difficult marketplace.

One particular difficulty was that more than 60 per cent of online prospective consumers who started to order products from websites never completed the purchase because they found the "shopping cart/checkout line" process cumbersome, frustrating and time-consuming. Finding something to buy online was easy, particularly given the cookie technology that most e-tailers used (by sending your computer a cookie — a bit of software code — when you first visited their site, the next time you came back to the site, the cookie would allow the e-tailer to "recognize you" so that ads tailored to your own preferences — based on what you looked at last time — would be served up to you). It seems like magic — "My, how fortuitous that all of these ads showcase books that are of interest to me! It's as though they know me!" But it's not magic, of course; it's just simple cookie technology at work.

While the new e-consumer was wowed by the personalization features of e-tailers' websites, they were underwhelmed by the check-out buying process. Each time the "shopping cart" was ready to be pushed through the online cash register process, multiple screens confronted the customer with information to complete, instructions to follow, and precious time to waste (usually typing in the same information they had given on their previous visits). As noted above, the statistics showed that well over half the people who started this check-out process never completed it.

To address this real, practical problem, the clever folks at Amazon.com invented, developed, perfected and deployed on their own website their so-called "One-Click" product-ordering system. Essentially, when you wanted to purchase something from their site the second and subsequent time, you could do so by merely clicking the "One-Click" button (this would populate your order with the same information you used the last time you ordered something, thereby getting you through the check-out process in a fraction of the time). In essence, if you used Amazon, you only had to endure the check-out hassle once; after that the Amazon computer remembered who you are (courtesy of the cookie they put on your computer that first visit) and, by using your previously provided check-out data, could give you a much more satisfying online purchasing experience.

Amazon's US One-Click Patent
Amazon obtained a US patent for the One-Click invention. In the fall/Christmas season of 1999, it used this patent to great effect when, on the strength of it, Amazon successfully obtained an injunction against Barnes and Noble, preventing them from using a similar one-click check-out system on the B&N website (at the time B&N was a key rival of Amazon).
In this injunction case, B&N argued that the Amazon patent should be found invalid given all the other online ordering systems that B&N brought to the court's attention (that B&N argued proved that Amazon's system was neither novel nor inventive). The court considered each of these examples of prior art, but concluded that none actually implemented a "one-click" type functionally.
This was an important patent victory for Amazon, and forced B&N to redesign its check-out system for that critical 1999 Christmas e-commerce season. (It should be noted that subsequent litigation ensued, and the parties ultimately settled their dispute in 2002).

Amazon's Canadian Patent Application
Amazon filed for a Canadian patent for the One-Click invention, but so far has been unsuccessful in having it issued. The initial review was undertaken by an Examiner at the CPO. In Amazon's case, the Examiner concluded that the One-Click idea was not inventive, and moreover that it did not constitute patentable subject matter.

Amazon appealed to the Canadian Patent Appeal Board and the Commissioner of Patents (collectively, the "Board"). Interestingly, on the issue of inventiveness, the appeal was successful. There was one particular book on the subject of online e-commerce that pre-dated the patent application, and the Examiner held that various references in this book anticipated what Amazon had developed in its One-Click invention.

The Board carefully reviewed the book, and concluded otherwise. While use of cookies to enhance the e-consumer experience was at that time obvious, the Board found that Amazon's single-action ordering system was not obvious: the Board concluded that a skilled technician would not have directly and without difficulty conceived of the One-Click system.

Canadian Subject Matter
On the other hand, in what cannot be termed anything but a surprising decision, the Board concluded that a patent should not be issued to Amazon for the One-Click invention because it did not constitute patentable subject matter. In essence, the Board stated unequivocally that in its view, a pure business method that has no "technological effect" is not patentable in Canada.

This is startling for several reasons. First, the current CPO Manual of Patent Office Practice expressly states that business methods are not automatically excluded from patentability by jurisprudence or statute. In its decision, the Board considered and rejected that statement in the Manual. Therefore, for the Board to take such a hard and unnuanced view of business methods is disappointing (more recently, a proposed amendment to the Manual would bring it in line with the Amazon decision, also denying patentability to business methods).

The second surprising aspect of the Amazon decision is that the Board found that the term "art" and "process" in the Patent Act are confined to acts performed by "some physical agent upon some physical object and producing in such object some change of character or condition." That is, the Board believes that all categories of invention in the Patent Act are physical in nature; they involve tangible object or instruments. The decision also seems to ignore the prevalence of computers and processing systems in today's environment in assessing the "technological effect" issue.

Describing this conclusion in another way, the Board stipulates that the common characteristics of the five categories of invention is that they are "technological" in nature. And the Amazon One-Click invention does not qualify because it is only a retailing concept and some rules for ordering items. (As the Board stated, "Single-action ordering without checkout ... involves streamlining the rules for practice for shopping, that is, it relates to a business decision with business implications. There is nothing technical about this aspect of the claimed invention.").

The authorities relied upon by the Board for its conclusion on patentable subject matter are strange, particularly in terms of its use of American authorities. For example, it cites the dissent in a Canadian Supreme Court decision that refers to the State Street Bank case, which did not involve a physical system! And the Board cites the Bilski decision, which as we shall see in the next TLQ, actually takes a much more nuanced view of business method patents. (After reviewing Bilski, we will also draw some conclusions about the practical — and strategic — impact of these two cases.)

Disclaimer : The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Canada´s Federal Court Of Appeal Limits Damages Available To Delayed Generics-

2010-01-08T15:16:00.000-05:00

On June 4, 2009, in Merck Frosst Canada Inc. v. Apotex, Inc., the Federal Court of Appeal released an important decision limiting the range of damages available in actions under section 8 of the Patented Medicines (Notice of Compliance) Regulations. In particular, the Court of Appeal confirmed that section 8 damages do not include either an accounting of the innovator's profits or any damages for loss of market share that extends beyond the period for which the generic company's approval was actually delayed.

Background-

The Regulations-

The Regulations are intended to provide innovators with protection from early generic entry in light of Canada's scheme to allow early working of patented drugs by generic pharmaceutical companies ("second persons") for the purpose of seeking regulatory approval. Under the Regulations, a drug company that files an abbreviated new drug submission (ANDS) with the Minister of Health for approval of a generic version of an innovative drug must serve a notice of allegation for each relevant patent listed by the innovator on the Patent Register. If a generic company makes an allegation of invalidity or non-infringement in respect of any patent, the patentee may apply to the Federal Court for an order prohibiting the Minister of Health from approving the ANDS on the ground that it would result in the infringement of a valid patent. The Regulations provide that the filing of such proceeding automatically stays the Minister's approval of the ANDS for the duration of the proceeding, up to a period of 24 months.

Triggering an automatic stay is not risk-free for patentees. Section 8 of the Regulations provides that a generic company may bring an action against the patentee to receive compensation for "any loss suffered" by virtue of a delay in receiving its approval. The period of delay is defined to be the period beginning on the date on which the ANDS would have been approved by the Minister "in the absence of these Regulations," and ending on the date of the withdrawal, discontinuance, dismissal or reversal of the proceeding brought under the Regulations. Subsection 8(4) states that the court may make such order for relief "by way of damages or profits" as the circumstances require.

Apotex's Section 8 Claim Against Merck Frosst
In Merck Frosst, Apotex brought an action in damages under section 8, following the Federal Court's dismissal of Merck Frosst's application for a prohibition order in respect of Apotex's proposed alendronate drug product. Merck Frosst defended Apotex's damages action on a variety of grounds, including the argument that Apotex could not claim an accounting of profits or damages for any permanent loss of market share (allegedly caused by the delay attributable to Merck's failed proceeding).

In October 2008, the Federal Court held that section 8 does not enable second persons to claim an innovator's profits. They could claim damages for any permanent loss of market share caused during the period set out in section 8, as a result of the innovator's unsuccessful proceeding under the Regulations. That decision also dismissed several administrative and constitutional arguments as to why section 8 should not be enforced by the federal courts.

The Federal Court of Appeal Limits the Damages Available Under Section 8
The Federal Court of Appeal affirmed the Federal Court's finding that section 8 does not authorize a generic company to claim an accounting of profits from the innovator for any delay allegedly caused by an unsuccessful proceeding under the Regulations. While disgorgement of profits is a remedy available to a patentee under the Patent Act, the Court of Appeal emphasized that a delayed generic company is not in the same position as a patentee.

The Court of Appeal held that the use of the terms "damages or profits" in section 8 should be interpreted to mean "damages or lost profits" because the purpose of this provision is to compensate generics for any delay: "a measure which compels a first person to place the second person in the position in which it would have been, if the operation of the stay had not been triggered, fits well within the contemplated balance" (para. 90). The Court of Appeal also affirmed the Federal Court's decision on the administrative and constitutional arguments, permitting the section 8 claim to go forward.

The Federal Court of Appeal reversed the Federal Court on the issue whether a second person may claim for any ongoing loss of market share. Relying on the wording of section 8, which defines the specific period of time for which damages are available, the Court of Appeal held that an innovator is not liable for any long-term losses caused by a failed proceeding under the Regulations. Although an innovator may be liable for lost sales during the defined period, Apotex's market share claim was barred to the extent that its alleged disadvantage (i.e., its late market entry) would result in lost sales after the period defined in section 8.

Disclaimer : This information is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Canadian Patent Disclosure Requirements Clarified

2010-01-07T09:59:00.000-05:00

In a decision dated August 12, 2009, the Federal Court clarified the disclosure requirements in patent drafting. This case is important to patent owners as it makes clear that misinformation, lack of information or insufficient information to support the invention can be fatal to a patent's validity. In Ratiopharm Inc. v Pfizer Limited 2009 FC 711, the Federal Court found a patent that contained inaccurate information invalid on the basis of obviousness, lack of utility, insufficiency, invalid selection and Section 53(1) of the Patent Act (which provides that a patent is void when there were material misstatements willfully made in the patent for the purpose of misleading).

The case in question involved a claim to the besylate salt of the pharmaceutical ingredient amlodipine. The patent promised that the besylate salt had certain advantages over other salts that were "unexpected" and that it had a "unique" combination of properties that made it "outstandingly" suitable for pharmaceutical preparation of amlodipine. (para. 108) Such superlatives can often be found in patents, particularly in improvement patents, however, those superlatives are often accepted at face value or side-stepped as, in effect, puffery.

In the present case, the court looked closely at the disclosure and data in the patent in light of evidence presented at the trial. The Court considered whether the superlatives were justified and found that, contrary to the representations in the patent, the unique or outstanding properties of the besylate salt were shared with other salts as well. The patent omitted data that would have shown similar properties in other salts. The court noted that the superlative words such as "unique and outstanding" were not words used by the inventors respecting the besylate salt but were words that had been selected by the patent department who had drafted the patent.

As amlodipine and its pharmaceutically acceptable salts had been claimed previously, the Court considered whether the claim to amlodipine besylate qualified as a selection patent. The Court concluded it did not merit such status as "adjectives and adverbs without solid foundation cannot create a 'selection patent' where none in fact exists". (para.179) Neither the patent itself, nor the evidence demonstrated the besylate salt to be sufficiently superior to the other salts to qualify.

The Court also conducted a utility analysis based on the promise that amlodipine besylate was superior to other salts. It accepted the evidence at trial that the besylate salt did not deliver the superior performance promised by the patent. The court went on to say that an inventor has a duty to act uberrima fides, to give all information known to him that will enable the invention to be carried out to its best effect as contemplated by him. On the evidence at trial, the promised utility of the invention was not fulfilled.

The court further analyzed the patent under sufficiency, in accordance with Patent Act requirements to correctly and fully describe the invention and its operation or use as contemplated by the inventor. It noted that courts in the past had focused on whether the patent itself provided sufficient information to enable a person skilled in the art to make use of the invention as contemplated by the inventor. On the evidence, the court accepted that what the inventor contemplated, and what the patent disclosed, were not one and the same. It noted that other courts, when assessing the sufficiency of the disclosure in the absence of other evidence, had to assume that the words of a specification coincided with what the inventor contemplated. In this case, the evidence showed that the specification of the patent did not disclose the invention, as contemplated by the inventors. The patent was found invalid as failing to correctly and fully describe the invention as required by the Patent Act.

The court also analyzed the patent under Section 53.1 of the Patent Act, which indicates that a patent will be void if the patentee willfully provides in the specification more or less than is necessary, so as to mislead a person skilled in the art. The court found a breach of Section 53 in that the patentee, Pfizer, (i) omitted to mention the stability of another salt and stated that the salt was unsuitable for tablet formulation, when it was in fact suitable, (ii) omitted test data demonstrating the suitability of other salts and (iii) added a statement that none of the salts had been found to be satisfactory, when in fact that was not the case. The court concluded there were misstatements that served to enhance the alleged uniqueness and outstanding characteristics of the besylate salt and that these misstatements and the selection of superlative descriptive words were the work of patent draftsmanship and not of the inventors. The court also concluded that proper disclosure was essential in a patent and that intent to mislead could be inferred. The court found sufficient intent to make such misleading statements based on the evidence.

Counsel who are drafting or supervising the drafting of patent applications are well advised to carefully consider the disclosure requirements set out in this case. The Court quoted the inventor who stated that "a patent has to be clear, honest and right" with approval. (para. 55) The patent specification must describe the invention made by the inventor, not a super version of that invention. The patent drafter cannot choose patent data in support of the invention that omits relative data that might detract from a promise of uniqueness or special attributes. Careless patent drafting or inflating an invention so as to increase its patentability, risks not only a finding of invalidity for insufficient or inadequate disclosure but also a finding of fraud by the patentee itself. The conclusion to be drawn from this case is that care must be taken by those drafting a patent. The patent specification and claims must correctly and fully describe the invention rather than a wished-for invention. Disclosure in support of the invention should be full and frank and not selective and incomplete.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Disclaimer : This information is intended to provide a general guide to the subject matter. Specialist advise should be sought about your specific circumstances.

Canada: CIPO's New Draft Guidelines Could Result In Higher Disclosure Standards For Canadian Patents

2010-01-06T07:04:00.000-05:00

The Canadian Intellectual Property Office (CIPO) has released a further update to the Manual of Patent Office Practice (MOPOP), an administrative document of CIPO that examiners refer to during the patent examination process.

The latest update is a draft version of Chapter 9: Descriptions, and is now available for public comment. Chapter 9 sets out CIPO's views on the description requirements of Canadian patent applications. While the MOPOP does not carry the force of law, it reflects CIPO's interpretation of the patent statute and surrounding jurisprudence and the administrative position that CIPO is likely to take when examining an application.

The new Chapter 9 is expected to overhaul the current edition in use at CIPO, which was relatively brief in reciting the technical requirements of a patent description and contained only two short paragraphs discussing the requirement that the description be sufficient to support the claimed invention. In the newly proposed guidance, there is an expansion on the disclosure requirements necessary to identify, enable and establish the utility of an invention. The new guidance would have examiners analyzing the description to determine whether the application provides sufficient disclosure of a solution to a practical problem that is reflected in the claims.

Additionally, new Chapter 9 indicates that for an invention to be enabled, a person skilled in the art must be able to practise the invention without "undue burden or the need to exercise their inventive ingenuity." The new chapter also provides a detailed discussion of obviousness for examiners to verify properties of the claimed invention. Examiners are now likely to look for literal support for the invention as claimed, which would be a very rigid and restrictive interpretation of the support requirements under the Canadian Patent Act. This approach is, however, not explicitly stated in the chapter.

Further, the new Chapter 9 describes how examiners will determine which aspects of an invention are "essential elements," – that is, elements necessary to provide a solution to the practical problem at hand. Under the doctrine set forth by the Supreme Court of Canada, claim construction requires a purposive analysis of which elements are considered to be essential or non-essential by a person skilled in the art. However, Chapter 9 now directs examiners to take a different perspective in determining essential elements of the description/invention than the courts take in determining essential elements of the claims.

The new Chapter 9 indicates that "[w]here the description requires that an invention comprise a given element, that element must appear in each claim to that invention in order that the claim not be broader than the description," and that an element may be essential even if a person of ordinary skill would not view the same element to be essential. It is unclear why examiners are to ignore the views of the notional person of ordinary skill or why they are to take a different approach to defining essential elements of a description/invention – an approach that appears to be a different requirement to the purposive construction principle for construing claims as set out by the Supreme Court.

Patent applicants in Canada are required to demonstrate the utility of the claimed invention as of the filing date, either by demonstration or by "sound prediction." The new Chapter 9 cites recent case law from the Federal Court that may raise the bar for disclosure requirements in the context of soundly predicting the usefulness of a claimed invention. We expect there to be more calls for supporting data to satisfy examiners of demonstrated utility.

Overall, new Chapter 9 would be problematic if ultimately adopted, especially for applicants with international patent programs as it appears to elevate the disclosure requirements for a Canadian patent description to a standard that is much higher than in other jurisdictions. Subsection 27(1) of the Patent Act directs the Commissioner of Patents to grant a patent if an application "is filed in accordance with th[e] Act and all other requirements for the issuance of a patent under th[e] Act are met".

Disclaimer – This information iss for knowledge purpose only and should not be interpreted as legal advise.

AUSTRALIAN PATENT OFFICE: Patent term extension available if it has certain pharmaceutical characteristics

2010-01-04T10:16:00.000-05:00

The Australian Patent Office has handed down a significant decision in the land down under, which impacts the type of pharmaceutical subject matter that is eligible for term extension. N.V. Organon [2009] APO 8.

According to Section 70 of the Australian Patent Statute, in order to be eligible for an extension of term, either or both of the following conditions must be satisfied:

(a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;

(b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.

The “per se” limitation has been held to mean that the claim cannot be limited by reference to how that pharmaceutical substance is made, or by reference to dosage regimes or the like.

“Pharmaceutical substance” is defined in the statute as being “a substance (including a mixture or compound of substances) for therapeutic use…”. There have been several patent office decisions which have considered the meaning of “a substance (including a mixture or compound of substances) for therapeutic use…”.

Before discussing the N.V. Organon case which has just issued, it is worthwhile briefly sketching out the prior landscape:

The first case was LTS Lohmann Therapie-Systeme GmbH & Co KG [2002] APO 12. The subject matter of this case was a transdermal patch. In this case, the Commissioner concluded that, if the claim defined features specifying the “spatial configuration” of the entities within the mixture, then the claim was not directed to a pharmaceutical substance per se. The Commissioner reasoning focused on the fact that, once spatially confined, the substance ceases to be a “mixture”. There has been some criticism of the decision.

The second case was Sanofi-Aventis [2007] APO 35. The subject matter of this case was a bi-phasic controlled-release dosage form. After initial rejection, the Commissioner concluded that the word “compound” must be understood in the sense that it is used within the pharmaceutical industry rather than the narrow meaning in pure chemistry. Hence, the bi-phasic form was a “compound”.

The third case was Euro-Celtique, S.A. [2007] APO 13. The subject matter in this case was a transdermal patch, although the claim did not expressly claim the backing layer and there was some small distinction over the earlier LTS case which did expressly claim the backing layer. Notwithstanding this point of distinction, it was held that the claim was not to a substance per se due to the implied presence of a backing layer.

In the present case, N.V. Organon, the subject matter is a vaginal ring for delivery of steroids. The claim defines a polymer core, in which the steroids are impregnated, and a permeable polymer skin surrounding the core. The critical question was whether such a structure was “a substance (including a mixture or compound of substances).” In following the Sanofi decision, the Commissioner held that “substance” and “compound” should be given broad meanings in order to reflect the statutory intent.

At paragraph 21 of the decision, the Commissioner states that the “spatial configuration” reasoning of LTS “ceases to be persuasive” and is not determinative of the question. The Commissioner held that while “compound”, even in a pharmaceutical context, can be given broad meaning, it was not intended to assist the developers of other therapeutic products or processes including medical apparatus used with therapeutic substances, no matter how innovative and despite also being subject to regulatory approval processes:Pharmaceutical substance (including a mixture or compound of substances) can include a compound with a controlled spatial configuration if, as a whole, it can still be considered a pharmaceutical “substance” but the combination of such a substance with what would reasonably be considered a separate physical device, layer or structure or, from Sanofi, “any purely physical integers” is excluded and indeed would not be a “pharmaceutical substance per se”.

Ultimately, the Commissioner held, at para 23, that the question to be asked is “whether the characteristics of what is claimed more predominantly lies with it being a substance rather than a substance in combination with a separate integer”:

Many pharmaceutical substances involving mixtures of active and other additives can be characterised as a delivery system. What is more important is the actual features of the product claimed. In this case it can be said that the thermoplastic materials in NUVARING have a physical purpose to position, contain and provide for the controlled release of the steroidal components for interaction with the human body. There are also two distinct and adjacent physical layers or regions that differ in composition, that is, the core and skin. I note that the bi-layered tablet considered in Sanofi could be said to have similar characteristics although, in that case, the excipients or additives dissolve in the body and do not retain their structure after the active is delivered. The latter could well suggest that the thermoplastic core and skin are more in the nature of separate physical integers. However, from Dr de Graff’s evidence, the steroidal components in NUVARING are mixed with and necessarily diffuse through the thermoplastic materials in the core and skin regions and as such the product as a whole exhibits a level of integration or interaction between the component parts that, in my view, is more characteristic of a pharmaceutical substance in itself rather than a substance combined with another element or thing.

The Commissioner concluded that one must look to the “level of integration or interaction” when deciding whether the claim is to a substance, or to a substance in combination with a separate integer. In this case, the steroids were impregnated into the polymer core, and therefore the claim was to a substance rather than to a substance in combination with a separate feature.

Practical Implications-
The test is now one of “integration” between the active ingredients and the other feature(s). On this basis, it would appear that at least impregnated transdermal patches are now suitable subject matter for an extension. Similarly, impregnated polymer implants are clearly good subject matter. Undoubtedly, there are other similar drug delivery products which are now also suitable for extension of term (e.g. pulmonary delivery, etc).

Reference posts:
Australian Pharmaceutical Patent Term Extension for Patches and Implants Bill Bennett, of Pizzeys in Australia, sent a note detailing...
Australian Patent Office Clarifies Novelty Test For Enantiomers A recent decision of an Australian appeal court concerning a...
Patent Office Budget Shortfall Will Have Long-Term Effects You’re not alone in your suffering. The recession has even...
Life Cycle of an Australian Innovation Patent Today’s article looks at the life and practicalities of the...Australian Federal Court: Amend Patent Claims Before Filing Suit An Australian Federal Court decision provides a reminder to diligently...

Disclaimer : The above information has been cited from literature in public domain. This is for research purpose/ dissemination of knowledge only.

THREE IMPORTANT CANADIAN PATENT DECISIONS IN DECEMBER 2009-

2009-12-15T09:18:00.000-05:00

In Canada, linkage regulations similar to the Hatch-Waxman Act in the U.S. ensure that generics manufacturers have to address relevant patents listed on the Patent Register (the analog to the Orange Book) if they want to market their product prior to the expiry of listed patents. Generics manufacturers can do so either by accepting the terms of the patents, or by filing a Notice of Allegation (NOA) alleging, amongst other things, that they will not infringe the patent or that the patent is invalid.

On December 1, 2009,three recent decisions litigated in this context were highlighted. These contain important notes for pharma companies, biotech companies, generics companies and their patent attorneys and agents.

The Patent Act (post-1996) Imposes a Duty of Candour and Good Faith.
In Lundbeck Canada Inc. et al v. Ratiopharm Inc., Lundbeck’s patent was invalidated because the patent agents failed to “fully and fairly describe” the prior art in responding to an obviousness rejection raised by the patent examiner. This decision may take on a broader impact, particularly if it is interpreted to require Canadian applicants to affirmatively inform examiners of aspects of the prior art that are both favorable and unfavorable.

Formulation Patents Must Claim All Medicinal Ingredients.
In Bayer Inc. v. Canada (Minister of Health) et. al., Bayer’s patent was held to be ineligible for listing on the Patent Register, despite reading on the product. Where the approved product contains a formulation with more than one medicinal ingredient, only patents that claim formulations containing all of the approved medicinal ingredients may be listed on the Patent Register, regardless of whether the product is covered by the patent claims.

Disclaimers Can Be Validly Filed After Receipt of a NOA.
In sanofi-aventis Canada Inc. v. Hospira Healthcare Corporation, sanofi responded to Hospira’s NOA by filing a disclaimer in respect of a portion of one of sanofi’s listed patents. Hospira argued that the Court should consider the Sanofi patent as it read on the date the NOA was served and not as it read after the disclaimer was filed. Although the court held (in favor of Sanofi) that the patent should be read as of the date of the hearing, it also held that Sanofi’s particular disclaimer was invalid because the patentee had not unequivocally testified that the disclaimer was a result of claiming too broadly in the patent as issued. Such an admission was necessary to the validity of the disclaimer. The court also held that having attempted a disclaimer, Sanofi could not subsequently assert against Hospira the portions of the patent it had attempted to disclaim.

Disclaimer : The above information has been cited from literature in public domain. This is for research purpose/ dissemination of knowledge only.

Canadian Patent Law- example skeleton of a patent

2009-11-04T15:59:00.000-05:00

...contd/

Example of a Skeleton of a Patent :

The following is a skeleton for a typical patent application. What is written in italics would be replaced by that feature relevant to the invention.

____________________________________________________________________

TITLE

Abstract

A name of apparatus includes inventive features.

Field of the Invention

This invention relates in general to type of apparatus and more particularly to title of invention.

Background of the Invention

RECITE NATURE OF THE PROBLEM ADDRESSED BY THE INVENTION

Prior art name of apparatus have been devised to address to the problems cited above. For example, cite publicly available applications, patents, devices, papers.

Thus a type of apparatus which set out improved characteristics is desirable.

Summary of the Invention

One aspect of the present invention is to provide an improved type of apparatus.
In accordance with one aspect of the present invention, there is provided consistory clause.

Conveniently,
Preferably,

Advantages of the present invention are: list elements from the broadest claim. An advantage of an embodiment of the present invention is list from dependent claim.

Brief Description of the Drawings

A detailed description of the preferred embodiment(s) is(are) provided herein below with reference to the following drawings, in which like numbers refer to like elements. The drawings are:

Figure 1, in a describe view, illustrates a type of apparatus in accordance with an/the preferred embodiment of the present invention;

Figure 2, in a describe view, illustrates the type of apparatus of Figure 1.

Detailed Description of the Preferred Embodiment

Referring to Fig. 1, there is illustrated in a describe view, a type of apparatus in accordance with an/the preferred embodiment of the present invention. The type of apparatus includes describe parts in hierarchical fashion.

In Fig. 2, the type of apparatus of Fig. 1 is illustrated in a describe view. Fig. 2 shows describe parts in hierarchical fashion.

In operation, the type of apparatus can explain improved operation of device. How this is achieved is explained below with reference to Fig. list figures.

In summary, a *** is provided with *** for ***.

Other variations and modifications of the invention are possible. For example, set out alternative not described above.

While one (or more) embodiment(s) of this invention has (have) been illustrated in the accompanying drawings and described above, it will be evident to those skilled in the art that changes and modifications may be made therein without departing from the essence of this invention. All such modifications or variations are believed to be within the sphere and scope of the invention as defined by the claims appended hereto.

[start new page here]

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

Claims ...

____________________________________________________________________

For expert patent drafting and evaluation as well as handling infringement issues please visit http://www.drshrutibhat.com/

Disclaimer- This article is for information purpose only and not to be considered as any kind of legal advise.

Canadian Patent Law- description and drawings of a patent

2009-11-04T15:56:00.000-05:00

...contd/

The Description (Disclosure) :

The nature of the invention must be defined in the disclosure and the manner in which the invention is to be carried out, must be described. In the case of a machine (for example, a computer), the best mode of operation must be described. In the case of a process (for example, the implementation of an algorithm by computer process), the necessary sequence of steps must be explained for distinguishing the invention from the prior art.

The description is like a manual that accompanies a kit such as a home barbecue. In the case of a patent for an apparatus, it includes a parts list identifying the parts needed to make the apparatus and assembly instructions explaining how to put the parts together. This description is used as a cross-reference to a series of drawings bearing numbers corresponding to the parts illustrating how the device is put together. Operating instructions explain how to use the device in the best manner known.

The description must describe the invention and its uses contemplated by the inventor. The description must be clear, accurate, simple and easy to understand by the person or persons to whom the patent is directed, namely the skilled workers in the relevant field (See Claim Construction).

Body of the description -

The disclosure is usually divided into the following sections;

(a) the Area of the Invention,

- a general description of the field of the invention;

(b) a description of the prior art and their problems,
- what solutions existed in the past to similar problems and what problems were not overcome by the prior art;

(c) the Object of the Invention,
- this describes the desired results of the invention. A statement of the object of the invention is not mandatory and is sometimes dangerous to include because all claims must meet the object or they will fail for being too broad;

(d) the Consistory Clause,
- a generalized description of the invention. Usually the language from the broadest claim is restated to make the description consistent with the broadest claim;

(e) the description of the preferred embodiment of the invention,
- an example of an implementation of the invention. Usually the best version of the invention known at the time that the patent application was filed. It is described with reference to the drawings;

(f) a description of further embodiments; and

(g) a generalised statement that the embodiments are illustrative and not limiting,
- an attempt by the inventor to let everyone know that the monopoly is not limited to the embodiment shown in the patent.

Drawings :

The disclosure must also refer to any drawings forming part of the application. Many patent agents begin sketching informal or conceptual precursors to the formal drawings while drafting the claims and then finalize the drawings while drafting the description. If certain information that is not otherwise publicly available is needed in order to make or use the invention, then it must be included in the description or else the patent will be declared invalid for failing to describe the best mode of operation of the invention or its necessary sequence of steps.

Canadian Patent Law- types of claims

2009-11-04T15:53:00.000-05:00

...contd./

A patent can be for an article, a method or a composition. An example of a method claim is :

1. The method of conditioning fabrics which comprises commingling pieces of damp fabric by tumbling said pieces under heat in a laundry dryer together with a substrate carrying a transferable conditioning agent, thereby to effect transfer of the conditioning agent to the fabric while being dried.

An example of an article or product claim is:

A fabric conditioning article comprising a flexible substrate carrying a normally solid fabric conditioning agent, said fabric conditioning agent comprising a material which has a softening temperature below the temperature of from about 120o F. to about 190o F. encountered in a laundry dryer to enhance thereby transfer of said fabric conditioning agent to fabrics contacted therewith, the weight ratio of fabric conditioning agent to flexible substrate being at least 0.25:1.

Jepson claim :

In the United States, the Jepson claim is popular.

A Jepson claim recites the prior art in the preamble, uses the transitional phrase "the improvement comprising" and then recites the new elements or improvements to the prior device or method.

Rule 6.3 of the Patent Cooperation Treaty Rules requires that wherever possible, claims should be written in this form. It is not necessary to write them in this form in a P.C.T. application if you have filed your application in a country in which the form is not mandatory.

Markush claim :

Markush claims are often used in chemical composition patents where a selection can be made from a "class" of claim elements.

An example of a Markush claim is:

1. A liquid dishwasher detergent emulsion having high alkalinity, high levels of sequestrant and high temperature stability, said detergent emulsion comprising:

i) 4 to 25% w/w of an alkali metal hydroxide suitable for use in a dishwasher;

ii) 0.2 to 5% w/w of a low foaming free non-ionic surfactant;

iii) 0.5 to 3% w/w of a polyacrylic acid suitable for enhancing sheeting action on non-porous surfaces;

iv) 15 to 30% w/w of a potassium polyphosphate sequestering composition enriched in tripolyphosphate and comprising minimal amounts of ortho and long forms of polyphosphates to facilitate thereby solubility of said potassium polyphosphate in water;

v) 2 to 6% w/w of a polymeric emulsion stabilizer for said free nonionic surfactant, the polymeric emulsion stabilizer being a chemically associated polycarboxylic acid polymer and a nonionic surfactant formed by polymerization of said nonionic surfactant with a polymerizable reactant selected from the group consisting of acrylic acid, polyacrylic acid, copolymers of acrylic acid and an ethylenically unsaturated polycarboxylic acid or an anhydride thereof, copolymers of ethylenically unsaturated polycarboxylic acid or anhydride thereof with a non-carboxy containing ethylenically unsaturated monomer, said nonionic surfactant and said reactant being polymerized in an aqueous media;

vi) 0 to 15% w/w of a sequestering agent to enhance hard water sequestering characteristics of said potassium polyphosphate; and

vii) water to make up the balance of composition to 100% w/w.

2. A liquid dishwasher detergent emulsion of claim 1 wherein said alkali metal hydroxide is selected from the group consisting of sodium hydroxide, potassium hydroxide and mixtures thereof.

Canadian Patent Law- drafting claims

2009-11-04T15:41:00.000-05:00

...contd.

The Claims :

The claims define the monopoly in words.

A patent may have many claims, each defining the invention in different words and describing it broad or narrow functional language. A typical claim has the following form:

Preamble ... transitional phrase ... claim elements.

In Canada, claims are most commonly of the form having a brief preamble describing the apparatus or method in terms of its field of use, the transition "comprising", and followed by the claim elements (apparatus elements or process steps) which are like a checklist of the components of the claimed invention.

Claims are sometimes analogized as a series of "fences" surrounding and protecting the valuable invention. The claims define the metes and bounds surrounding the protected invention, much like surveying terminology defines the metes and bounds to a piece of land containing gold. The fences must be clearly defined in order to give the necessary warning. Property which is not owned by the inventor must not be fenced in, otherwise the claim will be invalid as being broader than the invention.

Claims are usually drafted with multiple, dependant claims.

As such, they are like a set of nested fences, each fence surrounding a more particularized form of the invention. If one of the outer most fences fails the inner ones remain to protect the invention. The larger fences are the broad claims; the narrowest fences are the narrow claims.

Another way of considering a claim is to describe them by use of a Venn diagram, which is a mathematical illustration used to identify "sets". The Venn diagram of some claims would be analogous to an aerial photograph of the "fences" surrounding the invention. The claims would be a series of sets and subsets, all including the invention at the centre of the sets. Anything that met the description of that set, would fall inside that claim and infringe it.

The invention can be described in a number of ways and therefore, there can be different sets of claims each with dependant claims, all protecting the invention at the core.

The broadest fence includes the most and would correspond to the broadest claim; the narrowest fence would include the least and would correspond to the narrowest claim.

The invention can be described in a number of ways. There can be different sets of claims, represented by the elliptical fences 5 to 9 at left, all of which protect the invention at the core.

A patent could have any number of these sets of independent claims; all of which would protect the invention. A patent’s claims can also be illustrated as a tree-structure, with branches indicating dependency.

The tree structure illustrates - Claim 2 is dependent on claim 1, claim 3 is dependent on claim 2, etc.

The form of the claim -

In Canada, an invention can be claimed in one patent in more than one statutory class: ie. as an apparatus or a process or both. For example, an invention may be defined by a process claim, or as an apparatus which carries out the process.

A combination-type claim is one where the invention is described as a combination of elements or steps which achieve a desired result or interaction.

In some instances, the invention is best described by either an improvement claim (a claim where only the improvement to an existing apparatus or process is claimed), or European-style claim (one where the preamble describes the known prior art).

A claim for an apparatus should not contain a process step as an element; similarly a claim for a method should not contain an article as an element. Such claims are referred to as ones with "mixed elements". An example of the first type is:

A digital signal processor comprising:

a) a first register for storing signal data,
b) transferring said signal data to a second register...

You can incorporate a process limitation in a claim for an apparatus. For example: A computer comprising:

"means for storing signal data..." or "a first register for storing data..."

The clause beginning with the word "for" describes the function or process carried out by the apparatus.

A claim can recite a process step that contains a hardware or machine limitation. For example:

A method for processing seismic data, comprising the steps of:

...collecting the time-varying seismic detector output signals from a plurality of seismic sensors positioned in a cable ...

In the latter example, the signals are collected from a recited structure. The structure is the hardware or machine limitation within the process step.

Preamble to the claim :

Combination-type claims traditionally begin with a preamble that is designed to identify the class of invention and recite any prior art elements with which the invention co-operates
The invention should be described in terms of statutory subject matter.

Body of the claim :

In a combination-type claim, the invention is described as a combination of parts which interact to achieve a certain result or function. In formulating a combination-type claim, functional limitations may be expressed in "means-plus-function" format. Under U.S. practice, the court will interpret the recited "means" as including the preferred means disclosed in the specification as well as functional equivalents, subject to any express limitation in the disclosure.

Dependant claims :

After drafting independent claims in one or more statutory classes, the patent agent usually then drafts a number of dependent claims for defining subordinate features to those recited in the independent claims or to further define features and/or structure of the essential claim elements.

Canadian Patent Law- introduction and anatomy of patent

2009-11-04T15:31:00.000-05:00

Introduction:

The article (as series) mentions a brief about Canadian patent law. Reader is advised to consider this article for information purpose only and not as legal advise of any kind. Hope you find the articles informative.

Patents protect inventions: either the functionality of a machine, a composition of matter or a process. In Canada, patent law is governed by the Patent Act, R.S.C. 1985, C. 33 (3rd. Supp.).

The Federal Government of Canada grants patents to inventors or assignees of inventors. Every patent grants to the patentee and its assignees for the term of the patent, beginning at the grant of the patent, the exclusive right, privilege and liberty of making, constructing and using the invention and selling it to others to be used.

The right to exclude others is exercised by suing infringers or granting licenses. It is up to the patent owner to enforce the patent. It has been said that a patent is not a monopoly but rather is a "licence to litigate".

A patent is sometimes described as contract between the inventor and the government. In consideration for the inventor disclosing the invention in the patent and making it available to the public after the expiration of the patent, the government grants to the inventor the right to exclude others from making, using or selling the invention during the term of the patent.

Anatomy of a Patent :

Every patent has a similar structure. The entire patent is called the "specification". The two main parts of the patent are the "description" (sometimes called the "disclosure") and the "claims".

The description and the claims serve two very different purposes:

(a) the description tells the public how the make or use the invention when the patent expires; and
(b) the claims describe what is not to be made or used during the term of the patent.

2.1 The Title Page

The title page of a patent provides "tombstone information" concerning the patent: the title, the inventors, the person to whom the patent was granted, the application date, the priority date, the grant date and, for patents filed after October 1, 1989, the date that the patent application was "laid open" to the public.

2.2 The Abstract

The Abstract is the "headnote" of the patent, providing a summary of the invention and its use. It includes a summary of the disclosure and indicates the technical field to which the invention relates. It should describe the technical problem and the solution of the problem by the invention. Its purpose is to provide a succinct description of an invention so that a reader can decide whether the rest of the patent is of interest.

Abstracts are now available through on-line computer databases and are commonly used for searching the technical literature to see what areas are already patented.

The Canadian Manual of Patent Office Practice, which describes the procedures followed by the Canadian Patent Office, describes the purpose of the Abstract as follows:

CONTENT OF ABSTRACTS :

Applicants for patents are required to submit an abstract of the disclosure with each application to provide a synopsis of the invention disclosed. The abstract shall be a summary of the disclosure, and shall indicate the technical field to which the invention pertains. It shall be drafted in a way which allows the clear understanding of the technical problem, the gist of the solution of that problem through the invention and the principal use(s) of the invention. Where applicable the chemical formula that best characterizes the invention shall also be included. The text of the abstract should avoid patent jargon so that it may be readily understood by technicians, scientists, industrialists and other persons who are interested in obtaining information about issued patents. It should provide a means for quickly determining the nature of the disclosure so that the reader can decide whether a copy of the full specification would be useful to him. It should be a clear and concise condensation of the technical content of the disclosure.

For expert opinion in patent matters please visit http://www.drshrutibhat.com

Additional information on Canadian patent law is available at-http://laws.justice.gc.ca/en/P-4/SOR-96-423/index.html

Canada and the U.S : Differences in Patent Law

2009-11-02T16:44:00.000-05:00

General

A patent may be invalidated if fees are incorrectly paid at the small entity rate. New regulations that are in their final stages of approval will require that small entity payments are accompanied with a small entity declaration. In order to avoid any possible errors associated with an incorrect entity fee payment, it is recommended that entity fees be paid at the large entity rate.

Voluntary Divisional applications should not be filed with the Canadian Patent Office. A divisional application should be filed following receipt of a unity of invention objection issued by the Examiner. In order to ensure that a unity of invention objection is raised, additional claims directed to any desired subject matter should be filed as early as possible during prosecution. There are no excess claim fees in Canada. However, maintenance fees on the divisional application are due from the date of filing of the parent application.

Joint Ownership of Patents: In Canada, a patent co-owner cannot dispose of anything less than their entire interest in the patent (e.g. a license) without first obtaining the consent of the other co-owners. Any form of disposition of a partial interest in a patent, which has the effect of diluting the interest of the other co-owners, requires the consent of such co-owners.

Life Science

Embryonic stem cells are considered patentable subject matter provided they cannot develop into an animal - for example, totipotent stem cells are not allowed. Pluripotent stem cells, multipotent stem cells, or adult stem cells are acceptable subject matter.

Animals at any stage of development, from fertilized eggs on, are considered higher life forms and not patentable. Plant are also considered higher life forms and not patentable. Claims to an animal cell or a plant cell are acceptable.

Organs and tissues are not considered compositions of matter and are not patentable. A Patent Office Notice (June 2006) states that “[o]rgans and tissues are created by complex processes, elements of which require no human intervention, and do not consist of ingredients or substances that have been combined or mixed together by a person.” However, an artificial organ-like or tissue-like structure, generated by the hand-of-man by combining various cellular components and/or inert components, may be considered to be a composition of matter and patentable.

• Methods of medical treatment are not allowed in Canada. Claims directed to a method of medical treatment may be amended to a "use" format which is accepted in Canada.

Information Technology

Computer programs per se expressed as lines of code or listings are the subject of copyright protection but software that has been integrated with a traditionally patentable subject matter may be patentable if the traditional criteria for patentability are satisfied. The Patent Office's position is that for a method to be considered a patentable art, the method must be: an act or series of acts performed by some physical agent upon some physical object and producing in such object some change either of character or of condition; and it must produce an essentially economic result relating to trade, industry or commerce.

Business method-related inventions are not automatically excluded from patentability. Rather, such inventions may be allowable in Canada provided they meet the substantive criteria for inventions as established by the Patent Act and Rules and the decisions of Canadian courts. For example, subject matter that relates to the skills of a professional is not considered patentable in Canada. Business methods implemented as computer programs must also meet the patentability requirements for such subject matter.

Computer-implemented inventions may be claimed using different claim types. The types typically include: 1. art or process claims (e.g. to a method); 2. machine claims (e.g. to an apparatus or system); and 3. manufacture claims (to a computer program product or computer media embodying code or data structures). At present and contrary to published Patent Office policy, computer programs embodied in a signal medium such as a propagated carrier wave are considered not to relate to patentable subject matter. The policy is presently under review and such claims are being rejected.

For further information, please contact:

Dr.Shruti Bhat
Phone 1.514.743.6159

Disclaimer : Information contained herein provides a brief overview of Canadian patent law and should not be regarded or relied upon as legal advice or opinions.

Patent watch : Drug molecules going off-patent by 2013

2009-05-03T09:21:00.000-04:00

Dr. Shruti Bhat

Here are few more drug substances going off-patent by 2013.

Drug - Rizatriptan
Application : Migrane
Company : Merck & Co. (USA)

Drug - Eberconazole
Application : Mycosis
Patent Assignee : Sociedad Espanola de Especialidades Farmaco Terapeuticas (Spain)

Drug - Ciliary Neurotrophic factor
Application : Amyotrophic lateral sclerosis
Company : Amgen (USA)

Drug - Olanzapine
Application : Schizophrenia, psychosis, depression
Patent Assignee : Lilly (USA)

Drug - Iopentol
Application : Imaging agent - diagnostic
Company : Nycomed Amersham (Norway)

Drug - Interferon gamma - 1b
Application : Cancer, bacterial infection, chronic granulomatus disease, dermatitis
Company : Roche (Switzerland)

Drug - Itasetron
Application : Emesis, anxiety
Company : Boehringer Ingelheim (Germany)

Drug - Iodixanol
Application : Imaging agent - diagnostic
Company : Nycomed Amersham (Norway : UK)

Drug - Alteplase
Application : Thrombosis, skin ulcer, stroke
Company : Roche (Switzerland)

Drug - Milodistim
Application : Cancer
Company : American Home Products (USA)

Drug - Technetium (99m Tc) tetrofosmin
Application : Imaging agents - diagnostic
Company : Nycomed Amersham (Norway : UK)

Drug - Aptiganel
Application : Stroke, neuropathy, trauma, Parkinson disease, pain
Patent Assignee : Oregon State University (USA)

Drug - Peldesine
Application : Cancer, psoriasis, rheumatoid arthritis, transplant rejection, eye disease, dermatitis, HIV infection
Patent Assignee : BioCryst (USA)

Drug - Iobitridol
Application : Diagnosis
Patent Assignee : Guerbet (France)

For formulation development inquiries please contact 1-514-743-6159 or email at drshrutibhat@gmail.com

List of additonal few molecules going off-patent by year 2013

2009-04-27T08:55:00.000-04:00

By Dr. Shruti Bhat

Below is a list of few more drugs which would be going off-patent soon-

Drug - Somatomedin C
Application : Hormone deficiency
Company : Pharmacia & Up John (U.S.A.)

Drug - Sabcomeline
Application : Alzheimer disease
Company : Smithkline Beecham (U.K.)

Drug - Blonanserin
Application : Schizophrenia
Patent Assignee : Dainippon (Japan)

Drug - Lepirudin
Application : Thrombosis, restenosis
Patent Assignee : Hoechst (Germany)

Drug - Danaparoid Sodium
Application : Thrombosis, thrombocytopenia
Patent Assignee : Akzo (Netherlands)

Drug - Labcode YM 529, YH 529
Application : Osteoporosis, Cancer
Patent Assignee : Yamanouchi (Japan)

Drug - Technetium (99m Tc) nofetumomab merpentan
Application : Diagnosis
Patent Assignee : NeoRx (U.S.A.)

Drug - Pemetrexed
Application :Cancer
Patent Assignee : Princeton University (USA)

Drug - Bosentan
Application : Heart failure
Patent Assignee : Roche (Switzerland)

Drug - Zanamivir
Application : Viral Infection
Patent Assignee : Biota (Australia)

Drug - Aripiprazole
Application : Psychosis
Patent Assignee : Otsuka (Japan)

Drug - Reteplase
Application : Thrombosis, myocardial infarction
Company : Roche (Switzerland)

Drug - Avitriptan
Application : Migrane
Patent Assignee : Bristol - Myers Squibb (USA)

Drug - Sargramostim
Application : Cancer, infectious disease, HIV infection, leukopenia
Company : American Home Products (USA)

Drug - Vaccine, hepatitis B - surface antigen
Application : Hepatitis
Patent Assignee : Institut Pasteur (France)

Drug - Nevirapine
Application : HIV infection
Patent Assignee : Boehringer Ingelheim (Germany)

Drug - Saquinavir, trans.
Application : HIV Infection
Patent Assignee : Roche (Switzerland)

In the next chapter, I shall present few more molecules due to go off-patent soon.

For inquiries on patents, patenting and product development, contact me at 1-514-743-6159 or email at drshrutibhat@gmail.com

A snap shot at molecules going off-patent between 2009- 13

2009-04-21T20:45:00.000-04:00

by Dr.Shruti Bhat

Continuing our series on molecules going off-patent between 2009- 13............

Please find below some molecules likely to go off-patent in coming years-

Drug - Denileukin diftifox
Application : Diabetes, HIV infection, rheumatoid arthritis, psoriasis, cancer
Patent Assignee : Harvard University (U.S.A.)

Drug - Verteporfin
Application : Cancer, psoriasis, arthritis, retinopathy
Patent Assignee : British Columbia Univ. (Canada)

Drug - Xemilofiban
Application : Thrombosis
Patent Assignee : Searle (Monsanto)

Drug - Nesiritide Citrate
Application : Heart failure, hypertension
Patent Assignee : Scios (U.S.A.)

Drug - Dosmalfate
Application : Gastrointestinal ulcer
Patent Assignee : FAES (Spain)

Drug - Labcode S1090
Application : Bacterial infection
Patent Assignee : Shionogi (Japan)

Drug - Oprelvekin
Application : Cancer, HIV infection, mucositis, Crohn disease
Company : American Home Products (USA)

Drug - Silteplase
Application : Thrombosis
Patent Assignee : Genzyme (U.S.A.)

Drug - Abacavir racemic
Application : Viral infection, HIV infection
Company : Glaxo Wellcome (U.K.)

Drug - Abacavir
Application : HIV infection
Company : Glaxo Wellcome (U.K.)

In the coming days, I shall bring to you, further list of molecules that may go off-patent soon. For inquiries, please contact me at email at drshrutibhat@gmail.com

Patents going off-patent between 2009- 13: Patent watch

2009-04-18T09:13:00.000-04:00

by Dr. Shruti Bhat

Continuing further our discussion on molecules going off- patent, please find below some additional potential revenue generators for the generic pharmaceutical industry-

Drug - Famotidine
Application : Gastrointestinal ulcer
Patent Assignee : Richter (Gedeon) (Hungary)

Drug - Remacemide
Application : Epilepsy
Company : Rhone-Poulenc Rorer (U.S.A.)

Drug - Brain-derived neurotrophic factor
Application : Amyotrophic lateral sclerosis, neuropathy
Patent Assignee : Max Planck Institute Regeneron (Germany, U.S.A.)

Drug - Labcode M 100907, MDL 100907
Application : Schizophrenia
Company : HMR (Germany)

Drug - Brinzolamide
Application : Glaucoma
Company : Nestle (Switzerland)

Drug - Darifenacin
Application : Irritable bowel syndrome, urinary incontinence
Patent Assignee : Pfizer (U.S.A)

Drug - Labcode M100907
MDL 100907
Application : Schizophrenia
Company : HMR (Germany)

Drug - Prucalopride
Application : Gastrointestinal motility disease
Company : Johnson & Johnson (U.S.A.)

Drug - Tiagabine crystalline hydrochloride monohydrate
Application : Epilepsy
Patent Assignee : Novo Nordisk (Denmark)

Drug - Labcode AS013
Application : Peripheral vascular disease
Patent Assignee : Sekikagaku (Japan)

Tomorrow, I shall present some additional molecules ready to go off-patent soon........

Do you have questions ?

Contact me !

Dr. Shruti Bhat, phone 1-514-743-6159 or email at drshrutibhat@gmail.com

Products going off-patent between 2009 -2013- Patent watch

2009-04-17T07:38:00.000-04:00

by Dr. Shruti Bhat,

The generic pharma industry business globally, is largely dependent on molecules going off-patent..............so what is our take on this ?

As research scientists, we have to know which products shall make more money for our organizations.........

As citizens, we need to know which medicines shall be available cheaper to us and by when......

As investors, we need to know which company market stocks might be hit !!

Below, I have listed some of the molecules that were filed in United States patent office and are now due to go off-patent between 2009- 13.

Drug - Ranelie acid
Application :Bone calcium
RegulatorsCompany : Servier (France)

Drug - Alatrofloxacin
Application :Bacterial infections
Patent Assignee : Pfizer (U.S.A.)

Drug - Gapxavanyl
Application :Pain
Patent Assignee : Korea Research Institute of Chemical Technology (South Korea)

Drug - Cefotiam hexetil
Application :Bacterial infection
Patent Assignee : Takeda (Japan)

Drug - Arofylline
Application :Asthama, inflammation
Company : Almirall - Prodesfarma (Spain)

Drug - Fasoracetam
Application :Cerebrovascular disease, cognitive defect
Patent Assignee : Nippon Shinyaku (Japan)

Drug - Citalopram
Application :Depression
Patent Assignee : Lundbeck (Denmark)

Drug - Thrombomodulin
Application :B1c Thrombosis
Patent Assignee : Mochida (Japan)

Drug - Gavestinel
Application :Stroke
Company : Glaxo Wellcome (U.K.)

Tomorrow, I shall present some additional molecules going off-patent.

Do you have questions regarding formulation development, process improvement, technology- transfer or trouble-shooting of products ?

Contact me !

at 1-514-743-6159 or email at drshrutibhat@gmail.com

I shall be soon initiating another series called ' The Expert's view - New strides in formulation development' and shall deal with formulating prescription medicines, OTC and consumer products . Come visit me.............

Pages from the history- a comparison of patent laws world wide-

2009-04-14T20:14:00.000-04:00

ARGENTINA:

Regulation no. 263/2003: allows applicant to waive the part of the examination related to international prior art. This is applicable to any application in which substantive examination has not yet been made.

Equivalent patent in a country that has similar novelty, inventive step and industrial applicability requirements as Argentina. Although the equivalent patent could have been issued in any jurisdiction- patents granted by the EPO followed by the USPTO are preferred.

The scope of the claims must be identical or less than those of the equivalent patent. However, the claims may have to be amended to comply with the requirements of Argentinean law-one independent claim and use of a characterizing clause. In many cases, combining the claims to the equivalent patent will expedite prosecution and grant.

AUSTRALIA:

SECTION 40(3) OF THE Australian patent Act provided “ The claim or claims must be fairly based on the matter described in the specification”. The body of the specification has to be read as a whole places no limitation on the invention set out in the “ consistory clause(s)”. Clauses describing the invention generally) then the claims would be fairly based if they reflect the invention set out in the consistory clause. In other words, there must be “a real and reasonably clear disclosure” of the claimed invention in the specification. A specification need not disclose any more than a single embodiment and even with a single embodiment, the patentee would still be able to include claims that were not limited to the embodiment so long as there was “ fair basis” for the other claims. The description of a single embodiment common in the applications for mechanical devices. However for chemical cases, it is still considered necessary to include multiple examples or embodiments in order to support broad claims. The patentee is required to submit search results from corresponding applications.

AIPO grants patents for computerized accounting, electronic commerce systems and the like.

CHINA:

Enforcement of patent right depends on the province and locality where the action is brought. Better results have been seen in Beijing. The Chinese patent law prevents competition from legitimate competitors an enforcement against legitimate competitors is possible. Also, there is provision for territorial; or global licensing. In line with the WTO, Patent term offered by Chinese patent office is 20 years from filing.

ISRAEL:

New data exclusivity legislation is in force. Pro-purports to protect the confidentiality of data submitted to the Israeli Ministry of Health in support of efforts to receive marketing authorization. Party seeking marketing approval of generic drug in Israel will not be able to rely on confidential data submitted in support of the marketing approval of the innovative pharmaceutical until the earlier of five years from the first data on which the innovative drug was first registered in Israel or six months from the date of registration in a recognized country.

Cons – data exclusivity is only for making use of the confidential data for the purpose of obtaining marketing approval of the generic drug in Israel. Law does not bar use of confidential information for developing and manufacturing a generic drug in Israel during the exclusivity period for export to other countries. Limitations on the ability of innovative drug company to bring an action on the ground of illegal use of its confidentiality data. The patentee is required to submit search results from corresponding applications.

INDIA:

To comply with its TRIPS obligation to grant product patents for agrochemicals and pharmaceuticals, India has enacted the Patents Amendment Ordinance 2005 which came into effect on January 1,2005. Apropos, this ordinance, “Invention” is any new process o product, which involves an inventive step and is capable of industrial application.

Product patents are now available in all categories – pharmaceuticals. Agrochemicals. Food, alloys, chemicals, optical glass, microorganisms etc. Although novelty-new invention is “ any invention or technology which has not been anticipated by publication in any document or used in the country or else here in the world before the date of filing of the patent application with complete specification” Prior publication or prior use any where in the world could destroy novelty of an invention. The inventive step- is a feature of an invention that involves technical advances as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.

The mere discovery of a new salt of a known substance is not patentable:

The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance.

The mere discovery of any new property or new use for a known substance and the mere use of a known process machine or apparatus- unless such process results in a new product or employs at least one new reactant “ is not patentable.

New form of a known substance having no therapeutic efficacy is not patentable. This means that salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances will be considered the same substance unless they differ significantly in properties with regard to efficacy.

With the old law, mathematical methods, business method or a computer program per se or algorithm were not patentable. The new ordinance allows, hardware, software in combination with hardware are patentable. However, soft ware per se and business methods are not paten table. There is requirement for Indian resident to obtain foreign filing permit for filing outside of India unless 6 weeks have passed since the filing of a corresponding Indian application. Additional fees are applicable to more than 10 claims. The no. of pages of the specifications should preferably be 30.

Examination of complete specification may be done 36 months from the date or filing from the earliest priority date whichever is earlier. Currently, 12 months after date of examination report to place application in condition for grant – must file a first response with in 4 months of the date of the action. The new provision- 6 months to obtain grant after issuance of examination report (3 months extension is available).

There is an obligation to advice the controller as to the status of foreign applications and the supply prosecution details (if requested) has been extended from the acceptance date up to the date of grant.

It is the duty of the patentee to supply list of prior art cited in corresponding applications.
Priority may be claimed from applications file at the EPO, ARIPO or other organizations that are parties to a regional international or bilateral treaty or arrangement to which India is also a party.

A working statement must be filed every year. The working requirement can b met by importation. There is a penalty for no filing a working statement reflecting the working of the invention in India has been increased from about 500 USD to 23,000 USD.

Permitted importation of patented product form a person who is authorized by the patentee or who is duly authorized under law to produce and sell or distribute the product.
There is a possibility that more compulsory license will be granted in the future, especially in the pharmaceutical field.

Opposition are possible both pre- and post -grant of the patent.

Pre-grant oppositions – challenge grant based on lack of novelty, inventive step, wrongful obtainment, and anticipation by traditional knowledge etc.

Post-grant opposition – to be filed within one year from the date of grant also on the same grounds as the pre-grant opposition.

Using, making, selling or importation of a patented product is an act of infringement. Importation of a product made by a patented process is also an infringement. Importation, use or sale of a patented product for purposes of obtaining date which is to b submitted to any regulatory authority is exempted and is not an infringement act.

GULF COOPERATION COUNCIL:

Includes the following countries viz. Kuwait, Qatar, Oman, Saudi Arabia, Bahrain, United Arab Emirates.

One patent application for all member countries. Requirements for patent ability include novelty, innovation and industrial application. The patent should not conflict with Islamic laws or rule of conduct observed in the GCC countries. Paten table subject matter does not include: scientific discoveries and theories , mathematical formulae and computer programs, plant varieties, animal species or biological processes used for production of plants or animals with the exception of microbiological procedures and products of such procedures. Methods of treatment of human or animal body, surgical or medical.

A patent issued by GCC patent office is valid in all member states. Article (7) of the GCC patent regulations provide for a claim for priority if the GCC application is filed within 12 Gregorian months of the filing date of the first application. The term of patent is 20 years from filing date f the GC application. On cannot have a GCC patent and a patent of a member state. If one has to have a patent from a member state must relinquish that patent before a GCC patent can be issued.

SAUDI ARABIA:

Payment of publication fee. Request for examination. Payment of annuities during pendency of application. Annuities do not have to be paid through the agent of record. In the future it may be possible it may be possible to pay annuities directly to the Saudi patent office. Filing in Saudi Arabia or GCC standards of novelty, inventive step and industrial applicability are the same as those of the GCC. At the present the filing fees and grant fees are higher for a GCC application than for a Saudi application. At present, the annuities for years 1-12 are higher for GCC application than in Saudi Arabia.

TAIWAN:

The Taiwan intellectual property office has announced the founding of the intellectual property institute. This institute is made up of people from universities, government, attorneys, patent examiners ad judges. The purpose of the institute is to promote the quality of Taiwan; IP procurement and enforcement.

Dr.Shruti Bhat

For queries regarding patenting and infringement opinions, please feel free to contact me at drshrutibhat@gmail.com