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June 2011 In this issue: Supreme Court of Canada news » Patented Medicine Prices Review Board news » Canadian Agency for Drugs and Technologies in Health news » Permanent loss of market share not recoverable pursuant to section 8 of the Regulations » |
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Update on data protection: CGPA does not have standing to attack data protection for AVAMYS; SAP authorization not a bar to data protection for ELOXATIN Data protection is based on international obligations to protect undisclosed data necessary to determine the safety and efficacy of a new chemical entity. Section C.08.004.1 of the Food and Drug Regulations provides an "innovative drug" with a period of market exclusivity of eight years, with an additional six months if the drug was the subject of clinical trials designed and conducted for the purpose of increasing the knowledge of the behaviour of the drug in pediatric populations. Further, a manufacturer may not file a submission seeking a notice of compliance ("NOC") on the basis of a direct or indirect comparison between the new drug and an innovative drug prior to the expiry of six years after issuance of the first NOC for the "innovative drug." An "innovative drug" is defined as a drug that contains a medicinal ingredient not previously approved in a drug by the Minister of Health and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. |
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Supreme Court of Canada news Supreme Court will review the standard of disclosure for demonstrated utility (leave granted). Teva Canada Limited ("Teva") has been granted leave to appeal the Federal Court of Appeal dismissal of Teva's appeal from an Order of prohibition regarding sildenafil (Pfizer's VIAGRA). As reported in the October 2010 issue of Rx IP Update, the Court of Appeal decision dealt squarely with the issues of disclosure and utility. The Court of Appeal found no error in the lower Court's conclusion that the relevant patent contained sufficient disclosure, as a claim claiming solely sildenafil was a separate invention from the class of compounds that encompassed sildenafil. Further, the Court of Appeal held that while as of the Canadian filing date, there must have been either a demonstration of utility or a sound prediction of utility, there is no requirement for a patent to demonstrate utility in the patent disclosure so long as the trier of fact finds it to be proven upon a legal challenge. Teva Canada Limited v. Pfizer Canada Inc., et al, May 5, 2011 (SCC Case No. 33951). Apotex denied leave regarding Saccharin doctrine. Apotex had filed an application for leave to appeal the Federal Court of Appeal dismissal of Apotex's cross-appeal from a determination that Apotex had infringed Eli Lilly's patents by importing bulk cefaclor (Lilly's CECLOR). The cefaclor had been produced outside Canada from an intermediate compound that Apotex's suppliers had made by a patented process. The Court of Appeal found no error in Justice Gauthier's conclusion that it is settled law that a process patent can be infringed by the importation, and use and sale in Canada of a product manufactured abroad by another person using the patented process (the "Saccharin doctrine"). Apotex's application for leave to appeal was denied on May 5, 2011. Apotex Inc. v. Eli Lilly and Company, May 5, 2011 (SCC Case No. 33946). Pharmascience denied leave to argue that successful prohibition applications ought to be dismissed where patent is later declared invalid. Pharmascience had filed an application for leave to appeal the Federal Court of Appeal decision dismissing its appeal from a decision of the Federal Court refusing to dismiss two prohibition applications relating to ramipril (sanofi-aventis's ALTACE) in view of Justice Snider's subsequent judgment in sanofi-aventis Canada Inc. v. Apotex Inc. (2009 FC 676, appeal pending) declaring certain claims of the patent invalid. Pharmascience sought to have the prohibition applications dismissed so that it could claim section 8 damages. Justice Zinn set aside the prohibition Orders but declined to dismiss the prohibition applications. Pharmascience's application for leave to appeal was denied on May 6, 2011. Pharmascience Inc. v. Aventis Pharma Inc. (SCC Case No. 33831). Apotex denied leave to argue that section 8 is triggered where innovator prevails in prohibition proceeding but patent is later declared invalid in action (leave denied). Apotex had filed an application for leave to appeal the Federal Court of Appeal decision dismissing Apotex's appeal from a decision of the Federal Court, dismissing Apotex's action for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to naproxen sustained-release (NAPROSYN SR). The Court of Appeal agreed with the Federal Court that the 1993 version of the Regulations applied to the action and that section 8 was not "intended to provide redress where the innovator prevailed in the prohibition proceeding, even if the generic was later successful in patent litigation." Apotex's application for leave to appeal was denied on May 6, 2011. Apotex Inc. v. Hoffmann-La Roche Ltd. (SCC Case No. 33832). GSK denied leave to appeal striking of colour mark applied to ADVAIR DISKUS inhaler as non-distinctive. GlaxoSmithKline ("GSK") applied for leave to appeal the Federal Court of Appeal decision upholding the Federal Court decision, striking the registration consisting of dark and light purple applied to its ADVAIR DISKUS inhaler from the Register of Trademarks. The Federal Court found, among other things, that consumers did not associate the colour and shape of the GSK mark with a single source. The Federal Court of Appeal found that the Judge had turned his mind to the proper burden of proof, and in any event, the presumption of validity simply requires that an examination of all the evidence establish that the trademark was not registrable at the relevant time, that the Judge applied the correct test for distinctiveness, and that GSK had not established any palpable and overriding error in the Judge's application of the law to the facts in the case. GSK's application for leave to appeal was denied on May 19, 2011. Glaxo Group Limited v. Apotex Inc. (SCC Case No. 34006). |
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Patented Medicine Prices Review Board news New NEWSletter released. The PMPRB has released its April 2011 NEWSletter. (Newsletter.) Voluntary Compliance Undertakings for NIASPAN and Technescan MAG3. The Board recently approved Voluntary Compliance Undertakings for Sepracor's NIASPAN (extended-release niacin) (Notice) and Lantheus Medical Imaging's Technescan MAG3 (technetium TC-99M mertiatide) (Notice). |
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Canadian Agency for Drugs and Technologies in Health news CADTH launches new website. The Canadian Agency for Drugs and Technologies in Health ("CADTH") has launched a new website. The new site includes recent products and projects in progress on the homepage, a revamped products section and search tool, a new services section designed to expedite requests for CADTH products and services, and a "My Files" tool to allow for the collection and downloading of multiple files simultaneously. (Notice, website.) |
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Recent Court decisions Patented Medicines (Notice of Compliance) Regulations Permanent loss of market share not recoverable pursuant to section 8 of the Regulations. Teva appealed from a decision of the Federal Court, striking portions of Teva's claim seeking recovery for permanent loss of market share relating to ramipril (sanofi-aventis's ALTACE) pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations. The Court of Appeal dismissed the appeal on the basis that the pleading could not be distinguished from that considered in Apotex Inc. v. Merck & Co. (2009 FCA 187, leave to appeal refused [2009] S.C.C.A. No. 347), and Teva failed to demonstrate that the Court's decision in Merck was manifestly wrong. A dissenting Judge would have allowed the appeal. Teva Canada Limited v. sanofi-aventis Canada Inc. and sanofi-aventis Deutschland GmbH, May 2, 2011. Federal Court grants Order of Prohibition for Pfizer's donepezil against Mylan; rejects sound prediction attack. On May 12, 2011, the Federal Court granted Pfizer an Order of prohibition, finding that Mylan's allegation of invalidity of the patent claiming donepezil (Pfizer's ARICEPT) was not justified. The claims at issue relate to the compound donepezil and a therapeutic composition for treating senile dementia comprising donepezil. Justice Hughes considered the single issue of lack of sound prediction. In his decision, Justice Hughes reviewed the jurisprudence on utility and in particular, on how the "promise" of a patent should be read. He held that the requirement for utility should not be confused with any necessity to put it directly or by inference in the claims, and in the case of a new compound, it is sufficient that the utility be stated in the specification. He also held that a low standard for utility has been established by the Courts; it is sufficient that it be new, better, cheaper, or afford a choice, and it can include an advantage or a disadvantage that is avoided. However, even given this standard, one must ask, "useful for what?" The concept of "promise" comes into play in answering this question. Justice Hughes stated that "in construing the specification of a patent, in particular the 'promise,' the Court is to look at the specification through the eyes of a person skilled in the art, bearing in mind commercial realities, being neither benevolent or harsh, in order to determine fairly the true intent." In this case, Justice Hughes concluded that the utility of the compound ("effective for the treatment of Alzheimer's") was soundly predicted. Justice Hughes was satisfied that the patent disclosed a line of reasoning that would have been considered to be prima facie reasonable in predicting utility of donepezil as an acetylcholinesterase inhibitor and thus, in accordance with a "reasonable theory of the day," useful in treating senile dementia such as Alzheimer's. He also held that proof of a lack of toxicity at this stage is not a necessary requirement to demonstrate utility. Pfizer Canada v. Mylan Pharmaceuticals ULC, May 12, 2011. Other decisions Ontario Court of Appeal grants Shoppers Drug Mart leave to appeal decision regarding formulary provisions for private label products. As reported in the February 2011 edition of Rx IP Update, the Shoppers Drug Mart group of companies (including Sanis Health Inc., which provides generic drugs under its own label to Shoppers Drug Mart pharmacies) and the Katz group of companies (which operates Rexall) challenged the validity of certain provisions of the Regulations made under the Ontario Drug Benefit Act ("ODBA," Ontario Regulation 201/96) and the Drug Interchangeability and Dispensing Fee Act ("DIDFA," Ontario Regulation 935) dealing with private label products, essentially those that are non-arms length from pharmacies. The Ontario Divisional Court held that these provisions are of no force and effect, including as they are beyond the scope of the regulation-making authority in the parent statute. On April 29, 2011, the Court of Appeal granted leave to appeal that decision. Shoppers Drug Mart v. Ontario, February 3, 2011. |
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New Court proceedings Patented Medicines (Notice of Compliance) Regulations
Other proceedings
To check the status of Federal Court cases, please click here. |
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Our pharmaceutical practice group Smart & Biggar/Fetherstonhaugh's pharmaceutical practice group calls upon decades of extensive and in-depth experience to keep your pharmaceutical IP rights where they belong — in your hands. For more information on our group and a full list of its members, please click here. Disclaimer The preceding is intended as a timely update on Canadian intellectual property and regulatory law of interest to the pharmaceutical industry. The contents of this newsletter are informational only and do not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly. To join the Rx IP Update mailing list, be removed from the mailing list or make changes to contact information, please send an e-mail to rxip.update@smart-biggar.ca. smart-biggar.ca | Ottawa | Toronto | Montreal | Vancouver |
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