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April 2011 In this issue: Court of Appeal affirms Order of prohibition against Pharmascience regarding latanoprost » Patented Medicine Prices Review Board news » Judge upholds discovery rulings in PLAVIX » Court of Appeal upholds Health Canada's refusal to issue an NOC for Apotex's ASA » |
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Court of Appeal affirms Order of prohibition against Pharmascience regarding latanoprost Pharmascience appealed from the decision of Justice Heneghan of the Federal Court granting Pfizer's application for an Order of prohibition against Pharmascience regarding latanoprost (Pfizer's XALATAN). The patent at issue includes claims for latanoprost and the use of latanoprost in the treatment of glaucoma or ocular hypertension. The Federal Court found that Pfizer had demonstrated that Pharmascience's invalidity allegations were not justified. |
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Patented Medicine Prices Review Board news New Chairperson and Vice-Chair appointed to the PMPRB. On March 8, 2011, the Honourable Leona Aglukkaq, Minister of Health, announced the appointments of Mary Catherine Lindberg and Dr. Mitchell Levine as Chairperson and Vice-Chair respectively of the Patented Medicine Prices Review Board ("PMPRB"). Ms. Lindberg has served as Vice-Chair since 2006. Dr. Levine is a professor at McMaster University and Director of the Center for Evaluation of Medicines at St. Josephs's Healthcare in Hamilton, Ontario. He was a member of the PMPRB's Human Drug Advisory Panel. (Press release.) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Recent Court decisions Judge upholds discovery rulings in PLAVIX. In an infringement action relating to the patent claiming clopidrogel (sanofi-aventis's PLAVIX), Apotex sought to compel answers to refusals from the discovery of sanofi-aventis relating to validity. A Prothonotary refused to order certain questions answered primarily on the basis of lack of relevance or lack of proportionality (weighing relevance against breadth). On appeal, Justice Montigny of the Federal Court affirmed the decision. The questions refused included providing the factual basis for a prediction that "clopidogrel would be useful in terms of being tolerable in humans." Justice Montigny held that this is essentially a legal question regarding the construction of the patent and for sanofi-aventis to answer the questions, it would have to agree with the construction, which it disputes. Further, the work by the inventors was set out in great detail in the documents produced, which were the subject of extensive discovery. A further refusal was to produce trial testimony from experts who testified in the U.S., upheld in part on the basis that such trial testimony could only be used to impeach a witness at trial, and as such does not need to be produced on discovery. Apotex Inc. v. sanofi-aventis, January 17, 2011. Trial Judge considers order of presentation of infringement evidence under section 55.1 of the Patent Act. In a patent infringement action against Apotex regarding nefazodone and nefazodone hydrochloride, Bristol-Myers Squibb ("BMS") sought an Order directing that the evidence on infringement under section 55.1 of the Patent Act be presented in a certain sequence at the trial. Section 55.1 provides that "[i]n an action for infringement of a patent granted for a process for obtaining a new product, any product that is the same as the new product shall, in the absence of proof to the contrary, be considered to have been produced by the patented process." Justice Crampton allowed BMS's motion, ordering that once BMS has led evidence that nefazodone and nefazodone hydrochloride are new products, and that Apotex has made or sold nefazodone and/or nefazodone hydrochloride, Apotex will lead fact and expert evidence that its nefazodone hydrochloride was made by a non-infringing process, followed by BMS's reply to any evidence adduced. While the Judge did not make a determination as to whether the persuasive burden will remain with BMS or shift to Apotex, the Judge found that at a minimum, section 55.1 contemplates a shifting of the evidential burden to Apotex to prove non-infringement and that this is a significantly greater burden than simply having to adduce some evidence of non-infringement. In a related decision, Justice Crampton denied Apotex leave to file sur-reply expert reports on the basis that the new evidence adduced by the sur-reply reports should have been anticipated by the experts in their initial reports. BMS had given notice of its intent to rely on section 55.1 and therefore did not adduce expert evidence in chief regarding infringement of the processes at issue; such evidence was instead served by BMS in reply.
Judge upholds decision to strike Eli Lilly's Statement of Claim against Nu-Pharm regarding olanzapine. The Federal Court dismissed Eli Lilly's appeal of a Prothonotary's decision to strike its Statement of Claim in a patent infringement action relating to olanzapine (Eli Lilly's ZYPREXA). Eli Lilly submitted it had pleaded that Nu-Pharm's submission of an abbreviated new drug submission ("ANDS") and issuance of a notice of compliance ("NOC") and Drug Identification Number ("DIN") constitute infringement of its patent. The Court disagreed, stating that although based on a previous Federal Court of Appeal decision (AstraZeneca Canada Inc. v Novopharm Ltd., 2010 FCA 112) "it appears that a specific pleading that the ANDS, the NOC and DIN constitute acts of infringement may be a sufficient basis for allowing the action to proceed," in this case it was unclear if Eli Lilly had pleaded that the preparation of the ANDS and obtaining of the NOC are acts of infringement. The Court found in any event, that the Statement of Claim disclosed no reasonable cause of action on the basis that Eli Lilly had not pleaded that Nu-Pharm engaged in anything beyond the regulatory requirements for the preparation and filing of an ANDS, and, without something more, the section 52.2(1) defence of the Patent Act applies. Finally, the Court found that Eli Lilly's allegation that Nu-Pharm had done something that infringes or that may permit it to "springboard" were bare assertions without foundation or material facts. Eli Lilly Canada Inc. v. Nu-Pharm Inc., March 3, 2011. Court of Appeal upholds Health Canada's refusal to issue an NOC for Apotex's ASA. As reported in the June 2009 edition of Rx IP Update, Apotex appealed the Federal Court's dismissal of its application for judicial review of the Minister's decision not to issue it a notice of compliance ("NOC") for its acetylsalicyclic acid ("ASA") 81 mg enteric-coated tablets. Apotex had filed an abbreviated new drug submission ("ANDS") with Health Canada for its ASA, using Bayer's ASA as the reference product. In its ANDS, Apotex excluded the bioavailability results from two subjects in the fed study. Health Canada refused to issue an NOC based on the existing submitted data, and Apotex sought judicial review of the Minister's decision. The Court of Appeal dismissed Apotex's appeal of the Applications Judge's decision, holding that the Minister cannot issue Apotex an NOC on the basis of an ANDS naming Bayer's ASA as a reference product unless bioequivalence is demonstrated, and the finding of bioequivalence is a question of fact for the Minister. The Court found that the Applications Judge applied the correct standard of reasonableness, and his factual findings were reasonably open to him on the record. Apotex Inc. v. Canada (Health), March 8, 2011. |
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New Court proceedings Patented Medicines (Notice of Compliance) Regulations
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
