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IN THIS ISSUE: Recent developments in section 8 jurisprudence » Federal Court finds olanzapine selection patent invalid for inutility » Patented Medicine Prices Review Board news » Federal Court grants Order of prohibition for Allergan's COMBIGAN against Sandoz » Court rejects Apotex's challenge re: Apo-Omeprazole tablet submission » Opposing motions to stay and expedite appeal from prohibition Order for anastrozole dismissed » Recent developments in section 8 jurisprudence In very general terms, section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") provides for liability by an innovator to a generic manufacturer for the generic manufacturer's damages if an application for a prohibition Order is unsuccessful. While over 40 section 8 actions have been commenced, only four have been determined on their merits to date: Apotex Inc. v. Merck & Co. Inc. et al., 2008 FC 1185, rev'd in part 2009 FCA 187, leave to appeal to S.C.C. refused [2009] S.C.C.A. No. 347 (alendronate); Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al., 2009 FC 494, aff'd 2010 FCA 155, leave to appeal to S.C.C. refused [2010] S.C.C.A. No. 312 (naproxen sustained-release); Apotex Inc. v. Merck & Co., Inc. et al., 2010 FC 1264, appeal pending (lovastatin); Apotex Inc. v. Merck & Co., Inc. et al., 2010 FC 287, aff'd 2011 FCA 329 (norfloxacin; see below). Two recent decisions, including the appeal decision in norfloxacin, are summarized in this article.
Federal Court finds olanzapine selection patent invalid for inutility As reported in the August 2010 issue of Rx IP Update, the Federal Court of Appeal set aside a decision of the Federal Court finding Eli Lilly's patent for the compound olanzapine (ZYPREXA) invalid: Eli Lilly Canada Inc. v. Novopharm Limited — 2010 FCA 197, rev'g 2009 FC 1018. The Court of Appeal held that the Trial Judge erred by using the conditions for a valid selection patent as an independent basis upon which to attack the validity of a patent and remitted the matter to the Trial Judge to consider the utility and sufficiency of disclosure grounds of alleged invalidity. Upon reconsideration, on November 10, 2011, Justice O'Reilly held that the patent was invalid as the promised utility had not been demonstrated and could not have been soundly predicted: Eli Lilly Canada Inc. v. Novopharm Limited, 2011 FC 1288.
Health Canada news Auditor General reports on regulation of pharmaceuticals. In November 2011, the Auditor General of Canada reported the results of a Health Canada performance audit for the period January 1, 2009 to December 31, 2010. The audit examined timeliness, consistency, transparency, conflict of interest and risk-based post-market activities. The Auditor General concluded that Health Canada has not adequately fulfilled most of these key responsibilities in certain areas. The Auditor General made 10 recommendations in the areas of (i) regulating clinical trials; (ii) reviewing drug submissions (including ensuring service standards for review are met for all submission types); (iii) monitoring post-market safety (including improving the timeliness of safety assessments and the implementation of related recommendations); and (iv) enforcing compliance with the regulations. The report includes Health Canada's response to each recommendation. In a separate statement, Health Canada indicated "[t]he Department agrees with the 10 recommendations and we are already taking action to implement all of them. Clear and specific timelines for action have been adopted that will be used to measure and report progress." Auditor General's report; Health Canada's statement.
Patented Medicine Prices Review Board news New NEWSletter released. The PMPRB has released its October 2011 NEWSletter. Analysis brief released: "Trends in Sales of Patented Drug Products." This summary is the first in a series of summaries, based on analyses in the PMPRB annual report and research papers. The Board found that growth in use, not price is driving cost increases in patented drug products.
Recent Court decisions Patented Medicines (Notice of Compliance) Regulations Federal Court grants Order of prohibition for Allergan's COMBIGAN against Sandoz. On November 17, 2011, Justice Crampton prohibited the Minister of Health from issuing a notice of compliance ("NOC") to Sandoz for its proposed generic version of Allergan's COMBIGAN, a combination of brimonidine tartrate and timolol maleate, until the expiry of one of two patents at issue. The Court rejected Sandoz's allegation of obviousness of the first patent, which claims an ophthalmic topical pharmaceutical composition for treatment of glaucoma or ocular hypertension including brimonidine and timolol. However, the Court accepted Sandoz's allegation that it would not, through its product monograph, induce infringement of the second patent, which claims a new use. The Court rejected Sandoz's utility attacks on the second patent. Allergan Inc. v. Canada (Health) and Sandoz Canada Inc., November 17, 2011. Court rejects Apotex's challenge re: Apo-Omeprazole tablet submission. Justice Barnes rejected Apotex's challenge to decisions denying an NOC for Apo-Omeprazole tablets. The application was dismissed as outside the 30-day limit. However, the Court addressed the issue of whether Apotex had a vested interest in an NOC as of the date when the Minister advised by letter dated March 7, 2003, that the examination of Apo-Omeprazole had been completed but that an NOC would not issue until the requirements of the Regulations had been met. The Court determined that the Minister is fully entitled to revisit scientific issues at any point in the process up to the actual issuance of an NOC. Apotex has appealed. Apotex Inc. v. Canada (Health), November 14, 2011. Opposing motions to stay and expedite appeal from prohibition Order for anastrozole dismissed. In 2011 FC 1023, the Federal Court issued a prohibition Order for anastrozole against Mylan. AstraZeneca brought a motion to stay Mylan's appeal until after the Supreme Court decision is rendered in Teva Canada Limited v. Pfizer Canada Inc. (S.C.C. file no. 33951) regarding sildenafil (Pfizer's VIAGRA). Mylan moved to expedite the appeal. Justice Stratas dismissed both appeals. On AstraZeneca's motion, Justice Stratas determined that the tripartite test from RJR-MacDonald does not apply where the Court is merely deciding not to exercise jurisdiction until some time later rather than deciding to enjoin another body from exercising jurisdiction. Instead, the test is whether, in all the circumstances, the interests of justice support the appeal being delayed. Justice Stratas dismissed the motion, finding that AstraZeneca's request was for a lengthy delay, and only a very direct nexus between the issues in sildenafil and this appeal would warrant exercising discretion to delay, which had not been made out. On the motion to expedite, Mylan argued that the appeal (1) could be dismissed for mootness if not heard before the expiry of the relevant patent, and (2) could lead to a first-to-market advantage for Mylan if heard early. Justice Stratas determined that the appeal would be heard before patent expiry in any event and that the evidence was purely speculative that Mylan would gain a first-to-market advantage if successful. Justice Stratas also determined that Mylan had failed to proceed expeditiously. Mylan Pharmaceuticals ULC v. AstraZeneca Canada, Inc., November 17, 2011.
New Court proceedings Patented Medicines (Notice of Compliance) Regulations
Other proceedings
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