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IN THIS ISSUE: Federal Court of Appeal upholds Order of prohibition for Pfizer's donepezil » Supreme Court of Canada news » Patented Medicine Prices Review Board news » Court of Appeal affirms pleading amendments relying on factual findings by a foreign court » Federal Court of Appeal upholds Order of prohibition for Pfizer's donepezil On March 29, 2012, the Federal Court of Appeal dismissed Mylan's appeal from an Order of prohibition of Justice Hughes, finding that Mylan's allegation of invalidity of the patent claiming donepezil (Pfizer's ARICEPT) was not justified: Pfizer Canada v. Mylan Pharmaceuticals ULC, 2012 FCA 103, aff'g 2011 FC 547. The claims at issue relate to the compound donepezil and a therapeutic composition for treating senile dementia comprising donepezil. Mylan had alleged invalidity relying on the doctrine of sound prediction.
Supreme Court of Canada news Corlac denied leave to appeal decision regarding good faith requirement for patents. On March 29, 2012, the Supreme Court denied Corlac leave to appeal a decision of the Federal Court of Appeal that significantly narrowed the good faith requirement for patents in Canada. Corlac Inc. v. Weatherford Canada Ltd. (SCC Case No. 34459). Supreme Court to review standard of disclosure for demonstrated utility in April 2012. Teva's appeal to the Supreme Court from the Court of Appeal's refusal to set aside a prohibition Order regarding sildenafil (Pfizer's VIAGRA) has been scheduled for April 18, 2012. The Court of Appeal decision dealt with the issues of disclosure and utility. Teva Canada Limited v. Pfizer Canada Inc., et al. (SCC Case No. 33951).
Other news House of Commons Standing Committee on International Trade tables report on CETA. As reported in the March 2011 issue of Rx IP Update, the proposed Comprehensive Economic & Trade Agreement ("CETA") between Canada and the European Union includes intellectual property provisions in respect of pharmaceutical products. On March 12, 2012, the House of Commons Standing Committee on International Trade tabled a report on its study of the negotiations of the CETA. Canada and the EU aim to conclude negotiations in 2012.
Patented Medicine Prices Review Board news Voluntary Compliance Undertakings. The Board recently accepted a Voluntary Compliance Undertaking for Hospira Healthcare Corporation's PRECEDEX (dexmedetomidine hydrochloride for injection). Updated Patentee's Guide to Reporting. The Board has updated the Patentee's Guide to Reporting. The updated guide replaces the previous publication issued in March 2008. Teva Neuroscience ordered to pay $2.8M to offset excess revenues for COPAXONE syringes. In a 2008 decision, the Board had ordered that Teva Neuroscience repay approximately $2.4M to offset excess revenues for Teva Neuroscience's COPAXONE (glatiramer acetate) syringes. As reported in the December 2009 issue of Rx IP Update, the Federal Court set aside the Board's decision and returned the matter to the Board for redetermination (2009 FC 1155). On February 23, 2012, the Board issued its decision and ordered Teva Neuroscience to repay approximately $2.8M to offset excess revenues. The Board recognized that COPAXONE syringes became the lowest priced medicine relative to its therapeutic comparators once Teva Neuroscience removed another COPAXONE product from the market and considered this factor in formulating the remedy. However, the Board held that in the period following 2004, the price increase (for example, 7.23% in 2004 and 5.96% in 2005) exceeded the protection that Parliament had provided and held that this both sudden and significant price increase should be a factor considered in the remedy. Taking into account these two factors, the Board departed from its Consumer Price Index Adjustment Methodology outlined in the Board's guidelines and ordered Teva Neuroscience to reimburse revenues of approximately $2.8M. Teva Neuroscience has applied for judicial review. PMPRB-2010-D3-Copaxone decision/reasons and Order.
Recent Court decisions Patented Medicines (Notice of Compliance) Regulations Court of Appeal affirms pleading amendments relying on factual findings by a foreign court. On February 29, 2012, the Court of Appeal dismissed Apotex's appeal from a judgment of the Federal Court, which dismissed Apotex's appeal from a Prothonotary's Order granting leave to AstraZeneca to amend its pleading to assert that Apotex is estopped from litigating certain factual findings regarding Apotex's omeprazole product (AstraZeneca's LOSEC) made by a United States District Court. The Court of Appeal concluded that it is not plain and obvious that the factual findings are inextricably bound or related to the foreign court's construction of the claims and that the disputed amendments cannot succeed in law. Apotex Inc. v. AstraZeneca Canada Inc. et al., February 29, 2012. CIRA decisions BCICAC orders flovent.ca transferred to Glaxo. On March 12, 2012, the British Columbia International Commercial Arbitration Centre ("BCICAC") ordered the domain name flovent.ca to be transferred from the registrant to the complainant, Glaxo. The BCICAC found that the domain name is confusingly similar to Glaxo's registered trademark FLOVENT, the registrant had registered the domain name in bad faith, and the registrant had no legitimate interest in the domain name.
New Court proceedings Patented Medicines (Notice of Compliance) Regulations
Other proceedings
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