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Supreme Court clarifies access to information principles

On February 3, 2012, the Supreme Court issued Merck Frosst Canada Ltd. v. Minister of Health, 2012 SCC 3, which clarifies a number of principles relating to reviews of requests under the federal Access to Information Act, including exemptions from disclosure. Justice Cromwell, writing for the majority, dismissed Merck's appeal, affirming the Court of Appeal's decision that the records should be released.

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Supreme Court of Canada news

Sanofi-aventis and Schering seek leave to appeal decision affirming Trial Judge's dismissal of ramipril infringement claims. As reported in the November 2011 issue of Rx IP Update, the Court of Appeal dismissed sanofi-aventis and Schering's appeals from the judgment of Justice Snider, which dismissed their infringement claims against Apotex and Teva (formerly Novopharm) regarding a patent covering ramipril (sanofi-aventis's ALTACE). Justice Snider found that the relevant claims were invalid for lack of sound prediction and, in the alternative, as obvious. The Court of Appeal concluded that the Trial Judge properly cited the legal principles applicable to sound prediction, applied those principles to the evidence before her, and arrived at her conclusions. The Court also noted that the Judge's obviousness analysis was obiter and therefore it did not address obviousness.

Sanofi-aventis Canada Inc. v. Apotex Inc., January 3, 2012 (SCC Case No. 34600).
Federal Court of Appeal decision — 2011 FCA 300.
Federal Court decision — 2009 FC 676.

Merck Frosst Canada seeks leave to appeal decision confirming liability under 1998 version of section 8 re. norfloxacin. As reported in the December 2011 issue of Rx IP Update, the Court of Appeal dismissed Merck's appeal from Justice O'Reilly's decision finding Merck liable under section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") for holding Apotex off the market for norfloxacin (Merck's NOROXIN). The Court concluded that Merck's prohibition application was "pending" on the coming into force of the 1998 Regulations and the 1998 Regulations do not have retroactive or retrospective effects and do not interfere with vested rights. The Court also found no error in the Trial Judge's finding that Apotex would have gone to market with norfloxacin as of June 10, 1994.

Merck Frosst Canada & Co. v. Apotex Inc., January 23, 2012 (SCC Case No. 34627).
Federal Court of Appeal decision — 2011 FCA 329.
Federal Court decision — 2010 FC 287.

Pfizer denied leave to appeal decision setting aside Order of prohibition re. latanoprost (Pfizer's XALATAN). On February 2, 2012, the Supreme Court denied Pfizer leave to appeal a decision of the Federal Court of Appeal setting aside the Federal Court's Order prohibiting the Minister of Health from issuing a notice of compliance to Apotex for latanoprost. The Court of Appeal held that when the promise of the patent was properly construed, the promised utility was not soundly predicted.

Pfizer Canada Inc. v. Apotex Inc. (SCC Case No. 34497).
Federal Court of Appeal decision — 2011 FCA 236.
Federal Court decision — 2010 FC 447.

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 tentatively scheduled for April 20, 2012 (originally scheduled for February 7, 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).
Federal Court of Appeal decision — 2010 FCA 242.
Federal Court decision — 2009 FC 638.

 

Recent Court decisions

Patented Medicines (Notice of Compliance) Regulations

Patent not eligible for listing against Gilead's COMPLERA submission. On January 3, 2012, the Federal Court dismissed Gilead's application for a judicial review of the Minister of Health's decision that a patent was not eligible for listing on the Patent Register against its new drug submission for COMPLERA, which contains tenofovir disoproxil fumarate, emtricitabine, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor ("NNRTI"). The patent includes a claim for a formulation comprising tenofovir disoproxil fumarate, emtricitabine, and an NNRTI and a claim for a combination of such ingredients. The Minister held the patent was ineligible for listing as the patent referenced NNRTIs as a class without specifying rilpivirine. The Federal Court held that the eligibility should be considered pursuant to section 4(2)(b) of the Regulations as containing formulation rather than combination claims. The Court held that product specificity had not been met as the claimed formulation and the approved formulation did not match precisely. On this basis, the Federal Court held that the Minister's decision that the patent was not eligible for listing was reasonable. Gilead has appealed.

Gilead Sciences Canada, Inc. v. Minister (Health), January 3, 2012.
Federal Court decision — 2012 FC 2.

 

New Court proceedings

Patented Medicines (Notice of Compliance) Regulations

 

 

 

 

 

 

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