In Novopharm Ltd. v. Eli Lilly and Company (2010 FC 915), the Federal Court of Canada (“Federal Court”) considered allegations raised by Novopharm Ltd. (“Novopharm”) that Eli Lilly and Company’s (“Eli Lilly”) Canadian Patent No. 2,209,735 (“’735 patent”) was invalid and void under S. 60(1) of the Patent Act for being obvious, anticipated, an improper selection patent and lacking utility. The ‘735 patent claimed the new use of atomoxetine for treating attention deficit hyperactivity disorder (ADHD). The Federal Court dismissed the claims for obviousness, anticipation and improper selection patent, but held the ‘735 patent invalid and void for lack of utility.
Background
Atomoxetine was originally studied by Eli Lilly as a possible treatment for depression as early as 1979, however, subsequent clinical trials failed to establish atomoxetine’s efficacy and in 1991, research for this indication was terminated. By the end of 1994, Eli Lilly and the Massachusetts General Hospital had an agreement to jointly sponsor a clinical trial of atomoxetine as a treatment for ADHD, in part because of its recognized characteristic as a selective norepinephrine reuptake inhibitor (NRI). Continue Reading
In Jose Cuervo S.A. de C.V. v. Bacardi and Company Limited (2010 FCA 248), the Federal Court of Appeal (“FCA”) upheld a decision (2009 FC 1166) of the Federal Court of Canada (“Federal Court”) without providing additional reasons, dismissing an appeal from a decision of the Registrar of Trade-Marks (“Registrar”) to expunge Jose Cuervo S.A. de C.V.’s (“Jose Cuervo”) trade-mark registration # 341,290 CASTILLO for non-use.
Jose Cuervo markets alcoholic beverages, including Castillo rum. Jose Cuervo owned Canadian trade-mark registration No. 341,290 for its CASTILLO trade-mark. Bacardi & Company Limited (“Bacardi”) requested the Registrar issue a notice under S. 45 of the Trade-marks Act, which provides for the expungement of marks not used during a three-year period immediately preceding notice from the Registrar unless the non-use is due to special circumstances. Continue Reading
In Pfizer Ltd. v. Ratiopharm Inc. (2010 FCA 204), the Federal Court of Appeal (“FCA”) upheld a Federal Court decision (2009 FC 711) holding Pfizer’s Canadian Patent No. 1,321,393 (“’393 patent”) invalid for obviousness.
Amlodipine is a calcium channel blocker, its pharmaceutically acceptable besylate salt is marketed under the tradename NORVASC and used to treat high blood pressure. During its development Pfizer tested seven salts through the accepted process of salt screening. The Federal Court noted only certain salts were selected for further testing and “there was no effort to test all possible salts.” The ’393 patent was a selection from a previous European patent disclosing a broad class of amlodipine compounds. Claim 11 of the ’393 patent claimed the besylate amlodipine compound and promised it to be particularly suitable for preparation of amlodipine.
In AstraZeneca Canada Inc. v. Apotex Inc. (2010 FC 714), the Federal Court (“FC”) denied AstraZeneca Canada’s (“AstraZeneca”) application under s. 6 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations“) prohibiting ththe issuance of a Notice of Compliance (“NOC”) to Apotex Inc. until the expiration of Canadian Patent No. 2,139,653 (” ’653 patent”). The FC held Apotex’s allegations against the ’653 patent regarding obviousness and lack of sound prediction as to utility were justified, and denied AstraZeneca’s prohibition application.
Apotex’s Abbreviated New Drug Submission (ANDS) was for esomeprazole magnesium tablets, a drug useful in the treatment of conditions where a reduction of gastric acid secretion is necessary. The ’653 patent, entitled “Optically Pure Salts of Pyridinylmethyl Sulfiny – IH – Benzimidazole Compounds”, claimed optically pure salts of esomeprazole, process claims and use claims. The issue at way was limited to whether Apotex’s allegation that claim 8 of the ’653 patent was invalid was justified. Claim 8 is for a salt of esomeprazole having an optical purity of 99.8% or greater.
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