Posts Tagged ‘obviousness’
In Novo Nordisk Canada Inc. v. Cobalt Pharmaceuticals Inc., the Federal Court (“FC”) dismissed Novo Nordisk Canada Inc.’s (“Novo”) application for an order to prohibit the Minister of Health (“Minister”) from issuing a Notice of Compliance to Cobalt Pharmaceuticals Inc. (“Cobalt”) until the expiration of Canadian Patent No. 2,111,851 (“the ’851 patent”) for a compound named repaglinide useful for type 2 diabetes treatment. The FC concluded that one of Cobalt’s allegations of invalidity is justified. 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.
In Merck & Co. Inc. v. Pharmascience Inc. (2010 FC 510), the Federal Court (FC) dismissed Merck & Co. Inc.’s (Merck) application to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Pharmascience Inc. The FC found Canadian Patent No. 2,173,457 (the ’457 patent) invalid on the basis of double patenting and anticipation. Significantly, the FC held that, despite its finding of anticipation, the ’457 Patent was not obvious because prior art subsequent to the anticipating art would have discouraged any inquiry in to the relevant field of research.
Pharmascience had sought a NOC to market a generic version of the medicine finasteride, used in the treatment of male pattern baldness. Only dependent claim 5 of the ’457 Patent remained in issue, and the FC summarized it as follows: “the use of finasteride for the preparation of a medicament adapted for oral administration useful for the treatment of male pattern baldness in a person and wherein the daily dosage is about 1.0mg.” Continue Reading
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