Rx IP Update

Supreme Court grants Apotex leave to consider PLAVIX patent for the second time

by Junyi Chen

On January 30, 2014, the Supreme Court of Canada granted Apotex Inc. leave to appeal a decision of the Federal Court of Appeal which overturned a Federal Court's decision invalidating the patent that claims clopidogrel bisulphate (sanofi-aventis' PLAVIX): SCC Case No. 35562, case summary.

The Supreme Court of Canada is expected to address issues regarding the assessment of the promised utility of a patent, if any, providing guidance on an issue that has been central to a number of pharmaceutical patent decisions in the last number of years.

By granting leave to Apotex, the Supreme Court will consider the validity of the PLAVIX patent (the "777 Patent") for the second time.

The 777 patent discloses and claims an enantiomer clopidogrel and its bisulfate salt, as well as processes for its manufacture. An earlier patent (875 Patent) encompassed clopidogrel bisulfate within its claims and included an example describing the racemate. PLAVIX, which contains clopidogrel bisulfate as the active ingredient, is used to inhibit platelet aggregation activity in the blood.

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