Sanofi-Aventis and Bristol-Myers Squibb won their second legal victory this month related to the patent for Plavix, staving off launch of a generic copy in Canada.
The Canadian Federal Court of Appeals dismissed an appeal by Canadian generics firm Apotex of a judgment of the Federal Court of Canada in favor of the two big drug marketers. The federal court had prohibited the Minister of Health from issuing a Notice of Compliance, which Apotex would need to launch generic Plavix (clopidogrel) in that country.
Since the Canadian patent has withstood Apotex's challenge, generics will not be able to enter the market in Canada before August 2012—the expiration of the Canadian patent.
While the victory ensures patent protection in Canada, the US may prove another matter. Earlier this month, the US Court of Appeals for the Federal Circuit in Washington affirmed a district court's preliminary injunction to prevent Apotex from selling a generic. Sanofi and BMS would need to obtain a permanent injunction to prevent generic competition until the US expiry, 2011. A US trial on the patent’s validity is set to begin Jan. 22.