US PTO rejects Apotex re-examination of Plavix patent, as Sanofi enters another diabetes deal, gets orphan status for rifapentine

1 July 2010

In what continues to be a busy news week for French drug major Sanofi-Aventis, and another patent victory for Big Pharma, the US Patent and Trade Mark Office has denied a request by Canada-based generic drugmaker Apotex for a second re-examination of the US patent for the firm's blockbuster blood thinner Plavix (clopidogrel), which is co-marketed with Bristol-Myers Squibb, and generated sales of $9.1 billion last year, $5.6 billion in the USA.

The news follows that of a patent victory for AstraZeneca over its blockbuster cholesterol lowerer Crestor (rosuvastatin), and just a day after Sanofi-Aventis launched a takeover bid of US cancer drug developer TargeGen (The Pharma Letter June 30)

According to a report by the Wall Street Journal, the latest PTO ruling could help Sanofi-Aventis and B-MS to preserve US market exclusivity for the drug until 2012. The patent is due to expire in November 2011 but the companies might get an additional six months of exclusivity for having carried out pediatric studies with Plavix.

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Chairman, Sanofi Aventis UK