US PTO denies Apotex bid for re-exam of Plavix patent
This article was originally published in Scrip
Bristol-Myers Squibb and Sanofi-Aventis have achieved another legal victory, after the US Patent and Trademark Office (PTO) denied generic firm Apotex's second request for re-examination of the compound patent for the blockbuster antiplatelet drug, Plavix (clopidogrel).
In a decision released in late June, the PTO claimed that "no substantial new question of patentability" affecting the Plavix patent had been raised in the second request for re-examination, and therefore it would not perform another re-exam, according to the legal website Law360. The ruling should help BMS and Sanofi-Aventis preserve US market exclusivity for some time, as the Plavix compound patent (No '265) bars competition until November 2011.
The PTO upheld the validity of the '265 patent in March (which had followed a request from Apotex last year to conduct a re-examination), saying that Plavix was not an "obvious" invention as Apotex had claimed. But in April Apotex requested yet another re-examination. The '265 patent covers just the effective enantiomer, and Apotex has argued that separation would have been obvious. It began targeting the PTO as a possible way to overturn the patent after it had exhausted all of its appeals on the courts. Both a US district court judge and the US Court of Appeals for the Federal Circuit have upheld the patent's validity, with the appeals court saying it saw no clear error in the lower court's finding concerning the difficulty and unpredictability of the separation of the enantiomers.
Apotex has one month in which to file a petition with the director of the PTO to review the most recent denial.
damages
BMS is seeking damages from Apotex for the brief period when Apotex's generic version of Plavix was on the US market, which hurt sales of the branded product in 2006. A decision on damages is pending by a federal judge in New York (scripintelligence.com, 20 April 2010).
In November 2009, the US Supreme Court refused to weigh in on the Apotex dispute over the Plavix patent (scripintelligence.com, 3 November 2009).