2010 July : US PTO Litigation Alert™

Second Request for Reexamination of Plavix® Patent is Denied

| July 1, 2010

The USPTO has denied Apotex’ request for reexamination of U.S. Patent No. 4,847,265, finding that no substantial new question of patentability (SNQ) has been raised.  The main reference relied upon in the request – U.S. Patent No. 4,529,596 – had been applied by the PTO in an anticipation rejection in the original prosecution and in a double patenting rejection in an earlier reexamination, of the ‘265 patent.

The ‘265 patent covers clopidogrel bisulfate which is the active agent in Bristol-Myers/Sanofi’s anti-blood clot drug, PLAVIX®.  The ‘265 patent is the subject of a pending infringement suit between these companies in the Southern District of New York.

Does an Ex Parte Requester Have Two Bites at the Apple?

| July 1, 2010

A requester in an inter partes reexamination is estopped from arguing in subsequent litigation an invalidity issue that it “raised or could have raised” in the reexamination.  35 U.S. § 315(c).  There is no corresponding estoppel provision against ex parte requesters.  Nevertheless, reexamination practitioners often assert that there is a de facto estoppel against an ex parte requester who later reasserts in litigation the reexamination references.

That may not be true in all courts. 
Read More/続きを読む

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