FURTHER UPDATE ON PLAVIX® CASE

Scott Daniels | April 21, 2010

As we reported in January, the defendant in Sanofi-Synthelabo v. Apotex moved to stay the litigation pending completion of a reexamination of the patent-in-suit, U.S. Patent No. 4,847,265 for Sanofi’s anti-blood clot drug PLAVIX®.  In March, the PTO issued a notice that it intends to issue a reexamination certificate confirming the patentability of the claims.

Judge Sidney Stein has now denied Apotex’ motion to stay, finding that each of the traditional factors in considering such motions – simplification of issues, stage of the litigation, and prejudice to the patentee – weigh against a stay.  Significantly, the CAFC has already affirmed a judgment that the ‘265 patent is valid and infringed by Apotex.  The only issue remaining is the award of damages.

The last page of this story, however, may not have been written.  On April 4, Apotex filed a second reexamination request based on U.S. Patent No. 4,529,596, “as well as other art and admissions.”  And on April 16, Apotex filed a protest/petition, asserting that the examiner’s consideration of certain information submitted by Sanofi was ultra vires, i.e., that the information was not prior art or not otherwise suitable for consideration in a reexamination proceeding.  Apotex’ petition is unusual because the reexamination is ex parte.

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