Court Applied Four-Factor Test for Preliminary Injunction Relief
December 13, 2006
In Sanofi v. Apotex (Sanofi-Synthelabo, Sanofi-Synthelabo,Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Apotex, Inc. and Apotex Corp.), the Court affirmed the decision granted by the US District Court for the Southern District of New York granting a preliminary injunction in favor of Sanofi. At issue was a patent ("the '265 patent") for an active ingredient "clopidogrel bisulfate," an active ingredient in Plavix? - a medication manufactured by Sanofi to reduce events such as heart attacks and strokes. The '265 patent will expire on November 17, 2011. In November 2001, Apotex filed an Abbreviated New Drug Application ("ANDA") seeking FDA approval to manufacture and sell a generic version of clopidogrel bisulfate. Sanofi sued Apotex claiming that the filing of the ANDA infringed the '265 patent. Apotex counterclaimed, asserting that the '265 patent was invalid and unenforceable. A thirty-month stay of FDA approval for the ANDA was triggered when the suit was filed. Upon expiration of the stay, the FDA approved the ANDA. Sanofi and Apotex began settlement negotiations to resolve the litigation. The parties reached a first settlement agreement; however the settlement was not approved by the Federal Trade Commission or a consortium of state attorneys general. A second negotiated settlement again did not meet the approval of the FDA or the state attorneys general. Apotex declared a "regulatory denial" which allowed litigation to resume. Pursuant to the first settlement agreement, Apotex launched its generic clopidogrel bisulfate and, pursuant to the provisions of this agreement, Sanofi notified Apotex of is intent to move for a preliminary injunction. After a two-day evidentiary hearing, the district court granted a motion for injunctive relief, but denied Sanofi's request for product recall. In reaching its decision, the district court applied the established four-factor test for preliminary injunctive relief. Apotex move for a stay of the injunction which was denied by the Court, and filed its appeal from the district court's grant of preliminary injunction. In affirming the district court's decision to grant injunctive relief, the Court addressed a myriad of issues holding that Apotex failed to raise a substantial question of validity of the '265 patent. In affirming the district court's decision, Apotex is blocked from selling its generic drug until a judge can rule on the validity of the '265 patent. The trial is set for January.
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