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Sanofi-Synthelabo v. Apotex, Inc.

United States Court of Appeals for the Federal Circuit
470 F.3d 1368 (2006)


Facts

Sanofi-Synthelabo (“Sanofi”) (plaintiff) held the ‘265 patent to clopidogrel bisulfate, the active ingredient in the heart attack and stroke reducing drug, Plavix® which Sanofi also marketed. In November 2001, Apotex, Inc. (“Apotex”) (defendant) filed an Abbreviated New Drug Application (“ANDA”) in order to obtain Food and Drug Administration (“FDA”) approval to manufacture and market a generic version of Plavix®. As part of the ANDA, Apotex filed a Paragraph IV certification asserting that the ‘265 patent was invalid. Sanofi filed suit against Apotex in the U.S. District Court for the Southern District of New York, claiming that the Apotex’s ANDA filing infringed on the ‘265 patent. The filing of the suit triggered a 30-month stay of FDA approval of Apotex’s ANDA. Apotex then counterclaimed, asserting that the ‘265 patent was invalid and unenforceable. The stay expired May 17, 2005, and on January 20, 2006, the FDA approved Apotex’s ANDA. On August 8, 2006, Apotex launched its generic version of Plavix® and Sanofi thereafter filed a motion for a preliminary injunction on August 15, 2006, to prevent Apotex from selling the generic drug and to recall any disbursed shipments of the drug. The district court granted Sanofi’s motion for a preliminary injunction, but denied its recall request on August 31, 2006. Between Apotex’s August 8 launch and the court’s order of August 31, Apotex had shipped a six-month supply of the drug to distributors nationwide. In granting Sanofi’s request for injunctive relief, the district court relied on an established and commonly-used four-factor test. The court then set bond in the amount of $400 million. Apotex appealed the district court’s grant of the preliminary injunction.

Rule of Law

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Issue

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Holding and Reasoning (Lourie, J.)

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  • A "yes" or "no" answer to the question framed in the issue section;
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  • The procedural disposition (e.g. reversed and remanded, affirmed, etc.).

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