Sanofi-Synthelabo v. Apotex, Inc. And Apotex Corp.

470 F.3d 1368 (2006)

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Nature of the Case

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Facts

P markets Plavix(R), a platelet aggregation inhibiting agent used to reduce thrombotic events such as heart attacks and strokes. P markets Plavix(R), a platelet aggregation inhibiting agent used to reduce thrombotic events such as heart attacks and strokes. The active ingredient is clopidogrel bisulfate, which is covered by Sanofi's '265 patent, which will expire on November 17, 2011. Stereochemistry refers to the three-dimensional spatial arrangement of a molecule's constituent atoms. Molecules that have the same chemical substituents, but different spatial arrangements, are referred to as stereoisomers. In November 2001, D filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to manufacture and sell a generic version of clopidogrel bisulfate. D filed a Paragraph IV certification with its ANDA, pursuant to §355(j)(2)(A)(vii)(IV), asserting that the '265 patent is invalid. P sued D on March 21, 2002, claiming that the filing of the ANDA infringed the '265 patent. D asserted that the patent is invalid and unenforceable. A thirty-month stay of FDA approval for the ANDA was triggered when the suit was filed in the district court. The stay expired on May 17, 2005, and on January 20, 2006, the FDA approved the ANDA. Several days before the ANDA was approved, P and D began settlement negotiations in an effort to resolve the litigation. Agreements were reached but government officials refused to join in the agreements. Eventually, litigation resumed. P notified D of its intent to move for a preliminary injunction in the time frame permitted by the agreement. The district court granted the motion for injunctive relief on August 31, 2006, but denied the request for a product recall. During the period between the generic launch and the entry of the preliminary injunction, D shipped a six-month supply of its product to distributors in the United States. The district court applied the established four-factor test for preliminary injunctive relief and found that the factors weighed in favor of an injunction. The court noted that D conceded that its accused products infringe claim 3 of the '265 patent. The court found that d failed to establish a likelihood of proving invalidity at trial. The court rejected its claims of anticipation, obviousness, and obviousness-type double patenting invalidity defenses. It held that D failed to raise a substantial question as to whether the '265 patent is unenforceable due to inequitable conduct. the court concluded that the doctrine of laches was inapplicable, and it rejected D's unclean hands’ defense. The court set bond in the amount of $400 million. Trial was scheduled to commence on January 22, 2007. D appealed.