Sanofi-Synthelabo v. Apotex, Inc.
United States Court of Appeals for the Federal Circuit
470 F.3d 1368 (2006)
Sanofi-Synthelabo (Sanofi) (plaintiff) held the patent on the active ingredient in Plavix; Apotex (defendant) filed an abbreviated application to market a generic version, asserting the patent was invalid, which triggered patent litigation and a statutory stay of FDA approval. After the stay expired and the FDA approved Apotex's generic, Apotex launched it and shipped a six-month nationwide supply before Sanofi's preliminary-injunction motion was decided; the district court granted the injunction (though not a recall), relying on Apotex's own stipulation of infringement, evidence of price erosion and lost goodwill to Sanofi, Apotex's largely self-inflicted and avoidable hardship from launching before the ruling, and the public interest in a functioning patent system, and it set a $400 million bond.
Whether a district court has discretion to grant or deny a preliminary injunction based on likelihood of success on the merits, irreparable harm, the balance of hardships, and the public interest.