Justia Drugs & Biotech Opinion Summaries

Senju’s patent covers an ophthalmic solution for eye drops containing Gatifloxacin, an antimicrobial agent, to kill bacteria. Tear dilution and the outer layer of the eye can prevent Gatifloxacin from passing into and treating the aqueous humor. The patent discloses a solution combining Gatifloxacin with disodium edetate, to expand the intercellular spaces of the cornea, accelerating passage of Gatifloxacin solution into the eye. In 2007, Apotex filed an Abbreviated New Drug Application with the FDA (Hatch-Waxman Act, 98 Stat. 1585), requesting approval to manufacture and sell a generic version of the solution. Senju filed an infringement action. The district court held that, though the ANDA product infringed claims 1–3, 6, 7, and 9, claim 7 was invalid as obvious. The Federal Circuit affirmed. In the gap between the court’s 2010 issuance of findings and its December 2011 entry of final judgment, Senju requested reexamination of claims 1–3, 6, 8, and 9; amended claim 6 to include additional limitations; and added new independent claim. In October 2011, the PTO issued a reexamination certificate cancelling claims 1–3 and 8–11, and certifying amended claim 6, new independent claim 12, and new dependent claims as patentable. Before entry of final judgment in the first action, Senju sought a declaratory judgment that Apotex’s manufacture, use, or sale of Gatifloxacin ophthalmic solution infringed claims set forth in the reexamination certificate. The district court dismissed. The Federal Circuit affirmed, finding the suit barred by claim preclusion. View "Senju Pharm. Co., Ltd. v. Apotex, Inc." on Justia Law