Certification Pledge Is Not Enough To Avoid Infringement In Hatch-Waxman Litigation

Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.

Addressing a decision regarding infringement by a generic version of Lunesta®, the U.S. Court of Appeals for the Federal Circuit reversed a district court's decision that the generic made by an Abbreviated New Drug Application (ANDA) applicant fell outside the scope of the patent at issue, finding that infringement occurs when the ANDA specification describes a product that meets the limitations of the asserted claims. Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 13-1335 (Fed. Cir., Sept. 26, 2013) (Lourie, J.).

At issue in this case is Sunovion's patent, which claims the dextrorotatory (or (S)-enantiomer) of a compound known as zopiclone (trade name Lunesta). The claims recite the compound "in the form of its dextrorotatory isomer and essentially free of its levorotatory isomer." Reddy submitted an ADNA to the FDA for approval of the generic version of Lunesta. The ANDA