Unigene Laboratories, Inc. et al. v. Apotex, Inc. et al.: Reformulating an old drug is not as obvious as one might think

Abstract

In Unigene Laboratories, Inc. et al. v. Apotex, Inc. et al., 655 F.3d 1352 (Fed. Cir. 2011), the Federal Circuit addressed issues of obviousness and the crime fraud exception to privilege. The Federal Circuit affirmed the District Court's denial of summary judgment of obviousness and its grant of summary judgment of nonobviousness. In addition, the Federal Circuit found that the District Court had properly found that documents had not been improperly withheld based on the crime-fraud exception and that additional theories of inequitable conduct raised by Apotex at later stages of the litigation had either been previously addressed by the District Court or had been waived. This case report presents the arguments made at the District Court and Federal Circuit and how each of these courts addressed the issues raised by the parties.