In its third look at the Novo Nordisk A/S patent related to Prandin®, in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories Ltd., the Federal Circuit affirmed the district court’s finding that claim 4 of U.S. Patent No. 6,677,358 is invalid as obvious, but reversed the district court’s finding that the patent is unenforceable due to … Continue reading this entry
Tags: Caraco, Inequitable Conduct, Materiality, Novo-Nordisk, Obviousness, Prandin, Synergy, Therasense, Unexpected Results
On July 30, 2012 the Federal Circuit issued what should be its final decision in the litigation between Caraco Pharmaceutical Labs. and Novo Nordisk A/S surrounding Caraco’s generic version of Novo Nordisk’s Prandin® repaglinide product. Earlier this year the Supreme Court held that 21 USC § 355(j)(5)(C)(ii)(I) provides Caraco with a mechanism for challenging the use code associated … Continue reading this entry
Tags: ANDA, Caraco, Carve-Out, Hatch-Waxman, Novo-Nordisk, Orange Book, Prandin, Repaglinide
On April 17, 2012 the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Labs., Ltd. v. Novo Nordisk A/S, reversing the Federal Circuit decision and finding that 21 USC § 355(j)(5)(C)(ii)(I) provides a mechanism for a generic drug manufacturer to challenge the accuracy of a use code associated with an Orange Book listed patent. This decision … Continue reading this entry
Tags: ANDA, Caraco, Carve-Out, Hatch-Waxman, Novo-Nordisk, Orange Book, Prandin
Posted in Federal Circuit Decisions