Tag Archives: Caraco

Federal Circuit Invalidates Prandin Patent Claim As Obvious

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

Federal Circuit Has Final Say In Caraco Prandin Case

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

Supreme Court Reverses Caraco, Finds Right To Challenge Orange Book Use Code

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

Supreme Court To Hear Oral Arguments In Two Important Cases This Week

This week the Supreme Court will hear oral arguments in two cases that are important to the pharmaceutical industry: (i) Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S and (ii) Mayo Collaborative Services v. Prometheus Laboratories, Inc.… Continue reading this entry

Supreme Court To Hear Orange Book Listing Case

On June 27, 2011, the Supreme Court granted certiorari in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. This means that the Court will review the Federal Circuit decision which held that the ANDA litigation counterclaim provision of the Hatch-Waxman Act does not permit a counterclaim to challenge a method patent listing when the listed patent … Continue reading this entry