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Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2010)

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Kevin E. Noonan -- On April 14th, the Federal Circuit rendered a decision construing statutory language in a rather straightforward and unremarkable (albeit not unanimous) opinion. But the statutory language at issue involved the 2003 Medicare Prescription Drug Improvement and Modernization Act, which amended the 1984 Drug Price Competition and Patent Term Restoration Act (colloquially known as the Hatch-Waxman Act), thus raising the opinion's significance. The statutory provisions at issue involve the requirements for listing patents claiming drug products or their uses in the Orange Book. The statute requires an innovator and approved New Drug Application (NDA) holder to...

Full post as published by Patent Docs on April 28, 2010 (boomark / email).