All posts by Alan Macek

USSC on Orange Book information

The U.S. Supreme Court issued its decision today in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S on patent listing requirements in the FDA’s “Orange Book” for patented drugs. Caraco, an ANDA filer, brought a counterclaim in Novo’s Hatch-Waxman infringement action seeking an order that Novo correct patent information in the Orange Book on the basis the patent did not claim a use of the drug.

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