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  • Classen Immunotherapies, Inc. v. Biogen IdecClassen Immunotherapies, Inc. v. Biogen Idec
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Classen Immunotherapies, Inc. v. Biogen Idec

United States Court of Appeals for the Federal Circuit
659 F.3d 1057 (Fed. Cir. 2011)


The Hatch-Waxman Act provided a patent infringement safe harbor in 47 U.S.C. § 271(e)(1) that allowed companies to “make, use, offer to sell, or sell within the United States . . . a patented invention . . . solely for uses reasonably related to the development and submission of information” under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301, et seq., or other related federal law. Congress implemented the safe harbor to accelerate the production and regulatory approval of generic versions of patented products, when the marketing of such generic versions would commence only after the expiration of the relevant patents. Biogen Idec (Biogen) (defendant) participated in various studies evaluating the risks associated with the combination and timing of childhood vaccinations. Biogen reported the results of these studies to the Food and Drug Administration (FDA). Biogen did not report the results of the studies for purposes of FDA approval of a generic product. Classen Immunotherapies (Classen) (plaintiff) brought a patent infringement suit in the United States District Court for the District of Maryland. Classen argued that the § 271(e)(1) safe harbor applied only to activities conducted prior to FDA approval of generic versions of patented inventions. The district court disagreed and granted Biogen summary judgment based on the § 271(e)(1) safe harbor. Classen appealed. The United States Supreme Court granted certiorari and remanded the case to the United States Court of Appeals for the Federal Circuit.

Rule of Law


Holding and Reasoning (Newman, J.)

Dissent (Moore, J.)

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