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's safe harbor, 47 U.S.C. § 271(e)(1), shields activity that uses a patented invention "solely for uses reasonably related to" developing and submitting information under the FDCA — a provision meant to speed up generic drug approval. Biogen Idec (defendant) studied the risks of combined childhood vaccinations and reported those results to the FDA, but not in connection with seeking approval of any generic product. Classen Immunotherapies (plaintiff) sued for patent infringement; the district court found Biogen's reporting protected by the safe harbor, and after Supreme Court remand, the case returned to the Federal Circuit.
Whether the patent infringement safe harbor in 47 U.S.C. § 271(e)(1) is limited to activities conducted prior to FDA approval of generic versions of patented inventions.