Amgen, Inc. v. U.S. Int’l Trade Comm’n

519 F.3d 1343 (Fed. Cir. 2008)

After a patentee appealed the decision of the International Trade Commission (ITC), the Federal Circuit held that the ITC properly applied the infringement safe harbor under 35 U.S.C. § 271(e)(1) in a proceeding against the allegedly unlawful importation of products made by a patented process. The plaintiff, Amgen, claimed that certain importations of recombinant human erythropoietin violated Section 337 of the Tariff Act, which prohibits importation based on unfair competition derived from patent, trademark and copyright infringement. The alleged infringer imported its product for the purpose of obtaining Food and Drug Administration (FDA) approval. The ITC found no infringement, concluding that alleged infringer’s activities fell within the Section 271(e)(1) safe harbor, which prevents infringement liability if an import is made solely for “uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs or veterinary biological products.” The Federal Circuit held that seeking FDA approval fell under this statutory safe harbor.