A Safe Harbor for Drugs Made Offshore: The Federal Circuit Renders the Bolar Amendment Available in § 337 Actions in Amgen v. U.S. International Trade Commission
In Amgen v. International Trade Commission, the United States Court of Appeals for the Federal Circuit issued an important holding pertaining to the International Commission’s (ITC) role in regulating the importation of pharmaceuticals. Under the Patent Act, the owner of a patent on a pharmaceutical can sue another party for importing an infringing product. A statutory defense to infringement in this context exists, however, when importation is pursuant to obtaining regulatory approval for the imported drug from the Food and Drug Administration (FDA) (e.g., for developing a generic pharmaceutical to compete with a patented brand name drug). Aside from suing in federal court, however, under the Tariff Act, patentees can also complain to the ITC to prevent the importation of products that infringe patented products. In Amgen, the Federal Circuit held that under the Tariff Act, respondents to complaints at ITC may avail themselves of the same safe harbor as afforded importers of compounds pursuant to seeking FDA approval under the Patent Act.