Amgen Inc. v. Chugai Pharmaceutical Co. (US District Court, District of Massachusetts - 706 F. Supp. 94 1989)

Case Description

The Court ruled that the export/import of samples of a biological product protected by patent for the conduct of stability studies "solely for uses reasonably related to the development and submission of information under" reporting requirements of federal drug laws, is permitted under the regulatory review exemption.

Decision Year
Post-grant flexibilities