Patent-Infringement Issues with Drug Screening Outside the U.S.

摘要

Processes of Identifying Data Are Not Steps in Manufacture of Final Drug Products. Does drug screening outside the U.S., followed by importing the identified drug into the U.S., avoid infringement of a U.S. patent that protects the screening method? Arecent appeals court decision, Bayer AG v. Housey Pharmaceuticals Inc. (2003), clarifies that this activity outside the U.S. does avoid patent infringement; however, avoiding a U.S. patent hy performing screening off-shore and then importing the drug identified by the screen into the U.S. is not as cut-and-dried as it seems.