Patent Infringement at the ITC: Implications for Brand-Name Drug Companies

This article appeared in Pharmaceutical Compliance Monitor, September 22, 2015 and is reproduced with permission.

The U.S. International Trade Commission (ITC) is the federal agency tasked with determining the impact of imports on U.S. industries and directing actions against certain unfair trade practices, including violations of intellectual property rights, such as patent infringement.  Once a valid complaint is filed with the ITC alleging that an imported good infringes an enforceable U.S. patent, the ITC conducts an investigation to determine whether the imported good violates certain sections of the Tariff Act of 1930 (Tariff Act).  Actions resulting from an investigation that confirms a violation include issuance of an exclusion order that bars importation of the good and may include issuance of a related cease and desist order that directs a violating party to cease specific actions.  Given that brand drug companies rely so heavily on the exclusivity afforded by patents as a strategy for recovering costs associated with drug research and development, blocking importation of infringing drug products via ITC proceedings can, in some cases, provide a significant patent enforcement option by which a brand drug company can protect its patent rights.

If you have any questions about this article or would like to discuss this topic further, please contact the authors, Terry Mahn and Erin Knight, Ph.D.