Experimental Use Exception To Patent Infringement In Canada

Article by Sheldon Burshtein, ©2005 Blake, Cassels & Graydon LLP

This article was originally published in Blakes Bulletin on Intellectual Property, October 2005.

Significant research and development is conducted in Canada, especially in the biotechnology and pharmaceutical industries. Therefore, there has been much interest in a recent United States decision on experimental activity in the context of potential liability for patent infringement and the corresponding position in Canada.

In a much anticipated decision, the United States Supreme Court held that the use of a patented compound in preclinical studies is exempt from patent infringement where there is a reasonable basis for believing that the compound could be the subject of a regulatory filing to the United States Food and Drug Administration (USFDA) or where the experiment may produce information for use in a USFDA submission: Merck v. Integra Lifesciences. Merck funded research by the Scripps