Survey of the Safe Harbor in the United States and Europe


Fish & Richardson litigation attorney Brian Coggio recently co-authored the article “Survey of the Safe Harbor in the United States and Europe” published by Bloomberg BNA on December 2, in the Pharmaceutical Law & Industry Report. The survey reviews the scope and history of protection afforded by the Safe Harbor including the so-called Bolar Exception, Bolar Exemption and the broad research exemptions that exist in Europe.

“Understanding the scope of the Safe Harbor in the U.S. and the regulatory research safe harbors in the EU and Canada will allow companies to take advantage of the best geographical locations in order to avoid infringement accusations in researching and developing pharmaceutical products.”


Authors: Brian Coggio, Ron Vogel