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Expanded Rights for Preclinical Research Favor Innovator Drug Companies |
April 22, 2006
Previously published on June 15, 2005
In a unanimous decision anxiously awaited by many pharmaceutical and biotech companies, the U.S. Supreme Court reversed the Federal Circuit and held that the exemption from patent infringement granted under 35 U.S.C. §271(e)(1) extends broadly to preclinical research for any patented compound. According to the holding in Merck KGaA v. Integra LifeSciences I, Ltd., handed down on June 13, 2005, this "§271(e)(1) exemption" would protect a company that reasonably believes the compound being tested could be submitted for FDA approval and the experiments being undertaken would produce results and information relevant to such regulatory submissions.
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The views expressed in this article are solely the views of the author and not Martindale-Hubbell. This article is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance. |
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