My law review article on the 271(e)(1) safe harbor - background for Merck v. Integra

Posted by J. Matthew Buchanan

February 16, 2005

The Supreme Court recently granted certiorari in Merck KGaG v. Integra LifeSciences I, Ltd., Supreme Court No. 03-1237. At issue is experimentation and experimental use of patented inventions in the development of new drugs. The Court will consider the scope of the so-called FDA safe harbor from patent infringement, 35 U.S.C. 271(e)(1).

I previously published a Comment in the University of Toledo Law Review that examined the scope of the FDA safe harbor in relation to the Food and Drug Administration Modernization Act (FDAMA). While the substance of the analysis is different than the issue presented in Merck, the article includes a thorough background of the safe harbor and its incorporation into our patent law, as well as a primer on FDA regulation of medical products. As such, it may be of interest to those following the Merck case.

The Law Review has graciously granted me permission to republish the article on the blog (many thanks, Peggy!). View and/or download a .pdf of the article here.

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