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The FDA Exemption & Research Tools: The Federal Circuit Gets It Wrong






By E. Joshua Rosenkranz and David A. Manspeizer

Mr. Rosenkranz, a partner at Orrick, Herrington & Sutcliffe, argued the Merck case in the Supreme Court of the United States.  Mr. Manspeizer is Vice President – Intellectual Property and Associate General Counsel at Wyeth, and participated in briefing the original Merck appeal before the Federal Circuit.

One of the most hotly contested patent law questions in the life sciences arena is the scope of the so-called “FDA exemption.”  This provision, found in 35 U.S.C. § 271(e)(1), exempts from patent infringement experiments that “use ... a patented invention ... solely for uses reasonably related to the development and submission of information” to the FDA.  The big question for the biotech community has been:  what about research tools?  Is a pharmaceutical company free to use any patented research tool it wants—cell lines, animal models, etc.—so long as the experiment might arguably be relevant to the FDA?  The Federal Circuit recently issued an opinion, in Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1258 (Fed. Cir. 2008), that appears to carve research tools out of the safe harbor—exposing innovators to liability for using patented research tools. 

The biotechs breathed a collective sigh of relief­—for now.  The problem is that the Fed...

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