Patents, Copyrights and Trademarks -- 2005



Merck KGaA v. Integra Lifesciences I, Ltd.   (U.S. Supreme Court)

Patent exception for drug research

The Supreme Court unanimously held 6/13/05 that the use of a patented compound “in research that, if successful, would be appropriate to include in a submission to the FDA” does not infringe a patent if the user “has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect,” even if the results are not ultimately submitted to the FDA. Integra LifeSciences, a holder of several patents related to biological compounds used by Merck KGaA in research on anti-cancer drugs, brought an infringement action against Merck. The case turned on the application of 35 U.S.C. § 271(e)(1), which states that “uses [of patents] reasonably related to the development and submission of information under a Federal law which regulates the . . . use . . . of drugs” are not acts of infringement. The Court rejected Integra’s contention that § 271(e)(1) does not apply to uses of patented compounds in “experimentation of drugs that are not ultimately the subject of an FDA submission or . . . in experiments that are not ultimately submitted to the FDA,” noting that § 271(e)(1) leaves “adequate space for experimentation and failure on the road to regulatory approval.” This decision will be of great interest to any company that either holds patents commonly used in pharmaceutical research or uses such patents in the course of conducting such research.

Decision Below: 331 F. 3d 860 (Fed. Cir. 2003).