In a unanimous decision, the U. S. Supreme Court held that the "safe harbor" provision under 35 U.S.C. §271(e)(1) exempts from infringement "all uses of patented inventions that are reasonably related to the development and submission of any information" under the Federal Food, Drug and Cosmetic Act, which "necessarily includes preclinical studies of patented compounds that are appropriate for submission" to the Food and Drug Administration (FDA). Merck KGAA v. Integra LifeSciences I, Ltd., Case No. 03-1237 (Jun. 13, 2005) (Scalia J.). Because the Supreme Court found the district court’s jury instruction was consistent with standard, the Supreme Court declined to reverse the judgment and instead remanded for a determination of whether sufficient evidence supported the jury’s verdict.
Integra LifeSciences I, Ltd., the Burnham Institute and Telios Pharmaceuticals, Inc. (collectively Integra) brought suit against Merck KGAA (Merck), The Scripps Research Institute and Dr. David A. Cheresh alleging infringement of certain patents related to the tripeptide sequence Arg-Gly-Asp, known as the "RGD peptide." Merck answered, among other things, that its actions involving the RGD peptides did not infringe and, in any event, were protected by the safe harbor provision of §271(e)(1) (hereinafter "the FDA exemption"). At the close of trial, the district court instructed the jury on the legal standard as to the FDA exemption using the following instruction:
[t]o prevail on this defense, Merck must prove by a preponderance of the evidence that it would be objectively reasonable for a party in Merck’s and Scripps’ situation to believe that there was a decent prospect that the accused activities would contribute, relatively directly, to the generation of the kinds of information that are likely to be relevant in the process by which the FDA would decide whether to approve the product in question.
The jury found Merck liable for infringing the asserted patents. Applying the instructed legal standard, the jury found that Merck failed to show that its activities were protected by the FDA exemption and found for Integra. Merck filed a renewed motion for judgment as a matter of law (JMOL) under Federal Rule 50(b) with respect to the FDA exemption. The district court denied Merck’s motion, reasoning that "the evidence was sufficient to show that ‘any connection between the infringing Scripps experiments and FDA review was insufficiently direct to qualify for the [FDA exemption]’." Merck appealed the district court’s JMOL decision. At the Federal Circuit, Merck did not challenge the district court’s findings on the sufficiency of the evidence.
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