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Merck KGaA v. Integra Lifesciences I, LTD Uncertainty in the Scope of the Section 271(e)(1) Exemption
On June 13, 2005, the Supreme Court in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. ___, 2005 WL 1383624 (2005) ruled that the safe-harbor infringement exemption of 35 U.S.C. '271(e)(1) may apply to non-clinical research on a patented compound as long as there is a reasonable basis to believe that the compound tested could itself be the subject of an FDA submission or that experiments with the compound will produce the kinds of information relevant to an Investigational New Drug Application (“IND”) or a New Drug Application (“NDA”); the exemption may apply even though the patented compound never itself becomes the subject of an FDA submission or the experimental results arising from its use never reported in a submission. The decision reversed the holding of the Federal Circuit (331 F.3d 860 (Fed. Cir. 2003)) that the exemption applies only to research used to obtain information that is submitted to the FDA as part of an application for regulatory approval. The Court expressly refused, however, to consider whether '271(e)(1) might exempt “research tools” from infringement liability. Although the Court interpreted the reach of the '271(e)(1) exemption broadly, the issue of whether use of patented research tools falls within it remains unresolved.
In Merck, the patents at issue concern peptide sequences of cyclic arginine-glycine-aspartic acid (“RGD peptides”). Integra sued Merck for patent infringement based on Merck's sponsoring of preclinical studies of RGD peptides to measure the efficacy, specificity, and toxicity of the peptides as potential angiogenesis inhibitors.
Merck's activity arose from research initially conducted by Dr. David Cheresh at the Scripps Institute, who discovered that it was possible to inhibit angiogenesis by blocking avB3 integrins on proliferating endothelial cells. Based on those findings, Merck hired Dr. Cheresh and Scripps to identity potential drug candidates that might inhibit angiogenesis. As part of this research, Dr. Cheresh experimented with a cyclic RGD peptide provided by Merck, which was known to bind avB3 integrins, and with two other RGD peptides that he derived from the one supplied by Merck. Dr. Cheresh measured the efficacy and safety of the peptides as angiogenesis inhibitors by evaluating their mechanism of action and pharmacokinetics in animals. Dr. Cheresh chose one of the derived RGD peptides as the best candidate for human clinical research and development, and an NDA was submitted on that compound, but he also used the RGD peptides as positive controls in experiments on organic mimetics designed to block avB3 integrins.
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