Merck KGaA v. Integra Lifesciences I, LTD
Supreme Court
545 U.S. 193 (2005)
Integra Lifesciences and the Burnham Institute (plaintiffs, collectively Integra) held patents on RGD peptides that promote cell adhesion. Merck KGaA (defendant) funded a researcher, Dr. Cheresh, who used RGD peptides in angiogenesis research at the Scripps Research Institute. Integra sued for patent infringement; Merck argued its use fell within the safe harbor in 35 U.S.C. Section 271(e)(1), which exempts uses reasonably related to developing information for FDA submission. A jury found Merck liable and awarded damages, and a divided Federal Circuit panel affirmed that Merck wasn't covered by the exemption because its research was aimed at picking the best drug candidate for future testing, not directly generating an FDA submission.
Whether patented inventions used in preclinical research reasonably related to the development of drugs are exempt from infringement under 35 U.S.C. Section 271(e)(1), even if the research is not ultimately submitted to the FDA.