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1 Duke J. Const. L. & Pub. Pol'y Sidebar 1 (2006)

handle is hein.journals/dukjppsid1 and id is 1 raw text is: MERCK KGAA v. INTEGRA LIFESCIENCES I, LTD.: GREATER RESEARCH PROTECTION FOR DRUG MANUFACTURERS SAMUEL RUBIN* In Merck KGaA v. Integra Lifesciences I, Ltd.,' Merck KGaA (Merck) sought protection under a statutory exemption from claims of patent infringement brought by Integra Lifesciences. The Supreme Court addressed whether the use of patented inventions during preclinical research infringed the patent-holders' rights if the results were not submitted to the Food and Drug Administration (FDA).4 The Court held unanimously that a statutory safe-harbor provision contained in 35 U.S.C. § 271(e)(1) extend[ed] to 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]. The Court's interpretation of the safe-harbor provision broadened protection for those engaged in drug research at a substantial cost to patent-holders. I. BACKGROUND In 1988, Merck began funding research conducted by Dr. David A. Cheresh at the Scripps Research Institute.' Dr. Cheresh discovered that certain arginine-glycine-aspartate (RGD) peptides were an effective angiogenesis inhibiter. Angiogenesis, the process by which * 2006 J.D. Candidate, Duke University School of Law. 1. Merck KGaA v. Integra Lifesciences 1, Ltd., 545 U.S. (2005); 125 S. Ct. 2372 (2005). 2. Hatch-Waxman Act, 35 U.S.C. § 271(e)(1) (1994). 3. Respondents and the Burnham Institute co-owned the patented material peptides. Merck, 125 S. Ct. at 2377. 4. Id. at 2376. 5. Id. at 2380 (citing Eli Lilly v. Medtronic, Inc., 496 U.S. 661, 665 69 (1990)). 6. Both the Scripps Institute and Dr. Cheresh were dismissed from the initial patent infringement suit. Id.