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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.

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