Term: 2004
Docket: 03-1237
Merck Kgaa v. Integra Lifesciences I, Ltd., Et Al.
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03-1237 MERCK KGaA V. INTEGRA LIFESCIENCES DECISION BELOW: 331 F3d 860 JUSTICE O'CONNOR AND JUSTICE BREYER TOOK NO PART. CERT. GRANTED 1/7/2005 QUESTION PRESENTED: To encourage development and expedite introduction of phamaceuticals, Congress amended the patent laws in 1984 to insulate drug research from charges of infringement so long as the research is "reasonably related to the development and submission of information" to the Food and Drug Administration. Did the Federal Circuit err in concluding that this drug-research safe harbor does not protect animal studies of the sort that are essential to the development of new drugs, where the research will be presented to the FDA, and where barring the research until expiration of the patent could mean years of delay in the availability of life-saving new drugs? LOWER COURT CASE NUMBER: 02-1052, 02-1065
The U.S. Supreme Court case Merck KGaA v. Integra Lifesciences I, Ltd., et al., 2004 revolved around the interpretation of a statute that exempts from patent infringement certain drug-related research activities aimed at obtaining regulatory approval. The dispute began when Integra accused Merck of infringing its patents related to peptides promoting cell adhesion in laboratory experiments and preclinical trials for potential new drugs to treat various conditions including stroke and heart disease. In response, Merck claimed their use was protected under the "safe harbor" provision of the Patent Act which allows uses reasonably related to developing information for FDA submission. The Federal Circuit ruled in favor of Integra stating that safe harbor does not apply to exploratory research or general biomedical investigation but only applies once a particular candidate has been identified for further development. However, on appeal, the Supreme Court unanimously reversed this decision arguing that basic scientific research on a particular compound can fall within safe harbor if it is intended for eventual submission to FDA regardless whether specific drug candidates have been finalized or not yet.
In the dissenting opinion for MERCK KGAA v. INTEGRA LIFESCIENCES I, LTD., Justice Scalia argued that the majority's interpretation of 35 U.S.C. §271(e)(1) was too broad and not in line with Congress' intent when it enacted the statute. He contended that this provision should only apply to activities conducted to obtain regulatory approval of a generic drug, not a new one as Merck was attempting to do. This is because Congress intended this law to help expedite bringing cheaper, generic versions of drugs already approved by FDA into market once their patents expired - not aid development of novel drugs which could potentially infringe on existing patents during research phase itself without any liability under patent laws. Therefore, he disagreed with majority’s view that Merck's use of Integra's patented compounds for drug discovery experiments fell within safe harbor provided by §271(e)(1).
