Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), is a United States Supreme Court case with ramifications for patent law. The dispute dates to approximately 1996 and centers on a federal law known as the "FDA safe harbor" (ç 271(e)(1)).
While the Court refused to "quibble" with the Court of Appeals over its conclusion that the exemption âÂÂdoes not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process,â the Court held that:
Basic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, is surely not âÂÂreasonably related to the development and submission of informationâ to the FDA. It does not follow from this, however, that ç271(e)(1)âÂÂs exemption from infringement categorically excludes either (1) experimentation on drugs that are not ultimately the subject of an FDA submission or (2) use of patented compounds in experiments that are not ultimately submitted to the FDA. Under certain conditions, we think the exemption is sufficiently broad to protect the use of patented compounds in both situations.
The Court expressly adopted the construction of the law articulated by Federal Circuit Judge Pauline Newman.
See also
References
- Kintisch, E. (2005, April 8). Case probes what's fair game in the search for new drugs. In Science, 308, 174.
- Mamudi, Sam, Supreme Court broadens research exemption, Managing Intellectual Property, June 14, 2005
External links