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Merck KGaA v. Integra Lifesciences I, Ltd.

Docket No.: 03-1237
Certiorari Granted: Jan 7 2005
Argued: April 20, 2005
Decided: June 13, 2005

Topics:

Economic Activity, patent, preliminary injunction

PartyNames: Merck KGaA v. Integra Lifesciences I, Ltd., et al.
Petitioner: Merck KGaA
Respondent: Integra Lifesciences I, Ltd., et al.

Court Below: United States Court of Appeals for the Federal Circuit
Citation: 331 F3d 860
Supreme Court Docket

Merck KGaA
v.
Integra Lifesciences I, Ltd., et al.
545 U.S. 193 (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?

Question:

Did federal law allow the use of patented inventions in preclinical research, the results of which were not ultimately included in a submission to the FDA?

Note:

JUSTICE O'CONNOR AND JUSTICE BREYER TOOK NO PART.

Merck KGaA v. Integra Lifesciences I, Ltd.
ORAL ARGUMENT

April 20, 2005

Holding: vacated and remanded
Vote: 9-0
Opinion By: Justice Antonin Scalia
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