Merck KGaA v. Integra Lifesciences I, Ltd.

Merck KGaA v. Integra Lifesciences I, Ltd.

Supreme Court of the United States
Argued April 20, 2005
Decided June 13, 2005
Full case name Merck KGaA, Petitioner v. Integra Lifesciences I, Ltd., et al.
Citations 545 U.S. 193 (more)
125 S. Ct. 2372; 162 L. Ed. 2d 160; 2005 U.S. LEXIS 4840; 73 U.S.L.W. 4468; 74 U.S.P.Q.2D (BNA) 1801; 18 Fla. L. Weekly Fed. S 394
Prior history On writ of cert. to the United States Court of Appeals for the Federal Circuit. Integra Lifesciences I, Ltd. v. Merck KGaA, 331 F.3d 860, 2003 U.S. App. LEXIS 11335 (Fed. Cir., 2003)
Subsequent history On remand at Integra Lifesciences I, LTD. v. Merck KGaA, 2005 U.S. App. LEXIS 17342 (Fed. Cir., Aug. 17, 2005)
Holding
The Court held that the use of patented compounds in preclinical studies is protected under §271(e)(1) at least as long as there is a reasonable basis to believe that the compound tested could be the subject of an FDA submission and the experiments will produce the types of information relevant to an IND or NDA.
Court membership
Chief Justice
William Rehnquist
Case opinions
Majority Scalia, joined by unanimous
Laws applied
U.S. Const.; 35 U.S.C. § 271(e)(1)

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" (§ 271(e)(1)).

While the Court refused to "quibble" with the Court of Appeals over its conclusion that the exemption “does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process,” 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 “reasonably related to the development and submission of information” to the FDA. It does not follow from this, however, that §271(e)(1)’s 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.

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