Merck KGaA v. Integra Lifesciences I, Ltd.

Merck v. Integra

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; 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
Associate Justices: John Paul Stevens, Sandra Day O'Connor, Antonin Scalia, Anthony Kennedy, David Souter, Clarence Thomas, Ruth Bader Ginsburg, Stephen Breyer

Case opinions

Majority by: Scalia
Joined by: unanimous

Laws applied

U.S. Const.; 35 U.S.C. § 271(e)(1)

Merck KGaA, Petitioner v. Integra Lifesciences I, Ltd., et al., 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".

Additional recommended knowledge

References

Complete text of the decision
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

Category: Biotechnology law