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MERCK KGAA v. INTEGRA LIFESCIENCES I, LTD.

No. 03-1237.

545 U.S. 193 (2005)

MERCK KGAA v. INTEGRA LIFESCIENCES I, LTD., ET AL.

Supreme Court of United States.

Decided June 13, 2005.

Attorney(s) appearing for the Case

E. Joshua Rosenkranz argued the cause for petitioner. With him on the briefs were M. Patricia Thayer, James N. Czaban, and Donald R. Dunner.

Daryl Joseffer argued the cause for the United States as amicus curiae in support of petitioner. With him on the brief were Acting Solicitor General Clement, Assistant Attorney General Keisler, Deputy Solicitor General Hungar, Douglas N. Letter, Mark S. Davies, Alex M. Azar II, Richard Lambert, John M. Whealan, and Heather F. Auyang.

Mauricio A. Flores argued the cause for respondents. With him on the brief were Raphael V. Lupo, Cathryn Campbell, Mark G. Davis, M. Miller Baker, Richard B. Rogers, and David M. Beckwith.*

SCALIA, J., delivered the opinion for a unanimous Court.

JUSTICE SCALIA delivered the opinion of the Court.

This case presents the question whether uses of patented inventions in preclinical research, the results of which are not ultimately included in a submission to the Food and Drug Administration (FDA), are exempted from infringement by 35 U. S. C. § 271(e)(1).

I

It is generally an act of patent infringement to "mak[e], us[e], offe[r] to sell, or sel...

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