Merck KGaA v. Integra Lifesciences I, LTD case brief

Merck KGaA v. Integra Lifesciences I, LTD case brief summary
545 U.S. 193 (2005)

CASE SYNOPSIS

Petitioner drug company sought certiorari review of a judgment from the United States Court of Appeals for the Federal Circuit, which affirmed the district court's denial of judgment as a matter of law to petitioner in a patent infringement action on the ground that 35 U.S.C.S. § 271(e)(1)'s safe harbor did not apply to preclinical studies involving the use of respondent companies' patents for the tripeptide sequence Arg-Gly-Asp (RGD peptide).

CASE FACTS
Respondents alleged that petitioner infringed the patents by supplying RGD peptides to a research institute, which used the RGD peptides in preclinical research designed to evaluate their suitability as potential drug candidates. A jury found that petitioner failed to show that its activities were protected by § 271(e)(1).


DISCUSSION

• The court of appeals held that § 271(e)(1)'s safe harbor did not apply because petitioner's sponsored research institute work was not clinical testing to supply information to the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 301 et seq., but only general biomedical research to identify new pharmaceutical compounds. 
• The Court vacated the judgment, finding that the court of appeals applied the wrong standard in rejecting petitioner's challenge to the jury's finding. 
• The Court held that the use of patented compounds in preclinical studies was protected under 35 U.S.C.S. § 271(e)(1) at least as long as there was a reasonable basis to believe that the compound tested could be the subject of an FDA submission and the experiments would produce the types of information relevant to drug applications under 21 U.S.C.S. § 355.

CONCLUSION
The Court vacated the judgment and remanded the action for review on the basis of the proper construction of the statute and the relevant jury instruction, which the Court believed to be consistent with, if less detailed than, the Court's construction of the statute.

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