Supreme Court of the United States
Merck Kgaa v. Integra Lifesciences I, Ltd.
June 13, 2005545 U.S. 193
Summary
In an opinion by Justice Scalia, the Court held that 35 U.S.C. § 271(e)(1) protects uses of patented inventions in preclinical research reasonably related to developing information for FDA submission, even when the tested drug or experimental results are not ultimately submitted. The exemption encompasses relevant research concerning efficacy, mechanism of action, pharmacology, and pharmacokinetics, not merely safety testing. Protection requires a reasonable basis for believing the research will generate information relevant to an FDA submission; it does not encompass basic research lacking the requisite connection to drug development. The Court vacated the Federal Circuit’s judgment and remanded for review of the evidence under the proper statutory construction, without deciding whether Merck’s particular activities qualified or whether the exemption covers research tools. There were no separate opinions.
Holding
- Whether actual submission of a tested compound or experimental results to the FDA is necessary for the exemption.. The exemption does not categorically exclude experiments involving compounds that never become the subject of an FDA submission or experiments whose results are never submitted.
- Whether qualifying preclinical research is confined to safety testing conducted under good laboratory practices.. The exemption extends to relevant preclinical studies of efficacy, mechanism of action, pharmacology, and pharmacokinetics. Failure to comply with good laboratory practices does not categorically disqualify research.
- What relationship to prospective FDA review makes experimental use exempt.. The exemption applies at least when a drugmaker reasonably believes a patented compound may produce a particular physiological effect through a particular biological process and uses it in research that, if successful, would be appropriate for FDA submission. Basic research lacking drug-development intent or a reasonable belief in the relevant effect is outside that protection.
Docket 03-1237
Cited authorities
- 21 C.F.R. §§ 312.23
- 21 C.F.R. §§ 314.50
- 35 U.S.C. § 271
- 98 Stat. 1585
- 35 U.S.C. § 271
- 52 Stat. 1040
- 21 U.S.C. § 301
- 21 U.S.C. §355
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