Merck KGaA v. Integra Lifesciences I, Ltd.
162 L. Ed. 2d 160, 2005 U.S. LEXIS 4840, 545 U.S. 193 (2005)
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Rule of Law:
The safe harbor provision of 35 U.S.C. § 271(e)(1) exempts from patent infringement all uses of patented inventions that are reasonably related to the development and submission of information to the FDA. This protection extends to preclinical studies aimed at identifying and evaluating potential drug candidates, even if the specific compound or the data from such studies are not ultimately included in a regulatory submission.
Facts:
- Respondents Integra Lifesciences I, Ltd., and The Burnham Institute (Integra) own patents related to a tripeptide sequence known as the RGD peptide, which promotes cell adhesion.
- Beginning in 1988, petitioner Merck KGaA (Merck) funded angiogenesis research conducted by Dr. David Cheresh at the Scripps Research Institute (Scripps).
- Dr. Cheresh discovered that using cyclic RGD peptides provided by Merck could inhibit angiogenesis (the formation of new blood vessels), a process critical to tumor growth.
- In 1995, Merck and Scripps entered into a formal agreement to develop 'integrin antagonists as angiogenesis inhibitors,' with the goal of identifying a promising drug candidate for clinical trials and eventual FDA submission.
- From 1995 to 1998, Dr. Cheresh conducted experiments using several of Merck's patented RGD peptides to evaluate their efficacy, specificity, and toxicity as potential drug candidates.
- Based on this preclinical research, Scripps and Merck identified a specific peptide, EMD 121974, as the most promising candidate for human clinical trials.
- Merck then initiated a formal project to guide EMD 121974 through the regulatory approval process and began discussions with the FDA.
Procedural Posture:
- Integra Lifesciences I, Ltd. sued Merck KGaA in the U.S. District Court for the Southern District of California for patent infringement.
- The jury found that Merck infringed Integra's patents and that its activities were not protected by the § 271(e)(1) safe harbor, awarding Integra $15 million in damages.
- The District Court denied Merck's post-trial motion for judgment as a matter of law, holding that the connection between the infringing experiments and FDA review was 'insufficiently direct.'
- Merck (appellant) appealed to the U.S. Court of Appeals for the Federal Circuit.
- A divided panel of the Federal Circuit affirmed the District Court's judgment on infringement, holding that the § 271(e)(1) safe harbor did not apply because the research was 'general biomedical research to identify new pharmaceutical compounds' rather than research to supply information to the FDA.
- The U.S. Supreme Court granted certiorari to review the Federal Circuit's construction of § 271(e)(1).
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Issue:
Does the safe harbor provision of 35 U.S.C. § 271(e)(1) exempt from patent infringement the use of patented compounds in preclinical research designed to identify and evaluate promising drug candidates for potential FDA submission?
Opinions:
Majority - Justice Scalia
Yes. The statutory safe harbor exempts from infringement all uses of patented compounds that are reasonably related to developing information for submission to the FDA. The Court reasoned that the statutory language 'reasonably related' provides a wide berth for activities related to the federal regulatory process. This includes preclinical research necessary to identify and develop a drug candidate, not just the final studies on the chosen candidate. The Court rejected the Federal Circuit's narrow interpretation, explaining that drug development is a process of trial and error, and limiting the exemption only to the one compound that is ultimately submitted to the FDA would render the exemption for new drug development illusory. The exemption covers experimentation on compounds that are not ultimately the subject of an FDA submission and experiments whose data is not ultimately submitted, so long as the research is conducted with a reasonable belief that it could produce the type of information relevant for an FDA submission.
Analysis:
This decision significantly broadened the scope of the § 271(e)(1) safe harbor, clarifying that it protects not just late-stage clinical trials but also early-stage, exploratory preclinical research. By protecting the 'trial and error' phase of drug discovery, the ruling provides pharmaceutical and biotech companies with greater freedom to use patented compounds in research without risking infringement liability. This lowers a barrier to innovation and may accelerate the development of new drugs. However, the Court explicitly left open the question of whether the safe harbor applies to 'research tools'—patented inventions used in the research process but not themselves being evaluated as a potential drug.
