Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005)
Primary Holding
The Supreme Court held that the exemption from patent infringement under 35 U.S.C. §271(e)(1) applies to uses of patented inventions in preclinical research, even if the results are not ultimately included in a submission to the FDA, as long as those uses are reasonably related to the development and submission of information required by federal law regulating drugs.
In the case of Merck KGaA v. Integra Lifesciences, the Supreme Court decided that researchers can use patented inventions for early-stage drug research without worrying about being sued for patent infringement. This is important because it encourages innovation and helps bring new medicines to market more quickly, ultimately benefiting consumers by providing access to new treatments. This case is relevant if you're involved in drug development or if you're interested in how new medications are created and tested before they reach the pharmacy.
AI-generated plain-language summary to help you understand this case
In the case of Merck KGaA v. Integra Lifesciences I, Ltd., the dispute arose from the use of patented inventions related to the RGD peptide, which promotes cell adhesion and is implicated in angiogenesis research. Integra Lifesciences and the Burnham Institute held five patents concerning the RGD peptide. Merck KGaA funded research conducted by Dr. David Cheresh at the Scripps Research Institute starting in 1988, which involved the use of the RGD peptide in preclinical studies. The core issue was whether Merck's use of the patented peptide in its research, which was not intended for submission to the FDA, constituted patent infringement under 35 U.S.C. §271(e)(1). The procedural history of the case began with Integra Lifesciences filing a lawsuit against Merck KGaA, claiming that Merck infringed on their patents by using the RGD peptide in its research. The case was initially heard in the United States District Court for the Southern District of California, which ruled in favor of Integra. Merck appealed the decision, and the United States Court of Appeals for the Federal Circuit upheld the lower court's ruling. Subsequently, Merck sought a writ of certiorari, which the Supreme Court granted to resolve the question of whether the use of patented inventions in preclinical research falls under the exemption provided by §271(e)(1). The background context of this case is rooted in the Drug Price Competition and Patent Term Restoration Act of 1984, which established specific exemptions to patent infringement for activities related to drug development. The statute allows for the use of patented inventions for purposes reasonably related to the development and submission of information to the FDA. This case specifically examined the boundaries of this exemption, particularly concerning preclinical research that does not culminate in FDA submissions. The outcome would have implications for the pharmaceutical industry and its ability to conduct research without infringing on existing patents.
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).
The judgment is reversed.
- Court
- Supreme Court
- Decision Date
- April 20, 2005
- Jurisdiction
- federal
- Case Type
- landmark
- Majority Author
- Scalia
- Damages Awarded
- $6.4M
- Data Quality
- high
MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007)
Consumer WonA patent licensee does not need to terminate or breach its license agreement in order to seek a declaratory judgment that the underlying patent is invalid, unenforceable, or not infringed, as long as an actual controversy exists.
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)
Consumer LostThe Medical Device Amendments of 1976 preempt state law claims challenging the safety and effectiveness of medical devices that have received premarket approval from the Food and Drug Administration (FDA).
Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006)
Consumer LostA patent cannot claim a monopoly over a basic scientific relationship, such as the correlation between homocysteine levels and vitamin deficiencies, as this falls under the exclusion of laws of nature and natural phenomena from patent protection.
Warner-Lambert Co. v. Kent, 552 U.S. 440 (2008)
Consumer LostThe Supreme Court affirmed the judgment of the lower court by an equally divided Court, indicating that the decision of the lower court stands without establishing a new legal principle or rule.