Merck Kgaa v. Integra Lifesciences I, LTD., et al. (545 U.S. 193)
U.S. Supreme Court · decided June 13, 2005 · Supreme Court Database (Spaeth)
- Citation
- 545 U.S. 193 · 125 S. Ct. 2372
- Decided
- June 13, 2005
- Term
- October Term 2004
- Vote
- 9–0
- Majority author
- Justice Scalia
- Issue area
- Economic Activity
- Disposition
- Vacated and remanded
- Outcome
- Petitioning party won
- Ideological direction
- Liberal
Opinion excerpt
Justice Scalia delivered the opinion of the Court. This ease presents the question whether uses of patented inventions in preclinieal 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[l] any patented invention ... during the term of the patent therefor.” § 271(a). In 1984, Congress enacted an exemption to this general rule, see Drug Price Competition and Patent Term Restoration Act of 1984, § 202, 98 Stat. 1585, as amended, 35 U. S. C. § 271(e)(1), which provides: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4,1913). ..) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs ....” The Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended, 21 U. S. C. § 301 et seq., is “a Federal law which regulates the manufacture, use, or sale of drugs.” See § 355(a); Eli Lilly & Co. v.…
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