Merck KGaA v. Integra Lifesciences I, Ltd.

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.…