496 U.S. 661 (1990)
In the case of Eli Lilly and Co. v.
Does the 'safe harbor' provision of the Hatch-Waxman Act, 35 U.S.C. § 271(e)(1), apply to medical devices, thus exempting activities from being considered patent infringement if such activities are conducted to obtain premarketing approval?
35 U.S.C. § 271(e)(1) provides that it shall not be an act of infringement to make, use, offer to sell, or sell within the United States a patented invention 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 or medical devices.
The Supreme Court held that the 'safe harbor' provision under the Hatch-Waxman Act does apply to medical devices. Therefore, Medtronic's activities in preparing their device for regulatory approval did not constitute patent infringement.
Eli Lilly and Co. v. Medtronic, Inc. is critical in establishing that the safe harbor provision extends beyond pharmaceuticals to encompass medical devices. It underscores the balancing act in patent law between the proprietary interests of inventors and the societal value of competitive markets. For law students, this case illustrates the nuanced approach courts may take when statutory language intersects with complex industries, highlighting the importance of legislative history and public policy considerations in judicial decisions.