In the case of Eli Lilly and Company v. Medtronic, Inc., 1989, the U.S. Supreme Court ruled that medical devices were exempt from patent infringement suits under a clause in federal law allowing for "reasonable and necessary" testing before marketing approval is sought from the Food and Drug Administration (FDA). The dispute arose when pharmaceutical company Eli Lilly accused Medtronic of infringing on its patented technology for an automatic implantable heart defibrillator during their testing phase. However, Medtronic argued they were protected by a provision in the Patent Act known as the "experimental use exception," which allows potential competitors to use a patented invention for research purposes without being liable for infringement. The court sided with Medtronics ruling that such premarket testing falls within this experimental use exception.

In the dissenting opinion for Eli Lilly and Company v. Medtronic, Inc., Justice Scalia argued that the majority misinterpreted the intent of Congress in their ruling. He believed that Congress did not intend to exempt medical devices from patent infringement during pre-market testing under Section 271(e)(1) of The Drug Price Competition and Patent Term Restoration Act (also known as Hatch-Waxman Act). Instead, he suggested this exemption was only meant for generic drugs. According to him, if Congress had intended such a broad interpretation they would have used more general language in drafting the law rather than specifically referencing drug entities. Therefore, he disagreed with extending this provision beyond its original scope without clear evidence supporting it from legislative history or statutory text.