Eli Lilly and Company v. Medtronic, Inc. (1989)
- Docket
- 89-243
- Decided
- 1989-01-01
Summary
Question: Are activities that would normally constitute patent infringement excused if they are used to develop and submit information to the Food and Drug Administration to obtain marketing approval for a medical device? Conclusion: Yes. Justice Antonin Scalia delivered the opinion of a 6-2 majority. The Court held that, based on the phrasing of the FDCA, the exemption refers to all actions in the process of developing and submitting information to the FDA. Reading the statute in this way prevents distortions of patent law and allows the development of medical technology to logically proceed. The Court held that only the broader interpretation of the statute respects legislative intent. Justice Anthony Kennedy wrote a dissent where he argued that the FDCA refers specifically to an exemption for drugs, not medical devices and/or technologies. He argued that to read the statute in any broader manner is to unnecessarily twist Congress’ words from their normal meaning. He also wrote that Congress’ distinction between drugs and devices would be a logical one, as the use of a patent holder’s devices for medical testing would infringe on the patent holder’s sales in a way that the use of a drug would not. Justice Byron R. White joined in the dissent. Justice Sandra Day O’Connor did not participate in the discussion or decision of this case.