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Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661, 110 S.Ct. 2683, 110 L.Ed.2d 605, 58 USLW 4838, 15 U.S.P.Q.2d 1121

Facts

Issue

Rule

Section 271(e)(1) of the Patent Act states that it is not an act of infringement to make, use, or sell 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. This exemption applies broadly to any patented invention, not just those related to drugs, as long as the use is for regulatory approval purposes.

Analysis

Conclusion

The Supreme Court affirmed the Court of Appeals' decision, holding that Medtronic's use of the patented invention to develop and submit information for marketing approval under the FDCA was not infringement.

Held: Section 271(e)(1) exempts from infringement the use of patented inventions reasonably related to the development and submission of information needed to obtain marketing approval of medical devices under the FDCA.

Who won?

Medtronic's activities could not constitute infringement if they had been undertaken to develop information reasonably related to the development and submission of information necessary to obtain regulatory approval under the FDCA.

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