Eli Lilly & Co. v. Medtronic, Inc.

496 U.S. 661 (1990)

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Eli Lilly & Co. v. Medtronic, Inc.

United States Supreme Court
496 U.S. 661 (1990)

Facts

Eli Lilly & Company (Lilly) (plaintiff) owned patents for implantable defibrillator devices and sued Medtronic, Inc. (defendant) for infringement. Medtronic argued that its use of Lilly’s patent was to develop and submit for Food and Drug Administration (FDA) approval of its own device and was therefore exempt under 35 U.S.C. § 271(e)(1) of the Drug Price Competition and Patent Term Restoration Act of 1984. Lilly argued that the research exception in § 271(e)(1) only applies to drugs and does not include devices like the defibrillators in question. The district court concluded that § 271(e)(1) did not apply to medical devices. The Court of Appeals for the Federal Circuit found that § 271(e)(1) did apply to medical devices and reversed and remanded to determine whether Medtronic’s use of Lilly’s devices fell within the exception.

Rule of Law

Issue

Holding and Reasoning (Scalia, J.)

Dissent (Kennedy, J.)

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