As a community service, an educational series by the

IP and Business Law Offices of Howard L. Hoffenberg, Esq.

Copyright 2010 The IP and Business Law Offices of Howard L. Hoffenberg, Esq. All Rights Reserved.

Return to Index of Tour of US Supreme Court Patent Cases from 1961 to 1999

HOLDING: (1) 35 U.S.C. Section 271(e)(2) makes it an act of infringement to submit an ANDA or a paper NDA for market approval commencing prior to the expiration of a patent. (2) 35 U.S.C. 271(e)(1) provides the exemption that [i]t shall not be 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. (3) Based on the statutory language and legislative history, Subsection (e)(1) applies to medical devices.

 

LILLY & CO. v. MEDTRONIC, INC., 496 U.S. 661(June 18, 1990)

 

FACTS: Lilly sought to enjoin Medtronics from testing and marketing a cardiac defibrillator, a medical device. Medtronics defended on the grounds that its activities were reasonably related to the submission of information under the FDCA, and thus exempt from infringement under 35 U.S.C. 271(e)(1).

Tour of US Supreme Court Patent Cases from 1961 to 1999

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A Fast and Easy Way to Learn the High Points of Patent Law and Related Anti-trust Law

Community Service and

Pro Bono

In addition to this education series, Mr. Hoffenberg gives of his time to benefit the community and contribute to the quality justice in the State of California. For many years, he served as a volunteer pro tem in the Municipal Court in traffic, landlord-tenant, small claims and short cause matters. Currently, Mr. Hoffenberg serves as a volunteer arbitrator for the Dispute Resolution Service in attorney-client fee disputes and as a quasi-volunteer mediator in the Court of Appeals.