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Abstract

The Federal Circuit’s recent decision in Momenta v. Amphastar highlights the continuing uncertainty regarding the scope of the statutory exemption from patent infringement provided in 35 U.S.C. § 271(e)(1). The statute states that “[i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States 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 or veterinary biological products.” Since its adoption in 1984 with the passage of the Hatch-Waxman Act, however, the precise meaning of the statute has been the subject of considerable debate, triggering two U.S. Supreme Court decisions and multiple decisions of the Federal Circuit and various U.S. district courts. Judicial interpretations of key terms of § 271(e)(1), based on a textual analysis of the statute, the structure of the Hatch-Waxman Act and the legislative history of the Act, have resulted in conflicting views as to the scope and applicability of the statute. This Article provides a working interpretation of the meaning of the statute, based on currently controlling case law.

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