Finding the Line Separating Infringement and Exempt Uses: Enforcing Biotechnology Patents in View of 35 U.S.C. § 271(e)(1)

Biotechnology patented research method or tool and role of FDA data submission requirement in 35 U.S.C. § 271(e)(1) infringement safe harbor.

April 4,2014

For nearly a decade, companies involved in basic biotechnology research could rely on guidance from the Supreme Court in Merck KGaA v. Integra Lifesciences,1 which considered the scope of the 35 U.S.C. § 271(e)(1) statutory safe harbor. 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.2

1. Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005).
2. 35 U.S.C. § 271(e)(1).

Reproduced with permission from Life Sciences Law & Industry Report, 8 LSLR 321, 04/04/2014. Copyright 2014 by The Bureau of National Affairs, Inc. (800-372-1033)

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Jamie R. Kurtz


Co-Chair, Health Care Litigation Group

Matthew McFarlane

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