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)

The articles on our website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice. The views and opinions expressed in this article are those of the author(s) and do not necessarily reflect the views or official position of Robins Kaplan LLP.


Jamie R. Kurtz


Co-Chair, Health Care Litigation Group

Matthew McFarlane

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