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.

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).