Read the full article (PDF) >
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
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.