Publications
Merck KGaA v. Integra Lifesciences
In a significant decision sure to have a major impact on the pharmaceutical industry, the United States Supreme Court today held that the “safe harbor provision” of 35 U.S.C. §271(e)(1), which exempts from infringement, among other things, the making or using of a patented compound “solely for uses reasonably related to the development and submission of information [to the FDA],” is to be read quite broadly. At the same time, however, the Court held that it was not presented with, and so expressed no view about, the question of “whether, or to what extent, §271(e)(1) exempts from infringement the use of ‘research tools’ in the development of information for the regulatory process.”