Uncertainty Regarding Exemption From Infringement for Studies After approval, Or Not required, By the US FDA

Abstract

1Region North America, Fresenius Kabi USA, Three Corporate Drive, Lake Zurich, IL 60047, USA 2Goodwin Procter LLP The New York Times Building 620 Eighth Avenue New York, NY 10018, USA *Author for correspondence: Tel.: +1 212 459 7015 Fax: +1 212 355 3333 E-mail: jhanish@goodwinprocter.com Two recent decisions of the Federal Circuit applied differing interpretations to specific fact patterns, leading to substantial ambiguity regarding whether research related to an already approved drug, or research that is not required by the US FDA to gain approval, is exempt from patent infringement. Despite the Federal Circuit’s differing interpretations, the Supreme Court is unlikely to straighten out the confusion in the foreseeable future, which likely will result in increased risk and uncertainty in the pharmaceutical industry.