In a recent Life Sciences Intellectual Property Review article, Thompson Coburn partner Olga Berson was quoted extensively on the U.S. Supreme Court’s decision to review a dispute between a brand-name pharmaceutical company and a generic manufacturer—bringing renewed attention to the issue of “skinny labels” and induced patent infringement.
Across the life sciences sector, there is broad agreement on one point: greater clarity is needed. Olga framed the case as an opportunity for the Court to “restore predictability” by more clearly defining what constitutes inducement under the patent laws.
“Clarifying the pleading standard for inducement claims would also provide guidance on what allegations are sufficient to proceed past the motion to dismiss stage,” she noted.
That kind of clarity, Olga added, would “stabilise launch risk, preserve meaningful exclusivity windows for innovators, and support timely generic competition.”
She described the case as a direct test of “the balance Congress struck in Hatch-Waxman between innovation incentives and the timely entry of generic competition.”
In Olga’s view, the ramifications could extend well beyond pharmaceuticals, potentially shaping inducement doctrine across industries where equivalence statements play a critical commercial or regulatory role.
Read the full article here (registration required).
