Tuesday, July 21, 2026 | 11:00 a.m. (PT) | B-CLE Webcast
Presented by the Life Sciences Law & Policy Center
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In a unanimous June 2026 decision, the Supreme Court resolved a long-running question at the heart of generic-drug competition: when can a generic manufacturer be held liable for inducing patent infringement after launching with a “skinny label”? Skinny labeling is the carve-out pathway Congress built into Hatch-Waxman, letting a generic reach the market for a drug’s unpatented uses even while a patented method of use remains protected. A series of Federal Circuit decisions had unsettled how much room that pathway leaves —and Hikma v. Amarin resets the standard.
In this conversation, appellate and pharmaceutical-patent litigators William Jay, Jaime Santos, Daryl Wiesen, and Isabel Marin, from Goodwin Procter, who followed the case from oral argument through decision, unpack what the ruling changes: how it reshapes induced-infringement risk, what it means for generic labeling strategy and launch timing, and what it may signal for future legislative and regulatory action.
Moderator:
Vince Joralemon, Director of the Life Sciences Law & Policy Center, BCLT
Speaker(s):
William Jay, Partner, Appellate & Supreme Court Litigation, Goodwin Procter
Jaime Santos, Partner, Co-Chair, Appellate & Supreme Court Litigation, Goodwin Procter
Daryl Wiesen, Partner, Goodwin Procter
Isabel Marin, Associate, Goodwin Procter
Key Questions
- What is a “skinny label,” and how does the Section viii carve-out let generics launch around a brand’s method-of-use patents?
- What did the Supreme Court actually hold — and how does its “actively encouraged” standard differ from the Federal Circuit’s “could a physician read it that way” approach?
- Which routine generic communications are now safe — standard labeling, “generic equivalent” descriptions, AB ratings, investor press releases — and where does litigation risk remain?
- What does the decision mean for brand patent strategy, generic launch planning, and drug pricing and access?
- What comes next — for “implicit encouragement” theories, and for the legislative and regulatory action
on the horizon?
Who should attend?
This program is built for life sciences and IP practitioners — in-house counsel at brand and generic manufacturers, patent litigators and prosecutors, FDA and regulatory counsel, and Hatch-Waxman advisors — as well as investors, business leaders, and academics who follow pharmaceutical competition and innovation policy. It will also reward anyone tracking the balance between drug innovation and generic access, including students and scholars of patent law, FDA regulation, and the life sciences.