Skinny Labels, Big Stakes: The Supreme Court Resets Generic-Drug Competition

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PROGRAM INFO

  • Presentation Date 7/21/2026
  • Class Time 11:00 AM PT
  • Duration 70 min.
  • Format Webcast
  • Program Code BCLT0085
  • CA General CLE Credits: 1.50 hr(s)

Price: FREE

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DESCRIPTION

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