Yesterday, the U.S. Supreme Court heard oral argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, a case that could reshape the landscape of pharmaceutical patent enforcement and generic drug competition. The case concerns the scope of induced infringement liability under 35 U.S.C. § 271(b) in the context of “skinny labels” — the mechanism by which generic drug manufacturers may carve out patented indications from their FDA-approved labeling and enter the market for unpatented uses under Section viii of the Hatch-Waxman Act. A decision is expected by the end of the Supreme Court’s current term in June 2026. As we discussed in our earlier blog post on The Patent Playbook, this case squarely implicates the enforceability of method-of-use patents for later-developed drug indications, and the viability of the Section viii pathway for generic drug manufacturers.
Gregory A. Morris
Gregory A. Morris is a partner in the Intellectual Property (IP) and Patent Law Groups in New York. He has more than two decades of experience across the full spectrum of IP matters, including Hatch-Waxman disputesand inter partes review (IPR) proceedings. A seasoned trial lawyer and Ph.D. chemist, Gregory guides pharmaceutical, biotechnology and medical device companies in complex patent litigation and helps clients secure value by providing strategic IP counseling and due diligence advice.
Gregory’s work includes protecting innovative prescription drugs and biologics across key therapeutic areas, defending high-value patents and challenging competitor claims. Throughout his career, he has secured landmark decisions that have shaped patent law in the life sciences industry.
Gregory is widely regarded as one of the nation’s leading lawyers in his field. He has been consistently recognized as a “Life Sciences Star” by LMG Life Sciences, an “IP Star” by Managing IP and “Patent Star” by IAM Patent 1000, which ranks him among the world’s leading patent professionals. Gregory has also been repeatedly ranked as an IP leader by Chambers USA, where clients praise him as an [an] “outstanding attorney with first chair litigation capability, expert-level technical insight and an ability to marry technical expertise with a strategic view.”
Supreme Court Takes Up Hikma v. Amarin: Induced Infringement and Skinny Labels in the Crosshairs
By Gregory A. Morris & Fangli Chen on
The Supreme Court’s decision to review Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. places renewed attention on a familiar but unsettled issue in pharmaceutical patent law: how the induced infringement doctrine applies when a generic drug launches with a concededly “skinny” label, but engages in broader marketing and communications outside the FDA-approved label.
Although the case arises under the Hatch-Waxman Act, it squarely implicates the scope and enforceability of method-of-use patents, particularly for later-developed indications that often represent substantial additional investment by brand-name manufacturers.