{"id":100732,"date":"2026-01-28T09:16:07","date_gmt":"2026-01-28T14:16:07","guid":{"rendered":"https:\/\/www.mcguirewoods.com\/?post_type=insight&p=100732"},"modified":"2026-01-28T09:16:10","modified_gmt":"2026-01-28T14:16:10","slug":"skinny-facts-may-limit-supreme-courts-decision-in-skinny-label-generic-drug-approval-case","status":"publish","type":"insight","link":"https:\/\/www.mcguirewoods.com\/client-resources\/alerts\/2026\/1\/skinny-facts-may-limit-supreme-courts-decision-in-skinny-label-generic-drug-approval-case\/","title":{"rendered":"Skinny Facts May Limit Supreme Court\u2019s Decision in \u2018Skinny Label\u2019 Generic Drug Approval Case"},"content":{"rendered":"\n

The Supreme Court on Jan. 16, 2026, agreed to decide a case about how generic companies can communicate to the market about their products, including whether their product promotion may infringe innovators\u2019 use patents through an \u201cinducement\u201d theory of patent infringement. Sponsors should take heed of the forthcoming decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.<\/em>, but they should also be aware that further litigation shaping this landscape is likely.<\/p>\n\n\n\n

The case concerns generic \u201cskinny\u201d labeling \u2014 the practice of omitting certain patent protected indications and uses \u2014 that are used in launches for nearly half of first generic small molecule drugs.<\/p>\n\n\n\n

How Skinny Labels Are Created<\/strong><\/p>\n\n\n\n

Under the Hatch\u2011Waxman framework, a generic drug can obtain FDA regulatory marketing approval by filing an abbreviated new drug application (ANDA). It must show, among other requirements, that the labeling for the proposed generic \u201cis the same as the labeling approved for the listed [reference] drug.\u201d 21 U.S.C. \u00a7 355(j)(2)(A)(v). The ANDA must also include a certification for each patent relating to the reference product listed in FDA\u2019s publication, Approved Drug Products with Therapeutic Equivalence Evaluations<\/em> (the Orange Book).<\/p>\n\n\n\n

Although certain patent certifications may trigger patent infringement litigation, generic applicants may avoid litigation on patents directed to a method of use by submitting to FDA a \u201cSection viii statement\u201d under 21 U.S.C. \u00a7 355(j)(2)(A)(viii), that the innovator drug company\u2019s patent \u201cdoes not claim a use for which the applicant is seeking approval.\u201d Under Section viii, the generic drug applicant proposes to FDA a skinny product label that omits any indications\/uses for the product that are still protected by the innovator\u2019s patents. However, in such cases, pursuant to 21 C.F.R. \u00a7 314.127(a)(7), FDA may reject the proposed skinny label if that difference in labeling would \u201crender the proposed drug product less safe or effective than the listed drug for all remaining, nonprotected conditions of use.\u201d<\/p>\n\n\n\n

This mechanism is meant to allow generics to enter the market before the innovator\u2019s method-of-use patents expire, but only if the patented use is fully omitted from the generic product\u2019s labeling. The pathway does not, however, create a safe harbor from induced patent infringement claims. In induced infringement cases, the emphasis is often on (1) whether a patented use has been sufficiently omitted from the generic labeling, and\/or (2) whether a generic manufacturer is inducing others to use the generic product for the omitted uses through advertising and promotion, despite the skinny label.<\/p>\n\n\n\n

A case testing the bounds of induced infringement for generic skinny labeling is now set for review by the Supreme Court, which recently granted certiorari in Hikma v. Amarin<\/em>.<\/p>\n\n\n\n

Case Overview: Amarin v. Hikma<\/em><\/strong><\/p>\n\n\n\n

At a high level, Amarin markets the drug Vascepa (icosapent ethyl) for two FDA-approved uses: to treat severe hypertriglyceridemia (the SH indication) and to reduce certain cardiovascular risks in specified patients (the CV indication). Vascepa was approved for the SH indication in 2012. Seven years later, Amarin subsequently received supplemental approval for the CV indication. After Amarin added the CV indication to the Vascepa labeling, Amarin listed method-of-use patents in the Orange Book that covered this new CV indication. <\/p>\n\n\n\n

In 2016, Hikma submitted an ANDA seeking approval for a generic version of Vascepa. In 2019, Hikma submitted Section viii statements identifying the relevant patents for the CV indication, seeking to omit that use\/indication statement from its labeling and to market the generic product only for the SH indication. FDA approved the ANDA and corresponding labeling carve-out in 2020.<\/p>\n\n\n\n

Amarin sued Hikma for induced infringement, claiming Hikma was inducing others to infringe the CV patents through its public statements promoting icosapent ethyl. Amarin specifically pointed to:<\/p>\n\n\n\n