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’ use patents through an “inducement” theory of patent infringement. Sponsors should take heed of the forthcoming decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., but they should also be aware that further litigation shaping this landscape is likely.
The case concerns generic “skinny” labeling — the practice of omitting certain patent protected indications and uses — that are used in launches for nearly half of first generic small molecule drugs.
How Skinny Labels Are Created
Under the Hatch‑Waxman 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 “is the same as the labeling approved for the listed [reference] drug.” 21 U.S.C. § 355(j)(2)(A)(v). The ANDA must also include a certification for each patent relating to the reference product listed in FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
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 “Section viii statement” under 21 U.S.C. § 355(j)(2)(A)(viii), that the innovator drug company’s patent “does not claim a use for which the applicant is seeking approval.” 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’s patents. However, in such cases, pursuant to 21 C.F.R. § 314.127(a)(7), FDA may reject the proposed skinny label if that difference in labeling would “render the proposed drug product less safe or effective than the listed drug for all remaining, nonprotected conditions of use.”
This mechanism is meant to allow generics to enter the market before the innovator’s method-of-use patents expire, but only if the patented use is fully omitted from the generic product’s 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.
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.
Case Overview: Amarin v. Hikma
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.
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.
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:
- press releases calling the product a “generic version” or “generic equivalent,”
- statements to investors touting Vascepa sales without distinguishing which portion of sales pertained to each of the SH or CV indications, and
- a website listing the generic under the therapeutic category “Hypertriglyceridemia,” with an AB rating (i.e., therapeutically equivalent) and a disclaimer that Hikma’s product was approved for fewer than all of FDA-approved Vascepa indications.
Hikma filed a motion to dismiss, arguing the complaint did not sufficiently allege Hikma was inducing others to infringe Amarin’s patents. The district court agreed and dismissed. On appeal, the Federal Circuit reversed, holding that the totality of Amarin’s allegations plausibly pleaded induced infringement.
Hikma petitioned the Supreme Court for review, arguing the decision creates a permissive pleading standard that effectively nullifies Section viii by exposing generic skinny labels to inducement claims based on commonplace “generic version” statements and market data. After the Court requested the views of the United Sates, the Solicitor General submitted a brief supporting Hikma’s petition. The Court granted review on Jan. 16, 2026.
Potential Impact of SCOTUS Decision
This case tests the bounds of permissible communications about, and permissible marketing of, a generic drug with a skinny label. The Court will decide whether certain statements, when taken together as an overall marketing strategy for generics that fully omit patented uses from their labeling, are sufficient to plead induced infringement of those patented uses.
However, two factors could limit the impact of the forthcoming ruling. First, because of the procedural posture of this case, the Court will only consider whether, at the pleading stage, such statements by a generic manufacturer, if proven, are sufficient to constitute induced infringement. Second, this is a post‑launch inducement case focusing on statements made to the market after commercialization of the generic product has commenced, rather than a pre‑launch case in which the focus is on whether merely the skinny label alone can induce infringement.
We expect that the impact of the Court’s decision may thus be limited, rather than set forth a complete assessment of the Section viii skinny label carve‑out mechanism. We also do not anticipate any kind of broader rule that might curtail induced infringement theories across all labeling carve-out scenarios. The decision in Hikma may provide generic sponsors with more concrete limits to apply to their promotional activities, in the event the Federal Circuit is upheld. Section viii statements likely will remain a frequently utilized statutory pathway to provide generic applicants with earlier approval, although due to the posture and facts of the Hikma case, additional skinny label litigation is likely and will further shape the landscape on these issues for industry.
McGuireWoods continues to monitor developments related to the intersection of FDA regulatory and intellectual property issues. For questions about related topics, contact the authors or a member of the Life Sciences Industry Team.