Hikma and Amici Curiae Ask Supreme Court to Revisit Induced Infringement by Generic “Skinny Labels”

In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia.

Amarin nonetheless filed suit for induced infringement, stating that while Hikma’s labeling did not expressly include the cardiovascular risk indication, other modifications that conformed to the Vascepa label would induce infringement, such as the removal of a limitation of use that “[t]he effect of VASCEPA on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.” Amarin also claimed that certain public statements by Hikma would induce infringement, such as statements about the total revenues from Vascepa without distinguishing only the severe hypertriglyceridemia use and statements that the product was a “generic version” of Vascepa.

Hikma filed a motion to dismiss, stating that the alleged conduct did not arise to the level of induced infringement. The district court agreed, finding that neither the labeling nor the public statements induced infringement of the patents covering the cardiovascular indication. Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 578 F. Supp. 3d 642 (D. Del. 2022). Amarin appealed to the Federal Circuit, which reversed. Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 2023-1169 (Fed. Cir. 2024). The Federal Circuit agreed with the district court that allegations regarding labeling, taken alone, did not rise to the level of induced infringement. However, the Federal Circuit found that Amarin’s Hikma’s public statements were sufficient to support an induced infringement claim. Specifically, the Federal Circuit found that Hikma’s publishing sales data regarding branded Vascepa without delineating between infringing and non-infringing uses could lead a prescriber to prescribe Vascepa for the patented cardiovascular use. Additionally, the Federal Circuit found that Hikma’s statements that its product is a “generic version” of Vascepa, without specifying that it was an “AB-rated generic version” could lead prescribers to believe it is a generic version as to all uses, included the patented method.

Hikma petitioned for certiorari at the Supreme Court (No. 24-889). In its petition, Hikma argues that the Federal Circuit’s decision “effectively nullified a statutory mechanism for expediting access to generic drugs and breaks sharply with precedent on inducement.” It further argues that “[a]s a practical matter, any branded pharmaceutical company can now point to some public statement by the generic-drug manufacturer to justify a post-launch suit alleging induced infringement, even when the generic product is labeled only for unpatented uses—and that lawsuit could survive a motion to dismiss.” It also noted that it is the first inducement case “against a defendant for marketing a product that undisputedly lacks any instruction to perform the patented use.”

In March 2025, two amicus briefs urged the Supreme Court to take up Hikma’s appeal: one by the Association for Accessible Medicines (“AAM”) and one by 30 scholars of law, economics, and medicine (“30 Scholars”). AAM focused on the potential harms to consumers and the U.S. healthcare system if the Federal Circuit’s decision stands, arguing that it would have a chilling effect on generic manufacturers, who would be less likely to seek a skinny label for non-patented uses if their skinny label could force them into litigation. It noted that “[g]eneric versions of no-longer-patented drugs with patented uses launch with a skinny label nearly 50% of the time,” which saves patients and the federal government billions. On the merits, AAM argues that the Federal Circuit’s decision runs contrary to traditional theories of inducement liability, which require actively inducing patent infringement and must be “purposeful, culpable expression and conduct.” AAM argues that neither the labeling nor the public statements constituted active inducement, as they were all truthful statements (and, in some cases, statutorily required), and instead seemed to suggest that the onus was on Hikma to prevent physicians from prescribing for infringing uses.

The 30 Scholars make similar arguments to AAM, also arguing that the Federal Circuit’s decision runs afoul of inducement jurisprudence. In addition, the 30 Scholars argue more broadly about the potential risks for induced infringement patent liability going forward, as product equivalence statements, such as Hikma’s “generic version” statement, are common for a variety of products. The 30 Scholars express concerns that a future new-use patent for a decades-old product could open the door to inducement cases against a competitor for truthfully advertising a product as equivalent. The 30 Scholars note that both companies and consumers (not just in the drug industry) rely on equivalence statements to understand how a product relates to the market, such as equivalence of tires for a car. The 30 Scholars argue that due to the ambiguity in the Federal Circuit’s decision, it could create legal consequences for any statements of equivalence.

The Supreme Court has not yet decided whether to hear the petition, which follows on the heels of another induced infringement skinny label case, Glaxosmithkline LLC v. Teva Pharmaceuticals, No. 2018-1976, 2018-2023, which ruled against the generic manufacturer. The Supreme Court denied the certiorari petition, but Justice Kavanaugh indicated he would have granted the petition.