What’s going on?

The question involved in Hikma Pharmaceuticals USA Inc. (“Hikma”) v. Amarin Pharma, Inc. (“Amarin”), No. 24-889, is whether Hikma’s section viii carved out “skinny label” in combination with its public statements and marketing materials regarding its generic version of VASCEPA® (icosapent ethyl) constituted induced infringement by Hikma. Hikma makes and sells a generic version of Amarin’s VASCEPA.

A “section viii statement” is used when the composition of matter patents for a brand name drug have expired but the patents covering the approved methods of using the drug are still in force. A “skinny label” lets a generic drug copy the brand drug for uses that are not covered by the active patents and market the generic drug only for unpatented uses. This carved-out or “skinny” label allows the generic manufacturer to potentially launch its product without the 30-month freeze period imposed by the Food and Drug Administration (FDA).

VASCEPA’s use for cardiovascular risk (CV indication) was still under patent when Hikma marketed its generic version of VASCEPA with a label that carved out the CV indication. Amarin sued Hikma for induced infringement of its patents covering the CV indication, arguing that Hikma’s press release, website, and product label showed Hikma’s specific intent to actively encourage physicians to prescribe Hikma’s generic product for the off-label CV indication. The Federal Circuit held Hikma liable for infringement. The court emphasized the “totality” of Hikma’s communications: labeling details, press releases calling the product a “generic version” of VASCEPA and touting brand sales largely attributable to the patented use, and a website categorizing the product broadly as “Hypertriglyceridemia.” Hikma filed a petition for certiorari to the U.S. Supreme Court.

On December 5, 2025, the US Solicitor General filed an amicus brief in support of Hikma’s petition for certiorari, recommending that the Supreme Court grant certiorari and reverse the Federal Circuit’s decision. In the amicus brief, the Solicitor General argues that the Federal Circuit’s approach in Hikma threatens the Hatch-Waxman section viii carve‑out pathway for generics by treating routine, accurate statements and the skinny label itself as potential evidence of inducement. The Solicitor General’s amicus brief also argued that the Federal Circuit decision will hinder generic manufacturers from seeking FDA approval for non-patented uses and ultimately harm the consumers gaining access to generics.

Why should we care about this case?

The Hikma case spotlights the issue of off-label use and how much responsibility generic manufacturers have for off-label use. Even when a generic’s drug label omits a patented use, downstream dispensing and prescribing dynamics can still drive off‑label, allegedly infringing use. Hikma expands on what behaviors may be seen as inducing infringement. Under the Federal Circuit decision in Hikma, even when a label doesn’t literally describe an infringing use, ordinary, accurate statements—such as describing a product as the “generic version” of the brand, referencing total brand sales, or using broad therapeutic-category language—can collectively support a plausible inducement claim at the pleadings stage.

Why a generic manufacturer should care: The Federal Circuit’s decision in Hikma essentially imposes a requirement on generic manufacturers to ensure that the language in marketing materials (e.g., press releases, investor communications, and websites) is consistent with the language in the FDA label. Where a generic product is approved for indication X but not for indication Y, communications should clearly state the approved indication and avoid suggesting or implying use for any non-approved, patented indications. Similarly, revenue or market data cited in marketing or investor materials should exclude sales attributable to uses covered by still-patented indications, and any brand-referenced sales figures should be carefully framed to avoid implying approval or promotion for those patented uses. Misalignment between promotional language and the label can be cited as evidence of intent to encourage induced infringement.

Why a brand manufacturer should care: The Federal Circuit’s decision in Hikma emphasizes the importance of method of use patents which extend market exclusivity. Hikma also provides a strengthened and clear blueprint for pleading inducement, i.e., the complaint can point to a mix of evidence (e.g., public statements made by the generic manufacturer’s that deviate from the generic’s FDA label) to show encouragement of the patented use by the generic manufacturer.

Solicitor General Arguments

The Solicitor General contends the Federal Circuit’s approach is legally incorrect and undermines Congress’s balance in Hatch‑Waxman. Reversal of the lower court’s decision by the U.S. Supreme Court would narrow inducement theories tied to skinny labels and routine communications and restore more certainty to section viii strategies.

The Solicitor General argued that “Hikma’s skinny labeling cannot properly be treated as evidence of culpable encouragement to infringe. The section viii pathway is designed to enable generic versions of a brand-name drug to be marketed where the drug itself is not patented and only some of its FDA-approved uses are claimed by method-of-use patents” and “[a] particular carved-out label does not reflect a generic manufacturer’s unencumbered choice. Rather, it is driven by statutory and regulatory requirements that allow only narrow exceptions to the general statutory command that generic labeling must be the same as the brand’s labeling.”

With regard to the public statements made by Hikma, the Solicitor General noted that “those statements simply communicated that Hikma’s product meets the statutory and regulatory requirements for approval under an ANDA—including therapeutic equivalence to VASCEPA —and described the unpatented indication for which Vascepa is approved.” The Solicitor General further argued that “for Hikma’s press releases to induce infringement, a prescriber or pharmacist would need to (1) have read an outdated investor press release, (2) know of the relative contributions to sales made by each of Vascepa’s two indications, (3) construe the bare inclusion of total Vascepa sales in Hikma’s estimate of market size as encouragement to prescribe or dispense Hikma’s drug to reduce cardiovascular risk, and (4) act to prescribe or dispense Hikma’s drug based upon that encouragement rather than based upon other reasons such as the constraints imposed by state generic-substitution laws.”

Per the Solicitor General, under the Federal Circuit law, if Hikma’s website or investor statements are found to have led even a small number of doctors or pharmacists to prescribe or dispense its generic drug for an unapproved use, Hikma could be liable for damages for all infringing uses of that drug—including those not directly caused by its statements.

What’s next?

Now we wait to see if Supreme Court decides to hear this case. The last significant “patent” case the Supreme Court heard and decided was Amgen Inc. v. Sanofi in May 2023, dealing with patent enablement.