Introduction

On January 16, 2026, the U.S. Supreme Court agreed to hear Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., a patent dispute that could reshape the landscape of generic drug competition and patent enforcement.

This case centers on a contentious question: If a generic drug is labeled only for non-infringing uses (a so-called ‘skinny label’), can a generic company still be liable for inducing patent infringement of the branded innovator’s remaining patented uses, even when the FDA-approved label omits the patented use? The Supreme Court’s decision to grant review signals the importance of this issue for both branded and generic manufacturers.

What Is a Skinny Label?

Under the Hatch-Waxman Act, generic drug applicants can seek FDA approval only for indications no longer protected by patents. This “section viii carve-out” process creates a skinny label – a label that omits patented uses so that generics may enter the market before all patents covering the reference product expire. The goal of this framework is to balance affordable competition with innovation incentives.

In practice, a skinny label works like this:

  • A branded drug is approved for multiple indications.
  • Some of those indications are covered by patents that expire later than other indications.
  • A generic applicant carves out one or more patented indications from its label.
  • The generic launches with a label limited to expired indications.

Generic manufacturers have historically relied on this pathway to avoid patent infringement liability and bring generic products to market sooner. But the Hikma case raises the question of whether the protection from infringement liability has been nullified by the Federal Circuit’s decision.

The Hikma/Amarin Dispute

The dispute involves Amarin’s cardiovascular drug Vascepa® and a generic version marketed by Hikma. Vascepa® received FDA approval for an initial indication (severe hypertriglyceridemia) and later for a cardiovascular risk reduction indication – the latter still patent protected. Hikma’s generic was approved only for the off-patent hypertriglyceridemia indication, omitting the cardiovascular use from its skinny label, as permitted by the FDA. In 2020, Amarin filed suit alleging that Hikma’s marketing materials (e.g., press releases, public statements) encouraged physicians to prescribe the generic for the patented cardiovascular use, constituting induced infringement. A federal district court initially dismissed the infringement claims as insufficiently pled, but the U.S. Court of Appeals for the Federal Circuit reversed in 2024, finding Amarin’s allegation plausible when considering Hikma’s combined label and public statements. Hikma then petitioned the Supreme Court, arguing that the Federal Circuit’s approach effectively nullifies the statutory Section viii carve-out process and threatens generic competition.

The critical facts included that Hikma’s product had already been launched, as opposed to being a Hatch-Waxman case or merely a section viii case that did not involve ongoing, alleged induced infringement.  Further, while Hikma’s press release stated that its “product is not approved for any other indication for the reference listed drug VASCEPA®” and its website provided a disclaimer that “Hikma’s generic version is indicated for fewer than all approved indications of the Reference Listed Drug,” some of Hikma’s press releases referred to the product as either a “generic version of VASCEPA®” or “generic VASCEPA®” and did not include AB-rating disclaimers (indicating that “a generic drug is therapeutically equivalent to a branded drug when the generic drug is used as labeled. It does not reflect a decision of therapeutic equivalence for off-label use.”).  Further, Hikma’s press releases referred to VASCEPA’s entire revenue for all uses, including the CV indication, which the Federal Circuit considered as a factor indicating potential for encouraging use for all of VASCEPA’s indications.

Legal Questions Before the Supreme Court

This Hikma case presents the Supreme Court with a series of legal questions arising from the Federal Circuit’s decision. First, it must consider whether the use of a skinny label alone is sufficient to shield a generic manufacturer from liability for induced infringement. Although it has traditionally been presumed that carving out patented uses from a generic label avoids infringement, the Federal Circuit suggested that other public-facing conduct – such as marketing material, press releases, and representations of therapeutic equivalence to the branded drug – may still give rise to liability. Second, the Court must assess the role that that marketing and other non-label communications play in the inducement analysis, particularly where those communications are consistent with FDA approval but may nonetheless encourage infringing use. Finally, the case presents an opportunity to clarify the proper standard for induced infringement in the skinny-label context, including whether traditional inducement principles should apply or whether a modified standard is warranted when FDA-mandated labeling constraints are involved.

Practical Implications for Industry Stakeholders

Beyond doctrinal questions, the Court’s resolution is likely to have practical consequences for a range of stakeholders, shaping not only liability for skinny-label generics but also how both branded and generic companies assess risk, structure litigation strategies, and communicate about approved products, with downstream effects for the healthcare system more broadly.

Against the backdrop of heightened uncertainty, stakeholders should be thinking proactively about how to adapt their strategies in anticipation of a shifting legal landscape. Regardless of how the Court ultimately rules, the Hikma case underscores the need for careful planning and risk management when navigating skinny labels and post-approval conduct – making forward-looking strategic preparation essential. For branded manufacturers, enforcement strategies should incorporate inducement theories post-launch – but be wary of over-extension that could invite political scrutiny or antitrust issues. For generics, all product communications should be audited against potential inducement risk, including careful review of press releases, marketing content, and physician messaging for skinny labeled products.

A Landmark Case and Legislative Development

This is the first time in years that the Supreme Court has heard a patent dispute, and is set to provide a landmark decision for skinny labels. The decision will reset the balance of generic competition and patent protection– and how courts will interpret that balance in an era where marketing and product communications are increasingly scrutinized.  At the same time, Congress is considering the Skinny Labels, Big Savings Act, billed as a bipartisan bill to help lower prescription drug costs by protecting generic drug makers from abusive lawsuits and preserving patient access to affordable medications. The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act:

  • submitting or seeking approval of a skinny label for a generic or biosimilar drug;
  • promoting or commercially marketing a drug with skinny labeling approved by the FDA; or
  • describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.

Looking Ahead

We will continue to monitor further developments relating to skinny labels and provide insight and updates as they become available.

Disclaimer: The information contained in this posting does not, and is not intended to, constitute legal advice or express any opinion to be relied upon legally, for investment purposes or otherwise. If you would like to obtain legal advice relating to the subject matter addressed in this posting, please consult with us or your attorney. The information in this post is also based upon publicly available information, presents opinions, and does not represent in any way whatsoever the opinions or official positions of the entities or individuals referenced herein.