Are Skinny Labels Getting Heavier for Generics? Key Takeaways from Hikma v. Amarin, the Supreme Court's First Patent Case Since 2023

As prescription drug prices continue to soar in the United States, the Supreme Court recently heard the highly anticipated oral arguments in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the first patent case at the Court since 2023. While the Justices did not seem motivated to make significant changes to the current standards for induced patent infringement, the stakes are high for brand and generic pharmaceutical companies, as each side continues to wrestle with the main dilemma that this case raises: What is the right balance between marketing skinny labels to engage in lawful generic competition and avoiding induced infringement liability?

Background

In 2012, the FDA approved Amarin’s branded drug Vascepa for treating severe hypertriglyceridemia (the SH indication). In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: reducing cardiovascular risk in patients with moderately elevated triglyceride levels (the CV indication). Amarin listed two patents covering the CV indication in the FDA’s Orange Book.

In 2016, Hikma submitted an Abbreviated New Drug Application (ANDA) seeking approval for a generic version of Vascepa. After the CV indication was approved in 2019, Hikma filed a “section viii statement” seeking approval only for the SH indication by “carving out” the patented CV indication from its label, creating a “skinny label.” The FDA approved Hikma’s ANDA in May 2020. Throughout 2020, Hikma referred to its product as the “generic version” of Vascepa in press releases and cited Vascepa sales figures (over $1 billion annually) that were mostly attributable to the CV indication. Hikma also marketed its product on its website under the category “Hypertriglyceridemia” and as “AB” rated, but with a disclaimer that it was approved for fewer indications than Vascepa.

In November 2020, Amarin sued Hikma for induced infringement of its CV indication patents. The District Court for the District of Delaware granted Hikma’s motion to dismiss. The U.S. Court of Appeals for the Federal Circuit reversed, finding that Amarin’s allegations “based on the label in combination with Hikma’s public statements and marketing materials” plausibly stated a claim for induced infringement. The Supreme Court granted a petition for writ of certiorari on January 16, 2026, based on the following two questions:

1. The “Generic Version” Question: When a generic drug’s label omits a brand-name drug’s patented use, is induced patent infringement sufficiently pled by alleging the product is marketed as a “generic version” and promoted with public information about the brand-name drug?
2. The “No Mention, No Claim?” Question: Does a complaint state a claim for induced infringement of a patented method if it does not allege any statement by the defendant that encourages or mentions the patented use?

Oral Arguments

Many people in the pharmaceutical industry were interested to see if the Supreme Court would elaborate or adjust the standard for induced infringement by taking on this case, but the Court’s questions at oral argument primarily focused on applying the facts to the current standard. For example, after Hikma’s counsel argued that “‘actively induce infringement’ when dealing with statements requires a clear message that necessarily promotes infringement,” Justice Sotomayor asked: “You don't need all of the things you’ve been arguing about to win under Twombly and Iqbal, correct?” Hikma’s counsel agreed, as did the Deputy Solicitor General to a similar question from Justice Sotomayor. Amarin’s counsel similarly argued that Amarin should win under Twombly and Iqbal in response to a question from Justice Barrett. Additionally, Chief Justice Roberts challenged the test proposed by the Deputy Solicitor General (“acts or messages that reveal a clear intent to encourage infringement”) by stating “[t]hat’s a pretty broad safe harbor” and “low threshold.”

This line of questioning was directly addressed by Justice Barrett, who stated that she believed the key question is a fact question and that “Justice Alito observed the other day, I’m not sure why this case is here except four of my colleagues wanted it to be.”

In addition to focusing on the facts of the case, several Justices’ questions appreciated the significant effect induced infringement standards can have on the pharmaceutical industry. For example, Justice Kavanaugh asked the Deputy Solicitor General, who supported Hikma in this case, to address “the implications of the decision in the marketplace at large,” and the Deputy Solicitor General responded that affirming the Federal Circuit’s decision “would create a substantial disincentive to entering the generic market.” Justice Kavanaugh also noted that Congressman Waxman argued in an amicus brief that “the Federal Circuit’s decision threatens to decimate the compromise at the heart of the Hatch-Waxman Act, which, in turn, threatens to undermine the generic pharmaceutical industry if this kind of complaint’s good enough.” Reflecting concerns by brand pharmaceutical companies, Justice Thomas asked about the impact of states encouraging the use of generics for patented use, and the Deputy Solicitor General responded that “Amarin and similarly situated companies could urge state legislatures to take measures” or “attempt informational campaigns to doctors and tell the doctors [that Amarin’s] product is the only one that is authorized to be used for the CV indication.”

Key Takeaways

Hikma marks the first patent case that the Supreme Court has considered since 2023, following the Court’s decision in Amgen v. Sanofi, another pharmaceuticals case. The repercussions of this case could be significant for pharmaceutical companies at a time of high scrutiny over rising drug costs. A decision in favor of Amarin may reduce the appeal for generic pharmaceutical companies to seek and market skinny labels because of the higher litigation risks that may be involved and lead to a slowdown of having cheaper drugs in the market for patients. On the other hand, a decision in favor of Hikma may result in less incentives for brand pharmaceutical companies to discover new uses for existing drugs. While the Justices’ questions appear to foreshadow a limited ruling, the decision is expected to have broader implications in the industry as it can reshape how generic pharmaceutical companies market their products and brand pharmaceutical companies enforce their patents.

As the dust from oral arguments settle, the pharmaceutical industry and the patent community at large will have to wait for the Court’s decision to evaluate its effect on the induced infringement standard and what light, if any, is shed on striking a balance between marketing skinny labels and avoiding induced infringement liability.