Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

    Issues

    Does a “skinny label” insulate a generic drug manufacturer from induced patent infringement liability – and can a complaint state such a claim when the drug is marketed as the generic version of a brand-name equivalent?

    Oral argument:
    April 29, 2026
    Court below:
    United States Court of Appeals for the Federal Circuit

    This case asks the Supreme Court to consider whether the Hatch-Waxman Act permits generic manufacturers to rely on “skinny labeling” (an FDA-approved label that omits patented uses of the brand-name drug) to avoid liability for induced patent infringement, or whether they may still be held liable when their product is used for patented indications despite a carve-out. This case originates from a dispute between Hikma and Amarin and involves Hikma’s generic version of Amarin’s drug Vascepa. Hikma used a skinny label omitting certain patented cardiovascular indications while retaining approval for unpatented uses. Hikma argues that the FDA’s approval of the carve-out label under the Hatch-Waxman framework should shield it from liability since it did not actively promote the patented uses and followed regulatory requirements. Amarin argues that Hikma nonetheless infringed because of its labeling, marketing context, and foreseeability of physicians prescribing or encouraging use of the drug for the patented indications. A decision in favor of Hikma would strengthen the protection of generic drugs afforded by skinny labeling and reduce litigation risk for generics entering partially patented markets, while a decision in favor of Amarin would expand induced infringement liability and potentially weaken the practical effectiveness of the skinny labeling pathway under the Hatch-Waxman Act.

    Questions as Framed for the Court by the Parties

    (1) Whether, when a generic drug label fully carves out a patented use, allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) are enough to plead induced infringement of the patented use; and (2) whether a complaint states a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use.

    Facts

    Amarin Pharmaceutical (“Amarin”) is a pharmaceutical company that specializes in a sole commercial product, Vascepa.In 2012, the FDA approved Vascepa solely for the treatment of severe hypertriglyceridemia (“the first indication”). Amarin’s patents for the first indication were later invalidated. In 2019, Amarin received FDA approval for a second indication (use of the drug as approved by the FDA) as a treatment to reduce cardiovascular risk in patients with high blood triglyceride levels. Amarin holds valid patents for the second indication.

    The generic pharmaceutical company Hikma Pharmaceuticals (“Hikma”) submitted an Abbreviated New Drug Application (“ANDA”) for FDA approval of the generic version of Vascepa and use under the first indication. Hikma’s ANDA approval for generic Vascepa was still pending when Amarin’s second indication for Vascepa was approved. Due to the patent protection for Vascepa’s second indication, Hikma had to amend their application to remove any reference of the second indication’s use from the instructions on its generic drug label. This process, called “carving out,” is a strategy allowed under the Hatch-Waxman Act where a generic drug company can get approval if their generic drug’s label only includes instructions for uses not covered by the brand drug’s patents.

    Although Hikma’s generic drug was only FDA-approved for Vascepa’s first indication and had carved out the instructions on its label to avoid the patented use (the “second indication” at issue here), Amarin sued Hikma in the United States District Court for the District of Delaware, alleging that Hikma had induced infringement of multiple patents on the second indication of Vascepa. The district court found that Hikma’s inclusion of side effects for the second indication did not induce infringement, and that Hikma’s public statements were not enough for Amarin to allege that there was an “inducing act” under 35 U.S.C. § 271(b). The district court granted Hikma’s motion to dismiss; Amarin appealed the decision to the United States Court of Appeals for the Federal Circuit.

    The question on appeal was whether Amarin’s complaint plausibly pled that Hikma actively induced infringement of Amarin’s patents. For a motion to dismiss under Federal Rules of Civil Procedure Rule 12(b)(6), all well-pleaded facts are accepted as true and reasonable inferences are drawn in favor of the non-movant: in this case, Amarin. The Federal Circuit held that Amarin’s complaint plausibly pled that its induced infringement theory was based on the combination of Hikma’s skinny label, website, and press releases, which a direct infringer (such as a doctor) would have access to. Therefore, the Federal Circuit found that Amarin had pled enough in its complaint to survive a motion to dismiss, overturning the district court’s decision.

    On February 14, 2025, Hikma filed a petition to the Supreme Court of the United States for a writ of certiorari. The Supreme Court granted the petition on January 16, 2026.

    Analysis

    THE PLEADING STANDARD UNDER F.R.C.P. 12(b)(6)

    Hikma contends that Amarin’s allegations are not enough to plead a plausible claim for relief under Rule 12(b)(6). Hikma notes that the complaint itself must plead enough facts to support its claim for relief, without requiring discovery to provide the factual support for the defendant’s alleged wrongdoings. Hikma argues that here, Amarin’s allegations are based on conclusory inferences from non-infringing conduct, falling short of the Rule 12(b)(6) standard. For example, Hikma argues that the skinny label for its generic version of Vascepa only approved of the non-patented (and thus non-infringing) uses of Vascepa, while its warnings mentioning the second indication were intended to dissuade doctors from prescribing it for the patented use. Additionally, Hikma asserts that the pre-launch press releases regarding the generic product do not, as Amarin claims, “communicat[e] to and instruct[] healthcare providers and patients” because the press releases do not contain the alleged or actual instructions on how to use Hikma’s generic drug to infringe on Amarin’s patented indications. Hikma notes that even an unaccused 2020 press release merely explained what uses its generic drug were approved for, while clarifying that the drug was not approved for other uses, including the patented uses. Hikma posits that these allegations rely on conclusory inferences and cannot establish the plausible claim required under the Iqbal-Twombly standard, so Amarin’s complaint was properly dismissed following Rule 12(b)(6).

    Amarin responds by contending that their complaint states a claim for relief because, taking all of the factual allegations as true and drawing inferences in Amarin’s favor under the Iqbal-Twombly standard, Amarin’s allegations led to a plausible claim of active inducement of infringement. Amarin points out that Hikma did not dispute two of the three elements in an active inducement claim, direct infringement and specific intent, and that Amarin has sufficiently pleaded facts for the third element regarding Hikma’s active steps to encourage such direct infringement. Specifically, Amarin posits that their complaint identifies “discrete statements to a specific audience” for a “particular purpose” that would allow for a plausible inference of Hikma’s “mental state giving rise to liability” for inducement of infringement. For example, Amarin argues that Hikma’s communications to doctors describing their product as “generic Vascepa” have a plausible unlawful explanation sufficient at the pleadings stage: Hikma intending to market their product as a full generic equivalent of Vascepa suitable for uses including the patented indications. Amarin additionally notes that when Hikma made references to brand-name Vascepa in advertising statements and the skinny label, that was enough at the pleading stage. Amarin asserts that by offering the information on a website that the direct infringers would consult, Hikma has advertised to, and encouraged infringement by, a direct infringer – and as a result, the complaint allows non-conclusory inferences and sufficiently pleads a valid claim under Rule 12(b)(6). Further, Amarin argues that the ultimate question of whether there was active inducement by Hikma is a fact-intensive question for trial, which cannot be properly resolved at the pleadings stage.

    INDUCEMENT STANDARD UNDER 35 U.S.C. § 271(b)

    Hikma posits that § 271(b) requires that the defendant actively induce infringement of a patent by taking affirmative steps to bring about the resulting infringement. Hikma notes that the Supreme Court previously found an inducer to take such affirmative steps when there were advertisements, instructions, or promotions of another party’s direct patent infringement. Hikma argues that its actions do not meet these requirements, and that Amarin pleaded only enough facts to show that Hikma was a “passive” infringer. Hikma distinguishes its actions as less than the “affirmative steps,” stating that the complaint only alleged that Hikma had knowledge of the infringement potential or that it refrained from taking steps to prevent infringement by doctors. Hikma also argues that the claims require speculation of what a doctor (or other drug purchaser) might do with the information on the skinny label, advertising material, or promotional material for generic Vascepa. Thus, Hikma asserts that their actions do not rise to the “affirmative steps” level required for liability under § 271(b). Finally, Hikma asserts that Congress’s statute only created liability for active, not passive, inducement of patent infringement. Hikma also contends that Congress did not intend for generic drug companies to be held liable for inducing infringement, as the carve-out provision in the Hatch-Waxman Act allows generic drug manufacturers to create skinny labels and bring their products to market without infringing on brand-name drug manufacturers.

    Amarin disagrees, responding that Hikma’s advertisements for their generic product were “classic” forms of active inducement similar what the Supreme Court has found in the past, particularly in the case of Metro-Goldwyn-Mayer Studios, Inc. v. Grokster, Ltd. Amarin argues that the standard for induced infringement does not require the inducer to have given any explicit instructions to still be held liable, citing Grokster. Amarin asserts that § 271(b) liability can stem from Hikma’s advertising because it had suggestive implications, such as Hikma’s website and press releases suggesting to healthcare providers that they should use Hikma’s generic version of Vascepa for the second (patented) indication as well as the first (non-patented) indication. Further, Amarin contends that the skinny label included clinical information relevant to doctors treating the very condition that the second, patent-protected indication covers. Additionally, Amarin claims that Hikma included brand-name Vascepa’s sales data and press-releases in generic Vascepa’s advertising to implicitly advertise that generic Vascepa could be used for brand-name Vascepa’s patented indication, thus meeting the inducement standard under § 271(b). Amarin additionally posits that if Congress intended for generic drug companies to not be held liable for inducing infringement, Congress would have written a safe harbor provision to that effect. As an example, Amarin compares § 271(b) with the safe harbor provision in 35 U.S.C. § 271(e)(1) for certain regulatory approval-related use of patents. Amarin contends that because Congress did not also extend this safe harbor protection for circumstances after approval (such as the case here), nor did it include the provision in the statute allowing for carve-outs as a pathway to FDA approval, § 271(b) should not be construed to create a non-existent safe harbor from liability.

    Discussion

    HATCH-WAXMAN REGULATION AND MARKET ACCESS

    Shashank Upadhye, in support of Hikma, argues that imposing liability based in part on FDA-compliant labeling creates a direct conflict between regulatory obligations and patent law. The United States (“U.S.”), in support of Hikma, also claims that under the Federal Circuit’s interpretation of the Hatch-Waxman Act, branded drug manufacturers could create de facto monopolies and discourage generic drug entry by manufacturers like Hikma. The U.S. asserts that because generic drug approval pathways have saved consumers billions of dollars, a reduced market of generic drug manufacturers as a result of this case would directly harm consumers. Public Citizen, in support of Hikma, argues that such a restriction on generic drug competition would disproportionately harm low-income and elderly patients while increasing the costs of government programs like Medicare and Medicaid. Former Congressman Henry A. Waxman (“Waxman”), in support of Hikma, further contends that without clear limits on liability, generic manufacturers may avoid marketing drugs with skinny labels due to fear of costly litigation and financial instability, impacting the public’s access to generic versions of costly drugs. 

    Regeneron Pharmaceuticals Inc., in support of Amarin, argues that overreliance on the FDA regulatory framework will result in less patent protection for drug manufacturers compared to patents in other types of industries, running counter to the technology-neutral structure of the U.S.’s patent system. In addition, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization (“PhRMA and BIO”), in support of Amarin, contend that Hikma’s interpretation of the Hatch-Waxman Act would grant unfair market advantages to generic drug manufacturers beyond what was previously contemplated by Congress. PhRMA and BIO also claim that since the generic drug market has become robust after the passing of the Hatch-Waxman Act, giving them additional advantages here would undermine brand-name manufacturers like Amarin in a marketplace that already favors generic drug manufacturers like Hikma. PhRMA and BIO further assert that the dismissal of this case at the pleading stage here would effectively allow generic drug manufacturers to become their own judges on whether their label is properly “skinny” enough to avoid inducement liability.

    INCENTIVES FOR DRUG MANUFACTURERS TO INNOVATE AND THE IMPACT ON PATIENTS

    Waxman, in support of Hikma, argues that expansive inducement liability may undermine innovation by enabling the strategic use of patent applications to block competition. Waxman contends that the Federal Circuit’s approach incentivizes brand-name manufacturers to extend their period of exclusivity by regularly filing for new methods of use for existing drugs, instead of innovating to create entirely new and different drugs. Similarly, a group of seventy-six scholars of law, business, economics, and medicine (“seventy-six scholars”), in support of Hikma, states that overly broad limitations on skinny labeling directly counteract patent law’s goal of innovation. As a result, seventy-six scholars claim that a ruling against Hikma would disproportionately reduce incentives for companies to innovate in the drug market industry, compared to other industries such as agriculture and telecommunications. In addition, seventy-six scholars assert that overly broad limitations on skinny labeling may encourage manufacturers to promote drug uses supported by only tenuous evidence, thereby increasing the risk of misleading consumers.

    Former Federal Circuit Chief Judge Paul R. Michel and scholars of law and economics (“Judge Michel et al.”), in support of Amarin, argue that discovering new methods of use is itself an inventive and innovative act which also provides new public health benefits. Similarly, a group of academic medical centers, in support of Amarin, claim that brand-name drug manufacturers are paramount to discovering new treatment methods for diseases like cancer and Alzheimer’s as their researchers perform the clinical trials for those treatments. The academic medical centers contend that discovering these treatment options can require expensive investments, so strong patent protection is required to incentivize brand-name manufacturers to finance said clinical trials and research. Sanofi, in support of Amarin, contends that reducing the incentive for brand-name drug manufacturers to invest in clinical trials will ultimately harm patients by limiting their access to innovative treatments. Sanofi argues that this concern is particularly relevant here because many critical advances in medications come from discovering new therapeutic uses for existing drugs, not entirely new drugs.

    Conclusion

    Authors

    Written by:    Emma Babashak and Audrey Hager

    Edited by:      Esther In

    Additional Resources