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

Docket Number: 24-889
Citation: 608/2
Term: October Term 2025
Argued: April 29, 2026
Decided: June 4, 2026
Lower Court: United States Court of Appeals for the Federal Circuit
Author: Associate Justice Ketanji Brown Jackson
Concurring: Ketanji Brown Jackson

AI-Generated Summary

Case Information

Case Name: Hikma Pharmaceuticals USA Inc. et al. v. Amarin Pharma, Inc. et al.
Docket Number: No. 24–889
Dates: Argued April 29, 2026—Decided June 4, 2026
Lower Court: United States Court of Appeals for the Federal Circuit

Facts of the Case

Amarin developed Vascepa, containing icosapent ethyl. The FDA approved it in 2012 for severe hypertriglyceridemia (SH indication) and in 2019 for reducing cardiovascular risk in statin-taking patients (CV indication). Amarin obtained method-of-use patents for the CV indication.

Hikma filed an ANDA in 2016 for generic icosapent ethyl, initially with a paragraph IV certification for SH patents. After those patents were invalidated, Hikma filed a section viii statement seeking a skinny label limited to the SH indication, carving out the patented CV use. The FDA approved the skinny label in 2020 with an AB rating.

Amarin sued in the District of Delaware, alleging Hikma actively induced infringement of the CV patents through statements in the skinny label, patient information leaflet, website, and press releases. The District Court dismissed for failure to state a claim. The Federal Circuit reversed, finding it plausible that physicians could read the statements as encouragement to infringe. The Supreme Court granted certiorari.

Legal Issues Presented

Whether Amarin plausibly alleged that Hikma took active steps to induce infringement under 35 U.S.C. §271(b).
The case involves interpretation of the patent inducement statute and application of federal pleading standards under Twombly and Iqbal.
Amarin argued that the totality of Hikma’s statements created a plausible chain leading to infringing prescriptions. Hikma argued that no affirmative active steps were taken.

The Court's Decision (Main Opinion)

Author & Type: Justice Jackson delivered the opinion for a unanimous Court.
Holding: Amarin failed to state a claim for active inducement of infringement under §271(b).
Legal Reasoning: An inducement claim requires direct infringement by a third party, knowledge of infringement, and “active steps” to encourage infringement. “Active steps” demand affirmative, purposeful conduct, not ordinary acts of distribution, omissions, or vague statements. Amarin’s allegations failed the plausibility standard because many statements had obvious alternative explanations (legal compliance or industry practice), relied on nonfeasance, or were too vague to support a reasonable inference of active encouragement.
Disposition: Reversed and remanded.

Concurring Opinion(s)

None.

Dissenting Opinion(s)

None (unanimous decision).

Potential Significance

The ruling clarifies that induced-infringement claims against generic manufacturers using skinny labels must allege affirmative, plausible encouragement rather than mere possibility of misinterpretation by physicians, protecting standard labeling practices and industry norms from liability.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Key terms: Generic Drugs, Skinny Labels, Patent Infringement