IP Law Daily, STRATEGIC PERSPECTIVES: Supreme Court to hear arguments in ‘skinny labeling’ induced infringement dispute, (Apr 21, 2026)
Article previews upcoming patent battle that could have significant impacts on the availability and cost of generic versions of prescription drugs.
On April 29, the Supreme Court will hold an oral argument session in the case of Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889). This pharmaceutical patent infringement case involving Hatch-Waxman Act rules for “carving out” patented uses of a drug from a generic drug label (known as “skinny labeling”) is the Supreme Court’s second case this term involving standards for secondary liability for infringement of IP rights. In the first case, Cox Communications, Inc. v. Sony Music Entertainment, No. 24-171 (U.S. Mar. 25, 2026)), the Court held that an Internet service provider could not be liable for contributory copyright infringement for merely continuing to provide its service with knowledge that it will be used by some to infringe copyrights. The Court also explained that finding liability for inducement of copyright infringement requires that the defendant actively encouraged infringement through specific acts, such as the promotion and marketing of software as a tool to infringe copyrights.
Hikma is a patent infringement case involving a generic drug with the same active ingredient as the brand-name drop Vascepa, marketed by Amarin. The active ingredient was initially indicated for treatment of severely high triglycerides but later patented for use in reduction of cardiovascular disease risk. Hikma obtained FDA approval to make and market a drug for the non-patented triglyceride indication and carved out (that is, omitted) the patented cardiovascular indication from the label, pursuant to 21 U.S.C. § 355(j)(2)(A)(viii), a process known as “skinny labeling.” However, Amarin accused Hikma of infringing its patent on use of the drug for prevention of cardiovascular problems, and it filed suit for “actively inducing” doctors to infringe Amarin’s patent in violation of 35 U.S.C. § 271(b).
A district court dismissed the case because Hikma followed the skinny labeling rules, but the Federal Circuit reversed, holding that Amarin plausibly alleged that Hikma had engaged in conduct that could show specific intent to induce infringement, despite the label carveout.
The Supreme Court granted Hikma’s petition for certiorari on January 16, 2026, agreeing to decide whether Amarin’s complaint was sufficient to plead a case for induced patent infringement. Hikma argues that the Federal Circuit’s holding makes it impossible for generic drugmakers to rely on their compliance with the skinny labeling requirements, throwing a wrench into a mechanism designed to speed up the entry of noninfringing lower-cost generics on the market. Amarin contends that Hikma’s take on the law would disincentivize branded drugmakers from investing in new products, which could stifle revolutionary and life-saving discoveries.
A Strategic Perspectives article, titled “Skinny labeling” case gives Supreme Court another shot at clarifying secondary IP infringement standards, previews the arguments of both parties, as well as those of the U.S. government, which is participating in argument as an amicus curiae supporting Hikma. The article is available here.
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