Federal Circuit analysis would create “substantial disincentive” to generic entry, USDOJ tells Supreme Court in Hikma v. Amarin

Context:

• Biopharma innovator Amarin developed and patented Vascepa (icosapent ethyl), which received U.S. Federal Drug Administration (FDA) approvals for two indications in treating patients with elevated triglyceride levels, in 2012 and 2019.
• Hikma Pharmaceuticals filed an Abbreviated New Drug Application (ANDA) for a generic version in 2016, amending its application in 2019 to seek FDA approval for “skinny labeling” under the Hatch-Waxman Act that would allow it to market its product for off-patent use, while “carving out” other uses still covered by Amarin’s patents. 
• Amarin subsequently sued Hikma in the United States District Court for the District of Delaware, alleging that Hikma’s marketing led to induced infringement of patents covering Vascepa by the wider medical industry, potentially including doctors, pharmacists, and insurers.
• The district court dismissed the case in October 2022, but the United States Court of Appeals for the Federal Circuit reversed that decision in June 2024, finding “the totality of the allegations” in Amarin’s complaint “plausibly states a claim for induced infringement”.
• In February 2025, Hikma filed a petition for a writ of certiorari with the Supreme Court of the United States (SCOTUS). The U.S. Solicitor General filed an amicus brief in support of Hikma in December 2025. SCOTUS granted Hikma’s petition in January this year.

What’s new and direct impact: SCOTUS yesterday heard oral arguments from Hikma and Amarin, as well as from the Solicitor-General’s Office of the U.S. Department of Justice (DOJ) as amicus curiae in support of Hikma. Much of the argument from both sides, and questioning from the justices, revolved around differing perspectives on what kind of activities could plausibly be considered as inducement. Amarin’s counsel indicated that they would seek to amend the complaint, using information obtained during discovery that went forward after the Federal Circuit ruling; SCOTUS itself will not decide that procedural question.

Wider ramifications: As for the potential outcome, a lot will depend on where SCOTUS sets the plausibility bar for inducement. It seems unlikely that this will result in any radical departure from current standards; but whatever the Supreme Court’s eventual judgment, it will obviously be relevant to patent holders and implementers across many industries, in addition to innovators and generic producers in biopharma.