Federal Circuit IP
Hikma Pharms. USA Inc. v. Amarin Pharms., Inc.
Hikma Pharms. USA Inc. v. Amarin Pharms., Inc. (S. Ct. June 4, 2026) (Jackson)
Overview: A claim for active inducement requires clear and affirmative steps, not merely speculative conduct or vague language, especially when there are substantial non-infringing uses.
Facts / Procedural History
- Amarin developed Vascepa, a branded drug, and was FDA-approved for treatment of severe hypertriglyceridemia (“SH”).
- Hikma submitted ANDA and filed a paragraph IV certification, asserting the method-of-use patents for SH were invalid. In court, the patents were invalidated.
- Amarin then received FDA approval and patent protection for using Vascepa for cardiovascular risk in hypertriglyceridemia patients on statins (CV).
- Hikma supplemented their ANDA application with a section viii (i.e., carving out patented use) statement that sought approval of a skinny label that included only the SH indication.
- FDA approved the generic drug with the skinny label and assigned “AB” rating (i.e., equivalent therapeutic). Amarin then filed suit once the generic drug was marketed.
Issue: whether Amarin plausibly alleged that Hikma actively induced infringement of Amarin’s patented cardiovascular-risk indication based on Hikma’s skinny label.
Holding / Analysis: the Court upheld the 12(b)(6) motion to dismiss because:
- Inducer must take active steps to encourage direct infringement.
- Inducement cannot be based on vague language and speculative conduct of others.
- Inducement can be implicit; however, it must be clear and affirmative.
- Amarin failed to establish that Hikma took affirmative steps.
- Hikma’s skinny label containing the clinical study about CV indication was just Hikma following the law because the skinny label must be identical except for the carved-out use.
- Hikma is allowed to market it as a generic equivalent, because it is normal industry practice to do so.
- Hikma is allowed to list side effects for CV patients because this is not active inducement but rather passive inducement.
- Hikma’s financial press releases indicate use for SH and CV is allowable, because the press releases are not meant for medical providers.
Takeaways: To adequately plead inducement, ensure your complaint identifies clear, affirmative acts by the defendant encouraging medical providers to perform the infringing conduct, mere knowledge or passive conduct is not enough.