Research: FDA Drug Labels Not Proof of Patent Violation

Paper argues courts are incorrectly treating FDA-required drug labels as evidence of patent infringement against generic drugmakers

Published on Feb. 17, 2026

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A new paper co-written by a University of Illinois Urbana-Champaign legal scholar argues that recent court decisions have problematically treated the safety information in a drug's legally required package insert as key evidence in high-stakes patent cases against generic-drug manufacturers. The paper contends that these "infringement by label" decisions are incorrect and ought to be reversed by the U.S. Supreme Court in an upcoming case.

Why it matters

The overzealous and hyperbolic claims of patent infringement by drug companies is tantamount to "patent gamesmanship" that could potentially limit access to affordable generic drugs. The theory of "infringement by label" turns a regulatory document that many physicians don't routinely consult into a crucial piece of evidence in high-stakes patent litigation, hampering competition and delaying marketplace access to important medicines at a lesser cost.

The details

Federal law requires every prescription drug to include a document describing dosing guidelines, contraindications, results from clinical trials and safety considerations. However, recent court decisions have treated this safety information in a drug's legally required package insert as key evidence in patent cases against generic-drug manufacturers. The paper argues this is incorrect, as doctors rarely rely on the information in drug labels when making prescribing decisions, instead relying on guidelines, experience and medical literature.

  • The Supreme Court recently agreed to hear the case Hikma Pharmaceuticals USA v. Amarin Pharma, which involves a claim of infringement by label.

The players

Jacob S. Sherkow

A professor of law and of medicine and an affiliate of the Carl R. Woese Institute for Genomic Biology at the University of Illinois Urbana-Champaign, and the Richard W. and Marie L. Corman Professor of Law at Illinois.

Paul R. Gugliuzza

A co-author of the paper and a professor at the University of Texas at Austin School of Law.

Hikma Pharmaceuticals USA

A pharmaceutical company involved in the upcoming Supreme Court case Hikma Pharmaceuticals USA v. Amarin Pharma, which involves a claim of infringement by label.

Amarin Pharma

A pharmaceutical company involved in the upcoming Supreme Court case Hikma Pharmaceuticals USA v. Amarin Pharma, which involves a claim of infringement by label.

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What they’re saying

“It's a fallacy that doctors actually read these labeling documents that are required by the FDA.”

— Jacob S. Sherkow, Professor of Law and Medicine, University of Illinois Urbana-Champaign (New England Journal of Medicine)

“Clinicians usually rely on guidelines, experience and medical literature ― not legally required drug labels ― when making prescribing decisions.”

— Jacob S. Sherkow, Professor of Law and Medicine, University of Illinois Urbana-Champaign (New England Journal of Medicine)

“By creating liability risk for generic-drug manufacturers that are complying with FDA rules, the current guidance from the lower courts hampers competition and could delay marketplace access to important medicines at a lesser cost.”

— Jacob S. Sherkow, Professor of Law and Medicine, University of Illinois Urbana-Champaign (New England Journal of Medicine)

What’s next

The Supreme Court could use the Hikma Pharmaceuticals USA v. Amarin Pharma case as an opportunity to clarify that FDA-required labeling language, along with a generics manufacturer's straightforward statements about therapeutic equivalence, cannot alone prove patent infringement.

The takeaway

This case highlights the need for the Supreme Court to align patent law with clinical practice, FDA policy and traditional inducement principles, and to make clear that FDA-required labeling language and statements about equivalence do not constitute patent infringement.