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# Legal Scholars Warn ‘Infringement by Label’ Will Harm Generics
- URL: https://www.fdaweb.com/legal-scholars-warn-infringement-by-label-will-harm-generics/
- Published: 2026-02-12T12:00:00.000Z
- Updated: 2026-09-14T13:33:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160661

A new article in the *New England Journal of Medicine* is warning that recent federal court rulings are transforming FDA-required drug labels into powerful weapons in patent litigation — a shift the authors say could chill generic competition and keep drug prices high.

In a Perspective published 2/7, legal scholars **Paul R. Gugliuzza** (Temple University) and **Jacob S. Sherkow** (University of Illinois College of Law) argue that courts have increasingly embraced what they call a theory of “infringement by label.” Under this approach, statements in a generic drug’s FDA-approved labeling — and even routine assertions that a product is therapeutically equivalent to its brand-name counterpart — can be used as evidence that the generic manufacturer induced physicians to infringe a patented method of use.

The issue arises when a brand-name manufacturer holds a patent not on a drug itself, but on a specific method of using it, such as for a particular indication. Federal law allows generic companies to seek approval with so-called “skinny labels” that omit patented uses. Historically, courts required proof that physicians following a generic label would “inevitably” practice the patented method in order to find induced infringement. But the authors say that standard has shifted following recent decisions from the U.S. Court of Appeals for the Federal Circuit.

In a 2021 case, *GlaxoSmithKline v. Teva Pharmaceuticals*, the Federal Circuit upheld a $236 million verdict against Teva over its generic version of the heart drug carvedilol, despite the company having removed the patented indication from its label with FDA approval. The court relied in part on expert testimony that portions of the label could still direct physicians toward the patented use. The ruling also treated Teva’s statements that its product was equivalent to the brand-name drug as additional evidence of inducement — even though federal law requires generics to demonstrate and communicate therapeutic equivalence.

The Supreme Court has now agreed to hear a similar case, *Hikma Pharmaceuticals USA v. Amarin Pharma* ([see story](https://fdaweb.com/login.php?sa=v&aid=D5160507&cate=&stid=%241%24nf0.kC..%24leWWUyNtJOeIRsTnzO.du1&ref=fdaweb.com)), involving Amarin’s fish-oil-based drug Vascepa (icosapent ethyl). Amarin holds a patent on one of Vascepa’s two approved indications — reducing cardiovascular risk in certain patients — and sued Hikma after the generic manufacturer launched a version labeled only for the drug’s unpatented use in severe hypertriglyceridemia. Although a trial court dismissed the case, the Federal Circuit reinstated it, finding that references in Hikma’s label to clinical studies and cardiovascular risk, along with press releases calling the product the “generic version” of Vascepa, could be viewed as encouraging physicians to prescribe it for the patented use.

Gugliuzza and Sherkow argue that this legal trajectory ignores clinical reality. Physicians, they write, rarely consult package inserts when making prescribing decisions and often rely instead on professional guidelines, medical literature and experience. Allowing FDA-mandated labeling language to serve as evidence of inducement, they contend, misaligns patent doctrine with how medicine is actually practiced.

The stakes are substantial. In the Teva case, generic sales totaled $75 million, but damages reached $236 million. The authors warn that expanding inducement liability based on label text could deter generic manufacturers from entering markets involving drugs with multiple indications, prolonging periods of high prices and limiting access to essential medicines.

They urge the Supreme Court to use the Hikma case to clarify that FDA-required labeling language and routine equivalence statements cannot, by themselves, establish patent infringement. Courts, they argue, should require proof that a manufacturer meaningfully encouraged infringement and should treat compliance with FDA-approved skinny labels as evidence against inducement.

Absent such clarification, the authors conclude, the Federal Circuit’s current approach risks turning a regulatory disclosure document into a linchpin of high-stakes patent litigation — with significant consequences for generic competition and drug affordability.