DoJ Supports Generic Drug Skinny Label Provision
The U.S. Department of Justice (DoJ) says a Federal Circuit ruling on so-called generic drug “skinny labels” threatens to undermine the Hatch-Waxman framework for bringing generics to market by exposing compliant generic manufacturers to inducement claims based on ordinary, non-infringing behavior. A DoJ amicus brief argues that the appeals court erred by finding that general statements about a generic drug could plausibly constitute inducement of infringement. Under settled law, inducement requires credible allegations that the defendant encouraged specific infringing conduct — i.e., prompting a prescriber to use a drug in a way that violates a patent, the government contends, adding that simple truthful references to a drug do not meet that standard.
At issue is the U.S. Supreme Court has agreed to hear a patent-infringement dispute between generic drugmaker Hikma Pharmaceuticals USA, Inc. and brand-name company Amarin to decide whether generic drugmakers may face liability for inducement of patent infringement when they market a drug using a skinny label — i.e., a label that omits uses still under patent, even if the generic otherwise duplicates the brand-name drug.
In this case, Hikma followed a familiar path: its generic drug — a version of Amarin’s icosapent ethyl — is labeled only for severe hypertriglyceridemia (an unpatented use), excluding the cardiovascular-risk use that remains under patent. But the U.S. Court of Appeals for the Federal Circuit reversed a prior dismissal, holding that the combination of Hikma’s skinny label plus its public references (such as press releases and investor disclosures) about total sales and equivalence to the brand drug gave rise to a plausible claim that Hikma was “actively inducing” infringement.
The government’s brief stresses that Hikma’s descriptive statements do not show that Hikma urged any party to prescribe or use the drug in a way that infringes Amarin’s patent. These kinds of truthful factual statements should not form the basis for inducement liability.
Allowing liability in this context could deter generic manufacturers from using skinny labels or delay their entry for fear of patent litigation, the government argues. That outcome would raise drug costs and undercut federal policy goals of promoting competition and affordable medicines—a significant interest for Medicare, Medicaid and other federal programs.
Meanwhile, a brief by the Association for Accessible Medicines (AAM) also argues that the Federal Circuit’s decision improperly undermines the skinny label framework created by Congress under the Hatch-Waxman Act. The generic drug lobbying group says Congress designed the skinny-label pathway so generic entrants can avoid patent disputes for carved-out uses. Labels that comply with FDA requirements should not, by themselves, expose generics to accusations of inducing infringement.
AAM warns that upholding the Federal Circuit’s reasoning would “cloud” liability for everyday statements and dramatically weaken the utility of skinny labels — a mechanism that has enabled billions in savings by accelerating generic competition.