FDA Drug Labels Should Not Determine Patent Infringement, Legal Scholars Argue
Legal scholars argue FDA-required drug labels should not serve as evidence in patent infringement cases against generic manufacturers. The Supreme Court will hear a case involving this "infringement by label" theory, which could clarify that regulatory compliance alone doesn't prove patent violation. This approach threatens affordable generic drug access by creating liability for companies following FDA rules.
A new legal analysis argues that recent court decisions incorrectly treat FDA-required drug labels as key evidence in patent infringement cases against generic-drug manufacturers. The paper, published by the New England Journal of Medicine, contends that this approach creates liability risk for generic manufacturers complying with FDA rules and could delay access to affordable medicines.
The legal scholars argue that lower court decisions embracing what they call "infringement by label" are incorrect and represent a "fictional turn in the law." They note that although the FDA devotes substantial scrutiny to drug label content, empirical evidence and clinical experience suggest physicians rarely rely on this information when treating patients. Instead, clinicians typically rely on guidelines, experience, and medical literature—not legally required drug labels—when making prescribing decisions.
Disputes arise particularly when a company owns a patent not on the drug itself but on a particular method of using the drug—for example, using it to treat one of several conditions. Manufacturers of brand-name drugs sometimes claim that content in a generic product's label constitutes encouragement of patented use. The theory of infringement by label turns a regulatory document into a crucial piece of evidence in high-stakes patent litigation.
The Supreme Court recently agreed to hear the case Hikma Pharmaceuticals U.S. v. Amarin Pharma, which involves a claim of infringement by label. The court could use this 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 scholars argue that the court should take this opportunity to align patent law with clinical practice, FDA policy, and traditional inducement principles.
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. The risks are particularly acute for generic-drug manufacturers that refer to their product as "equivalent" to a brand-name counterpart—as FDA law requires them to do.