Paper urges Supreme Court to reject FDA labels as proof of patent infringement
A paper in the New England Journal of Medicine argues the Supreme Court should reject FDA-required drug labels as standalone evidence of patent infringement in Hikma Pharmaceuticals USA v. Amarin Pharma. The paper says lower-court guidance raises liability risk for generic-drug manufacturers complying with FDA rules and could hamper competition.
The U.S. Supreme Court recently agreed to hear Hikma Pharmaceuticals USA v. Amarin Pharma, which involves a claim of infringement by label. A new paper published by the New England Journal of Medicine argues that drug labels required by the U.S. Food and Drug Administration are intended to guide the safe and effective use of prescription drugs, but recent court decisions have treated that safety information in a drug’s legally required package insert as key evidence in patent cases against generic-drug manufacturers.
Federal law requires every prescription drug to include a document describing dosing guidelines, contraindications, results from clinical trials and safety considerations. When a generic-drug manufacturer seeks to enter the market, the patent owner may accuse the manufacturer of “inducing” physicians to use the generic drug according to the patented method.
Disputes arise, in particular, 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. Typically, to show inducement, a patent owner must prove that the defendant “encouraged, recommended, or promoted” a patented use. Manufacturers of brand-name drugs sometimes claim that content in a generic product’s label constitutes such encouragement.
According to the paper, the theory of infringement by label turns a regulatory document — one that many physicians don’t routinely consult — into a crucial piece of evidence in high-stakes patent litigation. Although the FDA devotes substantial scrutiny to the textual content of drug labels, empirical evidence and clinical experience both suggest that physicians rarely rely on the information when treating patients. By contrast, it is common practice for physicians to frequently prescribe medications “off label” on the basis of guidelines, peer-reviewed studies and clinical judgment.
The paper argues that the lower-court decisions are incorrect and ought to be reversed by the Supreme Court in the forthcoming case. 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 paper says current guidance from the lower courts creates liability risk for generic-drug manufacturers that are complying with FDA rules, 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.