Even after carefully omitting the infringing uses from its label, leaving a “skinny label,” a generic drug manufacturer can still induce infringement for a method-of-use patent, the Federal Circuit found last week. The court thus ruled in favor of the patent owner GlaxoSmithKline (GSK) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.

Generic manufacturer Teva waited to market generic carvedilol (brand name Coreg®) until after expiration of GSK’s patent on the drug itself. Teva then received FDA approval, initially with a label that listed, as indications, left ventricular dysfunction following myocardial infarction (post-MI LVD) and hypertension. Notably, the initially-approved label did not include congestive heart failure, an indication for carvedilol that was still covered by GSK’s unexpired method-of-use patent.

Nonetheless, the court noted earlier decisions, showing that circumstantial evidence can establish inducement, even in pharmaceutical cases. In this case, promotional materials identified Teva’s product as an “AB-rated generic equivalent of GlaxoSmithKline’s Coreg® tablets,” and experts testified as to doctors’ ability to infer its possible uses from statements like these. The appeals court therefore vacated the decision on infringement from the district court, reinstating a jury verdict in favor of the patent owner.

In a lengthy dissent, Chief Judge Prost reasoned that the generic manufacturer’s “skinny label” should have escaped induced infringement liability. Pointing to the establishment of the skinny label provisions in the statute, the dissent argued that Congress intended to allow generic equivalents to reach the market, as long as they avoided listing infringing indications. In rebutting the dissent, the majority disputed its application of the standard of review on appeal, paying little attention to the underlying reasoning about the practice of skinny labeling.

The court also found that Teva induced infringement after the FDA required a label amendment to include treatment of heart failure. In the dissent, Chief Judge Prost disagreed with this conclusion, based on testimony from GSK’s expert that he did not read the label before prescribing generic carvedilol.

This precedential decision at the Federal Circuit may strengthen the protection that a method-of-use patent can provide, even after compound or composition patents expire. From the perspective of generic manufacturers, it raises the hurdle for avoiding infringement.