Appeals Court Says Teva Carvedilol Sale Induced Patent Infringement
The Court of Appeals for the Federal Circuit has affirmed an earlier ruling that Teva’s sale of carvedilol induced infringement of a GlaxoSmithKline method-of-treatment patent, even though the Teva product was approved and labeled only for non-infringing uses. A Patentlyo post (contains link to decision) says the court made clear that the inducement liability was due to Teva’s additional marketing activity that encouraged others to infringe.
The post says the GSK patent covers the use of carvedilol to decrease a risk of mortality caused by congestive heart failure. FDA approved Teva’s sale of the drug under a “skinny label” that carved out the patented use. Teva labeled its version for treating hypertension and left ventricular dysfunction following a heart attack. Since the drugs contain an FDA AB rating, the post says, many insurers, pharmacies, doctors, patients, etc., began to use the Teva generic for the patented purposes and Teva profited.
When GSK sued for infringement, a jury sided with the company and awarded $200 million in damages. The district court rejected the jury decision, however, and found insufficient evidence to show that Teva’s actions caused the infringement. A 10/2020 Federal Circuit decision reinstated the jury verdict.
“The problem with the October 2020 decision is that it included an indication that a generic could be held liable for inducement by simply selling a generic version of a drug and noting the therapeutic equivalence with the branded drug, without ever mentioning the patented use,” the post says.
Teva petitioned for an en banc rehearing that led to an order vacating the October 2020 opinion and then the 8/5 precedential opinion again vacating the district court’s judgment as a matter of law and reinstating the jury verdict, but limited to the specific facts of the case, according to an analysis by two Locke Lord attorneys.
“The Federal Circuit has now released a new decision clarifying that such a straight use of the skinny label could not justify inducement liability,” Patentlyo says. “In this case, however, the court found sufficient evidence that Teva went further, labeling its drug in a way that encouraged the patented use.”
The Locke Lord attorneys say the Federal Circuit majority cited only circumstantial evidence, such as press releases and product catalogs published by Teva, to justify substantial evidence to support the jury’s finding of induced infringement during the skinny label period.