The U.S. Federal Circuit Court of Appeals in Washington, D.C. has reinstated a 2017 jury verdict against Teva Pharmaceutical Industry Ltd., ordering the company to pay GlaxoSmithKline Plc $235.5 million in a 13-year-old induced patent infringement case.
In a 2-1 decision, the federal court decided that there was “substantial evidence” that Teva induced doctors to prescribe its generic version of Coreg (carvedilol) – a beta-blocker intended to treat medical conditions covered under a GSK patent until 2015.
Coreg is prescribed for hypertension, left ventricular dysfunction after a heart attack, and congestive heart failure. The drug’s mechanism blocks the action of naturally occurring substances like epinephrine on the heart and blood vessels, thereby lowering heart rate, blood pressure and strain on the heart. After a heart attack, it provides an assist to help a sluggish heart to pump, increasing survival odds.
The history of the case dates back to 2007 when Teva began selling a generic version of Coreg indicated for the first two conditions with a “skinny label.” Under Food and Drug Administration rules, generic manufacturers like Teva can market a generic drug with a skinny label which omits the indications covered under the brand’s patent. The drug may end up being used in an off-label fashion, but this rule covers the manufacturer.
GSK sued Teva after the Food and Drug Administration (FDA) compelled Teva in 2011 to add the third indication, congestive heart failure, to the label. In 2017, A Delaware jury ordered Teva to pay GSK $234.1 million for lost profit, along with $1.4 million in royalties. U.S. District Judge Leonard Stark overturned the verdict in 2018, stating that the evidence did not support the jury’s finding.
In the October 2 verdict, Circuit Judge Pauline Newman said that promotional materials, press releases, product catalogs, FDA labels and witness testimony did support the “induced infringement” judgement against Teva.
Chief Judge Sharon Prost dissented, saying that the verdict went against Congress’ desire for efficient procedures to encourage room for low-cost generics in the marketplace.
“The majority’s holding undermines this purpose by creating infringement liability for any generic entering the market with a skinny label, and by permitting infringement liability for a broader label that itself did not actually cause any direct infringement,” Prost wrote.
Jeff Francer, General Counsel at the Association for Accessible Medicines, concurred.
“This decision will make it harder for patients to access more affordable generic medicines in a timely way, and it is antithetical to the Hatch-Waxman statute and FDA’s regulations that allow generic drug manufacturers to carve out patented uses of approved drugs.” Francer told BioSpace.
Teva, for its part, was “disappointed with the outcome” and remains firm in its claim that it did not induce doctors to prescribe its generic for conditions covered under Glaxo’s patent. The company plans to appeal and introduce additional defenses.
The case is GlaxoSmithKline LLC et al v Teva Pharmaceuticals USA Inc, U.S. Federal Circuit Court of Appeals, Nos. 2018-1976, 2018-2023.