Fed Circuit reinstates $235m verdict against Teva
In a victory for GlaxoSmithKline (GSK), the US Court of Appeals for the Federal Circuit has revived a 2017 jury verdict ordering Teva to pay $235 million over the drug Coreg (Carvedilol).
In a split decision, issued on Friday, September 2, the Federal Circuit found that Teva should pay $235 million over its sale of a generic version of GSK’s heart drug Coreg, reinstating both the infringement finding and the damages award.
Teva, on expiration of a patent covering Coreg (US number 5,760,069), launched its generic carvedilol in 2007 with “skinny” labels indicating treatment for two conditions, heart failure and hypertension. In January 2008, GSK’s ‘069 patent was reissued as RE40,000.
Three years later, in 2011, the US Food and Drug Administration (FDA) required Teva to amend its carvedilol label to be “identical in content to the approved [GSK Coreg] labeling” and include the indication for treatment of heart failure.
In 2014, GSK sued Teva, accusing the American Israeli company of inducing infringement of the ‘000 patent.
A jury at the US District Court for the District of Delaware concluded that Teva should pay $234.1 million for lost profits and $1.4 million in royalties.
But Chief Judge Leonard Stark overturned the verdict, finding that GSK had failed to show Teva’s alleged inducement had caused physicians to prescribe generic Coreg.
GSK appealed against the decision, arguing that Teva’s promotion of its generic drug as the same as Coreg meets the legal requirements of active inducement of infringement.
In response, Teva contended that it couldn’t be liable for inducing infringement because cardiologists already knew of carvedilol and its uses.
Last week, GSK won its appeal. Circuit Judge Pauline Newman, on behalf of the Federal Circuit, concluded that there was “ample record evidence of promotional materials, press releases, product catalogues, the FDA labels, and testimony of witnesses from both sides” to support the jury verdict of inducement to infringe.
Chief Judge Sharon Prost dissented in the decision, noting that one of Congress’ essential purposes in designing a procedure for generic approval was to help speed up the introduction of low-cost generic drugs.
“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. Congress did not intend either of these consequences,” she said.
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