Prove it, GlaxoSmithKline. So says a judge in the Coreg patent case that last year ended in a $235 million judgment against generics maker Teva. In the patent "carve-out" case, GSK didn't bring enough evidence to show that Teva persuaded any doctors to prescribe the drug for any indications still protected by patents.
Judge Leonard P. Stark ruled that the jury shouldn't have concluded Teva induced doctors to infringe GSK's patent, both during a "skinny label" and a "full label" period.
Glaxo's Coreg won U.S. approval in 1995 and ultimately picked up indications for treating hypertension, left ventricular dysfunction following a heart attack and congestive heart failure. Despite the trio of approvals, GSK only marketed Coreg for congestive heart failure in the U.S., according to Judge Stark.
Many years later, Teva won approval for a Coreg generic, but that nod didn't cover congestive heart failure because of remaining patent protections, according to the judge's opinion (PDF) released Wednesday.
In 2011, the FDA instructed Teva to rework its label, and in the revised version, the generics maker included all three of the branded drug's indications, even though GSK still had patent protections on the heart failure use through 2015.
Glaxo sued for infringement during both the "skinny label" and "full label" periods, prevailing in a trial last year that ended in a $235 million verdict against Teva. But after reviewing the trial record, U.S. District Judge Leonard Stark said GSK had failed to deliver enough evidence that Teva's actions caused patent infringement, according to a Wednesday opinion.
Specifically, he wrote, GSK didn't demonstrate that Teva's actions induced "even at least one doctor" to prescribe the generic for the patent-protected use.
"In sum, substantial evidence does not support the jury's finding on causation, and therefore does not support its verdict that Teva is liable for induced infringement, during both the skinny and full label periods," the judge wrote in the opinion.
"Without a finding of infringement, there is no liability, so Teva cannot be found to be a willful infringer and cannot be ordered to pay GSK any damages," he added.
A GSK representative said "we are disappointed with the judge’s decision and are reviewing our options." A Teva spokesperson declined to comment.
Coreg generated £134 million ($188 million) in sales for GSK last year.