Just when it looked like generic Pharma company carve-outs- aka ‘skinny labels’ – might be in permanent peril, a federal court of appeal is granting Teva another privilege to prove its case.
GlaxoSmithKline won an appeal ruling against Teva in the fall – and the $235 million judgment that came along with it. But Teva and eight other generic Pharma companies filed amicus briefs appealing for the full Federal Circuit Court to review the earlier ruling. Last Wednesday, they got a yes.
GSK originally won a $235 million patent infringement jury verdict against Teva, which had rolled out a copy of the branded heart medication Coreg. The generic could only be sold for Coreg initial indications – left ventricular dysfunction and hypertension after a heart attack – due to the fact that GSK maintained patients on its alternative use for congestive heart failure.
GSK’s argued that Teva marketed its generic Coreg as equivalent to the brand, which would ideally cover all of its approved indications – including the one currently on patent. GSK tabled Teva press releases and marketing materials to further its case.
The district court judge disagreed with the jury and threw out their verdict, so GSK appealed. Then in October 2020, a three-judge circuit court panel voted 2-1 in favor of the jury’s original verdict. Now, the appeals court will review the case “en banc,” which implies that the court’s full complement of 12 judges will listen to arguments.
The new hearing offers fresh hope for Teva – and for other generic Pharma companies, too. There have been fears in the industry that the ruling would have a chilling effect of future generic carve-outs and thus thwart less expensive copies until all of a brand’s approved indications are off-patent.
Lawsuits stemming from the ruling are already in the works –Amarin’s lawsuit challenging Vascepa, for example, which analysts and consumer groups point to as a case point. Amarin filed suit in November after the Teva ruling. It claims Hikma Pharmaceuticals used a skinny label – the drug’s original indication as an add-on drug to reduce triglyceride levels for adults with excessive levels – to induce doctors to prescribe the generic for the broader cardiovascular risk-reduction approval it scored later.