Recently, a panel of the Federal Circuit granted panel rehearing in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. In this case, Teva petitioned the en banc court to reconsider the panel’s decision that Teva induced infringement through use of a skinny label on its generic version of GlaxoSmithKline’s (GSK) drug Coreg. The panel treated the petition as requesting panel rehearing, granted the petition, and ordered a second oral argument in the case, which was held this morning. Here are the details of the case.
On October 2, 2020, Judges Newman and Moore vacated a district court’s grant of judgment as a matter of law and remanded the case with instructions to reinstate a jury verdict in favor of GSK that Teva induced infringement. Chief Judge Prost filed a thirty-three page dissenting opinion, admonishing the majority for “creating infringement liability for any generic entering the market with a [so-called] skinny label, and by permitting infringement liability for a broader label that itself did not actually cause any direct infringement.”
Like Chief Judge Prost, Teva in its petition for rehearing pointed to the Hatch-Waxman Amendments and asserted that Congress provided a statutory “carve-out” mechanism allowing a generic to adopt a skinny label for unpatented uses that cannot be blocked by a patent on one method of using the drug. Further, like the dissent, Teva contended that it cannot be held liable for induced infringement because the evidence shows Teva did not cause doctors to infringe.
In its response to the petition, GSK argued that the court’s decision did not spell the end of carve-outs when used as the statute intended. GSK asserted that, like cases where the court has rejected similar arguments in the past, Teva “didn’t carve out enough.” As a result, GSK contended, there was enough evidence from which a jury could conclude Teva encouraged patented use.
Three amicus briefs were filed in this case before the panel’s initial decision, and eight amicus briefs were filed in support of rehearing.
As discussed above, the panel granted Teva’s petition for rehearing and vacated its October 2, 2020 opinion.
This morning the panel heard oral argument again, this time limited to the issues raised in Teva’s petition.
We will report on the oral argument later this week. In the meantime, check out our panel case page and our en banc case page to access our coverage of this case, selected documents filed in the case, and today’s oral argument recording.