A Federal Circuit panel on Tuesday vacated its earlier finding that Teva induced infringement of U.S. Patent No. RE40,000, GSK’s patent covering its drug, Coreg®, and set a new round of oral argument for February 23. Back in October, the Court in a 2-1 decision found Teva liable for induced infringement, even though Teva’s original label did not include the indication covered by the ’000 Patent. In its ruling, the Court took issue with Teva’s marketing materials stating that its generic product is an AB rated generic of Coreg tablets without specific reference to any indication. Following the decision, generic drug manufacturers and other interest groups asked the Court to reconsider, arguing that the ruling would impede the availability of low-cost generic drugs to reach the market and would effectively nullify the purpose of the Section viii statement, which allows a generic company to “carve out” any reference to a patented indication from its product’s labeling.
Argument during February’s rehearing will be limited to whether there is substantial evidence to support the jury’s verdict of induced infringement during the time period from January 8, 2008 through April 30, 2011, or during the period when the ’000 Patent reissued to when the FDA ordered Teva to amend its label to conform with the approved Coreg® labeling. Thus, the order implies that the evidence at issue will be limited to Teva’s promotional and marketing materials, i.e., evidence other than Teva’s label.
The case is GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020).