On January 4, 2022, the District Court for the District of Delaware granted Hikma Pharmaceuticals USA Inc.’s (“Hikma”) motion to dismiss Amarin Pharma Inc.’s (“Amarin”) infringement claims, finding that Hikma’s “skinny label” for its generic heart drug, icosapent ethyl, did not induce infringement of Amarin’s three patents. This decision comes on the heels of the
Skinny Label
Federal Circuit Panel Rehears Skinny Label Case (GSK v. Teva)
On February 23, 2021, a Federal Circuit panel of Chief Judge Prost, Judge Newman, and Judge Moore reheard oral argument in GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. As discussed in our previous post, on February 9, 2021, the panel issued an order granting Teva’s petition for rehearing, vacating the prior October 2,…
Uncertain Future for Skinny Labels as Federal Circuit Panel Agrees to Rehearing
A panel of the Federal Circuit agreed on February 9, 2021, to rehear arguments in a case between GlaxoSmithKline LLC (“GSK”) and Teva Pharmaceuticals USA, Inc (“Teva”) regarding Teva’s generic to GSK’s carvedilol product, Coreg®. As discussed below and in our previous post, the three-judge panel previously held in a 2-1 decision in October…
Federal Circuit Decision Raises Concern over Whether Skinny Labels are Sufficient to Avoid Induced Infringement
The Federal Circuit recently held[1] in a 2-1 decision that there was substantial evidence supporting a jury finding that Teva was liable for induced infringement for an indication carved out of its skinny label for its generic version of carvedilol.
The case concerned GSK’s United States Patent No. 4,503,067 (“the ’067 patent”) and Reissue…