The "Skinny Label" - The Federal Circuit Has Second Thoughts

February 10, 2021 – Article

On Tuesday the Federal Circuit vacated its decision in GlaxoSmithKline LLC. V. Teva Parma., USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020) in response to GSK’s request for rehearing en banc. In vacating the decision and deciding to rehear the case, the panel limited the rehearing to Teva’s question in its en banc petition as “whether there was substantial evidence to support the jury’s verdict of induced infringement.”

Teva had not challenged the concept that a generic product with a “skinny label” (a label which omits a patented and approved indication) could be sold in a manner which induced infringement of the omitted indication. What Teva was challenging was the Court’s conclusion that sufficient facts existed to support a finding that Teva induced the infringement. The patent in suit was Re 40,000 (Re ‘000) which claimed treating congestive heart failure with GSK’s carvedilol drug, Coreg. Re’000 was issued on January 8, 2008. The facts are the subject of an earlier post [GSK v Teva - The Fedeal Circuit's First Look at Skinny Labels and 35 U.S.C. 271(b)]. What is relevant is that Teva’s only activities with respect to its product were press releases prior to the issuance of Re ‘000 which advised of the FDA approval of Teva’s carvedilol plus the notice that it had been rated AB substitutable. This AB rating means that the Teva product could be substituted for GSK’s product listed on a doctor’s prescription by the pharmacist including the patent congestive heart failure, the use claimed in Re ‘000. At least one of the press releases remained on Teva’s webs site after the throughout the life of Re ‘000. Teva also had a catalog published after Re ‘000 issued showing its carvedilol product and GSK’s Coreg product. One important fact making this situation different from others is that Teva was required to insert the congestive heart failure indication on its label after Re’ 000 issued since the underlying patent which caused the carve out was withdrawn from the Orange Book. Teva, instead of acquiescing in the FDA’s request could have advised the FDA that the carve out was still necessary because of Re ‘000. Teva’s failure may prove to be its downfall.

In the original decision, these facts plus the accompanying testimony were sufficient for the majority to overturn the JMOL motion and reinstate the jury’s verdict of infringement. It remains to be seen if Judge Newman can persuade Judge Moore to stay the course or will join Chief Judge Prost and affirm the JMOL in in Teva’s favor.