Federal Circuit Panel Rehears Skinny Label Case (GSK v. Teva)

Rothwell, Figg, Ernst & Manbeck, P.C.

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, 2020 judgment and withdrawing the October 2, 2020 opinion. The panel limited the oral argument to the issue of whether there is substantial evidence to support the jury’s verdict of induced infringement during Teva’s “skinny label” period from January 8, 2008 through April 30, 2011.

As we previously reported, in its original opinion the Federal Circuit held that based on the entire trial record there was substantial evidence to support the jury’s finding that Teva induced infringement throughout the term of the patent-at-issue, including during its “skinny label” period. In the vacated opinion, the Federal Circuit noted that “[p]recedent has recognized that the content of the product label is evidence of inducement to infringe” and cited “the FDA labels” as supporting the jury’s infringement verdict, but did not clarify whether those statements referred to Teva’s label during the skinny label period, the period when the label expressly included the patented indication, or both. See GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 976 F.3d 1347, 1355 (Fed. Cir. 2020). Following the Federal Circuit’s original opinion, Teva and several amici expressed concerns that the opinion could have monumental impacts in threatening the viability of Congress’s “carve out” statute (21 U.S.C. § 355(j)(2)(A)(viii)) and exposing generic companies to infringement liability despite the use of skinny labels.

During the oral argument on rehearing, the panel focused its attention on the specific facts of the case rather than the broader legal issues. The panel geared its questions towards the labels, the accessibility of Teva’s press releases, and the trial testimony of the parties’ experts. The panel appeared to remain aligned as it did in its original opinion. Chief Judge Prost, who dissented from the majority’s original opinion, focused much of her attention during the oral argument on questioning GSK’s attorney about the wording of the indications in GSK’s label and its declarations to the FDA, while Judge Moore, who joined in the original majority opinion, pressed Teva’s attorney on the accessibility of Teva’s press releases. Judge Newman remained silent throughout much of the rehearing, but questioned Teva’s attorney about how to address the amici’s concerns without discouraging the research and development of new methods of use for older drugs.

In light of the panel’s questions during the oral argument and the concerns expressed by Teva and the amici, it appears that the panel is inclined to issue a more narrowly tailored opinion reaching the same conclusions, but revising its reasoning to focus on the specific facts of the case.

We will provide additional updates on this important case once the Federal Circuit issues its opinion.GSK

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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