GSK V. Teva: Federal Circuit Opinion After Rehearing Confirms Induced Infringement Liability Despite Skinny Label

• Published date: 19 August 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Cooley LLP
• Author: Cooley LLP

In October 2020, as reported in a previous Cooley alert, the US Court of Appeals for the Federal Circuit reinstated a jury's verdict that Teva infringed GSK's patented method of using its Coreg drug product, even though Teva's product was initially launched with a skinny label that carved out the infringing method. See GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 2018-1976 (Fed. Cir. Oct. 2, 2020). The 2-1 opinion included a lengthy dissent from then-Chief Judge Sharon Prost, and Teva sought rehearing. The decision prompted widespread concern in the generic pharmaceutical industry that the decision conflicted with long-standing precedent on induced infringement liability in the context of a "section viii" skinny label.

On February 9, 2021, the court granted Teva's decision for rehearing, and vacated and withdrew its October 2020 opinions. Amici curiae briefs from several pharmaceutical companies and industry groups, and from former US Rep. Henry Waxman, one of the original sponsors of the Hatch-Waxman legislation, were filed on Teva's behalf. The court heard another round of arguments in February 2021 and issued its precedential new decision on August 5, 2021. See GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 2018-1976 (Fed. Cir. Aug. 5, 2021) (GSK).

The new opinion again confirms that Teva is liable for induced infringement of GSK's patent on a specific method of use for Coreg. Although the holding of the opinion was unchanged, the majority opinion addressed concerns raised by Teva and the amici, and repeatedly stressed that the case should be interpreted considering its specific facts and not as a change to the law of induced infringement. Judge Prost again filed a lengthy dissent, contending that the new opinion does not resolve the concerns caused by the court's prior opinion, and that it will still leave significant risk and uncertainty for generic drug manufacturers who follow a skinny label route to approval.

35 US Code ' 271(b): Induced infringement and new uses for old drugs

Section 271(b) defines liability for inducing the direct infringement of another party: "whoever actively induces infringement of a patent shall be liable as an infringer." To prove inducement, a plaintiff must present evidence of active steps taken to encourage direct infringement; mere knowledge about a product's characteristics or that it may be put to infringing uses is not enough.¹ A generic or biosimilar manufacturer may induce infringement of a method of treatment patent under ' 271(b) by proposing drug labeling with knowledge and specific intent to actively induce direct infringement by physicians.² When a plaintiff relies on a generic or biosimilar drug label for evidence of intent, courts examine whether the proposed label "encourage[s], recommend[s], or promote[s] infringement."³ "Merely describing the infringing use, or knowing of the possibility of infringement, will not suffice; specific intent and action to induce infringement must be shown."⁴

Jury found Teva induced infringement, but trial judge overruled them

The litigation involved GSK's blood pressure drug, Coreg, which is used to treat patients with congestive heart failure (CHF) and other cardiovascular disorders. Teva filed an abbreviated new drug application (ANDA) with the FDA to manufacture a generic version of Coreg, and sought approval under section viii⁵ for a label that carved out GSK's patented indication for treatment of CHF. By this time, composition of matter patents for Coreg had expired. Teva launched with this skinny label in 2007, but was required by the FDA to amend its label in 2011 to add back the patented CHF indication.

Although GSK's patent for the CHF indication had been reissued in 2008, GSK only brought suit for patent infringement in Delaware after the 2011 full label expansion. GSK alleged that Teva had induced infringement during the period when Teva's label included the CHF indication (full label period), as well as the period when Teva's label did not include the CHF indication (skinny label period). GSK argued, with support...