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 2020 that Teva’s carvedilol product induced infringement of a patent covering the treatment of congestive heart failure even during a period in which Teva’s label had “carved out” that indication, resulting in a so-called “skinny label.” The Panel (Judges Prost, Newman, and Moore) is scheduled to rehear arguments on February 23.
Whenever an Abbreviated New Drug Application (“ANDA”) is filed, among the many requirements the Applicant must address are whatever patents the reference drug application holder has registered with the FDA to protect its exclusivity in marketing the drug. For ANDA Applicants, this usually requires filing a certification that I) the application holder did not register patents covering the drug, II) the patent or patents have expired, III) the Applicant does not seek to market the drug until a patent has expired, or IV) the registered patent is invalid or will not be infringed. A certification under the fourth provision—a “Paragraph IV” Certification—typically results in patent litigation.
However, when an Orange Book listed patent covers only certain methods of use, ANDA Applicants may file a “Section viii Statement” asserting that “method of use patent does not claim … a use for which the applicant is seeking approval.” In other words, if a drug is approved for multiple indications, an ANDA Applicant can overcome patents that cover less than all of the approved indications as a regulatory hurdle by submitting a Section viii Statement (potentially avoiding patent litigation under the Hatch-Waxman Act).
Before Teva received approval for its carvedilol product, there were three indications listed for Coreg®: one had no patent protection, one was covered by a soon-expiring patent which Teva opted to wait out, and the third—for congestive heart failure (CHF)—had active patent protection. Teva omitted the CHF indication from its proposed label rather than challenge the CHF patents, creating a skinny label with two indications rather than three. However, Teva eventually reinserted the missing indication after its generic product had been on the market for several years.
The case was tried by a jury, which found that Teva had induced infringement of the CHF patent claims even during the several years that that indication was omitted from Teva’s label. The district court granted Teva’s Motion for Judgment as a Matter of Law, finding no inducement during any time period—including when Teva’s label included the CHF indication. The split Federal Circuit panel reversed, restoring the jury finding of infringement during all time periods, holding that evidence, including Teva’s marketing of its drug as equivalent to the existing Coreg® and physicians’ knowledge that Coreg® could be used to treat CHF, was sufficient to support the verdict regardless of the label’s stated indications.
Following the panel’s opinion, Teva filed a Petition for Rehearing En Banc arguing generally that the panel’s decision essentially nullified the utility of a Section viii Statement and harmed the doctrine of induced infringement by removing a causation element. Eight amicus briefs were filed supporting rehearing—seven of which explicitly supported Teva.
On February 9, 2021, the panel issued an order vacating its October 2020 judgment and scheduling a rehearing of the appeal on the merits. The oral argument is scheduled for Tuesday, February 23, and is limited to the question of whether there is substantial evidence supporting induced infringement during the time period that the CHF indication was not present on Teva’s label.
Additional coverage of this case will follow as it develops, including coverage of the oral argument scheduled to take place next week.