The US Court of Appeals for the Federal Circuit vacated the district court’s grant of judgment as a matter of law (JMOL) of non-infringement where substantial evidence supported the jury’s verdict of induced infringement by an attempted “skinny label” that nonetheless encouraged doctors to engage in a patented use. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Case Nos. 18-1876, -2023 (Fed. Cir. Aug. 5, 2021) (Moore, C.J.) (Prost, J., dissenting).

GlaxoSmithKline LLC (GSK) sells a drug called carvedilol (brand name Coreg®), which is approved for three indications: Hypertension, congestive heart failure (CHF) and left ventricular dysfunction following a myocardial infarction (post-MI LVD). In 2002, Teva filed an abbreviated new drug application (ANDA) for US Food and Drug Administration (FDA) approval of its generic carvedilol for all three indications. At that time, GSK’s patent on the carvedilol compound was still in force; Teva certified that it would not launch its product until the patent expired in 2007. GSK also had a second patent on a method of treating CHF using carvedilol and a second agent. In 2002, Teva sent GSK a Paragraph IV notice contending that the claims of that patent were invalid over prior art. Rather than sue Teva, GSK applied for reissue of the patent. In 2004, Teva received FDA “tentative approval” for its ANDA “for the treatment of heart failure and hypertension,” which was to become effective at the expiry of the compound patent in 2007.

In January 2008, the method-of-use patent reissued with claims directed to a method of decreasing mortality caused by CHF by administering carvedilol with at least one other therapeutic agent. Just before its launch in 2007, Teva certified to the FDA that its label would not include the indication listed in the Orange Book as covered by the original method-of-use patent (i.e., “decreasing mortality caused by congestive heart failure”), and thus included only the hypertension and post-MI LVD indications. Teva’s press releases stated that its generic carvedilol was “indicated for treatment of heart failure and hypertension.” In 2011, the FDA asked Teva to revise its labeling to be identical with GSK’s. Teva obliged (listing again the CHF indication) and took the position that it did not need to provide certification for the reissued patent because it received final approval of its ANDA before the patent reissued. GSK sued.

GSK won a jury verdict that the challenged patents had not been shown to be invalid and that Teva was liable for induced infringement. At trial, GSK contended—and the jury heard evidence—that post-MI LVD is a form (and fell within the Court’s construction) of CHF such that Teva’s attempted skinny label nonetheless encouraged doctors to engage in a patented use. After trial, however, the district court granted JMOL of non-infringement because the CHF and post-MI LVD indications were different. On appeal, the Federal Circuit found that substantial evidence supported the implied jury, finding that post-MI LVD is a form of CHF such that the label with the post-MI LVD indication induced infringement of the reissued patent notwithstanding the omission of the CHF indication. The Court thus vacated the grant of JMOL.

In dissent, Judge Sharon Prost argued that GSK’s identification of CHF but not post-MI LVD as a “patented use” to the FDA should estop GSK from seeking to impose liability on Teva based on the inclusion of post-MI LVD in its attempted skinny label.

The majority declined to decide such estoppel issues in the first instance. The district court will take up these issues on remand.

Practice Note: Pending a decision on the equitable issues, this case serves as a reminder that infringement is measured against the claims and not against (e.g., an Orange Book listing). To avoid liability, a skinny label must avoid not only those uses proscribed in the Orange Book, but also every use that is actually patented, regardless of listing in the Orange Book. If the claims are broad enough to encompass a use, liability may arise from including that use on a skinny label regardless of the Orange Book listing status of that use. To the extent a party reads the asserted claims as narrow enough to exclude the sought indication, such arguments seem most appropriate for claim construction. In this case, “congestive heart failure” was a construed term, but the construction was not appealed. It is unclear whether a more aggressive claim construction strategy—attempting, for example, to carve out post-MI LVD from the construction of “congestive heart failure” based on the estoppel arguments above—might have been successful.