Case Name: H. Lundbeck A/S v. Lupin Ltd., 87 F.4th 1361, 2023 WL 8462010 (Fed. Cir. Dec. 7, 2023) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Dyk, J.) 

Drug Product and Patent(s)-in-Suit: Trintellix® (vortioxetine); U.S. Patents Nos. 9,278,096 (“the ’096 patent”), 9,125,910 (“the ’910 patent”), and 9,101,626 (“the ’626 patent”)

Nature of the Case and Issue(s) Presented: Plaintiffs asserted three patents against Defendants’ ANDAs: two method-of-use patents (’096 and ’910) and one process-for-manufacturing patent (’626). But Defendants sought approval to market vortioxetine for only one indication—proposing a label carve out—and the ’096 and ’910 patents did not cover that method of use. Plaintiffs nonetheless maintained that the ANDAs infringe the those patents.

After a bench trial, the district court determined that Defendants’ ANDAs did not infringe the method-of-use patents (’096 and ’910 patents) but that one ANDA product (Lupin’s) infringed the process-for-manufacturing patent (’626 patent). Plaintiffs (Lundbeck, Takeda) appealed. Lupin cross-appealed. The Federal Circuit affirmed the district court’s findings.

Why Defendants (except Lupin) Prevailed: Defendants proposed a label carve out and, thus, avoided infringing the method-of-use patents. On appeal, Plaintiffs argued that “the district court erred in not finding infringement of the ’096 and ’910 patents because section 271(e)(2)(A) creates a separate cause of action that does not require a showing of direct, induced, or contributory infringement by the ANDA filer.” Plaintiffs further argued that the labels do not prohibit prescribing vortioxetine for patented uses, even though Defendants suggest that they will not market the drug for those uses.

The Federal Circuit disagreed with Plaintiffs: consistent with Warner-Lambert and its progeny, even under 271(e)(2)(A), the claimed use must be the use for which applicant is seeking marketing approval. “[A]ctions for infringement of method of use patents under section 271(e)(2)(A) are limited to patents that claim an indication of the drug for which indication the applicant is seeking approval.”

Lupin, on its cross appeal, argued that the district court erred in its claim construction analysis and related finding that Lupin infringes the manufacturing patent. The Federal Circuit affirmed the district court’s plain and ordinary meaning construction, finding that nothing in the intrinsic record required Lupin’s narrower construction.