The Trintellix (vortioxetine) saga has finally come to an end, and it illustrates just how complex Hatch Waxman cases can be to advocate for innovators, and how easily the Federal Circuit can be misled by generic challengers who accuse innovators of gaming the system.
The decision at issue, A/S v. Lupin Ltd., 2023 U.S. App. LEXIS 32302 (“A/S v. Lupin”), involved Trintellix (vortioxetine), an antipsychotic developed by Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and H. Lundbeck A/S (“Lundbeck”) and approved by FDA in 2013 for the treatment of Major Depressive Disorder (“MDD”).
The patent involved was U.S. Patent No. 9,278,096 (“the ‘096 patent”), which covers the use of Trintellix to treat MDD in patients who switch from another antipsychotic after experiencing treatment emergent sexual dysfunction (“TESD”). Takeda and Lundbeck filed their original PCT application for the ‘096 patent in 2008, and secured the ‘096 patent in 2016, but did not list the patent in the Orange Book until 2018, after they amended the Trintellix label to describe two studies they had conducted comparing the TESD rates for Trintellix with other antipsychotics.
Takeda and Lundbeck also asserted the ‘096 patent against several generic challengers who had carved out the two TESD studies from their proposed labels. Takeda and Lundbeck accused them of induced infringement based on the Adverse Reactions section of the challengers’ ANDA labels, which specifically cited TESD as an adverse event.
The Federal Circuit took issue with this infringement theory partly because Takeda and Lundbeck did not list the patent when it first issued. According to the Court, “the Adverse Warnings section … has been present in the Trintellix label since FDA first approved the drug.” The Federal Circuit even went so far as to imply that Takeda and Lundbeck were attempting to game the system, stating in dicta:
it cannot be, as plaintiffs suggest, that a patentee can bar the sale of a drug for a use covered only by patents that will have expired simply by securing a new patent for an additional, narrower use. … A patentee may not use Hatch-Waxman to maintain its exclusivity merely by regularly filing a new patent application claiming a narrow method of use not covered by its NDA.
A/S v. Lupin at 16-17. Takeda and Lundbeck were not, however, trying to maintain exclusivity merely by filing new applications for Trintellix. To the contrary, the application for the ‘096 patent was filed long before FDA even approved Trintellix.
The Federal Circuit appears to have been confused by Takeda’s and Lundbeck’s decision to delay listing the ‘096 patent in the Orange Book until after they had revised their label to describe the two TESD studies. However, the requirements for listing a patent in the Orange Book, and the requirements for bringing an induced patent infringement claim, are not coextensive. 21 U.S.C. 355 imposes two requirements before a method of treatment patent can be listed in the Orange Book:
- The patent must be one for which a claim of patent infringement “could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug,” and
- The patent must claim a “method of using such drug for which approval is sought or has been granted in the application.”
The Delaware District Court recognized this distinction and, while it cited Takeda’s and Lundbeck’s Orange Book listing decision in its ruling against Takeda and Lundbeck, it merely held that the decision to delay listing until after the TESD studies were added to the label for Trintellix “comports with an understanding that the '096 Patent does not cover products sold without the TESD comparative information.” H. Lundbeck A/S v. Lupin Ltd., 2021 U.S. Dist. LEXIS 204535 at 300.
We do not question the ultimate decision reached by the Federal Circuit to affirm the District Court’s finding of no induced infringement. Our only question is why the Federal Circuit could not confine itself to reviewing the sufficiency of the evidence that supported the District Court’s finding, under the clearly erroneous standard of review applicable to all trial court findings of fact, rather than sewing confusion into its judicial precedent with unnecessary and misapprehensive dicta.
