On Dec. 07, 2023, Federal Circuit affirmed district court’s judgment of non-infringement of method of use patents and infringement of process patent.

 

Lundbeck / Takeda (Plaintiffs) market Trintellix® (Vortioxetine) for the treatment of major depressive disorder (“MDD”) in adults. Defendants Lupin, Macleods, Sandoz, Sigmapharm, Zydus, Alembic, and Lek pharma filed ANDA with USFDA to market generic version of Trintellix®. District court held that defendants’ ANDA did not infringe two patents US 9,278,096 (use of vortioxetine in patients who have previously taken certain other antidepressant medications and had to cease or reduce use due to sexually related adverse events) and US 9,125,910 (use of vortioxetine to treat cognitive impairment). The district court also found that Lupin’s ANDA will infringe plaintiffs’ US 9,101,626 (process for making vortioxetine, and the district court’s construction of the term “reacting”).

 

On appeal, Plaintiffs argued that the district court erred in finding no induced infringement of claim 7 of the ’096 patent. Federal Circuit said that plaintiffs’ inducement case relied solely on defendants’ proposed ANDA labels as the inducing conduct. Because plaintiffs did not identify any advertising or promotional materials that encouraged infringement, this case is unlike GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320, 1333 (Fed. Cir. 2021), and other cases where we have found infringement based on communications outside the ANDA label. Moreover, plaintiffs’ infringement theory depends entirely on the “Adverse Reactions” section of the defendants’ ANDA labels, which was essential to FDA approval to market the drug for the treatment of MDD and has been present in the Trintellix label since FDA first approved the drug for the treatment of MDD on September 30, 2013—years before the PTO issued the ’096 patent in 2016. There is no new discovery requiring instructing how to safely take the drug, or identifying a class of patients who should not take the drug at all.

With FDA approval, defendants have “carved out” the portions of the NDA labels relating to the ’096 patent and identifying those individuals who would particularly benefit from taking the drug. Here, defendants’ ANDA labels “carved out” the superiority data in the clinical studies portion of the label and the cross-reference to that data.
The label itself does not even reference the patient class recited in claim 7 of the ’096 patent and instructs physicians not to compare rates of adverse reactions of sexual dysfunction between vortioxetine and other drugs. The district court correctly determined that, under these circumstances and consistent with our cases,9 the proposed ANDA labels “will not encourage, recommend, or promote an infringing use.

 

Plaintiffs next argued that the district court erred by concluding that the plaintiffs had not established contributory infringement of the ’096 and ’910 patents. Court said that there was no contributory infringement because there are substantial noninfringing uses of vortioxetine. With respect to the ’096 patent, the district court found that there will be substantial noninfringing uses including prescribing vortioxetine to patients with no prior treatment, patients with prior treatment other than with the drugs referenced in the ’096 patent, and in cases where the prior antidepressant was ceased or reduced for reasons other than sexually related adverse events (for example, due to poor efficacy). Similarly, with respect to the ’910 patent, there will be substantial noninfringing uses including prescription for treating MDD, prescription to patients without cognitive impairment, and prescription for purposes unrelated to cognition.

 

With respect to process patent (US’626), Lupin contended that “reacting” means “the specified chemicals are added to the reaction vessel at the beginning of the process as starting material.” During claim construction, the district court adopted plaintiffs’ construction and Federal Circuit saw no error. Court said that while it is true that the specification only refers to using compound II as a starting material, nothing in the claims, specification, or file history requires Lupin’s narrower reading. Federal Circuit thus held that the district court did not err in its construction of “reacting” or in its determination of infringement.