Gleason IP News & Updates

Federal Circuit Affirms Use of Skinny Label for Vortioxetine

In December 2023, the United States Court of Appeals for the Federal Circuit affirmed a district court’s opinion regarding noninfringement of two patents related to specific uses of the antidepressant drug Trintellix^® (vortioxetine).  This opinion reaffirmed the use of the “section viii” statement, allowing companies to not list (or “carve out”) patented methods of use of a product on their FDA label and obtain FDA approval solely for non-patented methods of use.

Defendants sought FDA approval of their respective Abbreviated New Drug Applications (“ANDAs”) for vortioxetine exclusively for the treatment of major depressive disorder (“MDD”) in adults, an indication not covered by the two disputed method of use patents.  In response, plaintiffs sued defendants for patent infringement of the two disputed method of use patents, seeking to prevent the defendants from marketing and selling a generic version of Trintellix^® until after the expiration of the disputed method of use patents.

The two patents that were the specific focus of the litigation cover the 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 the use of vortioxetine to treat cognitive impairment.  Notably, the plaintiffs’ patents on the vortioxetine compound and methods of using vortioxetine for the treatment of MDD had either expired or were set to expire before the two disputed method of use patents.

Following a bench trial, the district court concluded that the defendants’ ANDAs neither induced nor contributorily infringed the disputed method of use patents.  The district court found that the defendants had “carved out” the relevant indications on the Trintellix^® label associated with the disputed method of use patents, focusing solely on the approved MDD indication for the proposed generic vortioxetine labels.

The Federal Circuit affirmed this decision, highlighting that defendants cannot be held liable for inducement when they exclude all sections of the label related to the patented method of use.  The court noted the absence of evidence indicating advertising or promotional materials encouraging infringement, distinguishing this matter from prior cases.  The court also explained that a brand cannot restrict a potential competing drug’s sales by regularly filing a new patent application claiming a narrower method of use if the ANDA filer is not seeking approval for such indication.

1. Lundbeck A/S, et al. v. Lupin Ltd., et al., Nos. 2022-1194, 2022-1208, 2022-1246 (Fed. Cir. Dec. 7, 2023)(Opinion by Judge Dyk, joined by Judges Prost and Hughes).