On February 22, 2022, Cohen Milstein and co-counsel, on behalf of all End-Payors, filed a second consolidated amended class action complaint before the United States District Court for the Southern District of New York, alleging that Defendants engaged in an illegal scheme to delay competition in the United States and its territories in relation to generic versions of Bystolic®, a prescription medication containing the active pharmaceutical ingredient nebivolol hydrochloride and approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of hypertension.
On March 20, 2023, Plaintiffs filed an appeal of the court’s February 21, 2023 order granting motion to dismiss.
On October 13, 2020, Judge Lewis J. Limian of the United States District Court for the Southern District of New York appointed Sharon K. Robertson of Cohen Milstein as Interim Co-Lead Counsel for the proposed End-Payor Class.
Direct Purchaser and Indirect Purchaser or “End-Payor” Plaintiffs seek to recover damages arising from Forest Laboratories Inc., now a part of AbbVie, allegedly unlawful agreements with more than a dozen pharmaceutical generic manufacturers (“Settling Generics”) not to compete in the market for Bystolic in the United States and its territories.
Bystolic is a beta blocker. It blocks the effects of the hormone epinephrine, thereby causing the heart to beat more slowly and with less force, which in turn lowers blood pressure.
In December 2011—as soon as it was possible to do so—seven of these generic drug companies filed applications for FDA approval of generic versions of Bystolic. In March 2012, Forest Laboratories sued them for infringement of U.S. Patent No. 6,545,040 (the “‘040 patent”). Each generic company contended that its generic would not infringe Forest’s asserted patent claims or that the claims were invalid.
Plaintiffs allege that the generic companies’ position in the patent litigation was very strong and that either their products did not infringe the ‘040 patent, or the ‘040 patent was invalid.
Nonetheless, between October 2012 and November 2013, Forest entered into settlement agreements with each of the Settling Generics, each of which required the Settling Generics to defer the launch of their generic Bystolic products until September 2021only three months before the expiration of the ‘040 patent.
In 2019, the reason that Forest was able to forestall competition for so long was revealed: these settlement agreements included large, unjustified payments to the Settling Generics in exchange for the Settling Generics’ agreements not to compete in the market for Bystolic. According to documents in connection with Forest’s Merger Agreement with Actavis, which became public in March 2019 in the course of a different lawsuit involving Forrest. Forest’s settlement agreements required Forest to pay at least $15 million to each generic company after February 2014—to say nothing of what Forest may have already paid the Settling Generics—and included side deals and reimbursement of the Settling Generics’ litigation costs.
Four of the Settling Generics obtained approval of their generic Bystolic products in 2015, and two obtained approval thereafter. In June 2015, the last patent protecting Bystolic (other than the ‘040 patent) expired. It is asserted that the only reason that generic Bystolic did not enter the market in 2015 is Forest’s unlawful pay-for-delay settlement with each Settling Generic. Due to these settlements, purchasers allege they must pay higher prices for brand Bystolic until September 17, 2021.