- Publisher:Phexcom
- Publication:2025/4/1
A New York City federal court has dismissed a proposed class-action lawsuit against Bristol Myers Squibb that accused the drugmaker of deploying anticompetitive tactics to protect the market exclusivity of key multiple myeloma drug Pomalyst.
U.S. Judge Edgardo Ramos sided with BMS, saying that Blue Cross and Blue Shield of Louisiana and other purchasers of Pomalyst failed to show that the company used an unlawful scheme to gain illegitimate patents and file sham lawsuits against generic drugmakers to maintain its monopoly.
In the lawsuit, which was filed in September 2023, the purchasers claimed that Pomalyst should have been subject to generic competition by at least October 2020 and that BMS’ strategy caused them to overpay by “hundreds of millions, if not billions” of dollars over the years. They were seeking a jury trial and repayment worth three times the amount of the alleged overcharges.
Pomalyst was approved by the FDA in 2013 as a third-line treatment after use of chemotherapy and another Celgene blockbuster, Revlimid.
BMS, for its part, picked up Celgene—and with it Pomalyst and Revlimid—in a 2019 merger.
Pomalyst accounted for sales of more than $3 billion in each of the last five years, including $3.55 billion in 2024, accounting for 7% of Bristol's overall revenue of $48 billion.
In the lawsuit, purchasers claimed that Celgene knowingly “obtained fraudulent patents” using information that was already in the public domain. The purchasers cited six patents.
Additionally, Celgene initiated lawsuits against would-be generic competitors that had “no realistic likelihood of prevailing,” according to the complaint.
To further protect its drug, Celgene compensated generic companies in so-called “reverse payment” patent deals, which ran into nine-figures, the purchasers claimed. These deals were made with generic drugmakers including Dr. Reddy’s, Teva and Viatris’ predecessor Mylan, according to the lawsuit.
In protecting the market exclusivity of Pomalyst, Celgene and BMS have employed the same strategy they used with Revlimid, which was originally approved 20 years ago and finally lost patent protection in 2022.