BMS Accused by HMO of Patent Fraud to Allegedly Sustain Pomalyst Monopoly
07 Sep 2023
Drug ApprovalAcquisitionPatent InfringementBiosimilarImmunotherapy
Pictured: BMS office in California/iStock, hapabapa
Blue Cross and Blue Shield of Louisiana on Tuesday filed a class action lawsuit against Bristol Myers Squibb, accusing the pharma giant of unlawfully extending the market exclusivity for its multiple myeloma drug Pomalyst (pomalidomide), according to Reuters.
The Baton Rouge-based health maintenance organization is being joined by HMO Louisiana, a subsidiary of Blue Cross and Blue Shield of Louisiana. The plaintiffs are representing a proposed class of entities in the U.S. and its territories that paid for or reimbursed Pomalyst from October 2020.
In the 151-page complaint, the not-for-profit health insurance company alleged that BMS and its subsidiary Celgene committed patent fraud by misrepresenting and concealing data regarding Pomalyst’s properties, formulations and uses that had already been publicly available.
The pharma companies also “abused the federal judicial system” by launching a barrage of “sham lawsuits” against generics companies that were trying to enter the U.S. market for pomalidomide, contends the legal complaint. BMS and Celgene also allegedly engaged in anti-competitive practices by paying off several competitors to have them drop their respective legal challenges to the pomalidomide patents “and delay their entry into the U.S. market.”
The generics competitors include Teva, Aurobindo, Eugia and Natco, all of which are also named as defendants in the lawsuit.
“While the form of the payment is cloaked under an effort at absolute secrecy, each of the reverse payment agreements include a payment well into nine figures, and each vastly exceeds the net revenues any one of the generic companies could hope to earn even if it had prevailed in the patent litigation,” according to the legal complaint.
As a result of these alleged violations, the plaintiffs and other purchasers of Pomalyst have overpaid “and continue to overpay … by many hundreds of millions, if not billions, of dollars,” states the complaint. In return, the plaintiffs are seeking monetary recompense and injunctive relief, especially since they allege that the companies’ violations are ongoing.
Pomalyst is an immunomodulatory antineoplastic agent that works by suppressing the proliferation of hematopoietic cancer cells and triggering their apoptosis. The drug also boosts T-cell and natural killer cell function. It carries a boxed warning for embryo-fetal toxicity and venous and arterial thromboembolism.
Developed by Celgene, Pomalyst won its first FDA approval in February 2013 for multiple myeloma. It picked up another indication—AIDS-related and HIV-negative Kaposi Sarcoma—in May 2020 and joined the BMS portfolio in 2019, when it acquired Celgene for $74 billion.
Pomalyst has since become one of BMS’ top-performing assets. In 2022, Pomalyst secured nearly $3.5 billion in revenues, a 5% increase from its 2021 sales.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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