In a significant legal development, EmblemHealth, a nonprofit health plan, has filed a class-action lawsuit against AstraZeneca's rare disease unit, Alexion Pharmaceuticals, alleging patent misuse related to its blockbuster drug, Soliris (eculizumab). The lawsuit, lodged on April 16, 2025, in the U.S. District Court for Massachusetts, accuses Alexion of extending its monopoly on Soliris through deceptive patent practices, which the health plan claims has resulted in overpayments exceeding $2 billion for consumers.
Soliris was initially approved by the U.S. Food and Drug Administration (FDA) in 2007 for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. Over the years, it has also gained approvals for treating atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), pediatric gMG, and neuromyelitis optica spectrum disorder. Once the sole treatment option available for PNH, Soliris reached blockbuster status in 2016, generating substantial revenue for AstraZeneca.
According to EmblemHealth's 171-page complaint, the original patent for Soliris was set to expire in 2021, but Alexion allegedly added five "fraudulent" patents to extend its exclusivity until 2025. The complaint states that these actions not only violate U.S. antitrust laws but also hindered competition by delaying the entry of biosimilars into the market.
At its peak, Soliris was one of the most expensive drugs in the United States, costing more than $650,000 per year before discounts. EmblemHealth argues that the overpayments incurred by purchasers during the four-year delay of cheaper biosimilars have been substantial. "Alexion’s wrongful actions in improperly maintaining its monopoly over the eculizumab market in the United States has allowed it to make billions in additional profit at the expense of purchasers," the complaint reads.
In recent months, the landscape for Soliris has changed with the arrival of biosimilars. Amgen's interchangeable product, Bkemv, entered the market in March 2025 due to a settlement reached between Alexion and Amgen in 2020. Moreover, Teva and Samsung Bioepis launched their biosimilar, Epysqli, just last week at a notable 30% discount compared to Soliris. As a result, Soliris has seen a decline in sales, generating $2.5 billion in 2024, marking an 18% decrease from the previous year.
Amidst the ongoing litigation, AstraZeneca has refrained from commenting on the lawsuit. However, a spokesperson for EmblemHealth emphasized the importance of this legal action, stating, "We are concerned about practices that shut down competition and increase drug costs. That's what this litigation is about." The health plan aims to represent a class of U.S. Soliris buyers seeking unspecified monetary relief, potentially doubling or trebling damages where appropriate.
In a related context, on April 10, 2025, a court decision overturned an earlier ruling that had permitted a generic drug maker to launch a version of a $300-million treatment for diabetes, chronic heart failure, and kidney disease. This decision highlights the ongoing complexities surrounding patent protections in the pharmaceutical industry, particularly as they relate to competition and drug pricing.
As the legal battle unfolds, the implications for AstraZeneca and the broader pharmaceutical market remain to be seen. The outcome of EmblemHealth's lawsuit could set a precedent for how patent laws are interpreted and enforced, especially in cases involving high-cost medications like Soliris. With the introduction of biosimilars, the landscape for patients requiring treatment for rare blood disorders is poised for transformation, potentially offering more affordable options in the near future.
In summary, the lawsuit against AstraZeneca's Alexion Pharmaceuticals underscores a critical moment in the ongoing struggle between pharmaceutical companies and health plans over drug pricing and patent rights. As EmblemHealth seeks to challenge the alleged patent misuse, the case may pave the way for increased scrutiny of practices that contribute to soaring drug costs in the United States.
