In a significant setback for Regeneron Pharmaceuticals, Chief District Judge Thomas Kleeh has denied the company’s attempt to prevent the sale of Amgen Inc’s biosimilar version of Eylea. This decision marks a potential turning point in the fight over the lucrative market for treatments for eye diseases.
Regeneron has wasted no time in appealing the ruling to the U.S. Court of Appeals for the Federal Circuit. This appeal targets the September 23, 2024, order that rejected Regeneron’s request for a preliminary injunction, as well as any related decisions or rulings stemming from that order. An Amgen spokesperson expressed satisfaction with the court’s decision, stating that the company will unveil the timeline for launching Pavblu, its Eylea biosimilar, “in due course.”
The legal battle between Regeneron and Amgen dates back to January, when Regeneron initiated the lawsuit. The heart of the dispute lies in Regeneron’s claims that Amgen’s biosimilar infringes on key patent protections for Eylea. The lawsuit alleges the violation of over 30 patents, which Regeneron contends would irreparably harm its business if Amgen is allowed to proceed without restrictions.
Regeneron’s lawsuit underlines the financial stakes involved, stating that Amgen’s actions will cause “injury” to Regeneron and justify potential damages or monetary compensation. Amgen’s biosimilar, ABP 938, received approval from the FDA in October 2023, paving the way for its potential entry into the market.
This decision comes as a surprise to some observers, considering that the same judge previously granted Regeneron’s requests for injunctions against other companies seeking to launch Eylea biosimilars. In December 2023, a court ruling found that Viatris Inc’s replica of Eylea violated Regeneron’s patent rights. This recent ruling, however, signals a shift in the legal landscape surrounding Eylea biosimilars.
The impact of this legal battle is already being felt in the market. REGN stock closed down 6% at $1,025.44 on Tuesday, reflecting investor concerns over the potential competition from Amgen’s biosimilar.
This legal dispute is poised to have significant consequences for both Regeneron and Amgen, and the outcome of the appeal could have far-reaching implications for the broader pharmaceutical industry. The battle over biosimilars will likely continue, as pharmaceutical companies seek to navigate the complex legal landscape and carve out their share of a lucrative market.
