Takeda Launches First Patent Suit Over Entyvio Biosimilar
Takeda has filed the first patent infringement lawsuit under the BPCIA against a proposed biosimilar version of its blockbuster inflammatory bowel disease drug, Entyvio.
Takeda Pharmaceuticals has initiated the first patent litigation under the Biologics Price Competition and Innovation Act (BPCIA) concerning a proposed biosimilar for its blockbuster drug Entyvio (vedolizumab). The lawsuit, filed in the U.S. District for New Jersey, targets Polpharma's proposed biosimilar, PB016, and alleges infringement of six of Takeda's method-of-treatment patents.
This litigation is a significant development for clients in the life sciences sector, as Entyvio generated approximately $3.9 billion in U.S. sales for Takeda in its last fiscal year. The case will be the first to test the patent portfolio protecting this major revenue stream. According to the complaint, Polpharma declined to participate in the BPCIA's pre-litigation information exchange, known as the "patent dance," a strategic decision that shapes the early phases of such disputes. Counsel should monitor the litigation, as its outcome will influence the timeline for biosimilar market entry. A second biosimilar application, from Alvotech and Teva, has also been accepted by the FDA, suggesting further litigation is likely.