Third Circuit Affirms Denial Of Stelara Biosimilar Injunction

As previously reported, litigation between Johnson & Johnson and Janssen (“J&J”) and Samsung Bioepis (“Samsung”) involving Samsung’s Stelara biosimilar, PYZCHIVA (ustekinumab-ttwe) (previously known as SB17), was resolved via a settlement agreement in 2023. Under the terms of the agreement, Samsung received a limited patent license, prohibiting Samsung from sublicensing with a few exceptions, one of which was for sublicenses it could grant to “commercialization partners to import, sell and offer to sell SB17 Product on behalf of [Samsung].” In 2025, Samsung sublicensed PYZCHIVA to Quallent, a subsidiary of Cigna, a vertically integrated healthcare conglomerate that owns a healthcare provider, an insurance company, a pharmacy benefits manager (PBM), and a network of specialty pharmacies. Under the sublicense agreement, Quallent would sell the biosimilar product under its own private label.

J&J brought a breach of contract claim, arguing that Samsung’s sublicense did not fall within the commercialization-partner exception in their settlement agreement. In seeking a preliminary injunction, J&J argued that if Quallent were allowed to sell SB17 in the market, J&J would lose market share, suffer negotiating leverage against Cigna (and other industry participants), and that it would lose its ability to compete. The District of New Jersey denied the preliminary injunction, finding that J&J had failed to establish irreparable harm.

Last month, the Third Circuit affirmed the District of New Jersey’s denial of J&J’s preliminary injunction against Samsung. The Third Circuit held that J&J had not provided sufficient evidence to show immediate, irreparable injury. The court also noted that it was unusual to find irreparable harm in a breach of contract matter, and that “mere difficulty calculating damages from loss of market share is not the standard.”