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…
On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. (“Janssen”) and Johnson & Johnson’s motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. (“Samsung”) from launching a private label biosimilar of Janssen’s STELARA® (ustekinumab) in a breach of contract…
As we previously reported, on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved aflibercept biosimilar, PAVBLU (aflibercept-ayyh). A redacted version of the previously-sealed district court opinion was filed earlier this month. The…
On March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and offer for sale of ABP 654, Amgen’s ustekinumab biosimilar. On the same day, just prior to filing the motion,…
Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on the parties’ joint stipulation and proposed schedule for a preliminary injunction motion. A redacted version of the parties’ proposed schedule…
On March 1, 2019, Novartis sued Johnson & Johnson subsidiary Janssen for allegedly presenting false and misleading data about its plaque psoriasis drug Tremfya® (guselkumab). Novartis alleges that its Cosentyx® (secukinumab) drug, which is also indicated for the treatment of plaque psoriasis, competes with Tremfya®. Novartis claims that Janssen failed to…