On November 29, 2022, Janssen filed a BPCIA complaint in the District of Delaware against Amgen related to Amgen’s ustekinumb biosimilar ABP 654 of Janssen’s STELARA. This is Janssen’s first BPCIA case filed with respect to an ustekinumab biosimilar. Janssen alleges that its “scientists and clinicians spent decades developing STELARA (ustekinumab), a complex biological product and a first-in-kind anti-IL-12/IL-23 fully human antibody medicine.” Janssen seeks a declaratory judgement of infringement of two patents: U.S. Patent No. 6,902,734 (“the ’734 patent”), directed to “an isolated anti-IL-12 antibody with a certain amino acid sequence, and U.S. Patent No. 10,961,307 (“the ’307 patent”), directed to methods of “treating moderately to severely active ulcerative colitis (UC) with a “clinically proven effective amount of anti-IL-12/IL-23p40 antibody” having a certain amino acid sequence. Janssen also seeks an injunction preventing the commercial manufacture use, sale, offer for sale, and importation of ABP 654.

Janssen alleges that, on November 7, 2022, Amgen provided notice of its intent “to begin marketing its biosimilar version of STELARA in 180 days (i.e. on May 6, 2023) or immediately upon receiving FDA approval thereafter.” Janssen also alleges that Amgen “refused to disclose when it filed its aBLA [with the FDA], whether the FDA has accepted it, whether Amgen intends to participate in the ‘patent dance,’ or whether the BPCIA’s deadline by which Amgen must provide Janssen a copy of its aBLA has passed.”

As we previously reported, in April 2022 Amgen announced positive preliminary results from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate to severe plaque psoriasis.

Stay tuned to Big Molecule Watch for further developments with this case.

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