J&J settles Amgen clash over blockbuster psoriasis drug
Amgen can market biosimilar version of Stelara from January 2025 | J&J had alleged infringement of two Stelara patents.
Johnson & Johnson this week reached a settlement with Amgen in its patent lawsuit over the blockbuster drug Stelara, which enables Amgen to sell its biosimilar version of the medicine from January 2025.
Details of the settlement, which was confirmed at the Delaware district court on Monday (May 22), are confidential. However, the agreement sets a date of January 1, 2025 for Amgen to launch ABP 654, a biosimilar copy of Stelara, which J&J had said would infringe at least two of its patents.
Stelara is an immunosuppressive medication used to treat conditions including ulcerative colitis, psoriasis and Crohn’s disease that reportedly earned J&J more than $9.7 billion last year. It is a biologic so cannot be exactly replicated, and was first approved by the US Food and Drug Administration (FDA) in 2009.
In its complaint, J&J said that in November 2022, Amgen gave notice that it would begin marketing its biosimilar version of Stelara from May 2023, or immediately upon receiving FDA approval.
This was in accordance with 42 U.S.C. § 262(l)(8)(A) under the Biosimilar Price Competition and Innovation Act of 2009 (BPCIA), which stipulates a period of 180 days from notification of intent to marketing a biosimilar product.
Amgen stated it would market ABP 654 “for all indications for which Stelara is approved”, J&J said. This would infringe at least two Stelara patents, J&J alleged—US patent numbers 6,902,734 which covers ustekinumab, the active compound in Stelara, and 10,961,307 which covers methods of treating ulcerative colitis with the medication.
‘Artificial infringement’
Furthermore, J&J told the court that Amgen “refused to provide Janssen with either a copy of its aBLA [abbreviated Biologics License Application] or any other requested information”, including whether the BPCIA’s deadline by which Amgen must provide Janssen with a copy of its aBLA had passed. Its submission was therefore an act of “artificial infringement”, J&J said, with the firm identifying patents that could be infringed.
Amgen could gain FDA approval for ABP 654 in the second or third quarter of this year, J&J said, as the FDA had expressed its intention to “[r]eview and act on 90% of original biosimilar biological product application submissions within ten months of the 60 day filing date”.
However, the settlement between the firms means that ABP 654 will not be on the market until 2025. Commenting on the decision, a J&J spokesperson said the firm will “continue to defend the IP associated with our medicines to protect our ability to innovate and develop life-changing therapies for patients”, Reuters reported.
McCarter & English and Latham & Watkins represented J&J, and counsel for Amgen were Richards, Layton & Finger and Proskauer Rose.
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