On July 29, 2026, Genentech filed BPCIA litigation No. 2:26-cv-09585 (D.N.J.) against Biocon’s proposed Perjeta® (pertuzumab) biosimilar Bmab 1500. Genentech asserted 28 patents, including 14 with manufacturing claims, 11 with method of treatment claims, four with formulation / composition claims, one with composition of matter claims, one with mammalian cell claims, and one with article of manufacture claims. Nine of the asserted patents have not previously been asserted in litigation.
According to the complaint, Biocon submitted its aBLA for Bmab 1500 to the FDA before January 20, 2026. The parties completed the BPCIA patent dance prior to Genentech’s filing of the complaint.
Genentech previously filed ITC Case No. 337-3890 against Biocon related to Bmab 1500, asserting four patents that are also asserted in the BPCIA litigation (previously reported Genentech Files ITC Complaint Targeting Biocon’s Proposed Perjeta® (pertuzumab) Biosimilar). The ITC complaint was withdrawn based on representations from Biocon that the imported product was protected under § 271(e)(1) safe harbor, and that Biocon did not have any commercial distribution agreements or discussions with U.S. distributors.
This is Genentech’s second litigation related to a Perjeta® biosimilar, the first being Case No. 2:25-cv-14648 (D.N.J.) against Shanghai Henlius Biotech’s Poherdy® (pertuzumab-dpzb), which settled in January 2026 (previously reported Genentech and Shanghai Henlius Biotech Settle Perjeta® Biosimilar BPCIA Litigation). Poherdy® was approved as an interchangeable biosimilar of Perjeta® in November 2025 (previously reported FDA Approves First Perjeta® Biosimilar: Shanghai Henlius Biotech / Organon’s Poherdy®).
Roche reported U.S. sales of approximately $1.62B USD (1.27B CHF) for Perjeta® in 2025.
For more information about these and other biosimilars, please visit BiologicsHQ.
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The author would like to thank April Breyer Menon for her contributions to this article.
