On July 29, 2026, Genentech, Inc. (“Genentech”) and Hoffmann-La Roche Inc. filed a complaint in the U.S. District Court for the District of New Jersey against Biocon Biologics Inc. (“Biocon”) and related entities, alleging infringement of 28 patents relating to Genentech’s PERJETA and Biocon’s proposed biosimilar, Bmab1500. As we previously reported, Genentech had already challenged the same proposed biosimilar in a Section 337 complaint at the U.S. International Trade Commission.
PERJETA is approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of human epidermal growth factor receptor 2-positive, or “HER2-positive,” metastatic breast cancer. According to the complaint, Biocon submitted an abbreviated Biologics License Application (“aBLA”) seeking FDA approval to market Bmab1500 as a biosimilar to PERJETA.
The complaint alleges that Biocon infringed the asserted patents under 35 U.S.C. § 271(e)(2)(C) by submitting its aBLA and seeking approval to manufacture and market Bmab1500 before the expiration of Genentech’s patents. Genentech asserts that, although the Biologics Price Competition and Innovation Act (“BPCIA”) permits biosimilar applicants to rely on the reference product sponsor’s clinical studies and research data, it does not provide a license to infringe patents covering the reference product.
According to the complaint, Genentech and Biocon participated in the BPCIA’s pre-litigation information exchange and negotiation procedures, commonly referred to as the “patent dance.” On July 1, 2026, the parties agreed on the list of patents to be asserted in the litigation. Genentech filed its complaint within the applicable 30-day statutory period following that agreement.
Several of the asserted patents were also at issue in a separate lawsuit concerning a proposed PERJETA biosimilar brought by Genentech and Hoffmann-La Roche against Shanghai Henlius Biotech Inc. and Organon & Co. That litigation was settled in January 2026.
Genentech and Hoffmann-La Roche seek, among other relief, an injunction preventing Biocon from manufacturing, using, offering to sell, selling, or distributing Bmab1500 in the United States, as well as damages, attorneys’ fees, and costs.