On February 27, 2026, Genentech filed a complaint under Section 337 of the Tariff Act of 1930 with the U.S. International Trade Commission (ITC) against Biocon concerning its proposed Perjeta^® (pertuzumab) biosimilar, BMAB 1500 / PERT-IJS. Genentech seeks a permanent limited exclusion order barring importation and cease-and-desist orders.

Genentech alleges that Biocon imported commercial-scale quantities of BMAB 1500 / PERT-IJS from India despite not yet obtaining FDA approval (which could occur by the end of 2026). Genentech cites an October 18, 2025 shipment identified in FDA records as “BMAB 1500” (pertuzumab), totaling more than 17,800 pieces. Genentech asserts that this activity amounts to stockpiling and falls outside the protection of the 35 U.S.C. § 271(e)(1) safe harbor.

The asserted patents fall into two families. The first includes U.S. Patent Nos. 8,652,474 and 11,597,776, which relate to pertuzumab compositions containing defined acidic variants and associated formulation methods. The second includes U.S. Patent Nos. 12,145,997 and 12,173,080, which are directed to methods for preventing disulfide bond reduction during recombinant antibody production, including air sparging and related controls in CHO cell culture. Genentech alleges infringement under both 35 U.S.C. § 271(a), based on importation of a patented composition, and § 271(g), based on importation of a product made by a patented process.

Genentech asserts that, because Biocon’s product is not FDA-approved, the requested exclusion order would maintain the status quo and would not remove an approved therapy from patients, thereby satisfying the public interest considerations applicable to ITC proceedings.  Genentech further asserts that because it manufactures Perjeta^® in the U.S., the issuance of an exclusion order would protect U.S. competitiveness and national security.

The ITC complaint comes after Genentech’s recent BPCIA litigation involving another proposed Perjeta^® biosimilar. In August 2025, Genentech filed a BPCIA action in the District of New Jersey (No. 2:25-cv-14648) against Shanghai Henlius and Organon. That litigation settled in January 2026, following FDA approval in November 2025 of Shanghai Henlius / Organon’s Perjeta^® interchangeable biosimilar, Poherdy^® (pertuzumab-dpzb) (previously reported Genentech and Shanghai Henlius Biotech Settle Perjeta® Biosimilar BPCIA Litigation).

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, visit BiologicsHQ.

 

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The authors would like to thank April Breyer Menon for her contributions to this article.