On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the Same, seeks a permanent limited exclusion order and cease-and-desist orders.
Although rare, this is not the first time that a biologics innovator has used the ITC as a parallel forum in a biosimilar dispute. For example, in 2021, AbbVie sued Alvotech and Teva alleging theft of trade secrets relating to adalimumab and seeking to exclude importation of adalimumab, as we previously reported.
Here, Genentech alleges that although Biocon has not yet obtained FDA approval, it has already imported commercial-scale quantities of its proposed PERJETA® (pertuzumab) biosimilar from India. The complaint points to an October 18, 2025 shipment identified in FDA records as “BMAB 1500” (pertuzumab), totaling more than 17,800 pieces. Genentech contends the importation is not protected by the § 271(e)(1) safe harbor because it constitutes stockpiling in anticipation of commercial launch rather than activity reasonably related to FDA approval.
The asserted patents include two families:
- U.S. Patent Nos. 8,652,474 and 11,597,776 (pertuzumab compositions containing defined acidic variants and related formulation methods); and
- U.S. Patent Nos. 12,145,997 and 12,173,080 (methods for preventing disulfide bond reduction during recombinant antibody production, including air sparging and related controls in CHO cell culture).
Genentech pleads infringement under both § 271(a) (importation of a patented composition) and § 271(g) (importation of a product made by a patented process). As to the public interest prong for ITC cases, the complaint alleges that Biocon’s product is not yet FDA-approved, so exclusion would “maintain the status quo” without removing an approved therapy from patients. This filing emphasizes that the ITC remains a strategic venue in biosimilar battles where the various prongs to support jurisdiction can be satisfied, including domestic industry, instances of importation that constitutes “unfair acts” under Section 337, and that the relief requested would advance the public interest.
As we previously reported, Genentech filed a BPCIA complaint in August 2025 in the U.S. District Court for the District of New Jersey against Shanghai Henlius Biotech, Inc. and Shanghai Henlius Biologics Co., Ltd. and Organon LLC and Organon & Co., who were seeking approval of a pertuzumab biosimilar. Shanghai Henlius’s pertuzumab biosimilar was approved by FDA in November 2025. That case settled in January 2026.
Stay tuned for more coverage of this and other biosimilars related litigations.