On 27 February 2026, Genentech filed a complaint at the US International Trade Commission (ITC) alleging that Biocon’s importation of its pertuzumab biosimilar, BMAB 1500/PERT-IJS infringed four US patents: US8652474 (for pharmaceutical compositions comprising a HER2 antibody and certain acidic variants thereof); US11597776 (methods of making such compositions); US12145997 (methods for preventing reduction of disulfide bonds during an antibody manufacturing process); and US12173080 (related to US’997). Genentech alleges that on 18 October 2025, Biocon imported more than 17,800 units of BMAB 1500 from India before it received FDA approval. Genentech contends this conduct falls outside the safe harbour under 35 USC 271(e)(1) (allowing otherwise infringing conduct reasonably related to regulatory submissions) characterizing it as stockpiling of commercial supplies.
Genentech has recently settled US District Court litigation in which the same patents, among others, were alleged to be infringed by Henlius and Organon.
Genentech’s partner, Roche, has previously commenced legal action against a pertuzumab biosimilar in India, suing Zydus for patent infringement in the High Court of New Delhi.