On 14 August 2025, Genentech and Hoffman-La Roche filed BPCIA litigation in the US District Court for the District of New Jersey alleging infringement of 24 US patents relating to their Perjeta® branded pertuzumab cancer treatment. The allegations relate to Shanghai Henlius’ (in conjunction with Organon) application to the FDA for approval of its pertuzumab biosimilar, HLX11, which was accepted in January 2025.
The asserted patents cover pertuzumab, pharmaceutical compositions comprising pertuzumab, methods of treatment using pertuzumab, and methods of manufacturing therapeutic antibodies like pertuzumab and are US7862817, US865474, US9181346, US11414498, US11597776, US12110341, US7449184, US8404234, US10689457, US11655305, US11077189, US11638756, US11992529, US12128103, US10808037, US11078294, US12145997, US12173080, US9815904, US9969811, US12415998, US10662237, US10676710, and US12103975.
In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.
This action comes less than a month after Roche acknowledged that biosimilar competition to Perjeta® was closer than it previously anticipated, and just over a quarter since Roche downplayed the potential threat from Henlius. HLX11 is under also consideration for approval in Europe (March 2025) and China (December 2024).
Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.