Genentech Initiates First Patent Litigation Against Pertuzumab Biosimilar HLX11
- Genentech filed the first BPCIA litigation against Shanghai Henlius Biotech and Organon on August 14, 2025, alleging infringement of 24 patents by their proposed pertuzumab biosimilar HLX11.
- The lawsuit represents the first patent challenge for a pertuzumab biosimilar, with Henlius and Organon's aBLA being the only publicly announced application currently pending with the FDA.
- Genentech asserted 24 of the 47 patents it had listed during the BPCIA patent dance, including 10 method of treatment patents and 10 manufacturing patents.
- The litigation seeks injunctive relief to prevent commercialization of HLX11 and damages for alleged patent infringement under the BPCIA framework.