Genentech Initiates First Patent Litigation Against Pertuzumab Biosimilar HLX11
Key Insights
Genentech filed the first BPCIA litigation against Shanghai Henlius Biotech (search) 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.
Genentech has filed the first patent litigation targeting a pertuzumab biosimilar, initiating legal proceedings against Shanghai Henlius Biotech (search) and Organon over their proposed biosimilar HLX11. The lawsuit, filed on August 14, 2025, in the U.S. District Court of New Jersey, alleges infringement of 24 patents related to Perjeta® (pertuzumab).
Patent Portfolio and Legal Strategy
The litigation encompasses a comprehensive patent portfolio covering multiple aspects of pertuzumab development and commercialization. Genentech asserted 24 of the 47 patents it had listed during the BPCIA information exchange process. The patent portfolio includes 10 patents with method of treatment claims, 10 with manufacturing claims, three with composition/formulation claims, two with composition of matter claims, and two with article of manufacture claims.
Notably, 19 of the 24 asserted patents have not previously been challenged in BPCIA litigation, suggesting Genentech has developed a novel legal strategy specifically for defending its pertuzumab franchise.
Regulatory Background
Henlius and Organon's abbreviated Biologics License Application (aBLA) for HLX11 was accepted by the FDA in January 2025. This represents the only publicly announced aBLA for a pertuzumab biosimilar currently pending with the regulatory agency, positioning the litigation as a critical test case for future pertuzumab biosimilar development.
According to the complaint, Organon holds commercialization rights in the United States for Henlius's pertuzumab biosimilar and would serve as the U.S. distributor of the product upon approval.
Legal Relief Sought
Genentech is pursuing comprehensive legal remedies through six forms of relief. The company seeks a judgment that both Henlius and Organon have infringed the asserted patents under 35 U.S.C. § 271(e)(2)(C), which covers acts of infringement related to biosimilar applications.
The pharmaceutical giant is requesting both preliminary and permanent injunctive relief to prevent the manufacture, use, offer to sell, sale, distribution, or importation of HLX11. Additionally, Genentech seeks declaratory judgment that the activities described in the Henlius aBLA would constitute patent infringement.
Financial remedies include damages adequate to compensate for the alleged infringement under 35 U.S.C. § 271(e)(4)(C) and § 284. Genentech is also seeking a declaration that this constitutes an exceptional case warranting an award of attorneys' fees and costs under 35 U.S.C. § 285.
BPCIA Process Completion
The parties completed the required BPCIA patent dance prior to filing the litigation. This procedural requirement involves a structured information exchange between the reference product sponsor and biosimilar applicant to identify relevant patents and potential infringement issues before litigation commences.
The completion of this process indicates that both sides have had the opportunity to review technical information and engage in discussions about patent disputes, making the litigation filing a calculated strategic decision by Genentech to protect its pertuzumab intellectual property.