Genentech Files First Pertuzumab BPCIA Suit

On August 14, 2025, Genentech, Inc., and Hoffmann-La Roche, Inc. (“Genentech”), filed the first Biologics Price Competition and Innovation Act (BPCIA) litigation for its PERJETA® (pertuzumab) product. Genentech filed its complaint in the District of New Jersey against Shanghai Henlius BioTech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon, LLC, and Organon & Co. (“Henlius and Organon”), alleging that Henlius and Organon’s pertuzumab biosimilar will infringe Genentech’s patents related to pertuzumab. PERJETA® is indicated for the treatment of metastatic and early-stage breast cancer.  

Genentech’s complaint asserts 24 patents. Five of those patents were previously asserted in earlier BPCIA litigations initiated by Genentech related to HERCEPTIN®, HERZUMA®, ACTEMRA®, RITUXAN®, and AVASTIN®.  

The complaint also indicates that the parties engaged in and fully completed the “patent dance” between January and July 2025 pursuant to 42 U.S.C. § 262(l). Unlike other recent BPCIA complaints, Genentech’s does not allege any deficiencies in Henlius and Organon’s disclosures under 42 U.S.C. § 262(l)(3)(B)(ii).  

Genentech is seeking declaratory judgments of patent infringement for each of the 24 asserted patents, preliminary and permanent injunctions enjoining Henlius and Organon from selling their pertuzumab biosimilar, actual damages, and exceptional damages. 

We will monitor this case as it develops and provide updates in due course.