Genentech Files First Pertuzumab BPCIA Complaint Against Shanghai Henlius and Organon

On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Shanghai Henlius Biotech, Inc. and Shanghai Henlius Biologics Co., Ltd. (together, “Henlius”) and Organon LLC and Organon & Co. (together, “Organon”) seeking approval of a pertuzumab biosimilar.  Notably, this is the first BPCIA litigation on a pertuzumab biosimilar.

Genentech asserts that Organon has commercialization rights in the United States related to Henlius’s proposed pertuzumab biosimilar, and would serve as the U.S. distributor of the product.  In its complaint, Genentech alleges that Henlius’s proposed pertuzumab biosimilar could reasonably infringe 24 patents.

Genentech seeks 6 forms of relief:

  1. “A judgment that each of Henlius and Organon has infringed directly, contributed to, or induced the infringement of one or more claims of each of the Asserted Patents under 35 U.S.C. § 271(e)(2)(C);”
  2. “a preliminary and/or permanent injunction that enjoins Henlius, Organon . . . from infringing any of the Asserted Patents . . . by acts including the manufacture, use, offer to sell, sale, distribution, or importation of any current or future versions of a product that infringes, or the use, offer for sale, sale, distribution, importation, or manufacture of which infringes any of the Asserted Patents, in accordance with 35 U.S.C. § 271(e)(4)(B) and 35 U.S.C. § 283”;
  3. “a judgment declaring that the manufacture, use, offer to sell, sale, distribution, or importation of the products described in the Henlius aBLA would constitute infringement of one or more claims of each of the Asserted Patents, or inducement of or contribution to such conduct, by each of Henlius and Organon pursuant to 35 U.S.C. § 271(a), (b), (c), and/or (g)”;
  4. “a judgment compelling each of Henlius and Organon to pay to Plaintiffs damages adequate to compensate for Henlius’s and Organon’s infringement, in accordance with 35 U.S.C. § 271(e)(4)(C) and 35 U.S.C. § 284”;
  5. “a declaration that this is an exceptional case and an award to Plaintiffs of their attorneys’ fees and costs pursuant to 35 U.S.C. § 285”; AND
  6. other relief the court deems appropriate.

Stay tuned to Big Molecule Watch for further developments in this case and check out the BPCIA Litigations Tracker for updates on additional BPCIA cases.