Untitled case

This patent infringement litigation, Case No. 1:25-cv-12160, was filed in the New Jersey District Court by plaintiffs Amgen Inc. and Amgen Manufacturing Limited LLC (collectively, "Amgen"), both prominent biopharmaceutical operating companies. The defendants are Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co. (collectively, "Henlius" and "Organon"), which are biosimilar developers, manufacturers, and their commercial partners. The dispute centered on Henlius's efforts to market biosimilar versions of Amgen's reference products, Prolia® and Xgeva® (denosumab), specifically the accused biosimilar products BILPREVDA (denosumab-nxxp) and BILDYOS (denosumab-nxxp). The sole patent asserted in this case was U.S. Patent No. 7,364,736, which generally covers a denosumab antibody composition.

The procedural posture of the case saw it filed on June 25, 2025, in the District of New Jersey and assigned to Judge Christine P. O'Hearn, with Magistrate Judge Elizabeth A. Pascal also involved. The District of New Jersey is a notable venue for patent litigation, particularly Biologics Price Competition and Innovation Act (BPCIA) cases such as this, due to its specialized local patent rules designed to streamline and expedite such disputes, along with its judges' expertise in intellectual property matters. The case ultimately terminated on March 31, 2026, through a confidential settlement between the parties and a consent order and judgment. In the consent judgment, the asserted claims of U.S. Patent No. 7,364,736 were deemed valid, enforceable, and infringed by Henlius and Organon's denosumab biosimilar products for the purposes of that action. There is no indication from the provided information that any Inter Partes Reviews (IPRs) were filed specifically challenging U.S. Patent No. 7,364,736 in direct connection to this particular lawsuit.

This litigation is notable as a significant BPCIA dispute within the biopharmaceutical industry, involving a blockbuster biologic drug (denosumab) and a biosimilar challenger. The confidential settlement and consent judgment, which affirmed the strength of Amgen's patent rights for denosumab while also allowing for the eventual launch of the biosimilar products, highlights the complex landscape of biosimilar market entry. This outcome underscores the strategic importance of patent portfolios and BPCIA litigation in shaping competition for high-value biologic medicines.

Key Legal Developments and Outcome for Amgen Inc. et al v. Shanghai Henlius Biotech, Inc. et al

This patent infringement litigation, Case No. 1:25-cv-12160 in the New Jersey District Court, involved Plaintiffs Amgen Inc. and Amgen Manufacturing Limited LLC, and Defendants Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co.. The dispute centered on alleged infringement of U.S. Patent No. 7,364,736, among other patents, related to denosumab biosimilar products BILDYOS® and BILPREVDA® under the Biologics Price Competition and Innovation Act (BPCIA). The case was part of a larger multi-district litigation, MDL Case No. 1:25-md-03138, known as "In Re: Denosumab Patent Litigation". The litigation concluded relatively quickly with a settlement and the entry of a consent order and judgment.

Chronological Developments:

• Filing & Initial Pleadings:

  • 2025-06-25: Amgen Inc. and Amgen Manufacturing Limited LLC filed the patent infringement complaint in the New Jersey District Court. The complaint asserted claims under 35 U.S.C. § 271(e)(2)(C), related to the defendants' Abbreviated Biologics License Application (aBLA) seeking FDA approval for their denosumab biosimilar products.
  • 2025-08-18: Defendants Organon & Co., Shanghai Henlius Biologics Co., Ltd., Shanghai Henlius Biotech, Inc., and Organon LLC filed an Answer to the Complaint, which also included Counterclaims against Amgen Inc. and Amgen Manufacturing Limited LLC.

• Pre-trial Motions of Substance:
  Given the swift resolution of the case through settlement within approximately three months of filing the complaint and less than two months after the defendants' answer, significant substantive pre-trial motions such as motions to dismiss, transfer, or stay pending IPR, or extensive discovery milestones, do not appear to have been extensively litigated or reached a definitive judicial ruling. The parties engaged in an amicable resolution.

• Claim Construction (Markman) Outcomes:
  The case settled before it reached the claim construction (Markman) stage.

• Discovery Milestones:
  No significant discovery milestones with strategic significance are reported before the settlement, likely due to the early resolution.

• Trial Events, Verdict, and Post-Trial Motions:
  The case settled before any trial events, verdict, or post-trial motions occurred.

• Settlement, Dismissal, Judgment, or Appeal – Final Disposition:

  • 2025-09-30: The parties reached an amicable settlement of the Henlius Denosumab Litigation.
  • 2026-03-31: A Consent Order and Judgment was entered by the court, formally terminating the case. The Consent Order and Judgment stipulated, among other things, that the court had jurisdiction, venue was proper, and all remaining claims and counterclaims were dismissed with prejudice. It also stated that each party would bear its own costs.

• Parallel PTAB IPR/PGR Proceedings:
  While the patent US7364736 was at issue in the litigation, there is no readily available public record of parallel Post-Grant Review (PGR) or Inter Partes Review (IPR) proceedings specifically initiated against US7364736 at the PTAB by Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, or Organon & Co. that influenced this particular litigation's early settlement. PGR and IPR processes typically have a timeline of about one year from institution to a final written decision. Given the rapid settlement of this case, it is unlikely any such PTAB proceedings would have reached an influential stage prior to the settlement date.

The following attorneys represent the plaintiff(s), Amgen Inc. and Amgen Manufacturing Limited LLC, in Amgen Inc. et al. v. Shanghai Henlius Biotech, Inc. et al., case number 1:25-cv-12160, in the District of New Jersey:

• Liza M. Walsh

  • Role: Lead Counsel
  • Firm: Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ
  • Note: Ms. Walsh is identified as "counsel for Amgen" in an Order to Seal filed in October 2025, demonstrating her active role in the litigation. Her firm is also listed as "Attorneys for Amgen Inc. and Amgen Manufacturing Limited LLC" on the complaint.

• Marc D. Haefner

  • Role: Lead Counsel
  • Firm: Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ
  • Note: Mr. Haefner is listed on the complaint as counsel for the plaintiffs.

• Jessica K. Formichella

  • Role: Lead Counsel
  • Firm: Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ
  • Note: Ms. Formichella is listed on the complaint as counsel for the plaintiffs.

The aforementioned attorneys from Walsh Pizzi O'Reilly Falanga LLP appear to be the primary counsel for Amgen in this patent infringement case.

The following counsel of record represented the defendant(s) in the patent infringement case 1:25-cv-12160 in the New Jersey District Court:

• Charles M. Lizza
  • Role: Lead Counsel (Counsel of Record)
  • Firm: Saul Ewing LLP
  • Office Location: Newark, New Jersey
  • Relevant Patent Litigation Experience: Mr. Lizza brings over 40 years of litigation experience, specializing in high-stakes pharmaceutical patent litigation, particularly Hatch-Waxman ANDA cases. He is recognized for protecting the intellectual property of branded pharmaceutical and medical device companies and has served as New Jersey litigation counsel in numerous patent cases for major pharmaceutical clients. He is explicitly noted as having filed a Notice of Appearance on behalf of all defendants (Organon & Co., Organon LLC, Shanghai Henlius Biologics Co., Ltd., and Shanghai Henlius Biotech, Inc.) in this specific case on August 6, 2025.