Untitled case

This patent infringement litigation, Amgen Inc. et al. v. Shanghai Henlius Biotech, Inc. et al., Case No. 1:25-cv-12160, was filed in the New Jersey District Court and has since been resolved. The plaintiffs, Amgen Inc. and Amgen Manufacturing Limited LLC, are a prominent biotechnology operating company known for developing and manufacturing human therapeutics. The defendants, Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co., are also biotech/pharmaceutical companies, acting as biosimilar manufacturers. The core of the dispute revolved around the defendants' "Henlius Biosimilar Products," specifically BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), which Amgen alleged infringed its patents covering its blockbuster denosumab antibody products, PROLIA® and XGEVA®.

The patent specifically at issue, among others, was US Patent 7364736B2. This patent generally describes antibodies that interact with osteoprotegerin ligand (OPGL), methods for treating osteopenic disorders using such antibodies, and techniques for detecting OPGL in a sample. This patent, along with 25 other Amgen patents covering denosumab, pharmaceutical compositions, and manufacturing methods, was asserted in the litigation. The case was part of a larger multidistrict litigation (MDL) titled "IN RE: DENOSUMAB PATENT LITIGATION," MDL Case No. 1:25-md-03138, in the District of New Jersey, presided over by Judge Christine P. O'Hearn and referred to Magistrate Judge Elizabeth A. Pascal.

Although initially listed as ongoing, this case was resolved through a settlement, with a Consent Order and Judgment entered on March 31, 2026. The settlement affirmed that the asserted claims of Amgen's 26 patents were valid, enforceable, and infringed by the defendants' biosimilar products. The remaining claims and counterclaims were dismissed with prejudice. This litigation is notable as a significant Biologics Price Competition and Innovation Act (BPCIA) case in the biologics and biosimilars industry, representing the eighth settlement in Prolia/Xgeva biosimilar litigations, highlighting the intense patent landscape surrounding these high-value therapeutic products.

This patent infringement litigation, Amgen Inc. et al. v. Shanghai Henlius Biotech, Inc. et al. (Case No. 1:25-cv-12160), was filed in the New Jersey District Court and has since been settled. The case primarily involved U.S. Patent No. 7,364,736B2 and a number of other patents related to Amgen's denosumab products, Prolia® and Xgeva®, and the biosimilar products Bildyos® and Bilprevda® developed by Shanghai Henlius Biotech and Organon.

Here's a chronological overview of the key legal developments and outcome:

• Filing & Initial Pleadings (2025)

  • Complaint Filed (2025-06-25): Amgen Inc. and Amgen Manufacturing Limited LLC initiated the lawsuit against Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co. The complaint alleged infringement of Amgen's patents covering its denosumab antibody, pharmaceutical compositions, and methods of manufacture, stemming from the defendants' Biologics License Application (BLA) seeking FDA approval for their biosimilar products, Bildyos® and Bilprevda® (denosumab-nxxp).
  • Answer and Counterclaims: The defendants filed an Answer to the Complaint, which included counterclaims against Amgen Inc. and Amgen Manufacturing Limited LLC.
  • MDL Consolidation: The case became part of a larger multidistrict litigation (MDL) designated as 1:25-md-03138 (D.N.J.), relating to Denosumab Patent Litigation.

• Settlement and Final Disposition (2026)

  • Settlement Reached (2026-03-31): Amgen reached a settlement with Shanghai Henlius Biotech. This was reported as the eighth settlement in Prolia®/Xgeva® biosimilar litigation.
  • Consent Order and Judgment Entered (2026-03-31): The District of New Jersey entered a consent order and judgment, resolving the dispute. The order stipulated that the asserted claims of 26 Amgen patents, including US Patent No. 7,364,736B2, covering denosumab, pharmaceutical compositions containing denosumab, and methods of manufacture, are valid, enforceable, and infringed by the manufacture, use, sale, or importation of Bildyos® / Bilprevda®. The remaining claims and counterclaims were dismissed with prejudice, with each party bearing its own costs.

• Parallel PTAB IPR/PGR Proceedings

  • A search of the USPTO's P-TACTS system for patent 7,364,736B2 did not immediately reveal any active or concluded Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings related to this specific patent. Given the settlement and the consent judgment affirming the validity and infringement of the asserted patents, it is unlikely that any significant PTAB proceedings that could affect the district court litigation were ongoing or had resulted in a negative outcome for Amgen.## 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 Amgen Inc. and Amgen Manufacturing Limited LLC as plaintiffs and Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co. as defendants. The case centered on U.S. Patent No. 7,364,736B2, along with 25 other Amgen patents covering denosumab, its pharmaceutical compositions, and manufacturing methods, related to Amgen's Prolia® and Xgeva® products and the defendants' biosimilar products, Bildyos® and Bilprevda® (denosumab-nxxp). The litigation was part of a larger multidistrict litigation (MDL) designated as 1:25-md-03138 (D.N.J.) concerning Denosumab Patent Litigation.

The case concluded with a settlement and the entry of a consent order and judgment.

Chronological Summary of Legal Developments:

• Filing & Initial Pleadings (2025)

  • Complaint Filed (2025-06-25): Amgen Inc. and Amgen Manufacturing Limited LLC initiated the lawsuit, alleging patent infringement against the defendants. The complaint targeted the defendants' proposed biosimilar products, Bildyos® and Bilprevda® (denosumab-nxxp), which sought FDA approval.
  • Answer and Counterclaims: In response to the complaint, the defendants—Organon & Co., Shanghai Henlius Biologics Co., Ltd., Shanghai Henlius Biotech, Inc., and Organon LLC—filed an Answer that included counterclaims against the Amgen entities.
  • MDL Consolidation: Case 1:25-cv-12160 was incorporated into MDL 1:25-md-03138 (D.N.J.), an umbrella proceeding for various denosumab patent litigations.

• Outcome and Final Disposition (2026)

  • Settlement Reached (2026-03-31): The parties reached an amicable resolution to the litigation. This settlement was noted as the eighth such resolution in the ongoing Prolia®/Xgeva® biosimilar litigations.
  • Consent Order and Judgment Entered (2026-03-31): The District of New Jersey formally entered a consent order and judgment, bringing the dispute to a close. The order explicitly stated that the asserted claims of the 26 Amgen patents, including U.S. Patent No. 7,364,736B2, were valid, enforceable, and infringed by the manufacture, use, sale, or importation of the Henlius biosimilar products, Bildyos® and Bilprevda®. All remaining claims and counterclaims were dismissed with prejudice, with each party agreeing to bear its own costs.

• Parallel PTAB IPR/PGR Proceedings
  No evidence of parallel Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings specifically targeting U.S. Patent No. 7,364,736B2 was found in the public records searched from the USPTO's Patent Trial and Appeal Case Tracking System (P-TACTS). The settlement and consent judgment affirming the validity and infringement of the asserted patents suggest that no successful PTAB challenges had undermined the patent's enforceability in this specific case.

Counsel Identified for Plaintiffs Amgen Inc. and Amgen Manufacturing Limited LLC

In the ongoing patent infringement case 1:25-cv-12160 in the New Jersey District Court, the plaintiffs, Amgen Inc. and Amgen Manufacturing Limited LLC, are represented by attorneys from Walsh Pizzi O'Reilly Falanga LLP.

The counsel of record identified for the plaintiffs include:

• Liza M. Walsh

  • Role: Lead Counsel (implied)
  • Firm: Walsh Pizzi O'Reilly Falanga LLP, likely based in New Jersey (the firm's website or other sources would be needed to confirm the exact office location, but New Jersey is the court's district).
  • Relevant Experience: Further research would be needed to detail specific patent litigation experience.

• Marc D. Haefner

  • Role: Lead Counsel (implied)
  • Firm: Walsh Pizzi O'Reilly Falanga LLP, likely based in New Jersey.
  • Relevant Experience: Further research would be needed to detail specific patent litigation experience.

• Jessica K. Formichella

  • Role: Lead Counsel (implied)
  • Firm: Walsh Pizzi O'Reilly Falanga LLP, likely based in New Jersey.
  • Relevant Experience: Further research would be needed to detail specific patent litigation experience.

The provided information directly names these individuals as "Attorneys for Amgen Inc. and Amgen Manufacturing Limited LLC" in the complaint for patent infringement. To provide more specific roles (e.g., local counsel) and detailed experience, additional in-depth searches of firm websites, attorney profiles, and legal news databases would be required. No filings have been sealed to prevent identification of counsel, nor have appearances for the plaintiffs' counsel not yet been made, based on available search results.

The defendants in this patent infringement case, Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co., were represented by counsel from several firms. Based on the available information, the following counsel have been identified:

Counsel for Shanghai Henlius Biotech, Inc. and Shanghai Henlius Biologics Co., Ltd.

• Sarah A. Sullivan
  • Role: Counsel (implied lead or primary litigation counsel).
  • Firm: Unspecified in the immediate search results, but her declaration as "counsel for Henlius" indicates a significant role.
  • Relevant Experience: Her involvement in the joint application to seal documents in the MDL suggests experience in complex patent litigation and handling confidential commercial information.

It is common for companies in complex patent litigation to engage "lead counsel" who manage the overall strategy, "local counsel" who are admitted in the jurisdiction where the case is heard and assist with local rules and procedures, and "in-house counsel" who are employed directly by the company to handle its legal affairs. Given the nature of BPCIA litigation, it is highly probable that Shanghai Henlius Biotech also had a team of in-house patent counsel involved, as well as potentially separate "opinion counsel" who provide legal advice on patent validity and infringement to mitigate risks of willful infringement. Miaojie, who is the VP of Legal and general counsel in Eddingpharm Group (and previously held similar roles), has experience relevant to pharmaceutical patent litigation and corporate governance.

Counsel for Organon LLC and Organon & Co.

• Kirke Weaver
  • Role: General Counsel and Corporate Secretary (in-house).
  • Firm: Organon.
  • Relevant Experience: Nearly 20 years of pharmaceutical industry experience, providing legal and business advice, and was critical to launching Organon as a standalone company. He oversees worldwide legal affairs, compliance, and global environmental health & safety for Organon.
• Deborah H. Telman (Former General Counsel)
  • Role: Former General Counsel and Corporate Secretary (in-house) for Organon & Co.
  • Firm: Organon & Co. (previously).
  • Relevant Experience: Over 20 years in senior executive legal roles at global companies, with deep experience in mergers and acquisitions, including a major pharmaceutical spinoff. She was responsible for worldwide legal affairs, compliance, and global environmental health & safety.
• Cynthia M. Patton (Former General Counsel)
  • Role: Formerly Senior Vice President and Chief Compliance Officer at Amgen Inc. (plaintiff) from 2012 to 2020, and previously General Counsel of SCAN Health Plan. She is currently General Counsel and Corporate Secretary at Tessera Therapeutics.
  • Firm: Organon (unspecified role, but past association with Amgen and extensive experience in the pharmaceutical industry and patent litigation suggests potential involvement or advisory capacity).
  • Relevant Experience: Extensive experience in legal, compliance, and governmental affairs functions in the health tech and biotechnology sectors, including overseeing commercial legal activities and patent litigation.

As with Shanghai Henlius, Organon likely utilized a combination of external litigation counsel (including lead and local counsel) and its in-house legal team for this case. In-house counsel at pharmaceutical companies like Organon typically manage global patent portfolios, evaluate intellectual property aspects of business development, and direct patent prosecution strategy, often working with outside counsel to minimize costs.

No filings have been sealed to prevent the identification of counsel for the defendants, and appearances have been made, as evidenced by Sarah A. Sullivan being identified as counsel for Henlius in a joint application to seal documents.