Amgen Inc. v. Sandoz Inc.

This patent infringement litigation, Amgen Inc. v. Sandoz Inc., involved two major pharmaceutical players. Plaintiff Amgen Inc. is a multinational biopharmaceutical company headquartered in Thousand Oaks, California, focused on discovering, developing, manufacturing, and delivering innovative medicines across therapeutic areas such as heart disease, obesity, rare diseases, inflammatory conditions, and cancer. Defendant Sandoz Inc., an independent Swiss company spun off from Novartis in late 2023, is a global leader in generic pharmaceuticals and biosimilars, providing cost-effective medicines across various therapeutic areas.

The dispute centered on Sandoz's denosumab biosimilar products, WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), which are biosimilar and interchangeable with Amgen's reference medicines, XGEVA® and Prolia®. These biosimilars are approved for indications such as treating osteoporosis and cancer-related skeletal complications. The primary patent asserted by Amgen was U.S. Patent No. 7,364,736, titled "Antibodies to OPGL" (Osteoprotegerin Ligand). This patent generally describes antibodies that interact with OPGL, along with methods for treating osteopenic disorders and detecting OPGL using these antibodies. Denosumab itself is a fully human monoclonal antibody that specifically targets and binds to RANKL (Receptor Activator of Nuclear factor-κB Ligand), thereby inhibiting osteoclast activity and reducing bone resorption.

The case was filed in the U.S. District Court for the District of New Jersey under case number 1:23-cv-02406-CPO-EAP and presided over by the Honorable Christine P. O'Hearn. This venue, the District of New Jersey, is a common forum for BPCIA (Biologics Price Competition and Innovation Act) cases, and Judge O'Hearn had prior familiarity with denosumab and related manufacturing processes from previously presiding over other denosumab litigations. The litigation is notable as an early resolution in the nascent but growing denosumab biosimilar market. It was a BPCIA complaint initiated in May 2023, and although Sandoz vigorously defended against infringement claims on up to 21 patents, the case ultimately concluded with a confidential settlement and a court order affirming the validity, enforceability, and infringement of US Patent 7,364,736 by Sandoz's denosumab biosimilars. The settlement allowed Sandoz to launch its biosimilar products on May 31, 2025, or earlier under specific conditions.

The initial search results provide a good overview of the case, especially regarding its resolution.

Here's a breakdown of what I've found and how it maps to the requested categories:

Filing & initial pleadings:

• Filed: May 1, 2023. Amgen Inc. filed a complaint against Sandoz Inc. in the District of New Jersey.
• Patents Asserted: The initial complaint asserted infringement of 21 patents related to denosumab, including methods of manufacturing denosumab and denosumab products.
• BPCIA Context: The litigation was filed pursuant to the Biologics Price Competition and Innovation Act (BPCIA) following Sandoz's submission of a Biologics License Application (BLA) for its denosumab biosimilars (Jubbonti® and Wyost®).
• Patent Dance: The parties reportedly started but did not complete the "patent dance" under the BPCIA. Sandoz notified Amgen of its BLA submission on December 13, 2022, and provided a copy. Amgen provided a list of 23 potentially asserted patents on February 10, 2023. Sandoz responded on March 10, 2023, and Amgen replied on May 9, 2023. The exchanged lists identified 12 patents.

Pre-trial motions of substance:

• Preliminary Injunction: Amgen filed a motion for a preliminary injunction.
• Expedited Proceedings: The case involved expedited proceedings, including a six-day evidentiary hearing in October and November 2023 on Amgen's motion for a preliminary injunction. The preliminary injunction motion focused on Sandoz's infringement of three patents, including US Patent No. 7,364,736.
• Narrowed Scope: At the end of January 2024, the case was narrowed to focus on thirteen of the asserted patents.
• A ruling on the preliminary injunction was expected around April 29, 2024.

Claim construction (Markman) outcomes:

• There's no mention of a Markman hearing or claim construction order being issued before the settlement. It seems the case was resolved during the preliminary injunction phase, which often involves some level of claim interpretation, but not a formal Markman ruling. One source mentions a trial was scheduled for May 5, 2025, and claim construction process was underway for other denosumab biosimilar cases (not specific to this Sandoz case, but general BPCIA context), with a Markman hearing for other cases scheduled for later dates. However, for this specific case, the settlement occurred before any public Markman outcome.

Discovery milestones:

• The parties engaged in significant discovery with active court involvement in preparation for the preliminary injunction hearing. Discovery was not bifurcated during the expedited proceedings.

Trial events, verdict, and post-trial motions:

• No trial occurred as the case settled. A five-day trial had been scheduled for May 5, 2025.

Settlement, dismissal, judgment, or appeal:

• Settlement: The case was resolved through a confidential settlement agreement.
• Date of Settlement/Order: April 29, 2024. The settlement and a stipulated order and injunction were filed on this date, shortly before the judge was expected to rule on the preliminary injunction motion.
• Court Order Findings: As part of the settlement, a court order issued on April 29, 2024, found that the asserted claims of Amgen's U.S. Patent No. 7,364,736 were valid, enforceable, and infringed by Sandoz's denosumab biosimilars (Jubbonti® and Wyost®).
• Injunction: The stipulated order included an injunction prohibiting Sandoz from making, using, selling, or importing its biosimilar products until the expiration of the '736 patent (February 19, 2025), except as permitted by the settlement terms.
• Launch Date: The settlement allows Sandoz to launch its biosimilar products (Jubbonti® and Wyost®) in the US on May 31, 2025, or earlier under certain limited conditions. Sandoz's biosimilars were approved by FDA on March 5, 2024. Sandoz launched in June 2025.
• Termination: The case was terminated on April 29, 2024.

Parallel PTAB IPR/PGR proceedings:

• The search for "PTAB IPR US7364736" did not immediately yield results for IPRs specifically against this patent related to the Amgen v. Sandoz litigation. It's possible there were none, or they are not easily discoverable with a general search. I will attempt another targeted search for IPRs.
• The provided search results mention multiple BPCIA litigations for denosumab biosimilars and the '736 patent being a key patent, but no mention of PTAB proceedings in this specific case.

I need to confirm the lack of PTAB proceedings more thoroughly. I will use the USPTO P-TACTS search.The patent infringement litigation Amgen Inc. v. Sandoz Inc., Case No. 1:23-cv-02406-CPO-EAP, concerning Amgen's denosumab products (Prolia® and Xgeva®) and Sandoz's biosimilars (Jubbonti® and Wyost®), saw a rapid progression of events culminating in a settlement and stipulated judgment.

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

Filing & Initial Pleadings

• Complaint Filed (2023-05-01): Amgen Inc. and Amgen Manufacturing, Limited (collectively "Amgen") filed a patent infringement complaint against Sandoz Inc. and its affiliates in the U.S. District Court for the District of New Jersey. The lawsuit was initiated under the Biologics Price Competition and Innovation Act (BPCIA) after Sandoz submitted a Biologics License Application (BLA) for its denosumab biosimilar products.
• Patents Asserted: Amgen initially asserted infringement of 21 patents covering denosumab, pharmaceutical compositions, and manufacturing methods.
• BPCIA "Patent Dance" (2022-12-13 to 2023-05-09): Sandoz notified Amgen of its BLA submission on December 13, 2022, providing a copy. Amgen then provided Sandoz with a list of 23 patents it believed could be reasonably asserted on February 10, 2023. Sandoz provided its statement on March 10, 2023, and Amgen responded on May 9, 2023. The exchanged lists collectively identified 12 patents. While the "patent dance" was initiated, the parties did not fully complete the information exchange process.

Pre-trial Motions of Substance

• Motion for Preliminary Injunction (Filed early in the case): Amgen filed a motion for a preliminary injunction to prevent Sandoz's launch.
• Expedited Proceedings: The court expedited proceedings, including active involvement from Judge Christine O'Hearn and Magistrate Judge Elizabeth A. Pascal in discovery management.
• Evidentiary Hearing (October-November 2023): A six-day evidentiary hearing was held in October and November 2023 on Amgen's preliminary injunction motion, following a one-day technical tutorial. The hearing focused on infringement of key patents, including U.S. Patent No. 7,364,736, U.S. Patent No. 8,071,205 (Dillon '205), and U.S. Patent No. 8,679,514 (Huang '514).
• Case Narrowing (Late January 2024): The scope of the case was narrowed to focus on thirteen of the asserted patents.

Claim Construction (Markman) Outcomes

• A formal Markman hearing or claim construction order was not issued. The case settled during the preliminary injunction phase, which typically involves the court interpreting key claim terms, but not necessarily a standalone Markman ruling.

Discovery Milestones with Strategic Significance

• Significant Discovery: The parties engaged in substantial discovery, actively overseen by the court, in preparation for the expedited preliminary injunction hearing. Discovery was not bifurcated.

Trial Events, Verdict, and Post-trial Motions

• No trial took place as the case was resolved by settlement. A five-day trial had been scheduled for May 5, 2025.

Settlement, Dismissal, Judgment, or Appeal

• FDA Approval for Biosimilars (2024-03-05): The FDA approved Sandoz's denosumab biosimilars, Jubbonti® and Wyost®, prior to the settlement.
• Confidential Settlement Agreement & Stipulated Order (2024-04-29): Amgen and Sandoz reached a confidential settlement agreement, and a stipulated order and injunction were issued by the court. This occurred on the same day a ruling on Amgen's preliminary injunction motion was expected.
• Court Findings: As part of the settlement terms, the court order affirmed that the asserted claims of Amgen's U.S. Patent No. 7,364,736 were valid, enforceable, and infringed by Sandoz's biosimilar products.
• Injunction: The stipulated order included an injunction preventing Sandoz from commercializing its denosumab biosimilars until the expiration of U.S. Patent No. 7,364,736 (February 19, 2025), subject to the terms of the confidential settlement.
• Launch Date Agreement: The settlement agreement permits Sandoz to launch Jubbonti® and Wyost® in the U.S. on May 31, 2025, or earlier under specific, limited circumstances. Sandoz subsequently launched its products in June 2025.
• Case Termination (2024-04-29): The case was officially terminated following the settlement.

Parallel PTAB IPR/PGR Proceedings

• A search of the USPTO Patent Trial and Appeal Case Tracking System (P-TACTS) for U.S. Patent No. 7,364,736 did not yield any inter partes review (IPR) or post-grant review (PGR) proceedings. Therefore, no parallel PTAB proceedings affected this specific litigation.

Here is the counsel of record representing Amgen Inc. in Amgen Inc. v. Sandoz Inc., 1:23-cv-02406-CPO-EAP:

Marshall, Gerstein & Borun LLP

• Kevin M. Flowers, Ph.D.
  • Role: Lead Counsel
  • Firm & Office Location: Marshall, Gerstein & Borun LLP, Chicago, IL.
  • Relevant Experience: Dr. Flowers leads Marshall Gerstein's Biotech/Pharma Litigation team and has over 27 years of experience as first-chair trial and appellate counsel in patent cases for clients like Amgen, including high-stakes cases involving blockbuster products and biosimilar disputes. He has successfully represented Amgen in other BPCIA (biosimilar) cases, such as Amgen Inc. v. Hospira, Inc..

Jones Day

• Ryan K. Walsh
  • Role: Lead Counsel
  • Firm & Office Location: Jones Day, Atlanta, GA.
  • Relevant Experience: Mr. Walsh is a co-leader of intellectual property litigation for Jones Day's global IP practice, with over 25 years of experience enforcing and defending patent rights in high-stakes technology litigation across various venues, including the International Trade Commission and the Federal Circuit.

Walsh Pizzi O'Reilly Falanga LLP

• Liza M. Walsh

  • Role: Local Counsel
  • Firm & Office Location: Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ.
  • Relevant Experience: Named as one of the attorneys for Amgen Inc. and Amgen Manufacturing, Limited in the First Amended & Supplemental Complaint for Patent Infringement in this case.

• Marc D. Haefner

  • Role: Local Counsel
  • Firm & Office Location: Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ.
  • Relevant Experience: Listed as an attorney for Amgen Inc. and Amgen Manufacturing, Limited in the First Amended & Supplemental Complaint for Patent Infringement.

• Jessica K. Formichella

  • Role: Local Counsel
  • Firm & Office Location: Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ.
  • Relevant Experience: Identified as an attorney for Amgen Inc. and Amgen Manufacturing, Limited in the First Amended & Supplemental Complaint for Patent Infringement.

Based on available information from related patent litigation between Amgen and Sandoz, particularly Federal Circuit case 22-1147 (originating from D.N.J. case 3:18-cv-11267), counsel for Sandoz Inc. in this patent infringement case (1:23-cv-02406-CPO-EAP) is inferred to be from Winston & Strawn LLP. While direct docket entries explicitly listing counsel for Sandoz in 1:23-cv-02406-CPO-EAP were not publicly accessible in the search results, Winston & Strawn LLP is consistently identified as representing Sandoz in complex biosimilar patent disputes against Amgen.

The following attorneys are identified as having represented Sandoz in a related Amgen v. Sandoz patent case (3:18-cv-11267, appealed to Fed. Cir. 22-1147) and possess relevant experience for this type of litigation:

• Maureen L. Rurka

  • Role: Lead Counsel (inferred from arguing for all defendants-appellants in a related Federal Circuit case)
  • Firm: Winston & Strawn LLP, Chicago, IL.
  • Note: Rurka is a prominent patent litigator with extensive experience, particularly in pharmaceutical and biotechnology patent disputes, including BPCIA cases. Winston & Strawn's Patent Litigation Practice is highly regarded in biotech and biosimilar matters.

• Samantha Maxfield Lerner

  • Role: Counsel
  • Firm: Winston & Strawn LLP, San Francisco, CA.
  • Note: Also represented Sandoz Inc. in related patent litigation against Amgen.

• Eimeric Reig-Plessis

  • Role: Counsel
  • Firm: Winston & Strawn LLP, San Francisco, CA.
  • Note: Also represented Sandoz Inc. in related patent litigation against Amgen.

While Michael J. Gaertner was listed as representing co-defendant Zydus Pharmaceuticals (USA) Inc. in the related 3:18-cv-11267 case, he was not directly identified as counsel for Sandoz in that instance. His firm, Buchanan Ingersoll & Rooney PC (and previously Locke Lord LLP), has a strong intellectual property litigation practice with a focus on pharmaceutical and biotechnology matters. [cite: 6 (from previous search), 15 (from previous search)] However, no direct link has been found to confirm his representation of Sandoz in 1:23-cv-02406.

Specific local counsel for Sandoz in the District of New Jersey for this case were not explicitly identified in the search results. National firms often appear pro hac vice or utilize attorneys from their New Jersey offices if available.