Untitled case

This is an active patent infringement litigation case, 1:26-cv-00222, in the United States District Court for the District of Delaware, presided over by Judge Gregory B. Williams. The plaintiffs are Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively "Janssen"), which are global pharmaceutical and biotechnology companies focused on developing innovative medications, a subsidiary of Johnson & Johnson. The defendants are Bio-Thera Solutions, Ltd., a China-based biopharmaceutical company specializing in the research and development of innovative drugs and biosimilars, and its commercialization partner, Accord BioPharma, Inc. This case falls under the Biologics Price Competition and Innovation Act (BPCIA), as Janssen alleges that Bio-Thera's proposed golimumab biosimilar, BAT2506, infringes Janssen's patents related to its reference products, SIMPONI® and SIMPONI ARIA®. SIMPONI® and SIMPONI ARIA® are tumor necrosis factor (TNF)-alpha blockers used to treat various autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. BAT2506 is a proposed biosimilar to golimumab, designed to inhibit TNF-alpha, similar to the reference products.

Janssen initially filed a complaint on March 3, 2026, asserting infringement of 17 patents related to golimumab, generally covering manufacturing processes, method-of-treatment claims, and composition claims. However, some of the initially asserted patents, including U.S. Patent No. 12,291,566 (which broadly describes anti-TNFα antibodies and methods of treating active ankylosing spondylitis with intravenous golimumab) and U.S. Patent No. 12,122,824 (covering methods of treating active psoriatic arthritis using intravenous golimumab), were subsequently dismissed without prejudice by stipulation on March 17 and 18, 2026. The exact remaining subset of the original 17 asserted patents is not precisely detailed in publicly available summaries after these dismissals. Concurrently, Accord, Intas, and Bio-Thera filed Inter Partes Reviews (IPRs) challenging some of these patents, including 12,291,566, 12,122,824, 11,014,982 (method of treating AS), and 11,041,020 (method of treating PsA).

The case is notable as it represents Janssen's first BPCIA litigation concerning a golimumab biosimilar, highlighting the ongoing efforts by innovator companies to protect their biologic drugs against biosimilar competition. The District of Delaware is a prominent venue for patent litigation, particularly for pharmaceutical and biotechnology cases, due to its experienced patent bench and the fact that a significant number of major U.S. technology and pharmaceutical companies are incorporated there. The BPCIA framework itself, involving a complex "patent dance" for information exchange and potential litigation, makes these cases inherently significant for the biopharmaceutical industry as they shape the market entry of more affordable biosimilar alternatives. The acceptance of Bio-Thera's abbreviated Biologics License Application (aBLA) for BAT2506 by the FDA in July 2025, with a goal date of May 16, 2026, adds urgency and market context to this litigation.

This patent infringement litigation, Case No. 1:26-cv-00222, was filed in the U.S. District Court for the District of Delaware on March 3, 2026, by Plaintiffs Janssen Biotech, Inc. and Janssen Sciences Ireland UC against Defendants Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd.. The case is an active Biologics Price Competition and Innovation Act (BPCIA) litigation concerning Janssen's Simponi® (golimumab) and the defendants' biosimilar, BAT2506. While the prompt specifically identifies US Patent 12291566, the complaint itself, and news reports, indicate that the litigation involves multiple patents, including the '356, '325, and '889 patents, related to Simponi®.

Here's a chronological overview of the key legal developments to date:

• Filing & Initial Pleadings:

  • March 3, 2026: Janssen Biotech, Inc. and Janssen Sciences Ireland UC filed a Complaint against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. in the U.S. District Court for the District of Delaware, initiating the BPCIA litigation. The Complaint was initially filed under seal.
  • March 11, 2026: A version of the Complaint (Document 10) was filed, asserting claims of patent infringement under 35 U.S.C. §§ 271(b), 271(g), and 271(e)(2)(C). The complaint outlines infringement allegations related to the manufacture, use, sale, offer for sale, and/or importation of BAT2506, implicating various patents related to Simponi®, such as the '356, '325, and '889 patents.
  • Details of the defendants' answer and any counterclaims are not yet publicly detailed in the provided search snippets, though their subsequent motions imply such filings or forthcoming filings.

• Pre-Trial Motions of Substance:

  • May 21, 2026: U.S. District Judge Gregory B. Williams issued an order addressing discovery disputes and partially granting a request to extend the preliminary injunction briefing schedule. The deadline for the Defendants to file their response brief on non-infringement, invalidity, and/or unenforceability was extended to June 8, 2026. Other deadlines within the stipulated briefing schedule (D.I. 15) remained unchanged.

• Claim Construction (Markman) Outcomes:

  • As of the current date, there are no reported outcomes for claim construction (Markman) hearings. This stage typically occurs later in patent litigation.

• Discovery Milestones:

  • A discovery dispute was resolved by order on May 21, 2026, requiring Plaintiffs to complete limited additional document production by May 29, 2026. This indicates that discovery is actively underway.

• Trial Events, Verdict, and Post-Trial Motions:

  • Given the recent filing date of March 3, 2026, the case has not yet reached the trial, verdict, or post-trial motion stages.

• Settlement, Dismissal, Judgment, or Appeal:

  • The case is currently in active litigation and has not reached a final disposition such as settlement, dismissal, or judgment. No appeals have been filed.

• Parallel PTAB IPR/PGR Proceedings:

  • March 31, 2026: Defendants Accord and Bio-Thera filed four Inter Partes Reviews (IPRs) challenging some of Janssen's Simponi® patents. The institution status or final outcomes of these IPRs are not yet available. These IPRs could potentially impact the district court litigation if instituted and claims are found unpatentable.

Counsel of Record for Plaintiff(s) Janssen Biotech, Inc. et al. in 1:26-cv-00222

The plaintiff in this patent infringement case, Janssen Biotech, Inc. et al., is represented by attorneys from Latham & Watkins LLP and potentially local counsel from McCarter & English LLP.

Lead Counsel: Latham & Watkins LLP

The following attorneys from Latham & Watkins LLP are representing Janssen Biotech, Inc. and Janssen Sciences Ireland UC:

• Michael A. Morin

  • Role: Lead Counsel
  • Firm & Office Location: Latham & Watkins LLP, Washington, DC.
  • Relevant Experience: Michael A. Morin is a partner at Latham & Watkins and has extensive experience in patent litigation, particularly for pharmaceutical and biotechnology clients. He has previously represented Janssen and Genmab in other patent litigation matters.

• David P. Frazier

  • Role: Lead Counsel
  • Firm & Office Location: Latham & Watkins LLP, Washington, DC.
  • Relevant Experience: David P. Frazier is a partner at Latham & Watkins specializing in intellectual property litigation, including patent disputes in the life sciences sector. He has also been involved in representing Janssen Biotech in past cases.

• Inge A. Osman

  • Role: Lead Counsel
  • Firm & Office Location: Latham & Watkins LLP, Washington, DC.
  • Relevant Experience: Inge A. Osman is an intellectual property litigator at Latham & Watkins, with experience representing clients in patent cases.

• Cecilia Sanabria

  • Role: Lead Counsel
  • Firm & Office Location: Latham & Watkins LLP, Washington, DC.
  • Relevant Experience: Cecilia Sanabria is an attorney at Latham & Watkins focusing on intellectual property and patent litigation.

• Kevin N. Zhang

  • Role: Lead Counsel
  • Firm & Office Location: Latham & Watkins LLP, Washington, DC.
  • Relevant Experience: Kevin N. Zhang is an attorney at Latham & Watkins with a focus on patent litigation.

• Roger J. Chin

  • Role: Lead Counsel
  • Firm & Office Location: Latham & Watkins LLP, San Francisco, CA.
  • Relevant Experience: Roger J. Chin is a partner at Latham & Watkins and a litigator with experience in patent disputes, including those involving biotechnology. He has previously represented Janssen.

• Michael Seringhaus

  • Role: Lead Counsel
  • Firm & Office Location: Latham & Watkins LLP, Menlo Park, CA.
  • Relevant Experience: Michael Seringhaus is an attorney at Latham & Watkins with a practice in intellectual property and patent litigation, and has represented Janssen Biotech in prior cases.

Potential Local Counsel: McCarter & English LLP

• Alexandra M. Silver
  • Role: Likely Local Counsel (exact role not explicitly stated as "local counsel" but firm is identified in connection with the case in Delaware, suggesting this role).
  • Firm & Office Location: McCarter & English LLP, Delaware office (specific city not provided in snippets, but typically Wilmington for District of Delaware cases).
  • Relevant Experience: Alexandra M. Silver is associated with McCarter & English LLP and is listed in connection with this case. McCarter & English is known for intellectual property litigation, including patent litigation in Delaware.

Contradiction Alert: The information presented below for defendant counsel directly contradicts the "Previously generated sections of this case," which listed Gemini Law LLP attorneys (including Robert V. Cerwinski and Michael Johnson) and Anne Shea Gaza of Young, Conaway, Stargatt & Taylor LLP as representatives for the plaintiffs. Newer search results and docket entries indicate these attorneys and firms are, in fact, representing the defendants in this matter.

The counsel of record representing the defendant(s), Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., in Case No. 1:26-cv-00222 are:

• Robert V. Cerwinski

  • Role: Lead Counsel (Managing Partner)
  • Firm: Gemini Law LLP, New York, NY
  • Experience: Mr. Cerwinski is a seasoned patent litigator and IP strategist with over 20 years of experience, particularly in helping international clients launch biopharma products in the U.S. market. His practice includes BPCIA litigation, and he is recognized in Chambers and IAM Patent 1000. He has successfully driven the launch of over 20 biopharma products in the U.S. and Europe. He was added as a Pro Hac Vice Attorney for Accord BioPharma, Inc., and Bio-Thera Solutions, Ltd. for electronic noticing in this district court case on April 16, 2026.

• Michael Johnson

  • Role: Lead Counsel (Partner)
  • Firm: Gemini Law LLP, New York, NY
  • Experience: Mr. Johnson is an experienced trial attorney with a focus on patent litigation, counseling, and IP strategy, particularly in pharmaceuticals and biotechnology. He has represented major life sciences companies in district courts and the PTAB. He was ranked among leading practitioners in New York by Chambers USA and recognized by IAM Patent 1000. He was added as a Pro Hac Vice Attorney for Accord BioPharma, Inc., and Bio-Thera Solutions, Ltd. for electronic noticing in this district court case on April 16, 2026.

• Anne Shea Gaza

  • Role: Local Counsel (Partner and Co-Chair of Intellectual Property Group)
  • Firm: Young, Conaway, Stargatt & Taylor LLP, Wilmington, DE
  • Experience: Ms. Gaza has over 25 years of experience focusing on litigation in the U.S. District Court for the District of Delaware, representing national and international clients in intellectual property and complex commercial cases. She has been recognized as "Litigator of the Year - Delaware" by Managing Intellectual Property. She is highly regarded for her knowledge of the Delaware federal judges and local practice. Ms. Gaza filed a stipulation on behalf of Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. to extend time to respond to the complaint on April 17, 2026.

Note on Firm-wide Representation:
The Patent Trial and Appeal Board (PTAB) filings for the parallel inter partes reviews (IPRs IPR2026-00256 through IPR2026-00259) explicitly state that Petitioner Accord BioPharma, Inc. "appoints the practitioners associated with Gemini Law LLP" as its attorneys for those proceedings, which challenge patents asserted by Janssen in the district court, including US Patent No. 12291566. This strongly supports Gemini Law LLP's representation of the defendants across these related disputes. Therefore, it is highly probable that other Gemini Law LLP attorneys with relevant experience, such as Heather M. Schneider, Brigid Morris, and Michael Cottler, who were listed in the prior section, are also involved in representing the defendants in this broader litigation. However, specific docket entries confirming their individual appearances for the defendants in the district court case were not found in the immediate search results.