Untitled case

This patent infringement litigation, filed as Janssen Biotech, Inc. et al v. Accord BioPharma, Inc. et al (1:26-cv-00222), commenced on March 3, 2026, in the United States District Court for the District of Delaware before Judge Gregory B. Williams. The plaintiffs, Janssen Biotech, Inc. and Janssen Sciences Ireland UC, are operating pharmaceutical companies and part of the Johnson & Johnson family of companies, known for developing and manufacturing biomedicines, particularly for immune-related diseases. The defendants, Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., are also operating biopharmaceutical companies. Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, focuses on oncology, immunology, and critical care therapies, while China-based Bio-Thera Solutions develops innovative therapies and biosimilars.

The core of the dispute revolves around Accord BioPharma and Bio-Thera Solutions' BAT2506 product, a proposed biosimilar to Janssen's blockbuster immunology products, SIMPONI® and SIMPONI ARIA®. These reference products contain the active ingredient golimumab, a human monoclonal antibody targeting tumor necrosis factor alpha (TNF-alpha). BAT2506 recently received FDA approval and will be commercialized under the names IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi). The complaint alleges infringement of 17 patents, although specific patents, such as U.S. Patent No. 9,217,168 or 9,663,810, have been highlighted in motions for a preliminary injunction. While U.S. Patent 11041020 was identified as at issue in the case metadata, a technical sketch for this specific patent could not be retrieved from the available search results.

This case is particularly notable as a high-stakes Biologics Price Competition and Innovation Act (BPCIA) litigation within the immunology and biopharmaceutical industry, given that SIMPONI® and SIMPONI ARIA® generated approximately $3.2 billion in worldwide sales in 2023. The plaintiffs' immediate pursuit of a preliminary injunction underscores the critical and expedited nature of this legal battle over market entry for a biosimilar. The District of Delaware is a prominent venue for such complex pharmaceutical patent disputes, recognized for its experienced patent bench, rigorous procedural demands, and a mature body of patent-specific precedent, particularly in Hatch-Waxman (ANDA) and BPCIA cases.

This case is in its early stages, with the initial filings and some preliminary motions occurring shortly after the complaint was lodged.

Key Legal Developments and Outcome:

• Filing & Initial Pleadings (Complaint):

  • March 3, 2026: Janssen Biotech, Inc. and Janssen Sciences Ireland UC filed a patent infringement complaint against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. in the U.S. District Court for the District of Delaware, case number 1:26-cv-00222. The complaint alleges infringement of 17 patents related to golimumab and its manufacturing and methods of treatment, stemming from the defendants' proposed biosimilar, BAT2506.

• Pre-trial motions of substance:

  • March 17-18, 2026: Janssen and Accord/Bio-Thera filed stipulations to dismiss without prejudice some of the asserted patents from the litigation. Specifically, U.S. Patent No. 11,014,982, U.S. Patent No. 11,041,020, U.S. Patent No. 12,122,824, and U.S. Patent No. 12,291,566 were dismissed from the district court case in the context of parallel IPR proceedings.
  • April 6, 2026: A stipulation and proposed order concerning expedited discovery and a proposed schedule for preliminary injunction proceedings was filed. This indicates that Janssen is seeking a preliminary injunction on one to three patents and the parties have agreed to a schedule for discovery related to this motion.

• Parallel PTAB IPR Proceedings:

  • March 20, 2026: Accord BioPharma, Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd. filed four Inter Partes Review (IPR) petitions with the USPTO's Patent Trial and Appeal Board (PTAB) challenging four of Janssen's patents related to methods of treatment using golimumab. These challenged patents, U.S. Patent No. 11,014,982 (IPR2026-00256), U.S. Patent No. 11,041,020 (IPR2026-00257), U.S. Patent No. 12,122,824 (IPR2026-00258), and U.S. Patent No. 12,291,566 (IPR2026-00259), were among those initially asserted in the district court litigation. The petitions argue that the claims of these patents are unpatentable under 35 U.S.C. §§ 102 and 103, citing prior art including clinical trial protocols and approved prescribing information for golimumab. The filing of these IPRs led to the dismissal without prejudice of these specific patents from the Delaware district court case.

In the ongoing patent infringement case, Janssen Biotech, Inc. et al v. Accord BioPharma, Inc. et al, Case No. 1:26-cv-00222 in the District of Delaware, the plaintiffs, Janssen Biotech, Inc. and Janssen Sciences Ireland UC, are represented by the following counsel:

• Jack B. Blumenfeld

  • Role: Local Counsel
  • Firm: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE
  • Experience Note: Mr. Blumenfeld is a highly experienced patent litigator in the District of Delaware, frequently representing pharmaceutical and biotechnology companies in complex Hatch-Waxman and BPCIA cases.

• Karen De Vroede

  • Role: Counsel
  • Firm: (Information not explicitly stated in public search results, likely from in-house counsel or a non-Delaware firm)
  • Experience Note: Further docket review would be needed to confirm firm and specific patent litigation experience.

• D. Brian Kacedon

  • Role: Counsel
  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (various offices, including Washington D.C.)
  • Experience Note: Mr. Kacedon is a partner at Finnegan and has extensive experience in patent litigation, particularly in the biotechnology and pharmaceutical sectors.

• Douglas R. Nemes

  • Role: Counsel
  • Firm: Greenberg Traurig, LLP (various offices, including New York)
  • Experience Note: Mr. Nemes is a shareholder at Greenberg Traurig, focusing on intellectual property litigation, including patent and biosimilar disputes.

• Christine J. Hutchinson

  • Role: Counsel
  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (various offices, including Washington D.C.)
  • Experience Note: Ms. Hutchinson is a partner at Finnegan, specializing in patent litigation in the pharmaceutical industry.

• Rachel H. Townsend

  • Role: Counsel
  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (various offices, including Washington D.C.)
  • Experience Note: Ms. Townsend is an attorney at Finnegan, practicing in patent litigation with a focus on life sciences.

• Laura P. Burson

  • Role: Counsel
  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (various offices, including Washington D.C.)
  • Experience Note: Ms. Burson is an attorney at Finnegan, concentrating her practice on patent litigation, especially in the biotechnology and pharmaceutical areas.

• Evan C. N. Kline

  • Role: Counsel
  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (various offices, including Washington D.C.)
  • Experience Note: Mr. Kline is an attorney at Finnegan, focusing on patent litigation in the life sciences sector.

• Joseph A. Powers

  • Role: Counsel
  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (various offices, including Washington D.C.)
  • Experience Note: Mr. Powers is an attorney at Finnegan, with a practice that includes patent litigation in the pharmaceutical and biotechnology industries.

The information regarding counsel and their affiliations is primarily derived from court filings and legal databases. For attorneys other than local counsel, the specific office location may vary, as larger firms often operate across multiple jurisdictions. Some search results for the defendants' counsel also appeared when searching for plaintiff counsel, likely due to their involvement in the same case.

The defendants, Accord BioPharma, Inc., Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd., are represented by several law firms in this patent infringement case (1:26-cv-00222) and related proceedings.

Here is the identified counsel of record for the defendant(s):

McAndrews, Held & Malloy, Ltd.

• Alejandro Menchaca (Lead Counsel)
  • Firm Office: Chicago, IL.
  • Relevant Experience: Mr. Menchaca is an experienced IP litigator in the pharmaceutical space. He successfully defended Accord Healthcare, Inc. against patent infringement claims by Purdue Pharma in two separate instances, leading to the invalidation of Purdue patents related to OxyContin®. His expertise includes Abbreviated New Drug Application (ANDA) litigation.
• David E. Bennett (Lead Counsel)
  • Firm Office: Chicago, IL.
  • Relevant Experience: Mr. Bennett is an experienced IP litigator in the pharmaceutical space. He was also counsel for Accord BioPharma in a denosumab biosimilar patent case filed by Amgen.

Coats & Bennett, PLLC

• Firm Office: Unknown (likely in the Eastern District of North Carolina, as they represented Accord BioPharma in a prior case filed there by Amgen).
• Relevant Experience: This firm represented Accord BioPharma, Inc. in the Amgen, Inc. v. Accord Biopharma, Inc. denosumab biosimilar patent case.

Morris, Nichols, Arsht & Tunnell LLP

• While not explicitly named as lead counsel in the initial filings for this specific case (1:26-cv-00222), Morris Nichols is consistently identified as the premier patent litigation firm in Delaware and frequently serves as local counsel in complex patent litigation matters, particularly for generic and biosimilar pharmaceutical companies. They have represented branded pharmaceutical companies in over half of the ANDA litigation filed in the District of Delaware in the past three years. Their deep knowledge of the Delaware federal judiciary makes them a likely choice for local representation.

Potter Anderson & Corroon LLP

• David E. Moore (Local Counsel - highly probable, as they are a leading Delaware firm and he has significant experience)
  • Firm Office: Wilmington, DE.
  • Relevant Experience: Potter Anderson is a high-quality practice with a focus on patent infringement litigation, often appearing in the District Court of Delaware. The firm does a notable range of work for the pharmaceutical industry, including Hatch-Waxman litigation. David Moore practices as both lead and local counsel in state and federal courts and offers substantial experience in patent infringement cases. He served as Delaware counsel for Intel in a $2 billion patent infringement suit, where the jury found Intel had not infringed.

Gemini Law LLP

• This firm is identified as representing Accord BioPharma, Inc. for inter partes review (IPR) petitions at the Patent Trial and Appeal Board (PTAB) challenging U.S. Patent 11,041,020 and other patents. While their involvement in the district court case is not explicitly stated in the immediately available search results, it's common for firms handling PTAB challenges to also be involved in parallel district court litigation.

It is important to note that specific appearances in the district court case (1:26-cv-00222) for some of these attorneys as "counsel of record" would be confirmed by reviewing the official docket entries, which were not fully accessible through the provided search snippets beyond general firm affiliations. However, the identified attorneys and firms have strong ties to biosimilar litigation and the District of Delaware, making their involvement highly probable.