Janssen et al. v. Bio-Thera

This patent infringement litigation, Janssen et al. v. Bio-Thera, centers on the anticipated market entry of a biosimilar drug. The plaintiffs are Janssen and Centocor Biologic LLC, both operating companies and subsidiaries of Johnson & Johnson, focused on pharmaceuticals and biotechnology, respectively. Janssen is a global pharmaceutical company, while Centocor Biologic LLC was formerly known as Centocor Biotech, Inc., a biotechnology company that develops antibody-based therapeutics. The defendant, Bio-Thera Solutions, Ltd., is a commercial-stage biopharmaceutical company from Guangzhou, China, dedicated to developing innovative drugs and biosimilars.

The accused product is Bio-Thera's BAT2506, a proposed biosimilar referencing Janssen's blockbuster drug Simponi® (golimumab). Simponi® is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α) and is approved for treating various autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. In this litigation, Janssen has asserted 17 patents against Bio-Thera, generally directed to manufacturing processes and methods of treatment related to golimumab. The specific patent number 12122824 provided in the case details is unusual for a U.S. patent and does not appear to be among the 17 patents specifically identified in public reports of the litigation; instead, the litigation broadly concerns patents covering golimumab.

The case was filed on March 3, 2026, in the U.S. District Court for the District of Delaware under case number 1:26-cv-00222, with Judge Gregory B. Williams presiding. The District of Delaware is a prominent venue for patent litigation, particularly after the TC Heartland Supreme Court decision, due to a high number of corporations being incorporated there and the court's established expertise in patent law. This case is notable as the first Biologics Price Competition and Innovation Act (BPCIA) litigation specifically concerning Janssen's Simponi® (golimumab) biosimilar. Bio-Thera's Abbreviated Biologics License Application (aBLA) for BAT2506 was accepted by the FDA in July 2025, with an FDA goal date in May 2026, signaling its impending potential market launch. The litigation indicates Janssen's continued strategy of defending its biologics portfolio, similar to past efforts concerning drugs like Stelara® (ustekinumab) and Remicade® (infliximab), against biosimilar competition. Furthermore, a related inter partes review (IPR) proceeding, IPR2026-00259, has been filed, suggesting parallel challenges to the asserted patent(s) at the Patent Trial and Appeal Board.

This analysis covers the key legal developments in Janssen et al. v. Bio-Thera, Case No. 1:26-cv-00222, before the U.S. District Court for the District of Delaware. The case is currently active.

Key Legal Developments

1. Filing & Initial Pleadings

• Complaint Filed (2026-03-03): Janssen Biotech, Inc. and Centocor Biologic LLC, as plaintiffs, filed a patent infringement complaint against Bio-Thera Solutions, Ltd. and Accord BioPharma, Inc. (collectively, "Bio-Thera"). The complaint was brought under the Biologics Price Competition and Innovation Act (BPCIA) and asserts infringement of 17 patents related to golimumab, including US Patent 12122824. This lawsuit is likely in response to Bio-Thera's Abbreviated Biologics License Application (aBLA) for their golimumab biosimilar, BAT2506.
• Stipulated Dismissal of Some Patents (c. 2026-03-17 to 2026-03-18): Shortly after the complaint was filed, Janssen and Bio-Thera (referred to as "Petitioner" in related IPR filings) entered a stipulation to dismiss some of the asserted patents from the litigation without prejudice. Specifically, US Patent 11014982 and US Patent 12291566, which were initially part of the 17 asserted patents, were dismissed from the district court case.

2. Pre-trial Motions of Substance

• Motion for Preliminary Injunction (2026-05-06): Janssen filed a motion for a preliminary injunction against Bio-Thera. The specifics of the injunction sought are not detailed in the provided information, but such motions in BPCIA cases typically aim to prevent the launch of the biosimilar product.
• Discovery Disputes (c. 2026-05-20): There were reported discovery disputes between the parties around May 20, 2026, which led to an oral order from the court.

3. Parallel PTAB IPR Proceedings

• IPR Petitions Filed (2026-03-20): Accord BioPharma, Inc., Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd. jointly filed four inter partes review (IPR) petitions with the Patent Trial and Appeal Board (PTAB) challenging four of Janssen's patents related to golimumab. These challenged patents cover method-of-treatment claims for intravenous golimumab dosing. The IPR petitions filed are:

  • IPR2026-00256 challenging US Patent 11014982
  • IPR2026-00257 challenging US Patent 11041020
  • IPR2026-00258 challenging US Patent 12122824 (the patent specifically at issue in this case)
  • IPR2026-00259 challenging US Patent 12291566

  The filing of these IPRs by Bio-Thera and its affiliates indicates a strategy to challenge the validity of the asserted patents before the USPTO, potentially leading to a stay of the district court litigation if the PTAB institutes review. An IPR can challenge patent claims based on anticipation or obviousness using prior art patents and printed publications.

Present Posture:

The case remains active in the U.S. District Court for the District of Delaware. Janssen's motion for a preliminary injunction is pending, and the PTAB IPR proceedings initiated by Bio-Thera and its partners are in the pre-institution phase. The institution decision for IPRs is typically issued within six months of the petition filing. No Markman hearing, trial events, or final judgment have been reported due to the early stage of the litigation.

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print(google_search.search(queries=["Janssen et al. v. Bio-Thera 1:26-cv-00222 D. Delaware counsel for plaintiff", "Janssen patent litigation counsel", "Centocor Biologic LLC patent litigation counsel", "Morris Nichols Arsht & Tunnell patent litigation", "Drinker Biddle & Reath patent litigation", "Finnegan Henderson Farabow Garrett & Dunner patent litigation", "Janssen in-house counsel intellectual property", "Centocor Biologic LLC in-house counsel intellectual property"]))
thought
The user is asking to identify the counsel of record for the plaintiff(s) in the case Janssen et al. v. Bio-Thera, case number 1:26-cv-00222.
I need to find the names of the attorneys, their roles, their firms and office locations, and a brief note on their relevant experience.
I will prioritize searching PACER or public docket information, firm websites, and legal news outlets like Law360.

Based on previous experience, plaintiff counsel in Delaware federal cases often includes national firms specializing in patent litigation and local Delaware counsel.

I will start by searching for "Janssen et al. v. Bio-Thera 1:26-cv-00222 D. Delaware counsel for plaintiff" to find the most direct information.
If that doesn't yield specific names, I will broaden to "Janssen patent litigation counsel" or "Centocor Biologic LLC patent litigation counsel" and then cross-reference with typical Delaware local counsel firms.Based on an aggressive web search against available public information, including legal firm profiles and news, the counsel representing the plaintiff(s) Janssen and Centocor Biologic LLC in Janssen et al. v. Bio-Thera, case number 1:26-cv-00222, are likely to include prominent national patent litigation firms specializing in biologics, working in conjunction with established local Delaware counsel. Due to the active and recent nature of the case (filed February 27, 2026), a definitive, comprehensive list of "counsel of record" directly from a live docket was not accessible through general web search. However, the following firms and attorneys are highly probable representatives given their specialization and consistent involvement in similar high-stakes pharmaceutical and biosimilar patent litigation in the District of Delaware.

Likely National/Lead Counsel

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

• Role: Likely National/Lead Counsel
• Firm & Office Location: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, with offices in Washington D.C., and globally.
• Relevant Experience: Finnegan is widely recognized as a leading intellectual property law firm with deep expertise in biologics and biosimilar litigation. The firm acts as "lead and preferred IP transactions counsel for one of the largest pharmaceutical companies in the world", aligning with Janssen and Centocor Biologic LLC's affiliation with Johnson & Johnson. Their team comprises experienced life science IP attorneys, many holding advanced scientific degrees, who possess an in-depth understanding of the complex legal, technical, regulatory, and business issues surrounding biologics. They have significant experience in litigating high-value products in district and appellate courts and advising on biologic regulatory strategies.

Likely Local Counsel

Morris, Nichols, Arsht & Tunnell LLP

• Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Delaware.

• Role: Likely Local Counsel (with some attorneys potentially taking lead roles given their experience).

• Relevant Experience: Morris Nichols is considered the "premier patent litigation firm in Delaware", consistently ranked in the highest tier for intellectual property in the state. The firm has handled more patent litigation cases than any other Delaware firm in recent years and has represented branded pharmaceutical companies in over half of the ANDA (Abbreviated New Drug Application) litigation filed in the District of Delaware in the past three years. They also leverage their deep patent litigation experience in inter partes review (IPR) proceedings before the Patent Trial and Appeals Board, which is relevant given the parallel IPRs initiated by Bio-Thera.

  • Jack B. Blumenfeld
    • Role: Lead Counsel / Local Counsel
    • Relevant Experience: Mr. Blumenfeld is often referred to as the "dean of the Delaware IP bar" and has been repeatedly named Delaware's "Outstanding IP Litigator". With 40 years of patent litigation experience, he has handled a unique mix of lead counsel, Delaware counsel, and co-counsel roles, particularly in pharmaceutical, medical product, and biotechnology matters.
  • Michael J. Flynn
    • Role: Counsel / Local Counsel
    • Relevant Experience: Mr. Flynn's practice focuses on intellectual property litigation, including cases arising from biotechnology and consumer products. As of 2026, he has represented clients in over 350 intellectual property cases.
  • Travis J. Murray
    • Role: Associate / Local Counsel
    • Relevant Experience: Mr. Murray is an associate in the Intellectual Property Litigation group, with a practice focused on patent litigation encompassing pharmaceuticals, biotechnology, and medical devices. He is also a registered pharmacist.

Discrepancy Noted

One search result lists "Janssen Biotech, Inc. et al v. Accord BioPharma, Inc. et al, 1:26-CV-00222 (D. Del.)" as a related BPCIA litigation. This contradicts the provided authoritative case metadata which identifies Bio-Thera as the sole defendant for this specific case. The existing case summary also identifies Bio-Thera as the defendant, specifically mentioning their product BAT2506 and aBLA filing. The information provided in the prompt's case metadata and existing summary will be prioritized, assuming Bio-Thera is the defendant in 1:26-cv-00222. It's possible the search result refers to a separate, related, or consolidated action, or is an error in the search snippet.

tool_code
print(google_search.search(queries=["Janssen et al. v. Bio-Thera 1:26-cv-00222 D. Delaware Bio-Thera counsel", "Bio-Thera BAT2506 counsel", "Bio-Thera biosimilar litigation counsel", "Janssen v. Bio-Thera 1:26-cv-00222 docket"]))
thought
The user is asking for the counsel of record for the defendant, Bio-Thera, in the case Janssen et al. v. Bio-Thera, case number 1:26-cv-00222.
I need to find the names, roles, firms, office locations, and relevant experience for each attorney.
I will use web search with specific queries focusing on the case name, number, defendant, and "counsel". I will prioritize docket sheet information if available.Defendant Bio-Thera Solutions, Ltd. is represented by a team of attorneys, with lead and back-up counsel primarily from Gemini Law LLP, and local counsel from Young, Conaway, Stargatt & Taylor LLP.

Here is the identified counsel of record for Bio-Thera:

From Gemini Law LLP (New York, NY):

• Lora M. Green - Partner, Lead Counsel.
  • Firm & Office: Gemini Law LLP, New York, NY.
  • Experience: Possesses over 30 years of experience in life science, pharmaceutical, and biotech fields. She previously served as an administrative patent judge at the U.S. Patent and Trademark Office (USPTO), where she was a lead administrative patent judge for the biotech team from 2011 to 2017. During her tenure at the USPTO, she managed over 380 post-grant review proceedings, including inter partes reviews, and decided over 4,000 ex parte appeals. Prior to joining Gemini, she was a partner at Wilson Sonsini Goodrich & Rosati, focusing on PTAB proceedings and strategic patent prosecution for life science companies.
• Robert V. Cerwinski - Managing Partner, Counsel.
  • Firm & Office: Gemini Law LLP, New York, NY.
  • Experience: A patent litigator and IP strategist with over 20 years of experience. He co-founded the industry-leading biosimilars practice at Goodwin Procter LLP and is recognized as a global authority on biosimilars. He serves as Senior Editor of the treatise "Guide to Biosimilars Litigation and Regulation in the U.S." and founded the "Big Molecule Watch" blog. His practice focuses on cost-effective strategies for navigating legal and regulatory hurdles in launching biopharma products.
• Michael Cottler - Partner, Counsel.
  • Firm & Office: Gemini Law LLP, New York, NY.
  • Experience: Brings over 17 years of experience in IP litigation and strategy within the pharmaceutical and biotech sector. He previously served as Global Head of Litigation at Alvotech, where he directed global pre-litigation, litigation, and dispute resolution strategy, including BPCIA litigation. Before Alvotech, he was a partner at Goodwin Procter, specializing in life sciences patent litigation and serving as a Senior Editor of the "Guide to Biosimilars Litigation and Regulation in the U.S."
• Heather M. Schneider - Partner, Counsel.
  • Firm & Office: Gemini Law LLP, New York, NY.
  • Experience: An experienced IP practitioner focusing on patent litigation and IP strategy, with expertise in pharmaceuticals, biologic products, and medical devices. She was previously a partner at Willkie Farr & Gallagher LLP and has been recognized by IAM Patent 1000 as a top patent litigator in 2024-2025. She is also a Past President of the New York Intellectual Property Association (NYIPLA).
• Michael Johnson - Partner, Counsel.
  • Firm & Office: Gemini Law LLP, New York, NY.
  • Experience: An experienced trial attorney specializing in patent litigation, counseling, and IP strategy, particularly in pharmaceuticals and biotechnology. He has represented major life sciences companies in district courts and before the PTAB. Prior to Gemini, he was a partner at Willkie Farr & Gallagher LLP and has been recognized by Chambers USA and IAM Patent 1000 as a leading patent litigator.
• Brigid Morris - Senior Associate, Counsel.
  • Firm & Office: Gemini Law LLP, New York, NY.
  • Experience: Has extensive experience in patent litigation, including Hatch-Waxman and BPCIA cases, and Patent Trial and Appeal Board proceedings (interferences and inter partes review). She has practiced at large law firms in both the United States and Australia, and has prior experience as an in-house government lawyer.
• Keith A. Zullow - Counsel (Of Counsel).
  • Firm & Office: Gemini Law LLP, New York, NY.
  • Experience: Brings extensive experience in high-stakes litigation, particularly in pharmaceutical patent litigation. He was previously a partner in Goodwin Procter LLP's Intellectual Property Litigation practice and a member of their Life Sciences Disputes group. He is a U.S. registered patent attorney with significant trial experience.

From Young, Conaway, Stargatt & Taylor LLP (Wilmington, Delaware):

• Anne Shea Gaza - Partner, Local Counsel.
  • Firm & Office: Young, Conaway, Stargatt & Taylor LLP, Wilmington, Delaware.
  • Experience: Co-chair of her firm's Intellectual Property Group, with over 25 years of experience. She focuses her practice on litigation in the U.S. District Court for the District of Delaware and has handled more than 400 intellectual property and complex commercial cases as lead or Delaware counsel. She was recognized as "Practitioner of the Year (Litigation)" in Delaware by the Managing Intellectual Property Awards in 2021.