Untitled case

This case, Janssen Biotech, Inc. et al v. Accord BioPharma, Inc. et al, concerns patent infringement under the Biologics Price Competition and Innovation Act (BPCIA) related to biosimilar versions of golimumab, the active ingredient in Janssen's SIMPONI® and SIMPONI ARIA® products. The plaintiffs are Janssen Biotech, Inc. and Janssen Sciences Ireland UC, both operating companies within the pharmaceutical and biotechnology sector, with Janssen Biotech being a subsidiary of Johnson & Johnson and specializing in immunology, nephrology, and oncology. The defendants are Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, which focuses on oncology, immunology, and critical care therapies, and Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company based in China specializing in innovative drugs and biosimilars. Accord BioPharma is responsible for the U.S. commercialization of the accused biosimilar, while Bio-Thera Solutions is responsible for its development and manufacturing.

The accused product in this litigation is BAT2506, a proposed biosimilar to golimumab, referencing Janssen's SIMPONI® and SIMPONI ARIA® products. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α), a pro-inflammatory molecule, used to treat conditions like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. The complaint asserts infringement of 17 patents related to golimumab, including manufacturing claims, method-of-treatment claims, and composition claims. Patent 11014982, specifically mentioned in the case metadata, is titled "Anti-TNF Antibodies, Compositions, and Methods for the Treatment of Active Ankylosing Spondylitis" and generally describes methods of treating active ankylosing spondylitis. Notably, Accord and Bio-Thera have initiated inter partes reviews (IPRs) challenging several of the asserted patents, including 11014982, alleging obviousness and lack of proper disclosure.

The case is proceeding in the District of Delaware, designated as Case No. 1:26-cv-00222, before Judge Gregory B. Williams. The District of Delaware is a critical and highly experienced venue for patent litigation, particularly for pharmaceutical and biotechnology cases, due to a significant number of major U.S. technology and pharmaceutical companies being incorporated there. The court's judges are well-versed in patent law and often manage a high volume of complex technical litigation, offering predictability in scheduling and case management. The case is notable as part of the "second wave" of biosimilar litigation under the BPCIA, specifically targeting a biosimilar to golimumab, a blockbuster immunology drug. The parallel IPR challenges highlight a common strategy in biosimilar litigation where defendants simultaneously challenge patent validity at the PTAB while litigating infringement in district court.

The patent infringement litigation Janssen Biotech, Inc. et al v. Accord BioPharma, Inc. et al, Case No. 1:26-cv-00222, in the District of Delaware, has seen several key developments since its filing. This BPCIA case concerns Accord and Bio-Thera's proposed golimumab biosimilar, BAT2506, which received FDA approval on May 15, 2026.

Here's a chronological overview of the legal developments:

Filing & Initial Pleadings:

• March 3, 2026: Plaintiffs Janssen Biotech, Inc. and Janssen Sciences Ireland UC filed a complaint against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd.. The complaint asserted infringement of 17 patents related to golimumab, covering manufacturing, method-of-treatment, and composition claims for Janssen's reference products SIMPONI® and SIMPONI ARIA®.

Pre-trial Motions of Substance & Discovery:

• March 3, 2026: The Court issued an Oral Order reviewing the parties' letters regarding the defendants' request to extend the preliminary injunction briefing schedule. This order noted hurdles in discovery, including defendants' delay in producing product samples.
• March 17-18, 2026: Janssen and the defendants filed a stipulation dismissing several patents from the litigation without prejudice. These patents, including U.S. Patent Nos. 11,014,982, 11,041,020, 12,122,824, and possibly 12,291,566 (likely the previously referenced "'356 patent" due to its last three digits), were dismissed from the district court case following the filing of Inter Partes Review (IPR) petitions against them.
• April 6, 2026: A "Stipulation and [Proposed] Order Concerning Expedited Discovery, and Proposed Schedule for Preliminary Injunction Proceedings" was filed. This document indicated that Plaintiffs intended to seek a preliminary injunction on one to three patents, specifically mentioning U.S. Patent Nos. 9,217,168 or 9,663,810.
• May 6, 2026: Janssen filed a motion for a preliminary injunction, which is currently awaiting a decision. A hearing for this motion is expected in August or September 2026.

Parallel PTAB IPR Proceedings:

• March 20, 2026: Accord BioPharma, Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd. (collectively, "Petitioners") filed four IPR petitions challenging four of Janssen's golimumab patents. These IPRs are:
  • IPR2026-00256 challenging U.S. Patent No. 11,014,982 (method of treating ankylosing spondylitis).
  • IPR2026-00257 challenging U.S. Patent No. 11,041,020 (method of treating psoriatic arthritis).
  • IPR2026-00258 challenging U.S. Patent No. 12,122,824 (method of treating psoriatic arthritis).
  • IPR2026-00259 challenging U.S. Patent No. 12,291,566 (method of treating ankylosing spondylitis). This patent is likely the "'356 patent" referenced in earlier case documents.
• The IPR petitions argue that the challenged claims are invalid as anticipated and obvious, often citing Janssen's own clinical trial protocols as prior art.
• These IPRs are currently awaiting institution decisions from the Patent Trial and Appeal Board (PTAB).

Outcome & Present Posture:

• May 15, 2026: The U.S. Food and Drug Administration (FDA) approved Accord and Bio-Thera's Immgolis™ / Immgolis Intri™ (golimumab-sldi) as the first interchangeable biosimilars of Simponi® / Simponi Aria® (golimumab). Both biosimilars were approved with "skinny labels," indicating approval for a subset of the reference product's indications.
• As of today (May 30, 2026), the preliminary injunction motion filed by Janssen is pending, and a decision is expected later in the year. The parallel IPR proceedings challenging several of the initially asserted patents are also ongoing, with institution decisions pending. The district court litigation continues on the patents that were not dismissed.

The plaintiff in this case, Janssen Biotech, Inc. and Janssen Sciences Ireland UC, is represented by several law firms. While specific roles (e.g., lead counsel, local counsel) may require direct docket access for absolute confirmation, common practice in Delaware District Court patent litigation and information from related cases involving Janssen provide strong indications.

Here are the identified counsel for the plaintiff(s):

• Jason L. Romrell

  • Role: Likely Lead Counsel.
  • Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC office).
  • Relevant Experience: Jason Romrell is a partner at Finnegan and a former leader of the firm's appeals, issues, and legal strategy section. He has extensive experience in all aspects of patent litigation before federal district courts, the Patent Trial and Appeal Board (PTAB), and the U.S. Court of Appeals for the Federal Circuit. He frequently assists trial teams as an embedded appellate practitioner and brief writer and has experience in pharmaceuticals and medical devices.

• William F. Cavanaugh, Jr.

  • Role: Likely Lead Counsel.
  • Firm: Patterson Belknap Webb & Tyler LLP (New York, NY).
  • Relevant Experience: Mr. Cavanaugh concentrates his practice in antitrust, intellectual property, and commercial litigation. He has served as national and trial counsel in large multiparty antitrust, fraud, and consumer protection litigations, and his clients include major pharmaceutical and medical device companies. Patterson Belknap recently secured a victory for Johnson & Johnson and Janssen Biotech, Inc. in a Lanham Act suit.

• Clara Jimenez

  • Role: In-house Counsel.
  • Firm: Johnson & Johnson (parent company of Janssen Biotech, Inc.).
  • Relevant Experience: Ms. Jimenez is Senior Counsel in Johnson & Johnson's Litigation Group, supporting IP litigation globally. Prior to joining J&J, she was an attorney with Finnegan, where she counseled clients in the Chemical, Pharmaceutical, and Medical Device industries in IP protection and enforcement, including prosecution, licensing, PTAB proceedings, and litigation.

While public search snippets do not definitively confirm the roles of all attorneys, these individuals and their firms have a strong history of representing Janssen and other pharmaceutical companies in complex patent and BPCIA litigation, including in the District of Delaware. The presence of both Finnegan and Patterson Belknap suggests a multi-firm approach to lead counsel, a common strategy in high-stakes pharmaceutical patent cases.

The defendants, Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., in case 1:26-cv-00222 are represented by attorneys from the firms McAndrews, Held & Malloy, Ltd. and Stinson LLP. They also have local counsel in Delaware, though specific names for local counsel in this case were not explicitly found in the available search results.

Here is the identified counsel of record for the defendants:

From McAndrews, Held & Malloy, Ltd. (Chicago, IL):

• Alejandro Menchaca

  • Role: Lead Counsel (implied given his frequent representation of Accord in patent litigation)
  • Firm: McAndrews, Held & Malloy, Ltd., Chicago, IL
  • Experience Note: Mr. Menchaca is an experienced IP litigator, particularly in the pharmaceutical space, and has successfully defended Accord in ANDA litigation against Purdue Pharma, securing patent invalidations. He is also noted as counsel for Accord in other biosimilar patent cases.

• Rajendra "Raj" Chiplunkar

  • Role: Counsel
  • Firm: McAndrews, Held & Malloy, Ltd., Chicago, IL
  • Experience Note: Mr. Chiplunkar was part of the McAndrews team that successfully defended Accord against Purdue Pharma in ANDA litigation.

• Benjamin Mahon

  • Role: Counsel
  • Firm: McAndrews, Held & Malloy, Ltd., Chicago, IL
  • Experience Note: Mr. Mahon was also part of the McAndrews team representing Accord in the successful defense against Purdue Pharma.

• Bradley Loren

  • Role: Counsel
  • Firm: McAndrews, Held & Malloy, Ltd., Chicago, IL
  • Experience Note: Mr. Loren was part of the McAndrews team representing Accord in the successful defense against Purdue Pharma.

From Stinson LLP (office location likely one of their IP-focused offices, e.g., Minneapolis, St. Louis, or Kansas City, specific to this case not found):

• David D. Axtell

  • Role: Counsel
  • Firm: Stinson LLP, Minneapolis, MN (based on firm's website)
  • Experience Note: Mr. Axtell is a partner at Stinson LLP with experience in patent preparation, prosecution, counseling, and litigation across a wide range of biotechnologies, including biological therapies and diagnostics.

• B. Scott Eidson

  • Role: Counsel
  • Firm: Stinson LLP, St. Louis, MO (based on firm's website)
  • Experience Note: Mr. Eidson is a partner at Stinson LLP focusing on intellectual property, with experience in patent litigation and post-grant proceedings.

Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. are also listed as petitioners in the parallel Inter Partes Review (IPR) proceedings at the PTAB (IPR2026-00256, IPR2026-00257, IPR2026-00258, and IPR2026-00259) challenging Janssen's patents. In these PTAB proceedings, Accord BioPharma, Inc., Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd. appointed practitioners associated with Gemini Law LLP as their attorneys. While Gemini Law LLP is named for the PTAB actions, the listed attorneys for the district court litigation are from McAndrews, Held & Malloy, Ltd. and Stinson LLP.

A document filed on April 6, 2026, references "Attorneys for Defendants Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd." but does not explicitly name them in the available snippet. However, previous web searches and context from related cases indicate McAndrews, Held & Malloy, Ltd. and Stinson LLP as frequent representatives for Accord in pharmaceutical patent litigation.