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.

I'll research the docket and firm sources for Janssen's counsel in this case.

Good — the docket shows a McCarter & English / Latham & Watkins team for plaintiffs. Let me verify individual attorneys and roles.

Plaintiff's counsel of record — Janssen Biotech, Inc. et al. v. Accord BioPharma, Inc. et al., No. 1:26-cv-00222 (D. Del.)

Structure of the team: Janssen uses a two-tier arrangement typical of Delaware BPCIA cases — Latham & Watkins LLP as lead merits counsel (all substantive briefing, PI, PTAB) and McCarter & English, LLP (Wilmington) as Delaware/local counsel, which is where the D. Del. signatures and certificates of service come from. No in-house J&J/Janssen attorney appears of record in the publicly available docket entries.

Latham & Watkins LLP — lead counsel

McCarter & English, LLP — Delaware counsel

Sourcing: PacerMonitor public docket summary for No. 1:26-cv-00222 (https://cdn.pacermonitor.com/public/case/63414626/); Janssen Biotech's Patent Owner Mandatory Notices in IPR2026-00256 (Apr. 10, 2026) (lead/back-up counsel table, Latham & Watkins); Janssen's PI motion and dismissal stipulation in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN (D. Del.) (same McCarter/Latham lineup); Chambers USA profile for Daniel Silver. Note that McCarter's own client-alert/PTAB filings and the complaint-analysis summary of the 1:26-cv-00222 pleading also identify "McCarter & English, LLP; Latham & Watkins LLP" as plaintiffs' counsel.

Conflicts / corrections to the case metadata — flagged

1. Plaintiffs are misidentified in the case metadata. The docket caption is Janssen Biotech, Inc. et al. v. Accord BioPharma, Inc. et al., and the named plaintiffs are Janssen Biotech, Inc. (Pennsylvania) and Janssen Sciences Ireland UC — not "Centocor Biologic LLC." No Centocor entity appears as a plaintiff in the public filings. (Contrast the earlier-generated overview, which also mislabels the defendant set by omitting Accord BioPharma, Inc., the Intas U.S. subsidiary that is the lead defendant and the aBLA holder/commercializer.)
2. Patent 12,122,824 is no longer a live district-court patent. Per petitioners' Sotera stipulation in IPR2026-00257, Janssen and defendants stipulated on March 17, 2026 to dismiss the four method-of-treatment patents — including the '824 patent — without prejudice, and the stipulation was so ordered March 18, 2026 (D.I. 12, 13). The '824 patent survives only in IPR2026-00258, instituted September 9, 2026. Any section treating '824 as the operative asserted patent needs correction.
3. Filing date. Metadata says filed 2026-02-27; public reporting and the docket reflect March 3, 2026 (redacted complaint filed March 11, 2026 after seal order).
4. Sealed materials. The complaint was filed under seal (redacted version Mar. 11, 2026), and the September 30, 2026 preliminary-injunction memorandum opinion remains sealed pending redaction — so the PI reasoning, and any counsel-specific arguments in it, cannot yet be sourced.
5. I found no indication that any plaintiff-side attorney has been terminated or substituted, and no pro hac vice denials, as of the public docket. Latham's PTAB-side counsel (Bajaj, Zhang, Rosen) should not be described as district-court counsel of record without further docket confirmation.

I'll search for docket and counsel information on this case.

The docket snippet is jumbled across parties. Let me pin down who represents Accord and Bio-Thera specifically.

Now let me verify the defendant-side attorneys and their firms.

Counsel of Record for the Defendants

Bottom line: The defendants in D. Del. No. 1:26-cv-00222 are Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. (not Bio-Thera alone — see the correction section below). They are represented by a two-firm team: Young Conaway Stargatt & Taylor LLP (Wilmington, Delaware — local counsel) and Gemini Law LLP (New York, New York — lead life-sciences/biosimilar trial counsel).

Primary sourcing: the public PACER Monitor case page for Janssen Biotech, Inc. et al v. Accord BioPharma, Inc. et al, No. 1:26-cv-00222 (D. Del.) (https://cdn.pacermonitor.com/public/case/63414626/), the Justia docket (https://dockets.justia.com/docket/delaware/dedce/1:2026cv00222/92256), and IAM/ip fray's report on the preliminary injunction, which lists the appearances for both sides (https://ipfray.com/janssen-wins-landmark-preliminary-injunction-in-district-of-delaware/).

1. Local (Delaware) counsel — Young Conaway Stargatt & Taylor LLP, Wilmington, DE

2. Lead / national counsel — Gemini Law LLP, 40 W. 24th Street, Suite 6N, New York, NY 10010

Sourcing caveat on roles: Neither the Justia docket nor the PACER Monitor page labels anyone "lead" versus "of counsel," and the individual notices of appearance are behind the PACER paywall; I could not retrieve ECF numbers for the defendants' appearances. The lead/local split above is an inference from (a) Young Conaway being the Delaware firm of record and (b) Gemini Law being the New York biosimilar boutique that argued the PI and appears on the parallel PTAB filings. Gemini Law's address and attorney roster are confirmed from its PTAB powers of attorney and court filings in the Celltrion matters (e.g., Def. Celltrion's Notice of Appeal, N.D. W. Va. 1:23-cv-00089, ECF 198; IPR2025-00456 Power of Attorney).

3. No in-house counsel has appeared

No in-house attorney for Accord BioPharma or Bio-Thera has entered an appearance on the public docket; both defendants appear through outside counsel only.

4. Parallel PTAB counsel (same petitioners)

Accord, Intas and Bio-Thera filed IPR2026-00256/00257/00258/00259 on March 20, 2026; institution was granted September 9, 2026 (Goodwin Procter, https://www.goodwinlaw.com/en/insights/blogs/2026/09/uspto-institutes-four-iprs-challenging-janssens-golimumab-method-of-treatment-patents). I could not pull the petitioners' PTAB counsel-of-record designations, so I will not assert that the Gemini Law/Young Conaway teams are the same as the PTAB teams — though the Gemini Law–Celltrion PTAB practice makes that likely.

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Corrections to the earlier-generated sections (flagging contradictions as instructed)

1. Party names — significant. The case metadata (and the earlier "Case overview" and "Key legal developments" sections) name the defendant as "Bio-Thera" and list plaintiffs as "Janssen; Centocor Biologic LLC." The actual docket is Janssen Biotech, Inc. and Janssen Sciences Ireland UC v. Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. No Centocor entity appears in this action. Accord BioPharma (an Intas Pharmaceuticals subsidiary) is the U.S. commercializer of BAT2506 and is the lead named defendant; the court and press short-cite the case as Janssen Biotech, Inc. v. Accord BioPharma, Inc. (Justia docket, supra; Venable BiologicsHQ, https://biologicshq.com/janssen-files-first-bpcia-suit-over-simponi-golimumab-biosimilar/).
2. Filing date. Metadata says filed 2026-02-27; the complaint was actually filed March 3, 2026, under seal, with the sealing order entered March 4, 2026 by Judge Richard G. Andrews (D.I. 1, 2, 8), before reassignment to Judge Gregory B. Williams. March 3 appears to be correct.
3. Which patents were dismissed. The earlier section says only the '982 and '566 patents were dismissed. Per Goodwin Procter, on March 17, 2026 Janssen stipulated to dismiss all four method-of-treatment patent counts without prejudice — i.e., U.S. Patent Nos. 11,014,982, 11,041,020, 12,122,824, and 12,291,566 — and Judge Williams entered the order March 18, 2026 (see the public order posted at https://www.pearceip.law/wp-content/uploads/2026/10/Janssen-v-Accord-and-Bio-Thera-golimumab-ORDER-DISMISSING-METHOD-OF-TREATMENT-PATENT-COUNTS-WITHOUT-PREJUDICE.pdf). That is material because 12,122,824 — the sole patent in the case metadata — was dropped from the district court case in March 2026 and now lives only in IPR2026-00258 (instituted Sept. 9, 2026). The case's live district-court patents are the manufacturing/composition patents (per Venable, seven patents were being pressed as of May 2026).
4. Plaintiffs' counsel (prior section). The earlier "Plaintiff representatives" section speculated Finnegan and Morris Nichols. The docket shows Janssen's team is McCarter & English LLP (Daniel M. Silver, Alexandra M. Joyce — Wilmington) plus Latham & Watkins (David P. Frazier, Drew W. Roberts, Michael R. Seringhaus, Roger J. Chin). Ms. Joyce's signature appears on Janssen's D.I. 9 summons return, and the PACER Monitor "represented by" block places Silver/Joyce with the Janssen entities — so McCarter is plaintiffs' Delaware counsel here, not defendants'. This is an easy point of confusion because both sides' counsel appear interleaved on the PACER Monitor page.
5. Posture (update beyond the prior sections). Janssen's PI motion (filed May 6, 2026) was argued September 1, 2026 and granted September 30, 2026 in a sealed opinion, with a $98.8 million bond; the TRO motion was denied as moot. Defendants filed a Federal Circuit appeal on October 5, 2026, No. 27-1008 (Venable BiologicsHQ, https://biologicshq.com/preliminary-injunction-against-accords-simponi-simponi-aria-interchangeable-biosimilars-immgolis-immgolis-intri/). The prior sections describe the PI as "pending," which is now stale. I could not retrieve the Federal Circuit appearance list for No. 27-1008, so I cannot confirm whether the district-court defense team (Gaza/Mackrides/Vrana + Cerwinski/Morris et al.) is identical on appeal.