Unknown Petitioner v. Janssen Biotech Inc.

This Inter Partes Review (IPR) case, IPR2026-00258, involves an unnamed petitioner challenging the validity of US Patent 12122824, currently owned by Janssen Biotech Inc. Janssen Biotech Inc. is a global pharmaceutical and biotechnology company and a subsidiary of Johnson & Johnson, focused on developing and marketing innovative medications across therapeutic areas like oncology, immunology, and neuroscience. While the specific accused product, service, or technology leading to this IPR is not publicly available, Janssen's portfolio includes numerous blockbuster drugs such as Darzalex, Tremfya, and formerly Stelara, which are biologics addressing chronic and life-threatening conditions. The IPR targets US Patent 12122824; a detailed technical sketch of the patent is not yet available in public sources.

This IPR is pending before the Patent Trial and Appeal Board (PTAB), a specialized administrative body within the U.S. Patent and Trademark Office. The PTAB is a critical venue for challenging patent validity, offering a potentially faster and less expensive alternative to district court litigation. The outcome of IPRs can significantly impact the enforceability of a patent, and thus the market landscape for pharmaceutical products.

The case is notable due to Janssen Biotech's position as a major player in the pharmaceutical industry and its focus on innovative medicine. IPRs are frequently used in the pharmaceutical sector, often by generic drug manufacturers or competitors, to challenge patents covering high-value drugs, especially as they approach patent cliffs or face biosimilar competition. The initiation of an IPR against Janssen suggests a potential challenge to a key therapeutic or an emerging technology within their pipeline, which could have significant market implications depending on the subject matter of US Patent 12122824. Without more specific details about the patent's claims and the petitioner's identity, the exact impact and context remain to be fully understood.

I'll research this systematically. Let me start with parallel searches on the IPR docket, the patent, and any parallel litigation.

Excellent — the record is much richer than the prior sections assumed. Let me now dig into the IPR docket specifics and the district court's pre-trial track.

Key Legal Developments & Present Posture — IPR2026-00258 (and the parallel BPCIA litigation that gives it meaning)

Scope note. IPR2026-00258 is not "litigation" in the Article III sense — it is a PTAB trial. The "pleadings/motions/trial" sequence the task asks about exists in the parallel BPCIA case, Janssen Biotech, Inc. v. Accord BioPharma, Inc., No. 1:26-cv-00222-GBW (D. Del.). Because the two are tightly coupled (same patents, same parties, the IPR was filed three days after Janssen dropped the '824 patent from the district court case), I cover both and mark which track each event belongs to. I do not repeat the party/counsel material from the earlier sections.

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1. Chronological timeline

In IPR2026-00258, representing the petitioners Accord BioPharma, Inc., Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd., the counsel of record identified is:

Lora M. Green

• Role: Partner (likely lead counsel)
• Firm: Gemini Law LLP, New York, NY
• Experience: Dr. Green has over 30 years of experience in the life science, pharmaceutical, and biotech fields. She served as an administrative patent judge at the U.S. Patent and Trademark Office (USPTO) from 2001 to 2018, including a tenure as a lead administrative patent judge for the biotech team from 2011 to 2017. During her time at the USPTO, she managed post-grant review proceedings, including inter partes and post-grant reviews, and was involved in over 380 such proceedings. She also decided over 4,000 ex parte appeals. Prior to joining Gemini Law, she was a partner in the Washington, D.C. office of Wilson Sonsini Goodrich & Rosati, where she focused on PTAB proceedings and patent counseling for life science companies. She was recognized as one of the Top 50 Women in PTAB Trials (2025) by the PTAB Bar Association. Notable past cases include representing Celltrion in BPCIA proceedings related to EYLEA (aflibercept) and successful IPRs related to Actemra (tocilizumab) and EYLEA (aflibercept).

The Petitioners' Power of Attorney in IPR2026-00258 explicitly appoints practitioners associated with Gemini Law LLP as their attorneys. While other individual attorneys from Gemini Law LLP may be involved as backup counsel, Lora M. Green is specifically named as counsel in the initial filings and is a partner at the firm specializing in such proceedings.

I'll research the docket and Patent Owner's counsel. Note at the outset: in an IPR, Janssen Biotech is the patent owner (respondent), not a "defendant" in the district-court sense — so I'll identify Janssen's counsel of record. Let me search.

The docket shows a Patent Owner Power of Attorney and Mandatory Notices filed April 10, 2026, with a correspondence address of "Riverside Law LLP / J&J". Let me pull those filings and identify the named attorneys.

Let me try to pull the actual Patent Owner filings (Papers 7 & 8) to confirm the named practitioners.

Counsel of Record — Respondent/Patent Owner Side (Janssen Biotech, Inc.)

Threshold clarification (and a metadata flag). The case metadata lists "Defendant(s): Janssen Biotech Inc.," but in IPR2026-00258 Janssen is the Patent Owner / respondent, not a defendant. The party in the defendant's chair is actually Accord BioPharma, Inc., Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd. — the petitioners — whose IPR counsel (Lora M. Green, Gemini Law LLP) is already covered in the "Plaintiff representatives" section above and is not repeated here. This section therefore addresses the only other party of record: Janssen Biotech, Inc. as Patent Owner. In the parallel district court action, Janssen Biotech, Inc. v. Accord BioPharma, Inc., No. 1:26-cv-00222 (D. Del.), the roles are reversed — Janssen is plaintiff and Accord/Bio-Thera are the defendants.

Important limitation up front: I was able to confirm the firm and service address for Janssen's PTAB counsel from two independent docket sources, but I was not able to retrieve the text of Paper 8 ("Patent Owner's Power of Attorney," filed Apr. 10, 2026) or Paper 7 ("Patent Owner's Mandatory Notices," filed Apr. 10, 2026) in IPR2026-00258, which are the documents that name lead and back-up counsel. I therefore will not name individual attorneys as counsel of record for Janssen. Below is what is verified, and what is not.

Verified: counsel of record contact / firm

Rule 42.10 posture note: Because Paper 8 was filed alongside the mandatory notices on April 10, 2026 and no pro hac vice motion appears on the public docket summary retrieved, Janssen's lead counsel is presumably a registered practitioner (the Riverside Law attorneys/agents are all USPTO-registered). This is an inference, not a verified fact.

Not verified — individual attorneys

I could not source any of the following, and I am deliberately not filling the gap:

• The name of Janssen's lead counsel in IPR2026-00258.
• The name(s) of back-up counsel.
• Whether any in-house J&J attorney (e.g., from Johnson & Johnson's IP litigation group) is listed on the power of attorney.
• Whether Janssen retained separate PTAB litigation counsel (a trial firm) distinct from Riverside Law, which functions primarily as Janssen Biotech's patent prosecution firm.

Practitioners at the correspondence firm (context only — NOT confirmed as counsel of record here). USPTO OED-derived data shows the following registered practitioners at 175 Strafford Avenue, Suite 100, Wayne, PA, several of whom have Janssen Biotech prosecution work in their portfolios:

Treat this table strictly as a lead list for confirming Paper 8, not as an appearance list.

Practical point on why this matters for the case

The Riverside Law address is a prosecution correspondence address carried over from the '824 patent's file; its appearance in the certificate of service does not by itself prove Riverside is trying the IPR. Given that Janssen is simultaneously running BPCIA litigations over the same golimumab patent family — No. 1:26-cv-00222 (D. Del.), where Judge Gregory B. Williams granted a preliminary injunction on September 30, 2026, and Accord/Bio-Thera noticed an appeal on October 1, 2026, plus No. 1:26-cv-01754 (E.D. Va.) against Alvotech — Janssen would ordinarily use its BPCIA trial counsel (not its prosecution firm) for the instituted IPRs. That BPCIA counsel is not identified in any source I retrieved and should be pulled from the D. Del. docket (D.I. 5/12/13/14 appearances) or from Janssen's patent owner response due ~December 2026.

Contradictions with the previously generated sections (flagged)

1. Filing date. Metadata says "Filed: 2026-03-27." The petitions in all four golimumab IPRs were filed March 20, 2026; March 27, 2026 is the date the Board issued the Notice of Filing Date Accorded (Paper 6). The metadata appears to capture the accorded date, not the petition date.
2. Petitioner identity. The "Key legal developments" section states the petitioner "has not been publicly confirmed." That is now contradicted: petitioners are Accord BioPharma, Inc., Intas Pharmaceuticals Ltd., and Bio-Thera Solutions, Ltd. — consistent with the "Plaintiff representatives" section. (One caption variant lists "Accord Healthcare, Inc." rather than Accord BioPharma.)
3. Parallel district court litigation. That same section says no parallel infringement case involving the '824 patent exists. In fact, the '824 patent was asserted in No. 1:26-cv-00222 (D. Del., filed Mar. 3, 2026) and was dismissed without prejudice by stipulation entered March 18, 2026, as part of Janssen's dismissal of the four method-of-treatment counts.
4. Status date. That section is dated "as of May 30, 2026" and reports no institution decision. As of today (October 17, 2026), the Director instituted IPR2026-00258 on September 9, 2026 via a bulk Notice of Decisions on Institution without a written opinion, alongside IPR2026-00256, -00257, and -00259.
5. Patent subject matter. The overview says a technical sketch of the '824 patent is unavailable; it is publicly described as "Anti-TNF Antibodies, Compositions, and Methods for the Treatment of Active Ankylosing Spondylitis" (Harrison et al., issued Oct. 22, 2024), with claims 1–7 challenged as anticipated/obvious over ClinicalTrials.gov NCT02181673-V23 and related Phase III materials.

Recommended next steps to confirm counsel (not yet done)

• Pull Paper 8 (Patent Owner's Power of Attorney) and Paper 7 directly from PTAB P-TACTS for IPR2026-00258 — this is the definitive source for lead/back-up counsel names and registration numbers.
• Check the Patent Owner's Response (due roughly three months after the Sept. 9, 2026 institution, i.e., ~Dec. 9, 2026) signature block.
• Pull the D. Del. docket in 1:26-cv-00222 for Janssen's appearances (and the Oct. 1, 2026 notice of appeal, Fed. Cir.) to identify Janssen's BPCIA trial team.
• Note: I hit a research-step limit while attempting to open the Paper 7/8 PDFs on Docket Alarm, so the individual-name gap is a research limitation, not an indication that counsel has not appeared. Janssen has appeared (Papers 7 and 8, Apr. 10, 2026); nothing here is sealed as far as the docket summary shows, but the underlying documents were not retrievable in this session.