US 12291566

US patent 12291566, titled "Anti-TNF antibodies, compositions, and methods for the treatment of active Ankylosing Spondylitis," was filed on April 22, 2021, and issued on May 6, 2025. The current and original assignee is Janssen Biotech Inc. The inventors are Diane D. Harrison, Elizabeth C. Hsia, Lee-Lian Kim, and Kim Hung Lo.

Abstract:
The patent describes an isolated mammalian anti-TNF antibody with a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37 for use in the safe and effective treatment of active Ankylosing Spondylitis. It also covers compositions and methods for treating active Ankylosing Spondylitis using this anti-TNF antibody.

Independent Claims Overview:

• Independent Claim 1: This claim covers an isolated mammalian anti-TNF antibody designed for treating active Ankylosing Spondylitis. The treatment method involves administering the antibody to a diagnosed subject via intravenous (IV) infusion.

• Independent Claim 11: This claim describes a composition that includes an isolated mammalian anti-TNF antibody and a pharmaceutically acceptable carrier. This composition is intended for use in treating active Ankylosing Spondylitis by administering it intravenously (IV) to a patient diagnosed with the condition.

• Independent Claim 21: This claim outlines a method for treating active Ankylosing Spondylitis. The method involves administering a composition containing an isolated mammalian anti-TNF antibody to a diagnosed subject through intravenous (IV) infusion.

• Independent Claim 30: This claim pertains to an article of manufacture. It comprises packaging material and at least one vial containing a solution of an isolated mammalian anti-TNF antibody with a buffer, potentially in an aqueous diluent. The packaging includes a label indicating that the solution can be stored for a period of 1 to 72 hours or more.

USPTO and CAFC 2026 Dockets:
A search for US patent 12291566 indicates that the patent is currently active. The Google Patents record also shows that litigation related to this patent family has been filed. Specifically, a US case was filed in the Delaware District Court (case 1:26-cv-00222) and a PTAB case (IPR2026-00259) has been filed and is pending. No specific CAFC 2026 docket information was found that directly mentions a ruling or ongoing case at that appellate level at this time, beyond the indication of litigation in the district court and PTAB.


Note: The information regarding the legal status and litigation is based on the Google Patents record, which sources litigation data from Darts-ip and Unified Patents. These sources are considered reliable for indicating the presence of litigation, but a full legal analysis would require direct access to court and PTAB dockets.

US patent 12291566 is involved in the following known litigation:

• Case Number: 1:26-cv-00222

  • Jurisdiction: Delaware District Court
  • Status: Active litigation

• Case Number: IPR2026-00259

  • Jurisdiction: Patent Trial and Appeal Board (PTAB)
  • Status: Pending

Please note that the plaintiff(s), defendant(s), and filing dates are not explicitly provided in the available snippets for these cases.

Proceedings overview

There is one AIA trial proceeding on file for US patent 12291566, which is currently pending. This means the patent's claims have not yet been challenged through a final decision at the PTAB, offering no current defensive hardening but also no invalidations.

IPR2026-00259 — Accord BioPharma, Inc. et al. v. Janssen Biotech Inc

• Type: Inter Partes Review
• Filed: 2026-03-20
• Status: Pending. The petition has been filed and is awaiting an institution decision.
• Judge panel: Not yet public.
• Petition grounds: Not yet public.
• Institution decision: Not yet issued. The institution decision is pending.
• Final Written Decision: Not applicable, as an institution decision has not yet been issued.
• Settlement / termination: No settlement or termination has been reported.
• Appeal: Not applicable, as a Final Written Decision has not been issued.
• Defensive value: This proceeding indicates that at least one party, Accord BioPharma, Inc. et al., believes there are grounds to challenge the patentability of claims in US12291566. However, since the case is still pending institution, no claims have been invalidated or sustained. The outcome of this IPR will be crucial for future defensive strategies.

Strategic summary

Currently, all claims of US12291566 remain untested and valid, as the single IPR filed against it (IPR2026-00259) is still in the preliminary stage awaiting an institution decision. Therefore, there are no canceled or sustained claims to report at this time. The estoppel landscape is also not yet relevant, as no final written decision has been issued that would trigger § 315(e)(2) bars.

There is no discernible pattern of multiple IPRs filed by the same petitioner, nor has the patent owner pursued PTAB appeals aggressively, as this is the first and only reported proceeding. The petitioner, Accord BioPharma, Inc. et al., has initiated this challenge, but further details on the prior art grounds are not yet public.

Recommended next steps

For a defendant currently being asserted against US patent 12291566, it is crucial to monitor IPR2026-00259 closely. The next significant milestone will be the institution decision, which is typically due within six months of the preliminary response filing, or by approximately September 20, 2026, assuming the patent owner filed a preliminary response. If the PTAB institutes the IPR, the statutory 1-year trial deadline from institution would mean a Final Written Decision would be due around September 20, 2027. The absence of any prior PTAB activity means that all prior art grounds remain available for potential challenges, should a defendant choose to file their own IPR or if IPR2026-00259 is not instituted or does not lead to invalidation of relevant claims.

Inventors

• Diane D. Harrison
• Elizabeth C. Hsia
• Lee-Lian Kim
• Kim Hung Lo

The patent document does not specify the employers of the inventors at the time of filing.

Original assignee

The original assignee named on the issued patent is Janssen Biotech Inc.. Janssen Biotech Inc. is a pharmaceutical company focused on developing and commercializing biopharmaceutical products. They are part of the Janssen Pharmaceutical Companies of Johnson & Johnson and ship products embodying biological claims. Janssen Biotech Inc. is currently operating.

Assignment timeline

No assignments are recorded for US patent 12291566 in the USPTO Assignment Center as of 2026-05-29.

Timeline diagram

timeline
    title Ownership of US 12291566
    2021 : Application filed by Janssen Biotech Inc
    2025 : Application granted, issued to Janssen Biotech Inc

NPE / troll-pattern signals

1. Shell-entity transfer — not present
2. Known asserter in the chain — not present
3. Repeat correspondent across the chain — not present
4. Cascading transfers — not present
5. Pre-litigation transfer — not present
6. Bankruptcy fire-sale — not present
7. Privateering — not present
8. Defensive aggregator (anti-NPE) — not present

Verdict

Insufficient data. As of 2026-05-29, there are no assignment records for US12291566 on the USPTO Assignment Center. The patent was granted to the original assignee, Janssen Biotech Inc., and no subsequent transfers have been recorded.

https://patents.google.com/patent/US12291566/en
https://assignmentcenter.uspto.gov/patents/12291566

To identify the most relevant prior art for US patent 12291566, I would typically search for documents cited within the patent itself. Since I cannot directly access the full USPTO file wrapper for live patent data or specific cited references within US12291566B2 beyond what's in the provided Google Patents text (which primarily lists "Prior art keywords" rather than specific patent citations), I will explain the general process and what kind of information would be needed.

The "Prior art keywords" section on the Google Patents page for US12291566B2 lists "seq," "tnf," "antibody," "amino acid," and "human." These are general terms, not specific patent or publication numbers.

To provide the most relevant prior art, the ideal next step would be to consult the "References Cited" section of the issued patent document itself from the USPTO database. This section, typically found on the front page of a granted patent, lists all prior art (patents and non-patent literature) that was considered by the patent examiner during prosecution and/or submitted by the applicant.

Assuming access to the full patent document, for each cited prior art reference, I would then gather:

1. Full Citation: This would include the patent number (for other patents), publication number (for patent applications), or full bibliographic information (for non-patent literature).
2. Publication/Filing Date: This is crucial for determining if a reference is indeed prior art under 35 U.S.C. § 102.
3. Brief Description: A concise summary of what the prior art discloses.
4. Which Claim(s) it potentially anticipates under 35 U.S.C. § 102: This would require a detailed claim-by-claim analysis of US12291566B2 against the disclosures of each prior art document. Anticipation under 35 U.S.C. § 102 means that every element of a claim is found, either explicitly or inherently, in a single prior art reference.

General Guidance on Prior Art and 35 U.S.C. § 102:

35 U.S.C. § 102 outlines the conditions for patentability, specifically regarding novelty. A person is entitled to a patent unless, among other things, the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.

Without the explicit "References Cited" section from the patent document itself, I cannot provide a specific list of prior art citations and their detailed analysis. The Google Patents page for US12291566B2, while indicating litigation, does not provide a list of cited prior art documents.

Under 35 U.S.C. § 103, an invention is considered obvious if the differences between the claimed invention and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art (POSA) to which the subject matter pertains. This analysis requires identifying the scope and content of the prior art, ascertaining the differences between the prior art and the claims at issue, and resolving the level of ordinary skill in the pertinent art. Crucially, there must be some teaching, suggestion, or motivation in the prior art that would have led a POSA to combine the references to achieve the claimed invention, with a reasonable expectation of success.

For US patent 12291566, the primary independent claims (Claims 1, 11, and 21) focus on an isolated mammalian anti-TNF antibody comprising a heavy chain (HC) with SEQ ID NO:36 and a light chain (LC) with SEQ ID NO:37, for use in treating active Ankylosing Spondylitis (AS) via intravenous (IV) infusion. Dependent claims further specify administration details and clinical endpoints.

Prior Art References

The patent itself provides key pieces of prior art:

1. Golimumab (Simponi) for active Ankylosing Spondylitis: The patent explicitly references a "trial of Simponi (golimumab), administered intravenously, in subjects with active Ankylosing Spondylitis (AS)" [cite: FIG. 18]. This reference directly teaches the treatment of active AS with an anti-TNF antibody via intravenous infusion, thereby covering the core indication and route of administration for an anti-TNF therapy.
2. cA2 (Infliximab) as an anti-TNF therapy: The patent discusses "beneficial effects in open-label trials with a chimeric monoclonal antibody to TNF alpha (cA2)" for rheumatoid arthritis and Crohn's disease [cite: beneficial effects in open-label trials with a chimeric monoclonal antibody to TNF alpha (cA2) have been reported with suppression of inflammation and with successful retreatment after relapse in rheumatoid arthritis and in Crohn's disease]. This establishes the broad utility of anti-TNF antibodies for inflammatory conditions.
3. General knowledge in antibody development and engineering: The patent extensively describes well-known methods for producing, isolating, humanizing, and engineering antibodies, including through hybridomas, recombinant techniques, transgenic animals, and display libraries [cite: Human antibodies that are specific for human TNF proteins or fragments thereof can be raised against an appropriate immunogenic antigen, such as isolated and/or TNF protein or a portion thereof (including synthetic molecules, such as synthetic peptides)., Monoclonal antibody production can be performed using any suitable technique., Suitable methods of producing or isolating antibodies of the requisite specificity can be used, including, but not limited to, methods that select recombinant antibody from a peptide or protein library (e.g., but not limited to, a bacteriophage, ribosome, oligonucleotide, RNA, cDNA, or the like, display library..., single cell antibody producing technologies (e.g., selected lymphocyte antibody method (“SLAM”)..., a humanized or engineered antibody has one or more amino acid residues from a source which is non-human..., the anti-TNF antibody can also be optionally generated by immunization of a transgenic animal... capable of producing a repertoire of human antibodies)]. It also acknowledges that non-human or chimeric antibodies can elicit immune responses, providing motivation for developing human or humanized variants with improved safety profiles [cite: Such antibodies or fragments can elicit an immune response when administered to humans., repeated administration of antibodies or fragments comprising non-human portions can lead to serum sickness and/or anaphylaxis.].

Obviousness Analysis

A person having ordinary skill in the art (POSA) at the time of the invention (priority date: February 7, 2017) would have possessed a comprehensive understanding of immunology, molecular biology, and therapeutic antibody development. This would include knowledge of TNF-alpha as a validated therapeutic target for various inflammatory and autoimmune diseases.

Combination of References:

1. Golimumab (Simponi) for AS via IV infusion [cite: FIG. 18] and the general knowledge in antibody development [cite: Human antibodies that are specific for human TNF proteins or fragments thereof can be raised against an appropriate immunogenic antigen, such as isolated and/or TNF protein or a portion thereof (including synthetic molecules, such as synthetic peptides)., Monoclonal antibody production can be performed using any suitable technique., Suitable methods of producing or isolating antibodies of the requisite specificity can be used, including, but not limited to, methods that select recombinant antibody from a peptide or protein library (e.g., but not limited to, a bacteriophage, ribosome, oligonucleotide, RNA, cDNA, or the like, display library..., single cell antibody producing technologies (e.g., selected lymphocyte antibody method (“SLAM”)..., a humanized or engineered antibody has one or more amino acid residues from a source which is non-human..., the anti-TNF antibody can also be optionally generated by immunization of a transgenic animal... capable of producing a repertoire of human antibodies)].

   • Motivation to Combine: A POSA would have been motivated to develop new anti-TNF antibodies for the treatment of active Ankylosing Spondylitis (AS) to improve upon existing therapies, such as golimumab, which was already known to be effective and administered intravenously for this condition [cite: FIG. 18 shows diagram of the study design for trial of Simponi (golimumab), administered intravenously, in subjects with active Ankylosing Spondylitis (AS)]. The continuous drive in pharmaceutical research is to identify therapeutic agents with enhanced efficacy, better safety profiles (e.g., reduced immunogenicity compared to chimeric antibodies like infliximab), more convenient dosing regimens, or improved pharmacokinetic properties. The patent itself highlights the potential for immune responses to non-human antibody portions, providing a clear motivation to seek fully human or humanized antibodies [cite: Such antibodies or fragments can elicit an immune response when administered to humans., repeated administration of antibodies or fragments comprising non-human portions can lead to serum sickness and/or anaphylaxis.].
   • Reasonable Expectation of Success: Given the established role of TNF-alpha in AS, and the success of existing anti-TNF therapies, a POSA would have a reasonable expectation of success in developing new anti-TNF antibodies that bind to TNF-alpha and are efficacious in AS. The numerous known methods for discovering, engineering, and optimizing antibodies, including screening diverse antibody libraries or immunizing transgenic animals to produce human antibodies, would provide a POSA with the tools to achieve this [cite: Human antibodies that are specific for human TNF proteins or fragments thereof can be raised against an appropriate immunogenic antigen, such as isolated and/or TNF protein or a portion thereof (including synthetic molecules, such as synthetic peptides)., Monoclonal antibody production can be performed using any suitable technique., Suitable methods of producing or isolating antibodies of the requisite specificity can be used, including, but not limited to, methods that select recombinant antibody from a peptide or protein library (e.g., but not limited to, a bacteriophage, ribosome, oligonucleotide, RNA, cDNA, or the like, display library..., single cell antibody producing technologies (e.g., selected lymphocyte antibody method (“SLAM”)..., a humanized or engineered antibody has one or more amino acid residues from a source which is non-human..., the anti-TNF antibody can also be optionally generated by immunization of a transgenic animal... capable of producing a repertoire of human antibodies)]. The administration route (IV infusion) and the clinical efficacy endpoints (e.g., ASDAS inactive disease, ASAS20) are standard in the field of AS treatment and would be routinely applied in the evaluation of any new anti-TNF therapy.

While the specific amino acid sequences (SEQ ID NO:36 and SEQ ID NO:37) of the claimed antibody are not explicitly disclosed in the cited prior art, the general concept of identifying and optimizing novel anti-TNF antibodies to treat AS via IV infusion, with the goal of improving existing treatments, would be considered an obvious endeavor for a POSA using well-established techniques. The patent's own description of standard antibody discovery methods supports the view that such a search for new antibodies against a known target like TNF-alpha was routine. Any unexpected superior efficacy of the claimed antibody (as suggested in the patent's examples comparing TNV148 to cA2 in mouse models) would be a factor in rebutting a prima facie case of obviousness.