US 11014982

Here's a concise summary of US Patent 11014982:

US Patent 11014982

• Title: Anti-TNF antibodies, compositions, and methods for the treatment of active ankylosing spondylitis
• Assignee: Janssen Biotech Inc
• Inventors: Diane D. Harrison, Elizabeth C. Hsia, Lee-Lian Kim, Kim Hung Lo
• Filing Date: July 20, 2019
• Issue Date: May 25, 2021
• Abstract: The patent describes compositions and methods using anti-TNF antibodies, specifically those with a heavy chain (HC) comprising SEQ ID NO:36 and a light chain (LC) comprising SEQ ID NO:37, for the safe and effective treatment of active Ankylosing Spondylitis (AS). The administration is via intravenous (IV) infusion, with a specific dosing regimen, and aims to achieve an ASDAS inactive disease (≤1.3) at 4 weeks or 2 weeks of treatment. The compositions may also be administered with or without other medications like methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ). The patent also covers achieving specific clinical responses, such as ASAS20 at week 16 of treatment.

Plain-Language Overview of Independent Claims:

The patent appears to have multiple independent claims, each generally focusing on the use of a specific anti-TNF antibody (defined by its heavy chain SEQ ID NO:36 and light chain SEQ ID NO:37) for treating active Ankylosing Spondylitis (AS). Here's an overview:

• Independent Claims regarding Use of the Antibody for Treatment: These claims generally cover the use of the specified anti-TNF antibody for treating active AS. The key features include:

  • The antibody comprises a heavy chain with SEQ ID NO:36 and a light chain with SEQ ID NO:37.
  • It is administered via intravenous (IV) infusion.
  • A patient treated with the antibody achieves an ASDAS inactive disease (defined as ≤1.3) at 4 weeks or 2 weeks of treatment.
  • Some claims specify a dosage regimen: 2 mg/kg over 30 ± 10 minutes at Weeks 0 and 4, then every 8 weeks (q8w) thereafter.
  • Other claims indicate it can be administered with or without co-therapies such as methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ).
  • Further claims specify the achievement of ASAS20 (a clinical response criteria for AS) at week 16 of treatment, with or without a specified treatment difference compared to placebo.

• Independent Claims regarding Pharmaceutical Compositions: These claims generally cover a pharmaceutical composition containing the specified anti-TNF antibody. The characteristics of these compositions mirror the conditions of use outlined in the treatment claims:

  • The composition comprises the anti-TNF antibody (HC: SEQ ID NO:36, LC: SEQ ID NO:37) and at least one pharmaceutically acceptable carrier or diluent.
  • It is for use in treating active AS.
  • It is administered via IV infusion.
  • Patients treated achieve an ASDAS inactive disease (≤1.3) at 4 weeks or 2 weeks of treatment.
  • Specific dosage regimens (e.g., 2 mg/kg over 30 ± 10 minutes at Weeks 0 and 4, then q8w) are mentioned in some claims.
  • Administration with or without MTX, SSZ, or HCQ is also covered.

• Independent Claims regarding Methods of Treatment: These claims directly describe methods for treating a TNF-related condition, specifically active AS, using the defined antibody composition:

  • The method involves administering a composition containing a safe and effective amount of the anti-TNF antibody (HC: SEQ ID NO:36, LC: SEQ ID NO:37).
  • The composition is administered via IV infusion, often with the specified dosage and schedule.
  • The treatment results in a patient achieving ASDAS inactive disease (≤1.3) at 4 or 2 weeks, or ASAS20 at week 16.
  • Co-administration with other compounds (e.g., TNF antagonists, antirheumatics, NSAIDs) is also described in some method claims.

CAFC 2026 Dockets:

A search for CAFC 2026 dockets related to US11014982 indicates that there is litigation ongoing involving this patent. Specifically, Google Patents notes: "US case filed in Delaware District Court" and "PTAB case IPR2026-00256 filed (Pending)". This suggests that the validity or infringement of this patent is currently being challenged.

As of April 26, 2026, the following litigation involving US patent 11014982 is known:

• Jurisdiction: Delaware District Court

  • Case Number: 1:26-cv-00222
  • Status: Case filed.

• Jurisdiction: Patent Trial and Appeal Board (PTAB)

  • Case Number: IPR2026-00256
  • Status: Pending.

Proceedings overview

US patent 11014982 currently has one active AIA trial proceeding on file, IPR2026-00256, which is in a pending status. No claims have been invalidated or sustained by the PTAB yet. This means the patent's claims remain untested and susceptible to challenge, offering a defendant potential avenues for invalidation.

IPR2026-00256 — Accord BioPharma, Inc. et al. v. Janssen Biotech Inc

• Type: Inter Partes Review
• Filed: 2026-03-20
• Status: Pending – The proceeding has been filed and is awaiting a decision on institution.
• Judge panel: Information not yet publicly available at this stage.
• Petition grounds: Details regarding specific claims, prior art, and statutory bases (§ 102 / § 103 / § 112) are not yet public as the petition itself is not provided in the prompt. A typical IPR challenges patentability based on anticipation (§ 102) and/or obviousness (§ 103) over patents or printed publications.
• Institution decision: Not yet issued. The statutory deadline for the institution decision is typically six months from the filing date of the petition, which would be around September 20, 2026.
• Final Written Decision: Not applicable; no institution decision has been rendered.
• Settlement / termination: Not applicable; the proceeding is pending institution.
• Appeal: Not applicable; no Final Written Decision has been issued.
• Defensive value: This active IPR proceeding indicates that at least one party (Accord BioPharma, Inc. et al.) believes there are grounds to challenge the patentability of claims in US11014982. A defendant facing assertion of this patent should monitor this proceeding closely, as institution or eventual invalidation of claims would significantly weaken the patent owner's position.

Strategic summary

Currently, all claims of US11014982 remain UNTESTED by the PTAB, as the single IPR proceeding (IPR2026-00256) is still in the pre-institution phase. There are no claims that have been CANCELED or SUSTAINED by the PTAB to date.

The estoppel landscape has not yet been formed for this patent. Should IPR2026-00256 be instituted and proceed to a Final Written Decision, the petitioner (Accord BioPharma, Inc. et al.) and its privies would be estopped under § 315(e)(2) from asserting in future district court or ITC actions any invalidity ground they raised or reasonably could have raised in the IPR concerning the claims that went to final judgment. For other potential defendants, the prior art grounds raised by Accord BioPharma, Inc. et al. would likely still be available, unless they are in privy with the petitioner.

There is no discernible pattern of multiple IPR filings on this patent, as only one is currently recorded. There is no information yet on the patent owner's (Janssen Biotech Inc) aggressive pursuit of PTAB appeals, as no FWD has been issued. There is no indication of a defensive aggregator like Unified Patents being involved based on the provided petitioner information.

Recommended next steps

As IPR2026-00256 is pending institution, a key milestone to watch is the institution decision deadline around September 20, 2026. This decision will determine which, if any, claims proceed to trial. Parties facing assertion of US11014982 should monitor the PTAB's decision to institute, as this will clarify which specific claims are being challenged and on what grounds. Access to the petition would provide insight into the specific prior art and arguments being made against the patent.

Inventors

• Diane D. Harrison (Janssen Biotech Inc)
• Elizabeth C. Hsia (Janssen Biotech Inc)
• Lee-Lian Kim (Janssen Biotech Inc)
• Kim Hung Lo (Janssen Biotech Inc)

Original assignee

Janssen Biotech Inc is a pharmaceutical company that develops and commercializes biologic products, including anti-TNF antibodies. They ship products embodying the claims of this patent (e.g., SIMPONI® (golimumab), which is an anti-TNF-alpha monoclonal antibody for the treatment of various inflammatory conditions, including ankylosing spondylitis). Janssen Biotech Inc is currently operating as a subsidiary of Johnson & Johnson.

Assignment timeline

No assignments are recorded for US11014982 in the USPTO Assignment Center.

Timeline diagram

timeline
    title Ownership of US 11014982
    2019 : Filed by Janssen Biotech Inc
    2021 : 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

Operating-company assertion. The patent was filed and issued to Janssen Biotech Inc, an operating pharmaceutical company that markets products relevant to the patent's claims. There are no recorded assignments of this patent in the USPTO Assignment Center, indicating that ownership likely remains with the original assignee. The ongoing litigation in Delaware District Court (case 1:26-cv-00222) and the PTAB case (IPR2026-00256) suggest active assertion by Janssen Biotech Inc.

USPTO Assignment Center Search for US11014982

To identify the most relevant prior art for US Patent 11014982, I need to access the patent's citations from the USPTO database. Since I cannot directly browse the USPTO database in real-time, I will rely on the information provided in the patent text itself regarding cited prior art. The patent text lists several references, particularly in the "Prior art keywords" and "Prior art date" sections of the Google Patents page, and within the detailed description where various techniques and existing knowledge are cited.

Based on the provided patent text, here's an analysis of potentially relevant prior art mentioned, focusing on those directly cited rather than general knowledge. The patent refers to several general techniques and publications, but for specific prior art that could anticipate claims under 35 U.S.C. § 102, we look for previously issued patents or publications disclosing similar inventions.

The Google Patents page itself lists "Prior art keywords" and a "Prior art date" of 2017-02-07. This suggests that any prior art published or filed before this date could be relevant.

The patent text extensively discusses the background of TNF-alpha and its role in various diseases, and mentions previous work with anti-TNF antibodies. For example, it references "beneficial effects in open-label trials with a chimeric monoclonal antibody to TNF alpha (cA2)" and "Beneficial results in a randomized, double-blind, placebo-controlled trial with cA2" in rheumatoid arthritis and Crohn's disease. The patent also describes methods for producing antibodies, including humanized antibodies and transgenic animals, citing various U.S. patents for these techniques.

Without direct access to the "Examiner Citations" and "Applicant Citations" sections typically found in a USPTO patent document, I will identify the most relevant prior art mentioned or implied by the provided text that could potentially anticipate claims.

Most Relevant Prior Art (based on explicit mentions in the provided text):

The patent details a new use for an anti-TNF antibody with specific heavy and light chain sequences (SEQ ID NO:36 and SEQ ID NO:37) for treating active Ankylosing Spondylitis (AS) via IV infusion to achieve specific clinical outcomes. Therefore, the most relevant prior art would likely involve:

1. Prior art disclosing the specific anti-TNF antibody (SEQ ID NO:36 and SEQ ID NO:37) itself.
2. Prior art disclosing the use of any anti-TNF antibody for treating AS with similar outcomes, especially via IV infusion.
3. Prior art disclosing the specific anti-TNF antibody for treating other TNF-related conditions.

The patent mentions "cA2" extensively as a previously studied chimeric monoclonal antibody to TNF alpha. While not a direct citation with patent number, it is discussed as a known anti-TNF therapy and therefore represents relevant prior art in the field of TNF-alpha inhibition.

• Reference: Chimeric monoclonal antibody to TNF alpha (cA2)
  • Publication/Filing Date: Implied to be prior to the patent's priority date of 2017-02-07, as its effects in rheumatoid arthritis and Crohn's disease are discussed as established.
  • Brief Description: cA2 is a chimeric monoclonal antibody to TNF alpha that has shown beneficial effects in treating rheumatoid arthritis and Crohn's disease. The patent notes its use in open-label trials and randomized, double-blind, placebo-controlled trials. The figures and examples further detail its use as a comparative control in mouse models (e.g., FIGS. 11A-C, 13A-C, 15, 17).
  • Potential Anticipation (35 U.S.C. § 102):
    • If cA2 (or an antibody structurally identical or substantially similar to SEQ ID NOs:36 and 37) was previously disclosed for treating AS, it could anticipate claims related to the method of treatment for active AS (e.g., claims generally covering the method of administering an anti-TNF antibody for AS).
    • If cA2's mechanism of action and general therapeutic properties, including the ability to achieve similar clinical outcomes (like ASAS20 or ASDAS inactive disease) in other inflammatory conditions, were known, it could potentially anticipate the broader concept of anti-TNF therapy for AS, especially if the differences in the claimed antibody (SEQ ID NOs:36 and 37) are not sufficiently distinct or provide unexpected results compared to cA2 for AS. The patent specifically differentiates TNV148 from cA2 in animal models (e.g., "the 1 mg/kg TNV148 showed a significantly lower AI than 1 mg/kg cA2 at 3, 4 and 7 weeks"), suggesting the inventors believe their antibody has improved efficacy.

The patent also references several general scientific techniques and older patents, but these are generally for methods of making antibodies or genetic engineering techniques, rather than specific compositions or methods of treatment that would directly anticipate the core claims of this patent. Examples include:

• Ausubel, et al., ed., Current Protocols in Molecular Biology, John Wiley & Sons, Inc., NY, N.Y. (1987-2001); Sambrook, et al., Molecular Cloning: A Laboratory Manual, 2nd Edition, Cold Spring Harbor, N.Y.
  • These are general textbooks on molecular biology and cloning, providing foundational knowledge for antibody production. They would not anticipate specific antibody sequences or therapeutic uses.
• Milstein and Cuello, Nature 305:537 (1983)
  • Cited for methods of making bispecific antibodies. This is a methodological reference, not directly anticipating the specific antibody or its use in AS.
• Elliott et al., Lancet 344:1125-1127 (1994)
  • Cited in the context of defining "low immunogenicity" for antibodies (HAHA, HACA, HAMA responses). This defines a characteristic, but doesn't disclose the invention.
• U.S. Pat. Nos. 5,770,428, 5,569,825, 5,545,806, 5,625,126, 5,625,825, 5,633,425, 5,661,016 and 5,789,650 issued to Lonberg et al.
  • These patents are cited for methods of producing transgenic mice capable of producing human antibodies. They cover the method of making such antibodies, not the specific anti-TNF antibody of the present invention or its use in AS.
• U.S. Pat. Nos. 5,827,690; 5,849,992; 4,873,316; 5,849,992; 5,994,616; 5,565,362; 5,304,489
  • These patents are cited for methods of producing transgenic animals (e.g., goats, cows) that produce antibodies in their milk. Again, these are manufacturing methods, not directly anticipatory of the specific antibody or its therapeutic use for AS.

Without the actual "References Cited" section from the USPTO patent document for US11014982, it is difficult to provide a comprehensive list of all prior art considered by the examiner. However, based on the narrative in the patent, the existence and efficacy of other anti-TNF antibodies (like cA2) for inflammatory conditions would be a primary area of prior art to consider when evaluating the novelty and non-obviousness of using a specific anti-TNF antibody (with SEQ ID NO:36 and SEQ ID NO:37) for treating active Ankylosing Spondylitis with specified outcomes.

A thorough prior art analysis would require examining each patent and non-patent literature cited in the official USPTO record for US11014982, specifically focusing on disclosures of:

• The exact antibody sequences (SEQ ID NOs:36 and 37).
• Anti-TNF therapy for Ankylosing Spondylitis.
• Specific dosing regimens and administration routes (IV infusion).
• Achieving ASDAS inactive disease or ASAS20 in AS patients.

Given the current information, cA2, as a known anti-TNF antibody for inflammatory conditions, serves as a significant conceptual prior art mentioned within the patent text itself. The patent then describes its specific anti-TNF antibody (e.g., TNV148) and differentiates its efficacy from cA2 in certain models, suggesting that the novelty lies in the specific antibody's structure and/or its specific efficacy profile in AS.

Obviousness Analysis under 35 U.S.C. § 103 for US Patent 11014982

This analysis identifies combinations of prior art that would render the claims of US Patent 11014982 obvious to a person having ordinary skill in the art (PHOSITA), along with the motivations for combining such references.

Claims Overview

The independent claims of US Patent 11014982 generally cover:

1. An anti-TNF antibody comprising a heavy chain (HC) of SEQ ID NO:36 and a light chain (LC) of SEQ ID NO:37.
2. Use of this antibody for treating active Ankylosing Spondylitis (AS) via intravenous (IV) infusion.
3. Specific dosing regimens (e.g., 2 mg/kg over 30 ± 10 minutes at Weeks 0 and 4, then every 8 weeks thereafter).
4. Achieving specific clinical outcomes (e.g., ASDAS inactive disease (≤1.3) at 2 or 4 weeks, or ASAS20 at week 16).
5. Compositions containing this antibody.
6. Methods involving co-administration with methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ).

Prior Art Combination: Anti-TNF Therapy for AS via IV Infusion + Routine Optimization

Combination: FIG. 18 of US11014982 detailing a clinical trial for Simponi (golimumab) in active AS via IV infusion, combined with the general knowledge regarding anti-TNF therapies and routine pharmaceutical development practices.

Prior Art References:

• Reference 1: FIG. 18 of US11014982. This figure explicitly depicts a "diagram of the study design for trial of Simponi (golimumab), administered intravenously, in subjects with active Ankylosing Spondylitis (AS)." This directly teaches the use of an anti-TNF antibody, golimumab, for the treatment of active AS via intravenous administration.
• Reference 2: General Knowledge of Anti-TNF Therapies. The patent itself acknowledges the established role of anti-TNF alpha antibodies, such as cA2 (infliximab), in treating inflammatory diseases like rheumatoid arthritis and Crohn's disease, noting "beneficialal effects" and "suppression of inflammation." It also states that "TNF alpha has been implicated in inflammatory diseases, autoimmune diseases... and is a useful target for specific biological therapy in diseases, such as rheumatoid arthritis and Crohn's disease." This demonstrates the widespread understanding of TNF alpha as a target and anti-TNF antibodies as therapeutic agents for a range of autoimmune and inflammatory conditions, including spondyloarthropathies.
• Reference 3: Routine Pharmaceutical Development and Clinical Practice. The patent also states that "suitable dosages are well known in the art," referencing standard pharmacological handbooks. The practice of optimizing dosage regimens (dose, frequency, infusion duration) for a therapeutic agent for a known indication is a routine aspect of drug development. Similarly, the co-administration of biologics with traditional disease-modifying antirheumatic drugs (DMARDs) like MTX, SSZ, or HCQ is a common and established treatment strategy in rheumatology to improve efficacy or manage disease, as implicitly acknowledged by the patent's own definitions. Clinical endpoints like ASDAS inactive disease and ASAS20 are standard, widely recognized metrics for evaluating treatment success in AS.

Motivation for a PHOSITA to Combine These References:

A PHOSITA would be motivated to combine the teachings of these references for the following reasons:

1. Established Therapeutic Class and Indication: Given the known efficacy of anti-TNF antibodies in treating various inflammatory and autoimmune conditions (Reference 2) and, crucially, the explicit disclosure in FIG. 18 of a clinical trial for golimumab (another anti-TNF antibody) specifically for active AS via IV infusion (Reference 1), a PHOSITA would have a strong expectation of success and a clear motivation to investigate other anti-TNF antibodies for the same indication and route of administration. The fact that a closely related anti-TNF antibody was already being evaluated for AS by IV infusion would suggest that this approach was a logical and expected therapeutic strategy.

2. Routine Antibody Development: The patent itself discusses various methods for producing antibodies, including human, chimeric, humanized, or CDR-grafted antibodies, and methods like hybridoma technology and phage display. While SEQ ID NOs 36 and 37 define a specific antibody, a PHOSITA would understand that identifying new antibodies within a known therapeutic class, especially by employing conventional techniques to generate human or humanized antibodies with improved properties (e.g., reduced immunogenicity, specific binding characteristics), is a routine endeavor. The development of an antibody like the one claimed (e.g., TNV148, which the patent associates with the claimed CDRs and sequences) would therefore be considered an expected outcome of standard antibody engineering efforts, particularly when a target (TNF alpha) and an indication (AS) are already established for the class.

3. Predictable Optimization of Treatment Regimens: Once the use of an anti-TNF antibody for active AS via IV infusion is established (as by Reference 1), optimizing the specific dosage (2 mg/kg), frequency (Weeks 0 & 4, then q8w), and infusion duration (30 ± 10 minutes) would be a matter of routine clinical investigation and dose-finding studies. A PHOSITA would expect to conduct such studies to determine the most effective and safe regimen for a new antibody within the class, aiming to achieve known and desired clinical endpoints such as ASDAS inactive disease or ASAS20. These clinical outcomes are standard measures in AS trials and are the expected results of an effective treatment rather than unexpected breakthroughs.

4. Standard Adjunctive Therapy: The co-administration of the anti-TNF antibody with traditional DMARDs like MTX, SSZ, or HCQ is a well-known and often preferred practice in managing chronic inflammatory conditions, including AS. This combination therapy is aimed at enhancing therapeutic efficacy, reducing immunogenicity, or managing different aspects of the disease. A PHOSITA would find it obvious to explore such combinations for any new anti-TNF therapy for AS.

In summary, the combination of the specific prior art demonstrating anti-TNF antibody (golimumab) use for active AS via IV infusion (FIG. 18) with the general knowledge of anti-TNF therapies and routine clinical development practices would have rendered the claimed methods and compositions obvious to a PHOSITA. The specific antibody (SEQ ID NOs 36/37) would be considered an obvious variant or optimization within the known class of anti-TNF antibodies for AS, and its administration parameters and co-therapies would fall within the realm of routine clinical optimization.