US 11041020

US patent 11041020 is titled "Methods for the treatment of active Psoriatic Arthritis".

Assignee: Janssen Biotech Inc.
Inventors: Diane D. Harrison, Elizabeth C. Hsia, Lee-Lian Kim, Kim Hung Lo.
Filing Date: July 20, 2019.
Issue Date: June 22, 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 Psoriatic Arthritis (PsA). The invention includes antibodies, nucleic acids encoding them, and methods of making and using such antibodies for diagnosis and therapy of TNF-related conditions. The treatment can involve administering an effective amount of the anti-TNF antibody, optionally with other therapeutic agents, to a subject in need thereof.

Plain-language overview of each independent claim:

• Independent Claim 1: This claim covers a method for treating active Psoriatic Arthritis. The method involves administering a specific anti-TNF antibody via intravenous (IV) infusion. The antibody must have a heavy chain with the amino acid sequence of SEQ ID NO:36 and a light chain with the amino acid sequence of SEQ ID NO:37. The claim specifies that this treatment must achieve certain clinical responses, which are listed in a table within the patent (ACR20, ACR50, ACR70, PASI 75, Minimal Disease Activity MDA at Week 14, and ACR50 at Week 24).

• Independent Claim 2: This claim is similar to Claim 1, focusing on a method for treating active Psoriatic Arthritis using the same specific anti-TNF antibody administered via IV infusion. The key difference is that this claim specifies a particular outcome: at least 65% of patients receiving the treatment must achieve an ACR20 response at week 14 of treatment.

• Independent Claim 3: This claim builds upon Claim 2 by further defining the administration schedule and dose. It specifies that the anti-TNF antibody (with HC comprising SEQ ID NO:36 and LC comprising SEQ ID NO:37) is administered via IV infusion at a dose of 2 mg/kg over 30 ± 10 minutes at Weeks 0 and 4, and then every 8 weeks thereafter (q8w). The outcome requirement remains that at least 65% of patients achieve an ACR20 at week 14.

• Independent Claim 4: This claim adds another layer of specificity to Claim 3. It includes all the details of Claim 3 regarding the specific antibody, administration, dose, and schedule. Additionally, it requires that the 65% of patients achieving an ACR20 at week 14 demonstrate a "treatment difference" (improvement compared to placebo) of at least 50%.

• Independent Claim 5: This claim describes a composition for treating active Psoriatic Arthritis. The composition comprises a safe and effective amount of the isolated mammalian anti-TNF antibody (with HC comprising SEQ ID NO:36 and LC comprising SEQ ID NO:37). The claim specifies that this composition is for use in IV infusion at a dose of 2 mg/kg over 30 ± 10 minutes at Weeks 0 and 4, and then every 8 weeks thereafter. The composition, when used this way, must result in at least 65% of patients achieving an ACR20 at week 14.

• Independent Claim 6: This claim is similar to Claim 5 but adds the "treatment difference" requirement seen in Claim 4. It's for a composition comprising the specified anti-TNF antibody, for use in the same IV infusion regimen, where at least 65% of patients achieve an ACR20 at week 14 with a treatment difference (improvement compared to placebo) of at least 50%.

Regarding CAFC 2026 dockets, a review of the May and June 2026 scheduled cases for the United States Court of Appeals for the Federal Circuit (CAFC) did not show any cases specifically listing patent 11041020.

US Patent 11041020 has been involved in the following litigation:

1. District Court Case

• Jurisdiction: Delaware District Court
• Case Number: 1:26-cv-00222
• Status: Filed
• Plaintiff(s) and Defendant(s), and Filing Date: Not specified in the provided information.

2. PTAB Case

• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Case Number: IPR2026-00257
• Status: Pending
• Petitioner: Not specified in the provided information, other than "Petitioner:".
• Filing Date: Not specified in the provided information.

It is important to note that publicly available summaries of patent litigation, such as those found on Google Patents and Unified Patents, may not always contain all details of a case, such as the specific plaintiffs and defendants at the time of initial filing for all records. For comprehensive information, direct access to court dockets via PACER or a specialized IP litigation intelligence platform like Darts-ip would be necessary.

Proceedings overview

There is one AIA trial proceeding on file for US Patent 11,041,020. This proceeding is currently active and pending an institution decision. Given the active status, there are no claims invalidated or sustained, which means the patent's claims remain untested by a Final Written Decision. This situation presents a defendant with the opportunity to potentially leverage the pending IPR to challenge the patent's validity.

IPR2026-00257 — Accord BioPharma, Inc. et al. v. Janssen Biotech Inc

• Type: Inter Partes Review
• Filed: 2026-03-20
• Status: Pending. The proceeding is ongoing and has not yet reached a final decision on institution or merits.
• Judge panel: Information not publicly available yet through general search for this pending IPR.
• Petition grounds: Information not publicly available yet through general search for this pending IPR, as an institution decision has not been rendered.
• Institution decision: Not yet issued. The statutory deadline for the institution decision is 2026-09-20 (six months from the filing date).
• Final Written Decision: Not applicable; the proceeding is pending institution.
• Settlement / termination: Not applicable; the proceeding is pending institution.
• Appeal: Not applicable; no Final Written Decision has been issued.
• Defensive value: This active IPR means that the patent's validity is currently under challenge. A defendant facing assertion of this patent could monitor the outcome of this IPR closely, as a decision to institute and subsequently invalidate claims could significantly weaken the patent owner's position. Conversely, a decision to deny institution or sustain the claims would strengthen the patent owner's hand against future IPR challenges based on the same grounds.

Strategic summary

As of today, May 29, 2026, US Patent 11,041,020 has one active Inter Partes Review, IPR2026-00257, filed by Accord BioPharma, Inc. et al. This proceeding is in its early stages, with the institution decision pending. Consequently, all claims of US11041020 remain untested by a PTAB Final Written Decision, meaning there are no claims that have been canceled or sustained through an IPR.

The estoppel landscape is currently limited because no institution decision or Final Written Decision has been rendered. If IPR2026-00257 is instituted and proceeds to a Final Written Decision, § 315(e)(2) estoppel would apply to Accord BioPharma, Inc. et al. (and their privies) for any claims challenged and any grounds raised or that reasonably could have been raised. However, for a defendant not privy to Accord BioPharma, Inc. et al., the full range of prior art grounds under §§ 102 and 103 would remain available for potential future challenges, assuming the current IPR doesn't invalidate claims. There are no clear pattern signals yet, as this is the first listed AIA trial for this patent. The petitioner, Accord BioPharma, Inc. et al., is a named party, indicating a direct interest rather than a defensive aggregator like Unified Patents.

Recommended next steps

For a defendant being asserted against, the most important next step is to closely monitor the progress of IPR2026-00257. The institution decision is due by 2026-09-20.

• Monitor IPR2026-00257: Track the institution decision for IPR2026-00257. If the PTAB decides to institute the IPR, carefully review the institution decision to understand which claims and grounds were instituted. This will provide early insight into the patent's potential vulnerability.
• Evaluate potential for joinder or new IPR: Depending on the strength of the grounds in IPR2026-00257 and a defendant's own prior art analysis, consider whether joinder to the existing IPR is strategically advantageous (if available) or if preparing a new IPR petition with different, strong prior art is warranted if institution is denied or only partially granted.
• Access Public Information: Once available, the institution decision and any subsequent filings for IPR2026-00257 will be accessible on the USPTO PTAB E2E system. Search for "IPR2026-00257" on the PTAB website to access the public record.

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)

No unusual patterns observed regarding inventors' departure from the original assignee.

Original assignee

Janssen Biotech Inc. is the entity named on the issued patent. Janssen Biotech Inc. is a pharmaceutical company that develops and markets biological therapeutics. They ship products embodying the claims, specifically in the area of immunology and autoimmune diseases. Janssen Biotech Inc. is currently operating as a subsidiary of Johnson & Johnson.

Assignment timeline

No assignment records were found for US11041020 on the USPTO Patent Assignment Search database.

Timeline diagram

timeline
    title Ownership of US 11041020
    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 (no assignment records)
4. Cascading transfers — not present (no assignment records)
5. Pre-litigation transfer — unclear (no assignment records, litigation status is known to be present, but the transfer date is unknown, therefore it is unclear if there was pre-litigation transfer.)
6. Bankruptcy fire-sale — not present
7. Privateering — not present
8. Defensive aggregator (anti-NPE) — not present

Verdict

Insufficient data. There are no recorded assignments for US11041020 on the USPTO Assignment Center, making it impossible to reconstruct an ownership chain or identify any NPE/troll patterns from assignment records. The patent is currently assigned to Janssen Biotech Inc. as the original assignee.

USPTO Assignment Center search page: https://assignmentcenter.uspto.gov/

To identify the most relevant prior art for US patent 11041020, I will search the USPTO database for the specific patent number and examine its cited references. I will then analyze each reference for its publication/filing date, brief description, and potential anticipation under 35 U.S.C. § 102.

Search for US Patent 11041020:

Based on the provided patent text, US Patent 11041020 is titled "Methods for the treatment of active Psoriatic Arthritis" and was issued on June 22, 2021, from an application filed on July 20, 2019.

The patent itself lists prior art under "References Cited." I will extract these references and analyze them.

Prior Art Analysis for US Patent 11041020:

The patent text provides a "Prior art date" of 2017-01-30. The legal status is "Active".

To perform a thorough prior art analysis under 35 U.S.C. § 102, each claim would need to be compared in detail against the disclosures of the prior art references. Without access to a comprehensive list of all cited prior art within US11041020 from the provided text, I will identify the references mentioned in the "Prior art keywords" and "Other versions" sections.

From the "Prior art keywords" and "Other versions" sections in the provided text, the following are mentioned:

• US20190338022A1: This is listed as "Other versions" of the patent. This is likely an earlier publication of the same patent application, rather than prior art. Its publication date is 2019-11-07. This would not typically be considered prior art to US11041020 under 35 U.S.C. § 102 as it shares the same priority date and is an earlier publication of the same content.

To identify actual prior art, I would need to access the full list of "References Cited" from the patent document itself, which is not fully provided in the prompt. The provided text, however, defines "prior art" in general terms: "Information known publicly before the effective filing date of a U.S. patent application is called prior art." This includes U.S. patents and published patent applications, foreign patents and applications, journal articles, books, manuals, catalogs, websites, conference proceedings, and scientific papers.

Without the complete list of cited prior art from the patent document, I cannot definitively provide "full citation, publication/filing date, brief description, and which claim(s) it potentially anticipates under 35 U.S.C. § 102" for each reference. However, the patent itself makes general references to existing knowledge and techniques as "known in the art," which would broadly fall under prior art.

For instance, the patent mentions:

• Milstein and Cuello, Nature 305:537 (1983) for methods of making bispecific antibodies.
• Elliott et al., Lancet 344:1125-1127 (1994) regarding low immunogenicity.
• 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. for general recombinant antibody production.
• U.S. Pat. No. 5,627,052, Wen et al., J. Immunol. for SLAM technology.
• Winter (Jones et al., Nature 321:522 (1986); Riechmann et al., Nature 332:323 (1988); Verhoeyen et al., Science 239:1534 (1988)), Sims et al., J. Immunol. 151: 2296 (1993); Chothia and Lesk, J. Mol. Biol. 196:901 (1987), Carter et al., Proc. Natl. Acad. Sci. U.S.A. 89:4285 (1992); Presta et al., J. Immunol. 151:2623 (1993), U.S. for humanization or engineering of antibodies.
• 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.; Jakobovits et al. WO 98/50433, Jakobovits et al. WO 98/24893, Lonberg et al. WO 98/24884, Lonberg et al. WO 97/13852, Lonberg et al. for transgenic animals producing human antibodies.
• 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 for transgenic animals producing antibodies in milk.
• Cramer et al., Curr. Top. Microbol. Immunol. 240:95-118 (1999) and Hood et al., Adv. Exp. Med. Biol. 464:127-147 (1999) for transgenic plants producing antibodies.
• Colligan, Immunology; Kuby, Janis Immunology; Berzofsky, et al., "Antibody-Antigen Interactions," In Fundamental Immunology for affinity determination methods.
• U.S. Pat. Nos. 4,683,195, 4,683,202, 4,800,159, 4,965,188, to Mullis, et al.; U.S. Pat. Nos. 4,795,699 and 4,921,794 to Tabor, et al; U.S. Pat. No. 5,142,033 to Innis; U.S. Pat. No. 5,122,464 to Wilson, et al.; U.S. Pat. No. 5,091,310 to Innis for PCR methods.
• U.S. Pat. Nos. 4,399,216; 4,634,665; 4,656,134; 4,956,288; 5,149,636; 5,179,017 for DHFR markers.
• U.S. Pat. Nos. 5,122,464; 5,770,359; 5,827,739 for GS markers.
• U.S. Pat. Nos. 5,168,062; 5,385,839 for CMV promoter.
• U.S. Pat. Nos. 5,580,734, 5,641,670, 5,733,746, and 5,733,761 for methods of expressing nucleic acids in host cells.
• Katsube, Y., et al., Int J Mol. Med, 1(5):863-868 (1998) for phage display.
• Cunningham and Wells, Science 244:1081-1085 (1989) for alanine-scanning mutagenesis.
• Fisch et al., Bioconjugate Chem., 3:147-153 (1992); Werlen et al., Bioconjugate Chem., 5:411-417 (1994); Kumaran et al., Protein Sci. 6(10):2233-2241 (1997); Itoh et al., Bioorg. Chem., 24(1): 59-68 (1996); Capellas et al., Biotechnol. Bioeng., 56(4):456-463 (1997) for reverse proteolysis.
• Hermanson, G. T., Bioconjugate Techniques, Academic Press: San Diego, Calif. (1996) for methods to introduce activating groups into molecules and preparation of modified human antibodies.
• Wells et al., eds., Pharmacotherapy Handbook, 2nd Edition, Appleton and Lange, Stamford, Conn. (2000); PDR Pharmacopoeia, Tarascon Pocket Pharmacopoeia 2000, Deluxe Edition, Tarascon Publishing, Loma Linda, Calif. (2000) for suitable dosages.
• Gennaro, Ed., Remington's Pharmaceutical Sciences, 18th Edition, Mack Publishing Co. (Easton, Pa.) 1990; "Remington: The Science & Practice of Pharmacy", 19th ed., Williams & Williams, (1995); and "Physician's Desk Reference", 52nd ed., Medical Economics, Montvale, N.J. (1998) for pharmaceutical compositions and carriers.

These general references represent established scientific and patent knowledge that would contribute to the overall landscape of prior art but do not represent specific anticipatory citations for the particular anti-TNF antibody and treatment regimen claimed in US11041020. Without the actual "References Cited" section from the patent, I cannot provide the specific detailed analysis requested for direct anticipation under 35 U.S.C. § 102.

Obviousness Analysis of US Patent 11041020 under 35 U.S.C. § 103

This analysis aims to determine if the claims of US patent 11041020, which focuses on methods and compositions for treating active Psoriatic Arthritis (PsA) using a specific anti-TNF antibody (golimumab, identified by SEQ ID NOs: 36 and 37 for heavy and light chains, respectively), would have been obvious to a person having ordinary skill in the art (POSA) at the time of the invention (priority date January 30, 2017).

Background Prior Art

Prior to the priority date of January 30, 2017, the general concept of anti-TNF therapy for autoimmune diseases, including PsA, was well-established. Golimumab (Simponi) as a human anti-TNFα monoclonal antibody was approved by the US FDA in April 2009 for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) via subcutaneous (SC) injection. This demonstrates that the antibody itself and its efficacy in PsA were known.

Furthermore, prior to the patent's priority date, intravenous (IV) golimumab (Simponi Aria) had been FDA approved in 2013 for the treatment of moderately to severely active rheumatoid arthritis in combination with methotrexate. The recommended dosage for RA was 2 mg/kg administered via IV infusion over 30 minutes at Weeks 0 and 4, and every 8 weeks thereafter.

Crucially, the patent itself acknowledges that "FIG. 18 shows diagram of the study design for trial of Simponi (golimumab), administered intravenously, in subjects with active Psoriatic Arthritis (PsA)". This indicates that a clinical trial investigating IV golimumab for active PsA was either ongoing or its design was known at the time of the invention. Indeed, publicly available information confirms that the Phase 3 GO-VIBRANT study, which evaluated IV golimumab for active PsA using a 2 mg/kg dose at weeks 0 and 4, and then every 8 weeks, was underway and its data was presented at the 2017 Annual European Congress of Rheumatology in Madrid (before the FDA approval for IV PsA). The FDA was actively reviewing Simponi Aria for PsA and AS based on these Phase 3 studies prior to October 2017. The FDA approval for IV Simponi Aria for PsA ultimately occurred on October 20, 2017.

Obviousness Arguments

The independent claims of US 11041020 generally cover methods and compositions for treating active Psoriatic Arthritis using an anti-TNF antibody with HC SEQ ID NO:36 and LC SEQ ID NO:37 (golimumab) via IV infusion, often specifying a 2 mg/kg dose at Weeks 0, 4, and then every 8 weeks, to achieve particular clinical responses (e.g., ACR20 at week 14).

Combination of Prior Art: Golimumab (SC) for PsA + IV Golimumab for RA + Known Efficacy of Anti-TNF in PsA + Ongoing Clinical Trials of IV Golimumab for PsA

A POSA, as of January 30, 2017, would have been aware of the following:

1. Golimumab's established efficacy in Psoriatic Arthritis (PsA) via subcutaneous (SC) administration: Golimumab (Simponi) was approved for PsA in 2009 for SC injection. This provided a clear expectation that golimumab, regardless of the route of administration, would be an effective treatment for PsA.
2. Golimumab's established intravenous (IV) administration for Rheumatoid Arthritis (RA): IV golimumab (Simponi Aria) was approved for RA in 2013, with a well-defined dosage regimen of 2 mg/kg via IV infusion over 30 minutes at Weeks 0 and 4, and every 8 weeks thereafter. RA and PsA are both chronic inflammatory rheumatic diseases, often treated with similar classes of biologics, including TNF inhibitors.
3. The known role of TNF-α in PsA pathophysiology: Elevated levels of TNF-α are known to play a role in the pathophysiology of psoriatic arthritis, making anti-TNF therapy a rational approach.
4. The existence and design of the GO-VIBRANT trial: Prior to the priority date, the GO-VIBRANT Phase 3 study was evaluating IV golimumab for active PsA, specifically using the 2 mg/kg IV infusion regimen at weeks 0 and 4, and then every 8 weeks. The primary endpoint of this trial was ACR20 response at week 14. Data from this study, showing improvement in joint and skin symptoms, was presented in 2017.

Motivation to Combine:

A POSA would have been motivated to combine these pieces of prior art for several reasons:

• Established Mechanism of Action: Given that golimumab (SC) was already approved and effective for PsA, and IV golimumab was effective for RA (a related inflammatory condition), it would have been a logical and obvious step to investigate the IV formulation of golimumab for PsA. The mechanism of action (TNF-α inhibition) is the same regardless of the delivery method.
• Known Dosage and Regimen: The 2 mg/kg IV infusion regimen (Weeks 0, 4, then every 8 weeks) was already established and approved for IV golimumab in RA. It is common practice in pharmaceutical development to explore similar dosage regimens for related indications, especially when the drug itself (golimumab) is already known to be effective in the disease (PsA).
• Clinical Need and Preference: There is a continuous need for new treatment options and alternative administration routes for patients with chronic diseases like PsA. Some patients may prefer IV administration over SC injections, and a 30-minute infusion time would be considered an important new treatment option. Therefore, exploring an IV formulation for PsA would address a known patient and clinical need.
• Predictable Outcomes: The American College of Rheumatology (ACR) criteria (ACR20, ACR50, ACR70) and Psoriasis Area and Severity Index (PASI) scores are standard clinical endpoints for evaluating the efficacy of treatments for PsA and other rheumatic diseases. Given golimumab's known efficacy in PsA (via SC) and RA (via IV), achieving a clinical response as measured by these standard metrics (e.g., ACR20 at week 14) would be an expected outcome, not a surprising one, when applying the IV formulation and established RA dosing regimen to PsA patients. The patent itself provides clinical efficacy data at week 14 and week 24, including ACR20 results, for IV golimumab in PsA, which were generated from the GO-VIBRANT study that was already underway.

Therefore, the claims specifying the use of golimumab (HC SEQ ID NO:36, LC SEQ ID NO:37) via IV infusion at 2 mg/kg (Weeks 0, 4, then q8w) for active PsA to achieve standard clinical responses (ACR20, ACR50, etc.) would have been obvious to a POSA as of the priority date. The specific percentages of patients achieving these responses and the "treatment difference" compared to placebo (as recited in claims 2, 4, 5, and 6) represent the results of an obvious clinical study, rather than an inventive concept itself. These results would have been considered predictable variations of expected efficacy for an already-approved drug in a related indication, especially given that the clinical trial to generate these results was already in progress or its design was known in the art.

Conclusion

Based on the available prior art, the methods and compositions claimed in US patent 11041020, particularly the use of intravenous golimumab (Simponi Aria) at 2 mg/kg (Weeks 0, 4, then every 8 weeks) for the treatment of active Psoriatic Arthritis to achieve specific clinical endpoints, would have been obvious to a person having ordinary skill in the art by the priority date of January 30, 2017. The combination of established subcutaneous golimumab for PsA, established intravenous golimumab for RA (with the same dosage regimen), and the known pathophysiology of PsA would have provided a strong motivation for a POSA to apply IV golimumab to treat active PsA. The clinical outcomes described in the claims represent the expected efficacy of such a known drug in a closely related condition, especially when a Phase 3 clinical trial specifically investigating this use was already known in the art.