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.