US 12122824

Here's a concise summary of US Patent 12122824:

US Patent 12122824B2

• 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: May 14, 2021 (Application number US17/320,490)
• Issue Date: October 22, 2024
• 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).

Plain-Language Overview of Independent Claims:

The patent includes several independent claims, generally covering methods for treating active ankylosing spondylitis (AS) and specific anti-TNF antibodies for use in such treatment, with detailed administration protocols and efficacy criteria. All independent claims specify the use of an isolated mammalian anti-TNF antibody having a heavy chain comprising SEQ ID NO:36 and a light chain comprising SEQ ID NO:37.

• Claim 1 (Method of Treatment): This claim describes a method for treating active ankylosing spondylitis by administering the specified anti-TNF antibody via intravenous (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 method is defined by achieving a clinical response where at least 65% of patients reach an ASAS20 at week 14 of treatment.
• Claim 16 (Method of Treatment with Placebo Comparison): Similar to Claim 1, this method also treats active ankylosing spondylitis with the same antibody, dosage, and administration schedule. The key difference is the efficacy criterion: at least 50% of patients achieve an ASAS20 at week 14, with a treatment difference (improvement compared to placebo) of at least 50%.
• Claim 17 (Method of Treatment for ASAS40): This claim outlines a method for treating active ankylosing spondylitis using the same antibody, dosage, and administration as Claim 1. The efficacy measure here is that at least 40% of patients achieve an ASAS40 at week 14 of treatment.
• Claim 22 (Method of Treatment for ASAS40 with Placebo Comparison): This method targets active ankylosing spondylitis with the identical antibody, dose, and schedule. The efficacy is defined by at least 30% of patients achieving an ASAS40 at week 14, with a treatment difference (improvement compared to placebo) of at least 50%.
• Claim 23 (Antibody for Use - Clinical Response Table): This claim describes the isolated mammalian anti-TNF antibody (with SEQ ID NO:36 HC and SEQ ID NO:37 LC) for use in treating active ankylosing spondylitis. The antibody is administered via IV infusion and is characterized by inducing a clinical response selected from a group of responses detailed in an accompanying table (not explicitly reproduced here, but specifies various ASAS responses at different weeks and percentages).
• Claim 27 (Antibody for Use - ASAS20): This claim defines the isolated mammalian anti-TNF antibody (with SEQ ID NO:36 HC and SEQ ID NO:37 LC) for use in treating active ankylosing spondylitis via IV infusion, where at least 65% of patients achieve an ASAS20 at week 14 of treatment.
• Claim 30 (Antibody for Use - Specific Dosing & ASAS20): This claim specifies the isolated mammalian anti-TNF antibody (with SEQ ID NO:36 HC and SEQ ID NO:37 LC) for use in treating active ankylosing spondylitis. It includes the precise administration schedule: IV infusion at 2 mg/kg over 30±10 minutes at Weeks 0 and 4, then every 8 weeks thereafter. The efficacy criterion is that at least 65% of patients achieve an ASAS20 at week 14 of treatment.
• Claim 31 (Antibody for Use - Specific Dosing & ASAS20 with Placebo Comparison): Similar to Claim 30, this claim details the same antibody, dose, and administration schedule for treating active ankylosing spondylitis. The efficacy is defined by at least 65% of patients achieving an ASAS20 at week 14, with a treatment difference (improvement compared to placebo) of at least 50%.

Litigation Dockets (as of April 26, 2026):

While no direct CAFC dockets for 2026 were found, Google Patents indicates that the patent family is involved in active litigation:

• A case was filed in the Delaware District Court: 1:26-cv-00222.
• A PTAB case, IPR2026-00258, has been filed and is currently pending.