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.