On June 16, 2026, the U.S. Patent and Trademark Office issued U.S. Patent No. 12,655,207, titled “Safe and effective method of treating psoriasis with anti-IL-23 specific antibody,” to Janssen Biotech, Inc. Guselkumab — the IL-23-specific antibody named in the patent — is one of the anchor assets in the dermatology and immunology franchise Janssen built around interleukin-23 blockade, and this grant is a clean example of a method-of-treatment patent doing strategic work that a composition-of-matter patent cannot.
The first thing to fix in your mind is the category. This is not a patent on the antibody. It is a patent on a way of using the antibody — a method claim whose limitations are clinical: which antibody, at what kind of dose, in which patients, achieving which measured outcomes, by when. Method-of-treatment claims are the workhorse of biologic lifecycle management because they can issue years after the molecule patent, carry their own term, and force a generic or biosimilar competitor to thread the needle between copying the product and inducing the patented method of use.
"A method of treating psoriasis in a patient by administering an IL-23 specific antibody, e.g., guselkumab, in a clinically proven safe and clinically proven effective amount and the patient achieves PASI90, PASI100 or IGA 0 or 1 score as measured 16, 24, 32, 40 and 48 weeks after initial treatment and the patient achieves higher efficacy than a patient treated with the secukinumab antibody."— U.S. Patent No. 12,655,207, source
The claim limitations that matter
Read the abstract as a litigator would, limitation by limitation. The method recites: administering an IL-23-specific antibody — exemplified by guselkumab — in a “clinically proven safe and clinically proven effective amount.” The patient then “achieves PASI90, PASI100 or IGA 0 or 1” — these are standardized psoriasis endpoints, where PASI90 means a 90 percent reduction in the Psoriasis Area and Severity Index, PASI100 means complete clearance, and an Investigator’s Global Assessment (IGA) of 0 or 1 means clear or almost-clear skin. Those outcomes are recited “as measured 16, 24, 32, 40 and 48 weeks after initial treatment.” And the closing limitation is the unusual one: the patient “achieves higher efficacy than a patient treated with the secukinumab antibody.”
That last clause is what makes this grant interesting from a claim-construction standpoint. Secukinumab is an anti-IL-17A antibody — a different mechanism and a direct market competitor in moderate-to-severe psoriasis. Janssen has, in effect, attempted to write the head-to-head superiority result into the claim itself as a functional limitation. That is an aggressive drafting posture. Comparative-efficacy limitations of this kind raise immediate questions an examiner and, later, an accused infringer will press: is “higher efficacy than secukinumab” a definite, measurable boundary, or an indefiniteness problem? Is it a true limitation that narrows the claim, or surplusage describing an inherent result of practicing the dosing regimen? The answer turns on the issued independent claims and the prosecution history — and the cardinal rule applies here: the abstract describes embodiments, it does not define the enforceable scope. Anyone assessing this patent must read what the granted claims actually recite, not the marketing-flavored summary.
Where the inventive weight sits
The classification points to a method-and-formulation case rather than a molecule case. The patent carries CPC symbols C07K 16/244 and C07K 16/241 — immunoglobulins against interleukins — alongside A61K 39/395 (medicinal preparations containing antibodies), A61P 17/06 (the pharmacological-activity symbol for antipsoriatics), C07K 2317/21 and 2317/565 (antibody-structure sub-symbols), and notably A61K 45/06, the symbol for mixtures of active ingredients. The A61P 17/06 designation confirms the therapeutic indication is baked into the classification, and the A61K 45/06 tag hints at combination or comparative-treatment context. The inventor team — Julianty Angsana, Patrick Branigan, Samuel DePrimo, Susan Flavin, Shu Li, Xuejun Liu, Ernesto Munoz, and Bruce Randazzo — reads like a clinical-development and translational group, which is exactly who you would expect to name on a patent whose novelty rests on demonstrated clinical outcomes rather than on a new chemical entity.
Why Janssen drafts it this way
The strategic rationale is straightforward franchise defense. The guselkumab molecule is protected by earlier antibody patents that will eventually expire and invite biosimilar competition. A method-of-treatment patent that ties the antibody to a specific, label-relevant dosing-and-response regimen — and to demonstrated superiority over a named competitor — does two things. It extends the period during which a biosimilar maker faces patent exposure if its product is used the patented way, and it converts a clinical trial result (the head-to-head data against secukinumab) into a durable, separately enforceable asset. For Janssen, the comparative-efficacy claim also doubles as a commercial moat: the same superiority data that supports the patent supports the marketing message.
For an IP-literate reader, the caveats are the interesting part. Method-of-treatment claims that recite achieved clinical outcomes — “the patient achieves PASI90” — invite the inherency and indefiniteness defenses that have shaped a long line of pharmaceutical-method case law: a defendant will argue the recited outcomes are the natural result of administering a known antibody at a known dose, and therefore add nothing patentable, or that an outcome relative to another drug is not a definite claim boundary. None of that is resolved by the grant itself; it is the terrain on which the patent’s scope and validity would be contested. And as with any 2026-issued B2 grant, the operative term runs from the earliest priority date in the family, so the practical exclusivity it adds depends on where that chain begins — a figure this document alone does not settle.
The bottom line for the IP desk: U.S. Patent No. 12,655,207 is a comparative-efficacy method-of-treatment patent — a sophisticated, and contestable, way for Janssen to extend protection around guselkumab in psoriasis by claiming not just a dose but a measured outcome and a win over a rival mechanism. The limitations to watch are the PASI/IGA thresholds, the 16-to-48-week timepoints, and above all the “higher efficacy than secukinumab” clause, whose definiteness and limiting effect are exactly the questions a challenger would raise first.