How Dosing Humira for Rheumatoid Arthritis Works
This patent defines the specific 40mg biweekly injection schedule for the drug Humira to treat rheumatoid arthritis.
Original patent title: “Methods of administering anti-TNFα antibodies”
This patent defines the specific 40mg biweekly injection schedule for the drug Humira to treat rheumatoid arthritis. Granted to AbbVie Biotechnology Ltd in 2014 with 7 claims and 15 forward citations.
Key facts
Coverage
What does this patent actually cover?
The patent claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more → a specific treatment regimen for rheumatoid arthritis using a human anti-TNFα antibody. It mandates a 40 mg dose delivered subcutaneously (under the skin) once every 13 to 15 days. The antibody must contain specific amino acid sequences in its variable light and heavy chain regions, which are the parts of the protein that bind to the target molecule. By blocking TNFα, a protein involved in inflammation, the treatment aims to reduce the symptoms of the disease.
The gap
What does this patent NOT cover?
- Does not cover the use of this antibody for conditions other than rheumatoid arthritis.
- Does not cover dosing schedules that fall outside the 13-15 day window.
- Does not cover doses other than 40 mg.
- Does not cover antibodies that lack the specific amino acid sequences defined in the claimsclaimsThe numbered statements at the end of a patent that legally define what the inventor owns.Read more →.
These exclusions are unique to PatentBrief — derived from the actual claim language, not patent-office boilerplate.
What made this novel
The innovation lies in identifying a 'sweet spot' for dosing—40 mg every two weeks—that balances therapeutic efficacy against the risk of side effects, turning a biological molecule into a standardized, predictable medical product.
Schematic visualization of the patent's claim structure. Hand-drawn diagrams in progress for each landmark patent.
Where you've seen this
Real-world examples
Humira (adalimumab) pre-filled syringes
Humira (adalimumab) auto-injector pens
Why it matters
The bigger picture
This patent is central to the commercial life of Humira (adalimumab), one of the best-selling drugs in history. By patenting the specific dosing regimen, the assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more → secured a way to maintain market exclusivity for the drug's application in rheumatoid arthritis long after the original molecule patent expired.
Filed
June 5, 2002
Granted
November 18, 2014
Market context
Who's building on this
Companies in this space
AbbVie remains the primary holder of this technology. However, many biosimilar manufacturers, such as Amgen, Sandoz, and Samsung Bioepis, have built their business models around navigating the expiration and scope of these types of dosing and formulation patents.
Market impact
This patent helped establish the 'patent thicket' strategy in the pharmaceutical industry, where companies protect a successful drug with dozens of secondary patents covering dosing, delivery methods, and manufacturing. It significantly delayed the entry of cheaper biosimilar competitors, keeping the drug's revenue stream high for over a decade.
Claim 1 — Plain English
What this patent covers
The patent claims a specific treatment regimen for rheumatoid arthritis using a human anti-TNFα antibody. It mandates a 40 mg dose delivered subcutaneously (under the skin) once every 13 to 15 days. The antibody must contain specific amino acid sequences in its variable light and heavy chain regions, which are the parts of the protein that bind to the target molecule. By blocking TNFα, a protein involved in inflammation, the treatment aims to reduce the symptoms of the disease.
The clever bit
The innovation lies in identifying a 'sweet spot' for dosing—40 mg every two weeks—that balances therapeutic efficacy against the risk of side effects, turning a biological molecule into a standardized, predictable medical product.
What it does not cover
- Does not cover the use of this antibody for conditions other than rheumatoid arthritis.
- Does not cover dosing schedules that fall outside the 13-15 day window.
- Does not cover doses other than 40 mg.
- Does not cover antibodies that lack the specific amino acid sequences defined in the claims.
Patent timeline
Application submitted to the patent office
Application published, typically 18 months after filing
Patent officially issued
PatentBrief Score
Impact Score
Early stage
Citation count
24/40
Moderately cited
Claim breadth
5/20
Moderate scope
Recency
5/20
Granted 10–20 years ago
Assignee scale
0/20
Independent or smaller assigneeassigneeThe entity that owns the patent — usually the inventor's employer or a company.Read more →
PatentBrief Impact Score — based on citation count, claim breadth, recency, and assignee scale. Not a legal assessment.
Heuristic Value Estimate
What this patent might be worth
$27K – $86K
Midpoint $54K · expired or expiring · industry ×3.0
Heuristic only — blends forward/backward citation counts, claim scope, time remaining, litigation history, and CPC-derived industry baseline. Real valuations need a professional appraisal.
The original legal language
Original claims
7 claims as filed with the patent office.
Concepts involved
Citations
Patent lineage
Cite this patent
Fischkoff, S. A., Kempeni, J., & Weiss, R. (2014). How Dosing Humira for Rheumatoid Arthritis Works (U.S. Patent No. 8,889,135). U.S. Patent and Trademark Office. https://patentbrief.org/patent/us/8889135/humira-biosimilar-barrier
Auto-generated from the patent record. Double-check author order and the issue date against the official USPTO document before submitting.
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Common Questions
Frequently Asked Questions
What does How Dosing Humira for Rheumatoid Arthritis Works cover?
This patent defines the specific 40mg biweekly injection schedule for the drug Humira to treat rheumatoid arthritis.
Who owns patent US 8889135?
AbbVie Biotechnology Ltd owns this patent, granted in 2014.
When does this patent expire?
This patent is expected to expire on November 18, 2034, when the invention enters the public domain.
What is patent US 8889135 cited by?
This patent has been cited by 15 later patents that build on its ideas.
What problem does this patent solve?
This patent is central to the commercial life of Humira (adalimumab), one of the best-selling drugs in history. By patenting the specific dosing regimen, the assignee secured a way to maintain market exclusivity for the drug's application in rheumatoid arthritis long after the original molecule patent expired.
What does this patent NOT cover?
Does not cover the use of this antibody for conditions other than rheumatoid arthritis.
Patent monitoring