How Dosing Humira for Rheumatoid Arthritis Works

This patent defines the specific 40mg biweekly injection schedule for the drug Humira to treat rheumatoid arthritis.

What it 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.

What it doesn't 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.

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.

Why it matters

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.

Real-world examples

• 1.Humira (adalimumab) pre-filled syringes
• 2.Humira (adalimumab) auto-injector pens