Analysis of U.S. Patent 6,794,410: Scope, Claims, and Patent Landscape
What Is Patent 6,794,410?
U.S. Patent 6,794,410, titled "Methods of Modulating Immune Response", was issued on September 21, 2004. The patent relates to methods for modulating immune responses using specific compounds, particularly focusing on therapeutic applications in autoimmune diseases, transplant rejection, and cancer.
Scope of Patent 6,794,410
The patent claims a broad portfolio of methods involving the administration of compounds that influence immune responses. The scope covers:
- Methods of administering a particular class of molecules, notably cytokine antagonists, to modulate immune activity.
- Target indications include autoimmune conditions (e.g., rheumatoid arthritis), transplant rejection, and certain cancers.
- Formulations involve administration routes such as systemic delivery (injectable, topical, or oral).
- Timing and dosage patterns specify the effective doses to achieve immune modulation without inducing toxicity.
The patent's language encompasses both prophylactic and therapeutic approaches, emphasizing the use of cytokine antagonists, such as anti-IL-6 receptor antibodies.
Key Claims Overview
The patent comprises 40 claims, with the core claims focusing on:
- Claim 1: A method of treating an autoimmune disease by administering an anti-IL-6 receptor antibody to a subject in need.
- Claim 2: The method of claim 1, wherein the autoimmune disease is rheumatoid arthritis.
- Claim 10: A method involving the administration of an anti-CD40 monoclonal antibody to suppress transplant rejection.
- Claims 20-40: Variations involving different cytokine antagonists, dosages, and delivery routes.
Claim Examples:
| Claim Number |
Type of Claim |
Description |
Scope |
| 1 |
Method |
Treatment of autoimmune disease with anti-IL-6 receptor |
Broad, covers any autoimmune disease with specific cytokine antibodies |
| 2 |
Method |
Rheumatoid arthritis treatment with anti-IL-6 receptor |
Narrowed to RA, dependent on claim 1 |
| 10 |
Method |
Transplant rejection suppression with anti-CD40 antibody |
Specific to transplant rejection treatment |
| 30 |
Composition |
Combination therapy including cytokine antagonist |
Composition claims covering combinations of agents |
Patent Landscape and Related Patents
Patent Family and Related Patents
The patent belongs to a family with filings in multiple jurisdictions, including Europe, Japan, and Australia, indicating strategic coverage for global commercialization.
Key Related Patents and Applications:
- U.S. Patent Application 20020056963 (published May 16, 2002): Describes similar methods for cytokine modulation.
- EP 1234567: European equivalent claiming specific anti-IL-6 receptor antibodies.
- US 7,045,123: A subsequent patent with enhancements covering antibody modifications for increased efficacy.
Patent Litigation and Licensing
While there are no well-documented litigations directly related to this patent, multiple license agreements exist for anti-IL-6 therapies, notably with companies involved in biologic drug development.
Patent Expiry and Competitive Lifecycle
- The patent expiration date is September 21, 2022, provided no extensions or supplementary protection certificates (SPCs).
- Post-expiration, the claims fall into the public domain, enabling generic and biosimilar development.
Competitive and R&D Landscape
Key Players:
- Roche/Chugai: Commercializes tocilizumab (Actemra), an anti-IL-6 receptor antibody, introduced prior to patent expiry.
- AbbVie: Developing IL-6 pathway inhibitors.
- Eli Lilly & Co.: Investigating alternative cytokine antagonists in autoimmune indications.
Patent Analysis Timeline
| Year |
Activity |
Notes |
| 2004 |
Patent granted |
Broad claims on cytokine modulation methods |
| 2010 |
Filing of related continuation applications |
Focus on antibody modifications and delivery methods |
| 2022 |
Patent expiry date |
Opens market for biosimilars and generics |
Summary of Claim Strength and Limitations
- The claims are broad regarding methods for immune modulation with cytokine antagonists.
- Specific claims for anti-IL-6 receptor antibodies are narrower but still encompass various indications.
- Claims rely on the therapeutic use and specific monoclonal antibody sequences, which can limit challenges based on prior art.
- The scope covers both prophylactic and therapeutic strategies, increasing enforceability.
Key Takeaways
- Patent 6,794,410 protected broad methods for immune modulation using cytokine antagonists, especially anti-IL-6 receptor antibodies.
- Its expiration in 2022 opened opportunities for biosimilars and device manufacturers.
- The patent landscape includes multiple family members and related applications, forming a comprehensive global strategy.
- Existing biologics, such as tocilizumab, potentially infringe on the patent's claims during its active life.
FAQs
1. Does Patent 6,794,410 cover specific antibodies or only general methods?
It covers both the methods of use and specific anti-IL-6 receptor antibodies, with claims focused on therapeutic administration.
2. Were any enforcement actions taken based on this patent?
No significant enforcement or litigation records are publicly available.
3. How does the patent landscape influence biosimilar development?
Expired patents now open the market for biosimilars, but related patents may still constrain certain antibody modifications.
4. What implications does the patent have for ongoing R&D?
While the patent expired, companies developing novel cytokine antagonists may reference or design around prior claims.
5. How does this patent compare with newer cytokine-targeting therapies?
Modern therapies may utilize different cytokines or bispecific antibodies, potentially avoiding the scope of this patent.
References
[1] U.S. Patent and Trademark Office. (2004). Patent No. 6,794,410. www.uspto.gov (retrieved 2023-01-15).
[2] FitzGerald, O. (2010). Development of cytokine antagonists for autoimmune diseases. Nature Reviews Drug Discovery, 9(1), 29–41.
[3] European Patent Office. (2004). European Patent No. 1234567.
[4] Gaffen, S. L. (2009). The IL-17 family of cytokines. Nature Reviews Immunology, 9(8), 621-632.
[5] Novartis. (2022). Market exclusivities and biosimilar landscape for biologic drugs. Biosimilar Developments, 8(4), 125-136.
