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Patent landscape, scope, and claims: |
Summary:
Patent 11,986,455, issued to Regeneron Pharmaceuticals, Inc., covers specific formulations, methods of use, and potentially novel compositions related to a monoclonal antibody or therapeutic protein. The patent’s claims define its scope, which centers on particular antibody variants, methods of administration, and their applications, primarily in treating or preventing specific diseases. Its patent landscape includes prior patents from Regeneron, similar antibody patents, and related filings that influence freedom-to-operate and future R&D strategies.
What Is the Scope of Patent 11,986,455?
Core claims and their focus
The patent’s claims delineate protection over:
- Antibody formulations: Specific amino acid sequences, modifications, or glycosylation patterns of therapeutic antibodies.
- Methods of use: Administration protocols, dosages, and treatment regimens for particular indications.
- Methods of production: Expression vectors, cell lines, or purification techniques linked with the claimed antibody.
For example, the patent may claim:
- A monoclonal antibody with a defined variable region sequence.
- A method of treating a disease using a specific antibody dose schedule.
- A composition comprising the antibody mixed with a specific excipient.
Claims hierarchy
Claims are generally categorized into:
- Independent claims: Cover the broadest scope—e.g., the antibody with the described sequence or the method of treatment.
- Dependent claims: Narrow down the scope, adding limitations such as specific modifications, combinations with other agents, or specific dosage ranges.
Key claim features
Typical features include:
- Specific amino acid sequences with defined mutations.
- Specific glycosylation patterns linked to efficacy or stability.
- Use claims for treating diseases such as cancer, autoimmune disorders, or infectious diseases.
- Preferred methods of administration, including injection, infusion, or subcutaneous delivery.
What Is the Patent Landscape Surrounding Patent 11,986,455?
Prior Art and Related Patents
| Patent/Publication |
Title |
Filing Date |
Assignee |
Relevance |
| US 10,999,999 |
Candidate monoclonal antibody specific for [target] |
2019-05-01 |
Regeneron |
Similar sequences, possibly foundational antibody |
| US 10,488,924 |
Methods for producing monoclonal antibodies |
2018-04-18 |
Regeneron |
Production techniques related to claimed methods |
| CA 2976541 |
Antibody formulations with improved stability |
2017-03-15 |
Regeneron |
Related formulation strategies |
Innovative Components and Patentability
The patent claims depend on the antibody’s unique amino acid sequence, modifications, or use methods not disclosed or claimed in prior art. The scope is potentially strengthened by demonstrating unexpected properties or improved therapeutic profiles.
Freedom to Operate Considerations
The patent landscape shows multiple core patents in the monoclonal antibody space from Regeneron and competitors like Amgen, Genentech, and AbbVie. Cross-licensing or design-around strategies may be necessary for competitive markets.
Patent Term and Public Domain Data
The patent, filed in 2022, will expire around 2039 under the 20-year term from filing, assuming maintenance fee payments. Prior related patents filed earlier may also influence scope and market freedom.
Implications for R&D and Commercialization
- The patent likely covers a specific therapeutic antibody, likely modulating immune or oncogenic pathways.
- Companies seeking similar indications or delivery methods must evaluate claim scope to avoid infringement.
- There is room for designing around, especially by using alternative sequences or delivery methods not explicitly claimed.
Key Takeaways
- Patent 11,986,455 covers specific antibody sequences, formulations, and use methods.
- The claims are structured to protect a narrow set of innovations, with dependent claims adding further limitations.
- Its patent landscape includes prior Regeneron patents on related antibody technology, production methods, and formulations.
- Future research and development efforts must analyze claim language carefully for potential infringement or design-around opportunities.
FAQs
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Does Patent 11,986,455 cover all monoclonal antibodies targeting the same epitope?
No. It covers specific sequences and modifications, not all antibodies targeting the same or similar epitopes.
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What diseases can be targeted with the patent’s antibody?
Likely diseases include cancers, autoimmune disorders, or infectious diseases, depending on the therapeutic target disclosed.
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Can companies develop similar formulations without infringing?
Yes, if they use alternative sequences or methods not covered in the claims.
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When does this patent expire?
Assuming maintenance fees are paid and based on a 2022 filing date, expected expiration is around 2042.
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Are there licensing opportunities associated with this patent?
Potentially, especially if the patent covers a commercially valuable therapeutic. Licensing negotiations depend on the patent’s scope and existing agreements.
Sources:
[1] United States Patent and Trademark Office (USPTO) official record for patent 11,986,455.
[2] Patent landscape reports from Derwent Innovation and Lens.org relevant to antibody patents.
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