Analyzing the Scope and Claims of United States Patent 10,105,335
Introduction to Patent 10,105,335
United States Patent 10,105,335, titled "Pharmaceutical Compositions and Methods of Treating Multiple Sclerosis," is a patent that pertains to the use and preparation of monomethyl fumarate, a compound closely related to dimethyl fumarate, which is used in the treatment of multiple sclerosis.
Overview of Monomethyl Fumarate
Monomethyl fumarate is a derivative of fumaric acid and is known for its therapeutic properties, particularly in treating relapsing forms of multiple sclerosis. This compound is often discussed in the context of its pharmacological effects and the methods of its preparation and administration[1].
Claims of the Patent
Definition and Scope of Claims
The claims in a patent define the matter for which protection is sought and must be clear, concise, and fully supported by the description provided in the patent application. For Patent 10,105,335, the claims would typically include:
- Independent Claims: These define the broadest scope of the invention and are not dependent on other claims.
- Dependent Claims: These narrow the scope of the invention and refer back to one or more of the independent claims[5].
Specific Claims Analysis
- Claim 1: This would typically be the broadest claim, defining the pharmaceutical composition containing monomethyl fumarate.
- Dependent Claims: These might include specific formulations, dosages, methods of administration, and therapeutic uses.
Patent Landscape
Existing Patents and Prior Art
The patent landscape for monomethyl fumarate and related compounds is complex, with several patents covering various aspects of their preparation, formulation, and use. For example, patents like WO2015044853A2 describe processes for preparing dimethyl fumarate, a closely related compound[4].
Patent Analytics and Claim Coverage
To understand the full scope of protection and potential gaps, patent analytics tools are crucial. These tools help in categorizing patents by claims and scope concepts, making it easier to identify which patents and claims are actively protecting the intellectual property and where opportunities or gaps exist[3].
Method of Preparation
The patent may include detailed methods for preparing monomethyl fumarate, which could involve specific chemical reactions, purification steps, and formulation techniques. This is similar to the process described for dimethyl fumarate, where the preparation involves precise conditions to ensure the quality and efficacy of the final product[4].
Therapeutic Uses
The primary therapeutic use of monomethyl fumarate, as outlined in the patent, would be for treating multiple sclerosis. The claims might also cover other potential therapeutic applications, such as treating other autoimmune diseases or inflammatory conditions.
Interactions and Safety Profile
The patent might also discuss potential interactions and the safety profile of monomethyl fumarate. For instance, it is known that compounds like monomethyl fumarate can increase the risk or severity of infections when combined with certain vaccines or other medications[1].
Patent Expiration and Extensions
The patent is set to expire in 2035, based on the estimated expiration dates provided for similar patents in the same family. This timeline is crucial for understanding the period during which the patent holder has exclusive rights to the invention[1].
Economic and Strategic Implications
The economic implications of holding a patent like 10,105,335 are significant. It allows the patent holder to control the market for monomethyl fumarate-based treatments for multiple sclerosis, influencing pricing, distribution, and research directions. Strategic use of patent analytics can help in identifying future design opportunities and ensuring comprehensive coverage of the intellectual property[3].
Claim Charts and Scope Concepts
Using tools like ClaimScape®, the claims and associated scope concepts can be analyzed to determine their applicability to target products or methods. This helps in identifying gaps in current coverage and highlighting future design opportunities. The scope concepts can be categorized as high, medium, or low value, depending on their immediate or future importance to the company[3].
Updates and Amendments
The patent can be updated over time as more patents are filed or as new avenues of development are explored. This involves amending the claims according to the Administrative Instructions and ensuring that the numbering and formatting comply with PCT Rules 6 and other relevant regulations[5].
Conclusion
Understanding the scope and claims of United States Patent 10,105,335 involves a detailed analysis of the patent's content, the broader patent landscape, and the strategic implications of holding such a patent. This includes examining the claims for clarity and conciseness, analyzing the method of preparation and therapeutic uses, and using patent analytics tools to ensure comprehensive coverage and identify future opportunities.
Key Takeaways
- Clear and Concise Claims: The claims must define the matter for which protection is sought and be fully supported by the description.
- Patent Landscape: The patent landscape for monomethyl fumarate is complex, with several related patents covering preparation, formulation, and use.
- Therapeutic Uses: The primary therapeutic use is for treating multiple sclerosis, with potential applications in other autoimmune diseases.
- Patent Analytics: Tools like ClaimScape® are essential for analyzing claims and identifying gaps or opportunities.
- Economic Implications: Holding the patent allows control over the market, influencing pricing, distribution, and research directions.
FAQs
Q: What is the primary therapeutic use of monomethyl fumarate as described in Patent 10,105,335?
A: The primary therapeutic use is for treating relapsing forms of multiple sclerosis.
Q: How do patent analytics tools help in understanding the scope of Patent 10,105,335?
A: Patent analytics tools help in categorizing patents by claims and scope concepts, identifying gaps or opportunities, and determining the value of the patent claims.
Q: What are the potential interactions and safety concerns associated with monomethyl fumarate?
A: Monomethyl fumarate can increase the risk or severity of infections when combined with certain vaccines or other medications.
Q: When is the estimated expiration date for Patent 10,105,335?
A: The patent is estimated to expire in 2035.
Q: How can the claims of Patent 10,105,335 be updated or amended?
A: The claims can be updated or amended according to the Administrative Instructions, ensuring compliance with PCT Rules 6 and other relevant regulations.
Sources
- DrugBank: Monomethyl fumarate: Uses, Interactions, Mechanism of Action.
- USPTO: Patent Claims Research Dataset.
- SLWIP: Patent Analytics.
- Google Patents: Process for preparation of dimethyl fumarate.
- USPTO: The Claims - USPTO.
