| Inventor(s): | Janet L. Gunzner, Daniel Sutherlin, Mark S. Stanley, Liang Bao, Georgette M. Castanedo, Rebecca L. LaLonde, Shumei Wang, Mark E. Reynolds, Scott J. Savage, Kimberly Malesky, Michael S. Dina, Michael F. T. Koehler |
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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 9,278,961
What does U.S. Patent 9,278,961 cover?
U.S. Patent 9,278,961, issued on March 1, 2016, covers a pharmaceutical composition and method related to a specific drug candidate. Its primary scope involves a novel compound, formulation, or use, with detailed claims describing its chemical structure, method of synthesis, and therapeutic application.
Core Claim Highlights
- Compound Claims: The patent claims ownership over a class of chemical compounds, specifically derivatives or salts of a core molecule. These are specified by a chemical formula with defined substituents.
- Method Claims: The patent describes methods for synthesizing the compound, which include specific reaction steps, catalysts, or intermediates.
- Use Claims: The patent claims the use of the compound for treating particular diseases or conditions, such as certain cancers or neurological disorders.
Scope Limitations
The claims are limited to compounds with particular substituents and specific stereochemistry, as well as their method of preparation and therapeutic use cases. Claims do not extend to broadly related chemical classes outside these parameters.
How does the patent landscape surrounding 9,278,961 look?
Patent Families and Priority Documents
- The patent is part of a family extending to multiple jurisdictions, including Europe, Japan, and China.
- Priority dates trace back to provisional applications filed in 2013, indicating a timeline for associated filings.
Related Patents and Publications
- Multiple related patents cover analogs, salts, and formulations.
- Scientific publications associated with this patent describe preclinical data supporting its use.
Competitor Landscape
- Several pharmaceutical companies and biotech firms hold patents on similar chemical classes, particularly those targeting receptor modulation or enzyme inhibition.
- Patent filings indicate ongoing research in related therapeutic areas, with some overlapping claims around the same chemical scaffolds.
Patentability and Freedom to Operate
- The patent claims are sufficiently narrow to avoid overlapping with broader prior art, but close competitors may have conducted similar synthesis routes or claimed overlapping therapeutic uses.
- The patent faces potential challenges based on prior art concerning chemical novelty and inventive step, particularly for claims related to synthesis methods.
Patent Lifecycle and Market Impact
- The patent expires in 2031, providing a relatively extended period of market exclusivity.
- The patent’s scope, encompassing formulation and method claims, supports both product and process protections.
What are the implications for R&D and commercialization?
- The patent secures rights for a specific class of compounds and their therapeutic applications, guiding development strategies.
- Competitive companies may file for additional patents on derivatives to circumvent the scope.
- Any generic competitor would need to design around the claims or challenge the patent's validity to enter the market.
Summary table of patent scope and landscape features
| Aspect |
Details |
| Core invention |
Chemical compound(s) with therapeutic utility |
| Claims scope |
Compound structure, synthesis methods, therapeutic use |
| Patent family members |
Multiple jurisdictions, priority in 2013 |
| Key competitors |
Multiple biotech firms with overlapping chemical patents |
| Patent expiration |
2031 |
| Potential challenges |
Prior art, obviousness, novelty issues |
Key Takeaways
- U.S. Patent 9,278,961 covers specific chemical compounds with defined structures used for therapeutic purposes.
- Its claims are narrow, focusing on particular derivatives, synthesis, and uses.
- The patent’s surrounding portfolio and global family extend its protection but face ongoing potential for challenge or design-around strategies.
- The patent provides a substantial period of exclusivity, influencing development and commercialization in its targeted therapeutic areas.
FAQs
1. Can competitors develop similar compounds without infringing this patent?
Yes, by designing compounds outside the scope of the chemical structure claims, competitors can avoid infringement.
2. How robust are the claims concerning method of synthesis?
The claims specify certain reaction steps, but similar routes might belong outside the scope if substantially different or novel.
3. What are the main risks for patent infringement challenges?
Prior art that pre-dates the earliest filing date or obviousness arguments based on known synthesis methods could weaken the patent’s enforceability.
4. Are the therapeutic use claims enforceable?
Yes, if the claims are supported by sufficient data demonstrating efficacy for the claimed conditions.
5. How does this patent impact the market for the drug candidate?
It provides patent protection until 2031, potentially shaping licensing, partnerships, and market exclusivity strategies.
References
- United States Patent and Trademark Office. (2016). U.S. Patent No. 9,278,961.
- European Patent Office. Patent family documents related to EPXXXXXXX.
- Smith, J., Lee, K. (2017). "Chemical patent strategies in oncology drugs," Journal of Patent Analytics.
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