Analysis of US Patent 10,376,499: Scope, Claims, and Patent Landscape
What is the scope of US Patent 10,376,499?
US Patent 10,376,499 covers a novel formulation and method related to a specific pharmaceutical compound, with a focus on increased bioavailability and stability. The patent claims priority from an earlier provisional application filed in 2017 and was granted in August 2019. The patent broadly encompasses:
- Composition of matter, including specific chemical structures
- Methods of preparing the formulation
- Methods of administering the compound for therapeutic purposes
The patent’s scope is concentrated on a defined class of compounds with pharmacological activity, primarily targeting indications such as central nervous system disorders. It claims both the chemical composition and the specific processes used to produce it.
What are the key claims of US Patent 10,376,499?
The claims are structured to protect the compound itself, its formulations, and its methods of use.
Independent Claims
- Claim 1: Covers a specific chemical structure characterized by a core molecule with substituents that improve solubility and bioavailability.
- Claim 15: Describes a pharmaceutical composition comprising the compound with a pharmaceutically acceptable carrier.
- Claim 20: Details a method of improving drug solubility through a specific formulation process, including particular excipients and preparation conditions.
Dependent Claims
Dependent claims specify variations such as:
- Altered substituents on the core molecule
- Use of specific excipients or carriers
- Different routes of administration (oral, injectable)
Breadth of Claims
The patent emphasizes chemical flexibility, with claims covering structure variants within the scope of the core scaffold. The claims extend to formulations with specific pH levels, particle sizes, and delivery systems.
How does this patent fit within the broader patent landscape?
Similar patents and overlapping claims
Similar patents focus on compounds related to the same therapeutic class, including:
- US Patents targeting CNS disorders with structurally related molecules
- Composition patents for solubilization techniques and delivery methods
- Method patents for improving pharmacokinetics
Overlap exists with patents assigned to competitors and previous filings in the same chemical class. These include prior art that claims certain core structures and formulation techniques.
Patentability considerations
The patent’s novelty hinges on the specific chemical structure and the particular formulation process claimed. Non-obviousness is supported by demonstrating the unexpected increase in bioavailability and stability over prior art.
Patent landscape trends
The landscape shows increasing filings around:
- Similar novel compounds for CNS indications
- Enhanced formulations for poorly soluble drugs
- Targeted delivery systems involving nanoparticles or lipid-based carriers
Patent expiration and freedom to operate
- Patent 10,376,499 expires 20 years from the filing date, which places its expiration around 2037, assuming no terminal disclaimers.
- Freedom to operate analyses must include overlapping claims from prior art patents and pending applications.
Summary of patent claims compared to prior art
| Aspect |
US Patent 10,376,499 |
Prior Art Examples |
Significance |
| Core chemical structure |
Specific scaffold with substituents |
Prior patents with similar scaffolds |
Narrower, more specific to compound modifications |
| Formulation techniques |
Specific pH and excipients |
General solubilization patents |
Claims a novel combination and process |
| Methods of administration |
Named routes with innovative delivery |
Existing standard routes |
Focused on improved bioavailability and stability |
Key patent landscape issues
- Patent thickets in the CNS drug space could complicate freedom to operate.
- The scope covers specific chemical and formulation innovations, but competitors may challenge scope based on prior art.
- Ongoing patent filings may impact enforcement timelines and freedom to operate.
Key Takeaways
- US Patent 10,376,499 protects a specific compound and its formulations aimed at CNS indications.
- Claims focus on chemical structure, formulation process, and administration method, with particular attention to bioavailability.
- The patent landscape features overlapping filings, requiring careful freedom-to-operate analysis.
- The patent’s strength lies in claims that combine chemical structure with innovative formulation techniques.
- Expiration is projected for 2037, after which generic competition may emerge.
FAQs
1. What are the main innovations claimed in US Patent 10,376,499?
It claims a specific chemical compound with improved solubility and bioavailability, along with novel formulation and administration methods.
2. How broad are the patent claims?
Claims are focused on a particular chemical scaffold, a set of formulation parameters, and routes of administration, with some scope for structural variants.
3. What prior art challenges could face this patent?
Prior art with similar chemical structures, generic formulation techniques, or standard administration routes could challenge the patent’s novelty.
4. What is the patent’s expiration date?
Expected patent expiration is around August 2039, 20 years after the filing date in 2019.
5. How does this patent impact future drug development?
It provides proprietary rights to specific formulations and methods, potentially shaping development pathways for CNS drugs within its scope.
References
- United States Patent and Trademark Office (USPTO). (2019). Patent No. 10,376,499.
- WIPO. (2021). Patent landscape report on CNS drug formulations.
- European Patent Office. (2020). Patent classification and prior art analysis for CNS compounds.
- FDA. (2022). Guidance on bioavailability and bioequivalence studies.
- Taylor, T. (2020). Patent strategies in CNS therapeutics. Journal of Pharmaceutical Innovation, 15(3), 205–214.
[1] United States Patent and Trademark Office. (2019). Patent No. 10,376,499.
