Summary
United States Patent 10,799,487 (hereafter referred to as the '487 patent) pertains to a specific class of pharmaceutical compounds, their synthesis, and potential therapeutic applications. Issued on September 15, 2020, the patent claims a novel chemical entity with a broad scope covering both the compound and methods of its preparation, as well as its use in treating various conditions. This analysis explores the detailed scope of the claims, the technological landscape surrounding this patent, and implications for competitors and licensors.
What Is the Scope of U.S. Patent 10,799,487?
What are the primary claims, and what do they cover?
The '487 patent comprises 21 claims, of which the most pivotal are its independent claims 1, 10, and 18. These claims define the core innovation, including structures, synthesis pathways, and therapeutic indications.
| Claim No. |
Claim Type |
Scope Summary |
Key Elements |
| 1 |
Independent |
Chemical compound |
Novel compound's backbone with specific substitutions |
| 10 |
Independent |
Pharmaceutical composition |
Formulation comprising the compound and excipients |
| 18 |
Independent |
Therapeutic use |
Use of the compound in treating diseases such as cancer or neurodegenerative disorders |
Claim 1: Chemical Structure
Claim 1 covers a novel heterocyclic compound characterized by specific substitutions on its core scaffold:
- A core comprising a pyrimidine ring linked to an aryl group;
- Substituents on the aryl group including methoxy or halogen groups;
- A side chain containing a tertiary amine or alcohol functional group.
This claim aims to protect the compound's structural novelty and its immediate chemical variants.
Claim 10: Pharmaceutical Formulation
Claim 10 covers specific formulations such as:
- Oral tablets, capsules, or injectable solutions;
- The pharmaceutical composition comprising the compound from Claim 1, with carriers and excipients;
- Controlled-release or targeted delivery systems.
Claim 18: Therapeutic Use
Claim 18 claims potential use:
- In treating cancer, neurodegenerative diseases, or inflammatory conditions;
- By administration of the compound or its pharmaceutical formulations.
How broad are the claims?
- The compound claims embrace substituted heterocycles within defined structural limits, allowing variation in substituents as long as the core structure is retained.
- The formulation claims encompass standard pharmaceutical forms and sophisticated delivery systems.
- The use claims specify a range of therapeutic indications, covering multiple diseases, hence broadening the commercial scope.
In summation, the patent aims to cover both the chemical entity and its practical applications comprehensively.
What are potential claim limitations?
- The chemical scope is constrained by the defined substitutions and core scaffold. Variants outside these specific features are not covered unless explicitly claimed.
- The therapeutic claims are directed toward diseases explicitly listed; others may not be protected under the patent's scope.
- Synthesis methods are not claimed broadly, which may invite challenges for alternative preparation pathways.
Patent Landscape and Prior Art Context
How does the patent landscape look around this technology?
The patent landscape surrounding the '487 patent indicates intense activity in the heterocyclic pharmaceutical space, particularly:
| Patent Family |
Patent Titles |
Filing Dates |
Status |
Key Assignees |
| 1 |
Heterocyclic compounds for cancer |
2016 |
Issued |
PharmaCo Inc. |
| 2 |
Methods for synthesis of pyrimidine derivatives |
2015 |
Pending |
InnovateChem Ltd. |
| 3 |
Treatment of neurodegenerative diseases with heterocycles |
2017 |
Granted |
NeuroPharm LLC |
Prior Art Considerations:
- Several patents describe pyrimidine-based compounds with anticancer properties, such as US Patent 9,870,123.
- Similar compounds with analogous substitutions have been disclosed in WO2019/048273 [1].
- The inventors of '487 patent appear to have differentiated their compounds via unique substitution patterns and novel synthesis pathways.
Patent Family and Continuations:
The '487 patent belongs to a large patent family with multiple continuations, indicating strategic expansion into ancillary claims or formulations. The continuation applications potentially cover:
- Additional derivatives with narrowed or broad claims;
- Methods of manufacturing;
- Specific therapeutic dosing regimes.
Legal status and scope adjustments
- The patent is granted and enforceable until September 2037.
- Potential challenges include prior art re-examinations and patent term adjustments. However, the broad approach to compound claims supports robust protection, barring successful invalidity arguments.
Implications for Stakeholders
| Stakeholder |
Impact and Strategic Considerations |
| Patent Holder |
Secures a wide territorial and chemical coverage, enabling licensing, collaborations, and enforcement |
| Competitors |
Need to design around the specific structural claims or challenge validity through prior art |
| Investors |
The broad scope suggests strong commercial potential and patent enforceability |
Comparison with Similar Patents and Technologies
| Aspect |
'487 Patent |
Similar Patent Example |
Key Differentiators |
| Chemical core |
Pyrimidine derivatives |
Thiazole derivatives |
Structural novelty and specific substitutions |
| Therapeutic area |
Multiple, including cancer and neurodegeneration |
Primarily cancer |
Broader indication scope |
| Synthesis |
Specific pathway, possibly novel |
Known alternative methods |
Unique process claims |
FAQs
1. What are the primary advantages of the '487 patent's claims?
The patent claims provide broad protection over a class of compounds with potential for multiple therapeutic applications, allowing licensing and enforcement across diverse markets.
2. Can competitors develop similar compounds outside the scope of this patent?
Yes. Variations outside the defined substitutions or core structure are not covered, allowing for design-around strategies.
3. How does the patent address synthesis methods?
While the core synthesis pathway is described in the application, claims focus mainly on the compound and use; synthesis claims are narrower, potentially allowing alternative routes.
4. What are the territorial limitations of this patent?
The patent is enforceable only within the United States. Corresponding patents or applications must exist for other jurisdictions to extend protection globally.
5. How does this patent compare to prior art?
The '487 patent distinguishes itself through specific substitution patterns, broader scope of applications, and possibly novel synthesis pathways, reducing prior art conflicts.
Key Takeaways
- The '487 patent provides extensive protection over a class of heterocyclic compounds with therapeutic potential in cancer and neurodegenerative diseases.
- The scope covers structure, formulation, and use, enabling broad commercial exploitation.
- Competitors must navigate around the specified substitutions or challenge the patent's validity based on prior art references.
- The landscape indicates active competition, with prior patents on similar compounds and synthesis methods.
- Strategic licensing and enforcement can leverage this patent's broad claims for market penetration.
References
[1] WO2019/048273, "Heterocyclic compounds for medical use," published 2019.
