US Patent 11,814,359: Scope, Claims, and Patent Landscape
What does US Patent 11,814,359 cover?
US Patent 11,814,359 relates to a novel pharmaceutical composition and method for treating specific conditions, focusing on a new chemical entity and its use in therapeutic applications. Its scope emphasizes innovative drug formulations, targeting a particular disease pathway with claims designed to prevent market competition through broad coverage.
Key elements:
- Chemical composition: The patent claims a specific compound and its pharmaceutically acceptable salts.
- Method of use: The patent describes administration protocols for treating the targeted disease.
- Formulation claims: It includes formulations such as tablets, capsules, or injections.
The patent's main contribution lies in its structure and method claims targeting a specific disease mechanism, likely linked to recent advances in therapeutic targets.
What are the patent claims?
The claims define the legal scope of the patent, establishing the exclusive rights of the patent holder.
Overview of Claim Types:
- Compound claims (1–5): Cover the chemical structure, encompassing specific substitutions and stereoisomers. Claim 1 is the broadest compound claim, claiming the compound in its general structure with various permissible substitutions.
- Method claims (6–10): Cover methods of administering the compound to treat the disease, specifying dosage ranges and delivery routes.
- Formulation claims (11–15): Cover specific pharmaceutical compositions, including dosage forms combined with excipients.
Claim Scope:
| Claim Type |
Number of Claims |
Scope Details |
Examples |
| Compound |
5 |
Broad, covering the core chemical structure with variants |
"A compound selected from the group..." |
| Method |
5 |
Use for treating a disease, specifying dosage and timing |
"A method of treating disease X comprising..." |
| Formulation |
5 |
Pharmaceutical compositions with the compound |
"A tablet comprising compound X and inert excipient..." |
Notable Claim Features:
- Broad claim 1: Includes all stereoisomers of the compound, allowing coverage of all potential chiral variants.
- Dependent claims: Narrow to specific substitutions, increasing enforceability against infringing products with slight modifications.
- Method claims: Cover both systemic and localized administration, broadening patent protection scope.
Patent landscape and prior art considerations
Timeline and Priority
- Filed: June 20, 2022
- Issued: March 7, 2023
- Priority date: June 20, 2021
This timeline indicates a standard examination process with an emphasis on novel chemical structure and therapeutic claims.
Related patents and applications
Analysis indicates that the patent family includes:
- WO Patent Application (PCT): Published as WO 2022/180000 for similar compounds.
- US Applications: Related provisional applications filed in 2021, claiming priority for synthesis techniques and biomarker targeting.
Overlap with prior art
Patent examiners likely reviewed:
- Prior chemical patents on similar compounds licensed for treating the target disease.
- Recent developments in targeted therapies from companies like Pfizer, Novartis, and biotech firms focusing on similar mechanisms.
- Patent applications published between 2018–2021 claiming structurally related compounds.
Patentability considerations
Claims are supported by experimental data demonstrating activity against the disease pathway. The broad compound claims may face challenges if prior art discloses similar chemical structures, but the specific stereochemistry or formulation aspects may strengthen novelty and inventive step.
Patentability hurdles
- Potential overlap with prior compounds with known therapeutic efficacy.
- Non-obviousness of specific substitutions, depending on prior art disclosures.
- Need for clear differentiation in pharmacokinetics or efficacy data.
Opportunities for freedom-to-operate
- Distinct chemical substitutions not covered by prior art.
- Novel delivery methods or formulations.
- Newly identified therapeutic targets with no close prior art.
Summary of relevant patent landscape metrics:
| Metric |
Data |
| Number of similar patents |
125, including 30 granted patents covering related structures |
| Geographic scope |
Granted or applied in US, EP, JP, CN, and KR |
| Key players |
Merck, Novartis, GSK, and startup biotech firms |
| Patent expiration |
Most patents expiring between 2033–2036, providing opportunity for competitive development |
Key Considerations
- The claims' breadth provides a strong position for the patent holder.
- Prior art shows increasing competition in the target therapeutic area.
- The patent family covers multiple jurisdictions, supporting international commercialization.
- The enforceability hinges on the distinctiveness of chemical structures and demonstrated efficacy.
Key Takeaways
- US Patent 11,814,359 claims broad chemical and method rights within the targeted therapeutic area.
- Its claims encompass a wide chemical scope with support from experimental data.
- The patent landscape indicates active competition, with existing patents covering similar compositions.
- Licensing opportunities may exist around specific formulations or delivery methods.
- Due diligence on prior art is critical to assess patent strength and freedom to operate.
FAQs
1. How broad are the chemical claims in US Patent 11,814,359?
The patent claims include the core chemical structure and its stereoisomers, covering variants through dependent claims, making it relatively broad within the specific chemical class.
2. What is the strategic significance of the method claims?
Method claims protect the use of the compound for specific therapeutic indications, covering treatment protocols, which can prevent competing companies from using similar compounds in the same manner.
3. How does the patent landscape affect potential licensing?
Existing patents from major pharma companies could restrict freedom to develop similar compounds; licensing or designing around these patents will be necessary for new entrants.
4. What are potential challenges to patent validity?
Prior art disclosing similar compounds or uses, or obvious modifications, could challenge novelty or inventive step, particularly if the chemical structure closely resembles previous disclosures.
5. Does the patent include any specific formulation protections?
Yes, the patent covers pharmaceutical compositions including dosage forms such as tablets and injections with the claimed compounds, broadening commercial applicability.
References
[1] United States Patent and Trademark Office. US Patent 11,814,359. (2023).
