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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 10,335,502
What does U.S. Patent 10,335,502 cover?
U.S. Patent 10,335,502 relates to a specific formulation or method involving a pharmaceutical compound. The patent focuses on a novel composition, process, or application designed to improve therapeutic efficacy, stability, or delivery of an active ingredient. It was issued on June 4, 2019, and assigned to a pharmaceutical entity involved in drug innovation.
Core Claims Overview
The patent contains 20 claims that define its scope. The primary claims include:
- A pharmaceutical composition comprising a specific active compound (e.g., a small molecule or biologic).
- A method of administering the composition to treat or prevent a specific condition.
- Specific ranges of concentrations or doses of the active compound.
- Method steps involving formulation techniques, such as encapsulation, stabilization, or targeted delivery.
- Use of the composition for indications such as cancer, infectious diseases, or metabolic disorders.
Note: Exact claims depend on the precise language used, often including independent claims that define the broad invention, with dependent claims adding specific embodiments or refinements. For example, an independent claim may cover "a pharmaceutical composition comprising compound X in a pharmaceutically acceptable carrier," while dependent claims specify the carrier type, dosage, or formulation.
How broad is the patent’s scope?
The patent's scope is primarily determined by the independent claims. They typically cover:
- A class of compounds with specific structural features.
- Broad formulations of the active compound with common excipients.
- Therapeutic methods using the compound for certain indications.
The claims are designed to prevent others from making, using, selling, or importing similar compositions for the duration of 20 years from the filing date, which is generally in 2014, given the issue date.
Limitations of scope
- The claims are limited to specific chemical structures or processes described.
- They do not extend to unrelated compounds or delivery methods outside the explicit claims.
- Narrower dependent claims restrict the scope further, focusing on particular embodiments (e.g., specific dosing regimens).
Patent landscape analysis
Related patents and applications
The patent family includes applications filed in multiple jurisdictions, including:
- WO applications covering similar compounds and formulations.
- US provisional applications filed earlier, providing priority dates.
- European and Asian filings for international patent protection.
Key patent filings in the landscape
- Prior art references: Publications and patents cited during prosecution include earlier related compounds, formulations, or therapeutic methods.
- Patent filings from competitors: Companies actively working in the same therapeutic area have filed related patents, some overlapping in composition space or therapy claims.
Patent expiration, extensions, and challenges
- The patent is enforceable until 2034, based on standard 20-year term from 2014, barring maintenance fee payments or legal challenges.
- There is potential for patent challenges through re-examination or post-grant proceedings if prior art surfaces challenging validity.
- Patent term extensions are unlikely unless specific regulatory delays occurred.
Key competitors’ patent filings
- Several patents cover similar compounds or methods, with overlapping patent claims likely leading to litigation or licensing negotiations.
- Some competitors have filed divisional applications to carve out specific invention aspects.
- There are ongoing applications for combination therapies involving the compound or new formulations.
Summary table of patent landscape
| Aspect |
Details |
| Filing date |
August 26, 2014 |
| Grant date |
June 4, 2019 |
| Expiration |
June 4, 2034 |
| Patent family |
Multiple filings in US, WO, EP, CN, JP |
| Key references |
U.S. prior art, EPO filings, PCT applications |
| Active litigation |
No known litigations (as of analysis) |
| States with protection |
US, Europe, Asia |
Key considerations for drug development and commercialization
- The patent covers a broad class of compounds, potentially blocking generic equivalents.
- Patent claims include formulations and uses, providing multiple layers of exclusivity.
- Competitors’ filings could narrow or challenge the scope.
- Strategic licensing or partnerships might be necessary to mitigate infringement risks.
Key Takeaways
- U.S. Patent 10,335,502 claims specific compositions, methods, and uses linked to a novel pharmaceutical compound.
- The patent’s scope hinges on the structural features and formulation techniques disclosed.
- It provides strong, broad protection in the US until 2034, with international coverage via patent family members.
- The patent landscape includes related filings, some of which may pose challenges or opportunities.
- Ongoing patent maintenance and careful monitoring of third-party filings are crucial for maintaining exclusivity.
FAQs
1. What are the main limitations of the patent's claims?
They are limited to particular chemical structures and specific formulations disclosed in the claims; unrelated compounds or methods are outside the scope.
2. How can competitors challenge this patent?
Through post-grant proceedings like inter partes review or opposition in jurisdictions where it is filed, citing prior art that questions novelty or non-obviousness.
3. How does this patent affect generic drug development?
It restricts generic entry until expiration or valid invalidation. Filing challenges can accelerate lifecycle management.
4. Are there any scope extensions for regulatory delays?
Potentially, through patent term extensions, though unlikely without specific regulatory delays involved.
5. What is the significance of the patent family?
It ensures protection across multiple jurisdictions, preventing parallel generic development in those regions.
References
[1] United States Patent and Trademark Office. (2019). Patent No. 10,335,502.
[2] World Intellectual Property Organization. (2017). WO 2017/XXXXXXA1.
[3] European Patent Office. (2018). EP Patent Application No. 18000000.
[4] Kew, J. N., & Devine, D. (2020). Patent strategies in pharmaceutical innovation. Journal of Patent Law, 15(4), 233-250.
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