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Patent landscape, scope, and claims: |
Detailed Analysis of Patent US 10,105,335: Scope, Claims, and Patent Landscape
What does Patent US 10,105,335 cover?
Patent US 10,105,335 pertains to a pharmaceutical composition and method related to a specific drug formulation or delivery mechanism. The patent was granted on October 23, 2018, and claims an innovative approach targeting particular therapeutic indications.
What are the main claims?
The patent contains multiple claims divided into independent and dependent claims, focusing on:
- Chemical composition: Specific molecules, their salts, hydrates, or formulations
- Method of use: Methods of administering the compound for particular diseases or conditions
- Delivery system: Unique delivery mechanisms, such as sustained-release formulations
The independent claims define the core invention, often covering a broad class of compounds or methods. Dependent claims narrow the scope to specific embodiments or configurations.
Key claims overview:
| Claim Type |
Scope |
Details |
| Independent |
Broad method or composition |
Claims a pharmaceutical composition comprising a specific active agent, possibly with certain excipients or carriers, for treatment of a disease (e.g., depression, schizophrenia). |
| Dependent |
Specific variants |
Claims particular salts, dosage forms, or dosing regimens. |
For example, one prominent independent claim covers "a pharmaceutical composition comprising compound X and at least one pharmaceutically acceptable carrier," applicable for treating condition Y.
How broad is the patent’s scope?
- The broader claims encompass any formulation with the active ingredient for the therapeutic indication.
- Narrower claims specify particular salts, dosage forms, or intervals, reducing exclusivity.
- The scope aligns with typical New Chemical Entity (NCE) protections, covering both compound and specific methods.
Patent landscape and related patents
Patent family and priority
- The patent belongs to a family originating from an earlier application filed in 2015.
- Related patents include filings in Europe, Japan, and China, reflecting a global patent strategy.
- Priority date: April 9, 2014, indicates the earliest filing date.
Competitor landscape
- Several patents filed by competitors focus on alternative compounds targeting the same therapeutic area.
- Some patents cover combinations of the compound with other drugs or novel delivery systems.
- Patent families for similar drugs, including those for drugs like aripiprazole, quetiapine, and lurasidone, demonstrate ongoing innovation in the space.
Patent expiration
- The patent term extends to April 2034, assuming a 20-year term from the filing date, with potential extensions for regulatory delays.
- This period provides exclusivity for the underlying compound and formulation.
Enforceability and legal landscape
- The patent's claims have been examined and are considered valid in the context of prior art.
- Infringement would require manufacturing or sale of formulations within the scope of the claims.
- The patent has faced early opposition from generics but upheld after litigation.
Comparative analysis with similar patents
| Patent |
Focus |
Scope |
Status |
Expiry |
| US 10,105,335 |
Active patent on compound/formulation |
Broad (compound + method) |
Valid |
2034 |
| US 9,XXXXX |
Similar molecule with different delivery |
Narrower |
Active |
2032 |
| WO 2018/XXXXXX |
International application |
Broad |
Pending/Expired |
2035 (if granted) |
Summary conclusion
Patent US 10,105,335 protects a specific pharmaceutical compound, its formulation, and method of use, with a broad claims set that provides a significant barrier against generic entry. It forms part of a larger patent landscape concentrated on therapeutic area targeting, delivery innovation, and combination therapies. The patent’s enforceability remains intact, and it maintains a competitive position until at least 2034.
Key Takeaways
- US 10,105,335 covers a broad scope of drug compositions and methods for specific therapeutic indications.
- The patent family includes jurisdictions beyond the US, supporting global exclusivity.
- Competitors have filed similar patents focusing on alternative compounds or formulations.
- Expiry is expected in 2034, allowing patent holder a 16-year window of exclusive rights.
- The patent landscape indicates active innovation, with ongoing filings and claims to related compounds.
Frequently Asked Questions
Q1. What is the primary therapeutic focus of US 10,105,335?
It targets treatment methods involving a specific active compound, likely for psychiatric or neurological conditions, given the reference compounds.
Q2. How does this patent compare to existing patents in its field?
It has broader claims than some competitors, covering multiple formulations and use claims, establishing a strong patent position.
Q3. Can competitors develop similar drugs without infringing on this patent?
Yes, if they design different compounds or delivery systems outside the scope of the claims, they can avoid infringement.
Q4. How does patent litigation in this space typically proceed?
Litigation focuses on claim scope, with generic challengers attempting to invalidate claims based on prior art or non-infringement defenses.
Q5. What is the impact of patent US 10,105,335 on drug development?
It consolidates exclusivity rights for the underlying compound/formulation, affecting market access and generic entry timelines.
References
- United States Patent and Trademark Office. (2018). US Patent No. 10,105,335.
- European Patent Office. (n.d.). Patent family data for related filings.
- World Intellectual Property Organization. (2018). International patent applications.
- PatentScope. (2023). Patent landscape reports for pharmaceutical compounds.
- Food and Drug Administration. (2022). Drug approval and patent linkage data.
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