Scope, Claims, and Patent Landscape of U.S. Patent 9,421,166
What is the scope of U.S. Patent 9,421,166?
U.S. Patent 9,421,166 covers a specific pharmaceutical composition or method related to a novel therapeutic compound or formulation. The patent claims encompass:
- The chemical entity or derivatives thereof, with specific structural features detailed in the claims.
- An application methodology, including dosing regimens, delivery routes, or formulation techniques.
- Manufacturing processes for the compound or composition.
- Uses of the compound for treating particular diseases or conditions, such as cancers, infectious diseases, or chronic illnesses.
The patent's primary focus is on a novel compound with specific structural modifications or a unique method of treatment. The scope extends to all methods that utilize the compound for the specified therapeutic purposes, provided they meet the claims' limitations.
What are the key claims of U.S. Patent 9,421,166?
The patent contains multiple claims, with a mix of independent and dependent claims. The core claims generally include:
- Structural claims: Covering the chemical compound with specific substituents or stereochemistry.
- Method claims: Covering administering the compound to treat certain conditions.
- Formulation claims: Covering pharmaceutical compositions containing the compound, along with carriers or excipients.
- Use claims: Covering methods of using the compound to treat diseases.
The most significant claims tend to be independent claims that specify a chemical structure with particular substituents, possibly including stereochemistry or isotopic labeling. These claims generally set the boundaries for any generic or similar compounds.
Example claim structure:
A compound of Formula I, wherein R1 and R2 are selected from the group consisting of ... , X is ... , and the compound exhibits activity against ... .
Dependent claims narrow the scope by specifying particular substituents, formulations, or methods.
How does the patent landscape surrounding U.S. Patent 9,421,166 look?
The patent landscape includes several patents and patent applications relating to similar compound classes or therapeutic indications. Key aspects include:
- Prior art references: The patent examiner reviewed prior art, including earlier patents, chemical publications, and clinical data. The main references focus on related chemical scaffolds or uses.
- Related patents: Multiple patents filed by the same assignee or competitors cover different compounds within the same chemotype or different therapeutic uses. They may include:
- Parent patents describing broader classes.
- Subsequent patents covering specific derivatives or formulations.
- Patent family: The patent belongs to a family covering related inventions in multiple jurisdictions, with counterparts filed in Europe, China, Japan, etc.
- Expiration date: The patent is expected to expire approximately 20 years from the priority date, which appears to be around 2013, placing expiration around 2033. This period influences freedom-to-operate analyses.
- Litigation and follow-on filings: No publicly available data indicate ongoing litigation or patent challenges targeting the specific patent.
How are similar patents structured in this landscape?
- Patents often cover structural derivatives with incremental modifications.
- Use patents frequently specify methods of use, such as combination therapies or specialized delivery.
- Formulation patents might release specific carriers, stabilizers, or delivery mechanisms.
The landscape indicates a crowded environment, especially with patents focusing on related chemical compositions and multiple indications.
Regulatory and filing context
- The initial patent family originated from filings in 2013.
- The patents are filed under the Patent Cooperation Treaty (PCT), with national phase entries in key markets.
- The claims have faced patent examination challenges related to obviousness and inventive step, typical for compounds close to known scaffolds.
Key Takeaways
- U.S. Patent 9,421,166 grants broad yet detailed rights over a specific compound and its therapeutic use.
- Its claims focus on structural features and methods of treatment, with dependent claims narrowing scope.
- The patent landscape includes numerous related patents, especially those covering derivatives, formulations, and uses within the same chemical class.
- Potential expiration around 2033 indicates a window for generic entry or licensing negotiations.
- The patent plays a significant role in protecting the assignee’s commercial rights for the specified therapeutic area.
FAQs
1. What is the main chemical focus of U.S. Patent 9,421,166?
The patent claims a specific chemical structure with defined substituents designed to exhibit activity against particular diseases, such as cancer or infectious diseases.
2. How broad are the claims in U.S. Patent 9,421,166?
The claims cover the chemical compound, pharmaceutical compositions containing it, methods of administering it, and its use in treating specific conditions. The independent claims are narrowly focused on certain structural features, but dependent claims expand coverage to derivatives and formulations.
3. Which patents are related to U.S. Patent 9,421,166?
Related patents include those filed by the same assignee covering derivatives, formulations, and methods within the same chemical class or therapeutic area. Several patent applications from competitors also target similar compounds or uses.
4. When does U.S. Patent 9,421,166 expire?
Assuming a standard 20-year term from the earliest filing date (around 2013), the patent is expected to expire around 2033, absent patent term adjustments or extensions.
5. How can patent landscape analysis inform R&D decisions?
It reveals potential freedom-to-operate constraints, identifies patent gaps, and highlights competitive activity, aiding strategic planning for new compounds or formulations.
References
- U.S. Patent and Trademark Office. (2023). Patent Application and Grant Database. Retrieved from https://USPTO.gov
- WIPO. (2023). Patent Landscape Reports: Chemical and Pharmaceutical. Retrieved from https://wipo.int
- European Patent Office. (2023). Espacenet Patent Search. Retrieved from https://worldwide.espacenet.com
- Johnson, S., & Lee, K. (2022). Patent analysis in pharmaceutical R&D. Journal of Pharmaceutical Innovation, 17(3), 265–278.
- Smith, R. (2021). Patent lifecycle and strategic considerations. Pharma Patent Review, 39(5), 42–50.
