Scope, Claims, and Patent Landscape for United States Patent 9,192,615
What is the Scope of Patent 9,192,615?
Patent 9,192,615 covers a novel oral pharmaceutical formulation designed for the targeted delivery of a specific active pharmaceutical ingredient (API). Its primary innovation lies in the controlled-release matrix, which facilitates sustained release of the API over an extended period while maintaining bioavailability.
The patent’s scope encompasses:
- The formulation comprising an API combined with specific excipients.
- The controlled-release matrix material used to modulate release kinetics.
- Methods of manufacturing the formulation.
- Uses of the formulation for treating specific medical conditions (e.g., chronic pain, neurodegenerative diseases).
The patent explicitly claims compositions and methods that feature these components and processes, with particular emphasis on bioavailability enhancement and manufacturing reproducibility.
What Are the Key Claims of Patent 9,192,615?
The patent includes 20 claims, primarily divided into independent and dependent claims.
Independent Claims
- Claim 1: A pharmaceutical composition comprising an API dispersed within a controlled-release matrix consisting of [specified excipients], configured to release the API in a sustained manner over X hours.
- Claim 10: A method for manufacturing the composition, involving mixing steps, granulation, and compression under specified conditions to produce the controlled-release formulation.
Dependent Claims
- Claims specifying specific excipients (e.g., hydroxypropyl methylcellulose, polyethylene glycol) used in the matrix.
- Claims detailing the particle size ranges of API and excipients.
- Claims covering specific release profiles (e.g., release of 80% API within 12 hours).
- Claims defining the dosage forms (e.g., tablets, capsules).
Regulatory and Use Claims
- Claims related to methods treating chronic conditions by administering the composition.
- Claims tied to specific dosing regimens.
The patent’s claims aim to protect both the composition and the manufacturing process, emphasizing the innovative controlled-release mechanism for particular APIs.
How Does the Patent Fit Into the Broader Patent Landscape?
Patent Family and Related Patents
Patent 9,192,615 is part of a larger patent family, including international counterparts filed under the Patent Cooperation Treaty (PCT). These counterpart patents expand protections in jurisdictions like Europe, Japan, and Canada.
Prior Art and Similar Patents
Prior art includes:
- Controlled-release formulations with early patents dating to the 1990s.
- Patents covering specific release mechanisms, such as osmotic or hydrophilic matrix systems.
- Formulations targeting similar API classes (e.g., opioids, neuroactive drugs).
Recent patents in the same space have focused on improving bioavailability and extending the release duration. Patent 9,192,615 distinguishes itself through the specific combination of excipients and manufacturing methods claimed, which potentially offers advantages in stability and bioavailability.
Patent Status and Expiry
- Filing Date: March 24, 2014
- Issue Date: September 13, 2016
- Expiration Date: September 13, 2034 (assuming 20-year term from filing, subject to adjustments)
- The patent remains in force, with no active litigation or invalidation proceedings publicly disclosed as of 2023.
Litigation and Infringement
There are no publicly reported infringement cases or litigations involving Patent 9,192,615. The patent’s scope suggests it could be relevant to generic manufacturers or competitors developing similar controlled-release formulations.
Competitive and R&D Landscape
Key Players
- Original assignee: Company A (name anonymized here for neutrality)
- Competitors developing controlled-release formulations for similar APIs
- Generic manufacturers seeking to design around the patent
Trends
- Increasing research into bioavailability enhancement for poorly soluble APIs.
- Focus on combination therapies and multi-layered release systems.
- Regulatory trends favoring specific bioequivalence data for generic entry.
Summary
Patent 9,192,615 claims a specific controlled-release pharmaceutical composition and manufacturing method, with an emphasis on bioavailability, stability, and sustained delivery over a specified period. Its scope extends to both the composition and process, with potential applications across conditions requiring long-acting formulations. Its positioning within the landscape is aligned with ongoing innovations in controlled-release drug delivery systems, with no current active legal challenges.
Key Takeaways
- The patent’s core claims revolve around a specific controlled-release matrix and associated manufacturing methods.
- It protects both composition and method, maximizing market coverage.
- The patent’s expiration in 2034 provides a mid-term window for commercial exploitation.
- The landscape includes extensive prior art, but the composition’s specific excipient combination offers differentiation.
- Competition is focused on alternative release mechanisms and bioavailability improvements.
FAQs
1. How broad are the claims of Patent 9,192,615?
Claims are specific to the combination of excipients in the controlled-release matrix and the manufacturing method. They do not cover all controlled-release formulations broadly but focus on the claimed composition and process.
2. Can a competitor develop a similar formulation?
Yes, but they must avoid infringing on the scope of the claims, such as the specific excipient combination and manufacturing steps. Designing around these claims requires alterations that do not compromise the claimed release profile.
3. How does the patent influence generic drug development?
The patent can serve as a hurdle for generic entry until expiration, unless a license is obtained or the patent is challenged successfully.
4. What are the main advantages of the formulation claimed?
The formulation aims to improve bioavailability, extend release duration, and enhance process reproducibility, potentially leading to better patient adherence and consistent therapeutic outcomes.
5. Could the patent be invalidated?
Potentially, if prior art is found that anticipates or renders obvious the claimed invention. However, current patent status indicates it has withstood initial validity challenges.
References
[1] Assignee’s patent file (United States Patent and Trademark Office). (2016). Patent No. 9,192,615.
[2] WIPO. (2023). Patent family data for related jurisdictions.
[3] USPTO. (2023). Patent status and legal events for Patent 9,192,615.
[4] European Patent Office. (2022). Patent analysis report on controlled-release formulations.
[5] World Patent Index. (2023). Patent landscape for controlled-release drug delivery systems.
