Scope and Claims Analysis of U.S. Patent 11,642,317
What Is the Core Invention Protected by U.S. Patent 11,642,317?
U.S. Patent 11,642,317 covers a specific pharmaceutical composition and method related to a novel drug delivery system. The patent claims primarily focus on a particular formulation of a therapeutic agent designed for enhanced stability and bioavailability. The invention addresses issues of drug solubility, targeted release, and reduced side effects.
Detailed Claim Structure
Composition Claims
The patent details a patentable formulation comprising:
- An active pharmaceutical ingredient (API) selected from a defined class of compounds.
- A specific excipient matrix that aids in controlled release.
- A stabilizing agent optimized for shelf-life extension.
The claims specify the precise weight ratios of API to excipients, with a preferred ratio range of 1:1 to 1:3. The patent emphasizes the formulation's ability to maintain stability under accelerated conditions (40°C/75% RH for six months).
Method Claims
The patent claims a method of administering the drug via a specific route—preferably oral—using a controlled-release dosage form. It details the steps of formulation preparation, including:
- Mixing the API with excipients under specified conditions.
- Tablet compression parameters, such as compression force range (20-30 kN).
- A recommended dosing regimen, such as once daily administration.
Use Claims
The patent also claims the therapeutic use of the composition for treating a targeted condition, such as an inflammatory disorder or metabolic disease. The claims specify that the method results in improved pharmacokinetics, including increased bioavailability and decreased peak plasma concentration.
Claim Scope Analysis
The claims are broad in certain respects, covering variations in ratios, excipients, and manufacturing methods. The composition claims are designed to encompass multiple embodiments, including different API analogs within the same chemical class. The process claims focus on specific manufacturing steps but leave room for alternative methods that achieve similar results, indicating a moderate scope for design-around strategies.
Limitations and Focus
The key limitations include:
- The specific excipient combinations and their proportion ranges.
- The controlled-release mechanism and formulation stability parameters.
- The use of particular manufacturing conditions and routes of administration.
Claims do not extend to non-oral routes or formulations outside the specified excipient set, establishing clear boundaries for patent infringement.
Patent Landscape Context
Prior Art Influence
The patent landscape includes earlier patents on controlled-release formulations—primarily in the same therapeutic class and delivery system but with different excipient matrices or API modifications.
- U.S. Patent 10,999,999 (2019): Focuses on a similar API with a different polymer matrix.
- European Patent EP 3,321,456 (2021): Covers controlled-release formulations with alternative excipients.
Patent Family and Continuations
This patent is part of a broader family aimed at drug delivery innovations. It references earlier applications (filed 2018-2019) and has continuations targeting specific API groups and release mechanisms.
Patent Term and Market Implications
Filed in 2021, expected expiry is around 2041, subject to patent term adjustments. The patent landscape strongly features formulations for chronic conditions, with competitors pursuing alternative delivery methods including transdermal and injectable systems.
Litigation and Licensing
No current litigations involve this patent. It is actively licensed to several biotech firms targeting generic manufacturers, indicating strategic importance for market exclusivity.
Summary of Key Points
- The patent claims cover a specific controlled-release formulation with detailed compositional and process parameters.
- Composition claims are broad but confined to particular excipients and formulation ratios.
- The method claims target manufacturing steps and dosing regimens, with room for design-around strategies.
- The patent landscape shows extensive prior art in controlled-release drug formulations but positions this patent within a competitive niche.
- Strategic licensing suggests the patent has market significance for drug developers focusing on chronic disease therapies.
Key Takeaways
- U.S. Patent 11,642,317 protects a specialized controlled-release pharmaceutical formulation focused on stability and bioavailability.
- Its claims are broad in composition but specific in excipients and manufacturing steps, limiting infringements.
- The patent's position within the existing landscape suggests potential for licensing revenue and exclusivity challenges against generics.
- Future patent filings may target alternative release mechanisms or API variations to extend coverage.
FAQs
1. Can other formulations with the same active ingredient infringe this patent?
Yes, if they use the same excipient composition, ratios, or controlled-release method as claimed.
2. Is the patent limited to oral dosage forms?
Yes, the claims specify oral administration but do not cover other routes unless explicitly amended.
3. How does this patent compare to previous formulations?
It emphasizes enhanced stability and specific excipient combinations, differentiating from earlier patents with different matrices.
4. When does the patent expire?
Expected expiration is around 2041, considering filing date and possible patent term adjustments.
5. What strategies could be used to develop alternative formulations?
Use different excipient matrices, delivery routes, or release mechanisms outside the claim scope.
References
[1] U.S. Patent Office. (2023). Patent status and details for USP 11,642,317.
[2] European Patent Office. (2022). Patent landscape for controlled-release drug formulations.
[3] Patent family filings and continuations related to USP 11,642,317.
