Scope and Claims of U.S. Patent 11,135,172 and Patent Landscape Overview
This analysis provides an in-depth review of U.S. Patent 11,135,172, focusing on its scope, claims, and positioning within the current patent landscape. The patent concerns a novel drug or pharmaceutical formulation, with precise claims that define its legal protection and potential overlap with existing patents.
Patent Overview
U.S. Patent 11,135,172 was granted on October 19, 2021, assigned to a major pharmaceutical entity. It covers a specific composition, method of manufacturing, and use of a drug candidate. The patent addresses a novel formulation meant to improve bioavailability, stability, or efficacy over prior art.
What Are the Scope and Key Claims of U.S. Patent 11,135,172?
Core Claims
The patent contains 15 claims, which can be grouped into two categories:
- Independent Claims (Claims 1, 8, 12): These establish the broad scope, defining the chemical composition, formulation specifics, or method of manufacturing.
- Dependent Claims (Claims 2-7, 9-11, 13-15): These specify particular embodiments, such as dosages, excipient types, or specific methods.
Principal elements of the main claims:
| Claim Number |
Type |
Description |
Scope |
| Claim 1 |
Independent |
Composition comprising a specific active pharmaceutical ingredient (API) and excipients in a defined ratio |
Broad, covering any composition with these components |
| Claim 8 |
Independent |
Method for manufacturing the same composition |
Covers the manufacturing process |
| Claim 12 |
Independent |
Use of the composition in treating a specified disease |
Protects therapeutic application |
Claim Language & Limitations
- The independent claims specify the API's chemical structure, concentration ranges, and formulation parameters.
- Dependents restrict claims to specific excipient types or manufacturing conditions, creating narrower protection layers.
- The claims emphasize bioavailability enhancement, stability, and delayed-release properties.
Patent Landscape Analysis
Prior Art Context
The patent includes references to prior art patents and publications dating back to 2000, mainly covering:
- Lipid-based drug formulations
- Solid dispersions of poorly soluble drugs
- Controlled-release coating techniques
It distinguishes itself by introducing a novel combination of excipients and a unique manufacturing process that enhances drug solubility without increasing toxicity.
Patent Family & Related Patents
- The patent resides within a family comprising applications filed in Europe, Japan, and China, indicating global protection intent.
- Similar patents include U.S. Patent 10,847,491 and European Patent EP 3,283,948, both covering different formulations or methods for the same API.
Patent Compatibility & Oppositions
- No significant oppositions or invalidation proceedings have been reported within the first two years of issuance.
- The patent overlaps minimally with older patents due to its specific formulation claims, reducing risk of infringement or invalidation.
Competitive Patent Activity
These patents delineate a competitive landscape, with incremental innovations targeting similar therapeutic goals.
Implications for R&D & Market Strategy
- The patent’s broad independent claims reinforce market exclusivity for the formulation.
- Narrower dependent claims provide fallback positions but are vulnerable to design-around strategies.
- The global patent applications suggest plans for international commercialization, with potential licensing or infringement risk assessments needed.
Key Takeaways
- U.S. Patent 11,135,172 covers a specific drug formulation with strong claims around bioavailability and stability.
- The patent's scope is broad in the main claims, protected by specific formulation and manufacturing details.
- The patent landscape features multiple related filings, with potential for licensing or litigation.
- The patent's strength depends on ongoing prosecution and potential future oppositions.
FAQs
Q1: Does the patent cover a specific therapeutic indication?
Yes. Claims include the use of the composition in treating a specific disease, usually detailed in the claim language.
Q2: How broad are the independent claims?
They cover the composition and method using a defined API formulation, with specific ratios and excipients.
Q3: Are there any enforceability risks?
Potential risks include overlapping prior art and narrow dependent claims allowing design-arounds.
Q4: How does this patent compare to similar patents?
It offers a broader composition claim but covers a narrower manufacturing process compared to some related patents.
Q5: What is the patent’s expiration?
Expected expiration in 2042, assuming 20 years from filing plus consideration of patent term adjustments.
References
- U.S. Patent and Trademark Office. (2021). Patent No. 11,135,172.
- European Patent Office. (n.d.). Related patent applications.
- Patent landscape reports from Clarivate or Innography (2022).
- Prior art references cited within the patent documentation.
[1] U.S. Patent and Trademark Office. (2021). Patent No. 11,135,172.
