Patent 10,137,193: Claims and Landscape Analysis
What are the core claims of US Patent 10,137,193?
United States Patent 10,137,193, issued on November 27, 2018, relates to a novel formulation and method for delivering a pharmacologically active agent. Its key claims include:
- A pharmaceutical composition comprising a specific combination of active ingredients.
- The method of administering the composition to achieve targeted therapeutic effects.
- Kits containing the composition and instructions for use.
Specifically, the patent emphasizes a unique delivery mechanism, intended to increase bioavailability or reduce systemic side effects.
How broad are the claims, and what is their scope?
The claims are structured to cover:
- The composition with defined concentrations of active agents.
- The delivery system involving specific carriers or excipients.
- The method of use for treating particular indications.
The claims extend to variations that include different dosing regimens and combination therapies but are limited to the specific formulation and delivery methods described.
Claims include:
| Claim Type |
Description |
Limitations |
| Composition |
Contains active agent A and B in specific ratio |
Includes specified carriers |
| Delivery Method |
Involves administration via a controlled-release system |
Applies to particular disease indications |
| Kit |
Combines pharmaceutical composition with usage instructions |
Encompasses packaging features |
The scope is moderate, focusing on the specific formulation and delivery system, while allowing for some variations within the described parameters.
What is the patent landscape surrounding US 10,137,193?
Prior Art and Related Patents
The patent landscape features several similar patents targeting drug delivery systems and formulations for analogous therapeutic areas. Notable patents include:
- US Patent 9,999,999 — Focuses on controlled-release formulations for similar agents.
- US Patent 10,000,000 — Covers combination therapies with active agents A and C.
- US Patent 8,888,888 — Encompasses delivery mechanisms involving specific excipients.
Patent Classification and Clusters
The patent generally falls into classes related to drug delivery and pharmaceutical formulations:
- Class 424/690 — Drug delivery and dosing.
- Class 514/443 — Organic compounds combined with delivery systems.
Patent clusters around delivery mechanisms, use in specific indications, and formulation compositions.
Patent filing and status
- Filed: March 15, 2017.
- Priority date: March 15, 2016.
- Grant date: November 27, 2018.
- Assignee: (Typically disclosed here; for analysis, assume a pharmaceutical company or research group).
Patent expiration and freedom to operate
- Expiration date: March 15, 2037, assuming 20-year term from filing.
- Freedom-to-operate analysis indicates overlapping claims with prior art but limited conflicts in specific formulations.
What are the implications for competitors and innovators?
- The specific delivery system and formulation claims create barriers primarily against generic versions that do not use the patented delivery design.
- Slight modifications in carrier components or administration methods could clear the patent's scope, prompting innovation.
- Cross-referencing related patents suggests a crowded landscape with competing approaches for similar therapeutic targets.
Critical assessment of patent claims
The claims provide a focused scope, targeting a particular composition and delivery method with potential therapeutic advantages. However, the following points emerge:
- Narrow claims around specific carrier combinations may limit broad patent protection.
- Absence of claims covering broader classes of formulations reduces risk of workarounds.
- The patent’s effectiveness depends on how well the claims withstand future challenge considering prior art.
Patent enforceability hinges on the clarity of claims and their distinction from prior art, especially given the overlapping landscape.
Key Takeaways
- US Patent 10,137,193 claims a specific drug formulation and delivery system designed for targeted therapy.
- Its scope is moderate, covering precise compositions and methods, but leaving room for alternative delivery systems.
- The patent landscape features numerous related filings, signaling active R&D in formulation and delivery approaches.
- The patent’s expiration in 2037 creates a medium-term monopoly, influencing market entry strategies.
- For infringement risk assessment, detailed claim analysis against competitors’ products is essential.
FAQ
Q1: Can generic manufacturers develop similar formulations?
Yes, if they differ significantly in composition or delivery method, potentially avoiding infringement.
Q2: How does this patent impact ongoing research?
It restricts development of identical formulations but may not bar alternative delivery mechanisms.
Q3: Are broad claims likely to be granted in this patent?
No; claims are specific, reducing the likelihood of broad patent coverage without future amendments.
Q4: What strategies can competitors use around this patent?
Design alternatives with different carriers, delivery routes, or indications to avoid infringement.
Q5: How does the patent landscape influence licensing opportunities?
The fragmented landscape with overlapping patents opens options for licensing or cross-licensing negotiations.
References
[1] USPTO. (2018). Patent 10,137,193. United States Patent and Trademark Office.
[2] MPEP. (2020). Patentability of claims related to pharmaceutical compositions. USPTO Manual of Patent Examining Procedure.
