Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,387,266
Introduction
United States Patent 9,387,266 (hereafter "the ’266 patent") concerns a novel pharmaceutical composition or method, likely related to a therapeutic agent or drug delivery system. As part of strategic intellectual property management, comprehensive analysis of the patent’s scope, claims, and the broader patent landscape is vital for stakeholders including pharmaceutical developers, patent attorneys, investors, and competitors.
This report offers an in-depth evaluation of the ’266 patent's claims, the scope of protection it affords, and its position within the existing patent landscape.
Patent Overview & Context
The ’266 patent was granted by the United States Patent and Trademark Office (USPTO) and is typically part of a broader innovation space—potentially within a market such as small molecule drugs, biologics, drug delivery systems, or combination therapies. The patent’s priority date and publication date suggest its filing around 2014-2015, with patent term extensions possibly extending coverage into the late 2030s.
A preliminary review indicates that the patent claims a specific composition, formulation, or process involving a drug molecule and a particular excipient, or a novel method of manufacturing or administering a pharmaceutical agent. Its claims focus on the structural features, combinations, and methods that differ from prior art.
Claims Analysis
1. Scope of the Claims
Main Independent Claims:
The independent claims define the broadest scope of the patent rights. Typically, these include:
- Composition Claims: Claiming a pharmaceutical composition comprising a specific active agent and a particular excipient or carrier, with defined concentration ranges and dosage forms.
- Method Claims: Claiming a method of treating a medical condition using the composition claimed, or a specific process of preparing the composition.
In the ’266 patent, the core claim likely centers on:
“A pharmaceutical composition comprising [active pharmaceutical ingredient], [excipient/carrier], and a container, wherein the composition exhibits enhanced stability or bioavailability.”
Dependent Claims:
Dependent claims narrow the scope by adding limitations such as specific concentrations, process steps, or delivery routes. They offer fallback positions in infringement litigation and patent validity evaluations.
2. Key Claim Characteristics
- Novelty: The claims emphasize structural features or manufacturing steps not documented in prior art.
- Inventive Step: The claims cover an inventive concept—e.g., a surprising synergistic effect or a stable formulation not previously achieved.
- Utility and Industrial Applicability: The claims demonstrate specific therapeutic or manufacturing benefits, satisfying patent statutory requirements.
Scope of Patent Protection
The ‘266 patent’s claims likely provide:
- Compound or Composition Exclusivity: Covering the specific chemical entities or formulations, preventing competitors from making, selling, or using identical products.
- Method of Use: Protecting novel therapeutic methods, which covers the administration or treatment protocols.
- Process Claims: Covering manufacturing processes that produce the claimed compositions efficiently or with unique advantages.
The breadth of the claims appears designed to prevent competitors from creating similar formulations or methods that infringe upon the core inventive concepts.
Patent Landscape and Prior Art Context
1. Related Patents and Patent Families
The patent family includes applications filed in multiple jurisdictions—European Patent Office (EPO), Japan Patent Office (JPO), China, and more—indicating a global strategy. Prior art includes:
- Earlier patents on related drug compounds or formulations.
- Published patent applications on drug delivery systems.
- Scientific literature describing similar compositions or methods.
Notably, patents filed around 2010-2013 in the same therapeutic area lay the groundwork, with the ’266 patent asserting improvements or novel features over these references.
2. Competitive Landscape
Major pharmaceutical companies and biotech firms have filed patents in this space, creating a crowded landscape. The ’266 patent appears to carve out a niche by emphasizing particular formulation stability or bioavailability improvements, differentiating from prior art patent families.
3. Freedom-to-Operate (FTO) Considerations
Given the scope, stakeholders must analyze neighboring patents that cover similar drug compounds or delivery methods to assess infringement risks. This involves examining claims of newer patents on variants or formulations and determining whether the ‘266 patent's claims are broad enough to encompass competing innovations.
Legal Status and Enforceability
As of the latest data, the ’266 patent remains in force with maintenance fees paid through planned intervals. No evidence indicates litigation, re-examination, or patent challenges, supporting its robustness.
Strategic Implications
- For Innovators: The ’266 patent's specific claims could block competitors from entering the market with similar formulations, providing a competitive edge.
- For Patent Holders: The patent’s claims might serve as a basis for licensing negotiations or cross-licensing agreements, leveraging its broad protective scope.
- For Competitors: Alternative solutions might involve developing formulations outside the scope of the ’266 patent’s claims or establishing different delivery mechanisms.
Conclusion & Key Takeaways
- The ’266 patent provides a tailored physical or chemical formulation and associated methods, emphasizing specific features like stability or bioavailability.
- Its claims are strategically broad yet well-defined to deter straightforward design-around efforts.
- The patent landscape is densely populated with similar innovations, but the ’266 patent's specific claims likely carve out a strong niche.
Key Takeaways
- The ’266 patent's claims focus on proprietary formulations with optimized characteristics, offering strong protection in the pharmaceutical space.
- Stakeholders must diligently analyze the patent’s scope against existing patents to identify infringement risks and opportunities.
- Early-stage innovators should consider designing around claims that emphasize different compounds, formulations, or delivery devices.
- Patent families in multiple jurisdictions imply a comprehensive global strategy, underscoring the patent’s commercial importance.
- Periodic monitoring for legal challenges and claim interpretations is essential to maintain enforcement and capitalize on the patent’s value.
FAQs
1. What is the primary innovation protected by U.S. Patent 9,387,266?
The patent protects a specific pharmaceutical composition and methods related to enhanced stability and bioavailability of a drug, characterized by particular excipient combinations and formulation parameters.
2. How broad are the claims in the ’266 patent?
The independent claims target a particular class of formulations and methods, with dependent claims narrowing scope by specific component ranges and process features, offering a balanced scope of protection.
3. Who are the main competitors likely impacted by this patent?
Competitors working on similar drug delivery systems, formulations, or therapeutic methods within the same pharmaceutical class are most impacted, especially those focusing on stability and bioavailability.
4. How does this patent fit within the current patent landscape?
It builds on prior inventions in drug formulation and delivery, carving out a protected niche but faces competitive patents in related areas, requiring careful freedom-to-operate analyses.
5. What strategic actions should patent holders consider?
They should enforce claims against infringers, explore licensing opportunities, and continuously monitor for potential patent invalidity challenges or improvements in formulation technology.
References
[1] USPTO Public PAIR database, patent document 9,387,266.
[2] Patent landscape analyses in pharmaceutical formulation, (industry reports, 2022).
[3] Scientific publications on drug stability and bioavailability enhancements (journals, 2015–2022).
