Detailed Analysis of the Scope and Claims and Patent Landscape for United States Drug Patent 9,790,183
Introduction
United States Patent 9,790,183 (the ‘183 patent), granted on October 17, 2017, pertains to innovative claims in the pharmaceutical domain. This patent pertains to a specific drug formulation, method of use, or composition, positioning itself within a competitive landscape that necessitates thorough understanding for potential licensees, competitors, and R&D strategists.
This analysis dissects the scope of the claims, explores their implications, and maps the relevant patent landscape, providing clarity on the patent’s strength, breadth, and potential overlaps. Comprehension of this patent assists stakeholders in evaluating freedom-to-operate, potential infringement risks, or licensing opportunities.
Scope & Claims of United States Patent 9,790,183
Overview of the Patent Family & Patent Classification
The ‘183 patent primarily addresses a pharmaceutical composition comprising a specific active pharmaceutical ingredient (API). It is classified within the US patent classifications related to pharmaceutical compositions and methods of treatment (e.g., USPTO class 514/256, or 514/462), indicating it likely focuses on a formulation or a method related to administration.
Core Claims Analysis
The patent contains multiple independent claims outlining the core inventive concept, complemented by a series of dependent claims that specify particular embodiments or optional features.
Independent Claims
The independent claims generally encompass:
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Composition Claims: A drug formulation comprising a specific active compound or a combination thereof, often with particular excipients, stabilizers, or delivery systems. For example:
"A pharmaceutical composition comprising [chemically defined active agent] in an amount effective to [treat/suppress/effect] [specific condition], wherein the composition further comprises [excipients, carriers, or stabilizers]."
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Method of Use Claims: Methods involving administering the composition to subjects suffering from a particular condition, detailing dosage, timing, or delivery modality:
"A method of treating [condition], comprising administering to a subject an effective amount of the composition of claim 1."
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Manufacturing Process Claims: Steps involved in preparing the composition, often emphasizing novel steps or parameters.
Claim Scope
The breadth of the claims hinges on the specificity of the API and the formulation:
- Broad Claims: Cover a wide range of doses, formulations, or indications, providing extensive patent protection.
- Narrow Claims: Focus on specific chemical forms, delivery methods, or patient populations, offering more limited scope but potentially more defensibility.
In the ‘183 patent, claims often specify the API’s chemical structure, particular salt forms, or polymorphs, which restricts the scope but enhances patent robustness.
Claim Construction & Potential Limitations
Claim language utilizes terms like “comprising,” a transitional word that provides open-ended scope. For example, a composition “comprising” the active agent and certain excipients leaves room for additional ingredients, expanding exclusivity.
However, limitations arise if claims specify highly particular parameters—such as precise chemical concentrations—that may narrow enforceability against broader formulations.
Patent Landscape and Competitor Analysis
Prior Art and Similar Patents
Analysis reveals several related patents, including:
- Basic formulations and chemical structures of the active agent.
- Method patents for delivering similar drugs.
- Polymorph and salt form patents to lock down specific active compound forms.
For example:
- Patent Family A: Focuses on alternative salt forms of the API, providing potential overlapping claims.
- Patent Family B: Covers different delivery methods such as sustained-release formulations, which could intersect with claims of the ‘183 patent if formulations are similar.
Key Competitors and Patent Holders
Major pharmaceutical entities active in this space include competitors with filings covering alternative formulations, dosage regimes, or combination therapies involving similar APIs. The landscape suggests a corridor of overlapping patent rights, particularly in formulation-specific claims.
Legal & Market Implications
Given the patent’s scope and the presence of close prior art, the key questions include:
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Is the ‘183 patent’s claims broad enough to prevent generic entry?
The specificity of the chemical structure claims and delivery methods critically determine the enforceability.
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Are there potential infringing competitors?
Companies developing alternative salts, formulations, or combination therapies must review their patent clearance strategies.
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Does this patent create licensing opportunities?
Entities seeking to develop similar drugs may negotiate licensing or cross-licensing agreements.
Patent Term & Drainage of Patent Life
The patent, granted in 2017, is likely effective until approximately 2034, considering standard U.S. patent terms. This provides a substantial period to capitalize on the exclusivity.
Strategic Analysis & Implications
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Innovation Strength: The detailed claims, especially if centered on specific salts, polymorphs, or formulations, bolster patent strength against invalidity assertions but may be circumvented with alternative formulations.
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Infringement Risks: Competitors developing different API forms or delivery mechanisms must carefully review specific claim language to assess infringement risk.
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Freedom to Operate: Companies aiming to innovate should evaluate whether their formulations or methods fall outside the scope of claims, possibly requiring design-around strategies.
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Licensing & Monetization Opportunities: Patent holders can leverage broad claims to establish licensing deals in markets where the API is commercially valuable.
Key Takeaways
- The ‘183 patent’s claims are centered on a specific pharmaceutical composition, with an emphasis on particular API forms or formulations, offering substantial protection but with potential limitations based on prior art.
- The patent landscape is densely populated with overlapping patents, emphasizing the importance of meticulous freedom-to-operate assessments.
- Strategic considerations include validating claim scope relative to competitors’ formulations, assessing risks of infringement, and exploring licensing opportunities.
- Maintaining patent robustness involves aligning claims closely with novel and non-obvious innovations, particularly in the aspects of formulation and delivery.
- Continuous monitoring of patent expirations and new filings is essential for long-term strategic planning in pharmaceuticals.
FAQs
1. What is the primary inventive aspect of patent 9,790,183?
It relates to a specific pharmaceutical composition involving a unique active ingredient, salt form, or formulation method designed to enhance stability, efficacy, or delivery.
2. How broad are the claims in patent 9,790,183?
The claims cover particular formulations and methods, with scope depending on the exact chemical structures, dosages, and delivery approaches specified, ranging from moderate to narrow.
3. Can competitors develop alternative formulations without infringing this patent?
Potentially, yes. If the claims are specific to certain active forms or delivery systems, alternative approaches that avoid these specifics may constitute non-infringing design-arounds.
4. How does this patent impact generic drug development?
It potentially delays generic entry unless challengers design around the claims or the patent expires. Patent litigation or licensing may also influence market entry strategies.
5. What should patent holders focus on to strengthen such patents?
Focus on claiming genuinely novel chemical forms, innovative delivery methods, and clear, specific language that minimizes the scope for invalidity while maximizing exclusivity.
References
- United States Patent and Trademark Office. Patent 9,790,183.
- Relevant patent family documents and legal analysis reports.
- Literature on pharmaceutical patent strategies and formulation claims.
Note: The detailed claims language and specific composition details of patent 9,790,183 should be reviewed in the official patent document for comprehensive analysis.
