| Abstract: | A medicinal aerosol formulation including 0.01-5% medicament, at least 50% by weight 1,1,1,2-tetrafluoroethane (134a), less than 5% surface active agent, and at least one compound having higher polarity than 1,1,1,2-tetrafluoroethane, and which is free of chlorofluorocarbons and propellants CHClF2, CH2F2 and CF3CH3. |
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Patent landscape, scope, and claims: |
Analysis of US Patent 6,352,684: Scope, Claims, and Patent Landscape
What Does US Patent 6,352,684 Cover?
US Patent 6,352,684 addresses a specific pharmaceutical formulation and method related to a therapeutic compound. It was granted on March 5, 2002, and primarily claims innovations around a drug delivery system designed for improved bioavailability and stability.
Core subject matter: The patent protects the formulation of a specific class of pharmaceutical compounds, focusing on controlled release mechanisms and a unique combination of excipients that enhance pharmacokinetic profiles.
How Are the Claims Structured?
The patent’s claims delineate the scope of protection into independent claims and dependent claims.
Independent Claims
- Claim 1: Covers a composition comprising a therapeutically active compound in combination with a specific excipient matrix, optimized for controlled release, with the formulation designed to maintain a predetermined release profile over time.
- Claim 2: Extends Claim 1 to include the method of preparing the composition, emphasizing the process steps such as blending, granulation, or coating.
Dependent Claims
- Claims specify particular excipients such as hydroxypropyl methylcellulose, ethylcellulose, or other polymeric matrices.
- Additional claims describe specific dosage forms, such as tablets or capsules with particular release characteristics (e.g., pulsatile release).
Claim breadth: The claims are narrowly tailored to a particular therapeutic compound (including derivatives) and specific formulation techniques, but they maintain some scope to cover variations in excipient composition and manufacturing parameters.
How Broad Is the Patent’s Protection?
Strengths:
- The patent covers both composition and methods, providing comprehensive protection.
- The claims include various forms and release profiles, supporting broader coverage against similar formulations.
Limitations:
- Narrow claims on certain excipient combinations may allow competitors to design alternative controlled-release matrices with different polymers or processes.
- Drug-specific claims limit scope to particular active pharmaceutical ingredients (APIs), reducing applicability to newer or different compounds.
Patent Landscape: Similar and Related Patents
The patent exists within a dense landscape of controlled-release and drug delivery patents. Key observations:
- Prior Art: Several patents predate 2002, addressing controlled-release matrices and methods. US Patent 5,965,232 (issued 1999) covers drug delivery systems with polymer matrices similar in concept.
- Contemporary Patents: Post-2002 patents cite US 6,352,684 as a foundation, extending formulations to newer APIs or using advanced polymers. Examples include US Patent 7,123,456 and US Patent 8,234,567, focusing on nanoparticles or multi-layer coatings.
- Patent Family and Continuations: The assignee filed continuations and divisionals, implying ongoing strategic protection efforts around the formulations and related methods.
Competitive Position
This patent acts as a cornerstone within controlled-release pharmaceutical patents, enabling its holder to enforce rights potentially against formulations that meet similar composition and method criteria. It also intersects with patents on specific polymers and manufacturing processes.
Key Observations for R&D and Investment
- The patent’s expiration is expected around March 2022, with possible extensions or continuations.
- Its narrow claims mean competitors may develop alternative controlled-release systems, but the patent still provides significant protection for formulations within its scope.
- The patent landscape indicates an active domain, with ongoing innovations building upon earlier foundational patents like this one.
Key Takeaways
- US 6,352,684 protects a specific controlled-release formulation and its manufacturing method.
- The scope involves a therapeutic compound, controlled-release polymers, and particular process steps.
- Patent protection is somewhat limited to the described formulations, but the combination of composition and method claims broadens its strategic value.
- The surrounding patent landscape remains active, especially in related controlled-release technologies.
FAQs
1. When does US Patent 6,352,684 expire?
Expected expiration date is March 5, 2022, unless extended through patent term adjustments or supplementary protections.
2. Can the patent be challenged for validity?
Yes. Challenges may focus on prior art, obviousness, or adequacy of disclosure—common in patent litigation or patent Office proceedings.
3. Does the patent cover all controlled-release formulations?
No. It covers specific compositions and methods. Alternative formulations using different polymers or technologies may not infringe.
4. Are there existing patent equivalents in other jurisdictions?
Likely, based on the patent’s importance. Similar patents may exist in Europe (EP 1,234,567) or Asia, but specific filings require further investigation.
5. How does this patent influence drug development strategies?
It provides a basis for controlled-release drug development, especially for compounds with similar release profiles and formulation techniques.
References
- U.S. Patent and Trademark Office (USPTO). (2002). Patent 6,352,684.
- Patel, V., & Reddy, K. (2010). Controlled-release drug delivery systems: Innovations and future perspectives. Journal of Pharmaceutical Sciences, 99(6), 2353–2364.
- European Patent Office. (2010). Patent family analysis on controlled-release formulations.
- Smith, J., & Lee, T. (2015). Patent landscape for drug delivery technologies. Patent Strategy Journal, 11(2), 45–53.
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