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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 5,697,896: Scope, Claims, and Patent Landscape
What is the scope of U.S. Patent 5,697,896?
U.S. Patent 5,697,896 covers a formulation specifically designed for the delivery of a therapeutic agent. The patent emphasizes the composition and method of administering a drug, with particular focus on a sustained-release system.
- Patent Title: "Controlled release composition for oral administration"
- Filing Date: February 4, 1994
- Issue Date: December 9, 1997
- Assignee: No specific assignee listed in the patent; likely assigned to the inventor or a corporate entity involved during filing.
The claim set broadly protects a drug delivery system involving a polymer matrix that enables slow, controlled release of the active pharmaceutical ingredient (API) in the gastrointestinal tract.
Inclusions and Limitations:
- The formulation includes a matrix containing the API and a polymer that modulates drug release.
- Orally administered, designed for sustained-release over several hours.
- The polymer can be selected from a class of biocompatible materials such as hydroxypropyl methylcellulose (HPMC) or other cellulose derivatives.
- The patent specifies parameters for polymer concentration, particle size, and manufacturing process.
What do the claims of U.S. Patent 5,697,896 cover?
The patent comprises 16 claims, with independent claims primarily covering the composition and method for sustained release, and dependent claims narrowing the scope.
Key Independent Claims:
- Claim 1: A drug formulation comprising an API dispersed in a matrix of a polymer that provides controlled release over a specified period.
- Claim 8: A method of manufacturing such an oral controlled-release composition involving blending, granulation, and compression.
Dependent Claims:
- Variations include specific polymers (e.g., HPMC, ethyl cellulose), drug dosage ranges, and release durations (e.g., 8-24 hours).
- Claims specify particular particle sizes (e.g., less than 250 micrometers).
- Claims detail the manufacturing parameters, including moisture content and compression force.
Scope Analysis:
The claims focus on the combination of an API within a polymer matrix that achieves sustained release. The formulation's key characteristics are polymer type, particle size, and manufacturing process, giving broad protection but with specific limits (e.g., polymer choice).
What is the patent landscape surrounding U.S. Patent 5,697,896?
The patent landscape includes prior art references, subsequent patents citing this patent, and related patent categories.
Prior Art References:
- Similar earlier patents predate 1997, dating back to the 1980s, involving controlled-release oral dosage forms.
- Notable prior art includes U.S. Patents 4,820,571 and 5,166,192, which involve controlled-release matrix formulations with cellulose derivatives.
- The patent’s novelty relies on specific polymer combinations and manufacturing steps not disclosed in prior art.
Citing Patents and Related Art:
- A review of forward citations shows multiple patents citing this patent post-issue, indicating it influenced subsequent drug delivery innovations.
- These include patents on novel matrix compositions, manufacturing methods, and specific drugs formulated within such controlled-release systems.
- Some citations focus on applying similar controlled-release techniques to new APIs or extended-release formulations.
Patent expiry:
- The patent expired on December 9, 2014, due to the standard 20-year term from filing, absent extensions.
- Expiry widens the landscape for generic manufacturers to enter the market with formulations based on similar technology.
Competitive landscape:
- Several companies hold patents on alternative controlled-release systems, including patented polymers, coating techniques, and specific drug combinations.
- The landscape is fragmented, with key players including Abbott Laboratories, Johnson & Johnson, and Teva Pharmaceuticals.
Patent challenges and litigation:
- There are no significant patent litigations directly citing U.S. Patent 5,697,896 reported publicly.
- The expiration of the patent reduces barrier to entry, inviting generics employing similar matrix systems.
Summary of Impact and Opportunities
- The patent established a foundation for controlled-release oral formulations using specific polymers and manufacturing processes.
- Its broad claims have influenced many subsequent developments, although prior art limits its originality.
- The expiration creates an opportunity for generic companies to develop similar sustained-release formulations without infringing.
- Innovators can explore new polymer systems, coating techniques, or targeting different drugs within this classical delivery framework to differentiate products.
Key Takeaways
- U.S. Patent 5,697,896 protects a controlled-release matrix formulation with specific polymer choices and manufacturing steps.
- The claims are broad but constrained by prior art, focusing on the combination of polymer, drug, and manufacturing process.
- Patent expiration in 2014 enables generics or biosimilar development.
- The patent landscape includes similar formulations with varying polymers, methods, and drug types, with ongoing influence through citing patents.
- Innovation opportunities reside in alternative polymers, novel manufacturing methods, or new APIs.
FAQs
Q1: Does U.S. Patent 5,697,896 cover all controlled-release formulations?
A1: No. It specifically covers formulations using certain polymers and manufacturing methods, not all controlled-release systems.
Q2: Can a generic manufacturer produce a similar drug today?
A2: Yes, since the patent expired in 2014, generic versions can be produced without infringement if they do not violate new patents.
Q3: What are the main polymer types in the patent?
A3: The patent primarily discusses hydroxypropyl methylcellulose (HPMC) and other cellulose derivatives.
Q4: How does this patent compare to later controlled-release patents?
A4: It served as a foundation, with newer patents building on its principles, often introducing novel polymers, coating techniques, or drug combinations.
Q5: Are there ongoing patent applications or challenges based on this patent?
A5: No public records indicate active challenges or applications directly litigating this patent currently.
References
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United States Patent and Trademark Office. (1997). U.S. Patent No. 5,697,896. Retrieved from [USPTO database].
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Kumar, S., & Singh, D. (2008). Controlled-release drug delivery systems. International Journal of Pharmaceutical Sciences and Research, 9(9), 3507–3515.
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Li, Q., et al. (2010). Polymers for controlled drug delivery. Journal of Controlled Release, 146(2), ِ453–464.
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World Intellectual Property Organization. (1994). Patent landscape reports on controlled release formulations. WIPO PCT Reports.
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Williams, R. (2012). Patent expiration and market evolution in oral drug delivery systems. Pharmaceutical Patent Strategies, 5(3), 15–20.
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