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Patent landscape, scope, and claims: |
Analysis of US Patent 6,153,635: Scope, Claims, and Patent Landscape
What is the Scope and Content of US Patent 6,153,635?
US Patent 6,153,635, granted on Nov. 28, 2000, involves a pharmaceutical composition. It relates to a formulation designed for controlled drug delivery, specifically targeting a class of therapeutic agents. The patent covers a drug delivery system that prolongs the release of the active compound and improves bioavailability.
The patent's core invention involves a multilayered matrix comprising an active pharmaceutical ingredient (API), a polymer matrix, and optional excipients. The key objective is to optimize sustained-release properties and enhance patient compliance.
Composition and Configuration
- The formulation involves a core containing the API.
- A polymer coating surrounds the core, controlling drug release.
- The polymer may include hydroxypropyl methylcellulose (HPMC), ethyl cellulose, or polyvinyl acetate.
- The system can be tailored to modify the release profile over hours or days.
Therapeutic Focus
While the patent broadly addresses methods of formulating controlled-release drugs, examples specify drugs like diltiazem and theophylline, indicating applicability to cardiovascular and respiratory drugs.
What are the Patent Claims?
The patent contains 17 claims, which delineate the scope of legal protection.
Independent Claims
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A controlled-release pharmaceutical composition comprising:
- an active agent,
- a polymer matrix coating surrounding the active agent,
- wherein the polymer matrix is selected from a group including hydroxypropyl methylcellulose, ethyl cellulose, or polyvinyl acetate,
- and configured to release the active agent over a period of at least 8 hours.
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A method for producing the pharmaceutical composition, involving:
- forming a core containing the active agent,
- applying a polymer coating,
- and controlling the coating thickness to modulate the release profile.
Dependent Claims
Claims specify variations, such as:
- Using specific polymers for the coating.
- Targeting particular release durations (e.g., 12 or 24 hours).
- Incorporating additional excipients that modify dissolution.
Claim Interpretation
The claims broadly cover a multilayer controlled-release formulation, emphasizing the use of specific polymers and coating techniques. They do not specify a particular API beyond the examples, allowing wide applicability.
How Does This Patent Fit into the Broader Patent Landscape?
Patent Families and Related Patents
- The patent family includes counterparts filed internationally, notably in Europe (EP 1,255,764), Japan, and Canada.
- Related patents focus on extended-release formulations, often related to cardiovascular drugs.
- Similar patents by competing entities target different polymer combinations or formulations, emphasizing alternative release mechanisms.
Overlapping Patents and Potential IP Conflicts
- Patents targeting controlled-release formulations using hydroxypropyl methylcellulose date back to the 1990s and are relevant.
- The landscape includes patents covering specific devices (osmotic pump-based systems), which may intersect with the formulation-focused patent.
- The scope of claims and the polymers used can create potential for infringement or design-around strategies.
Legal Status and Enforcement
- The patent remains in force until Nov. 28, 2020, with a 20-year term from the filing date (May 4, 1998).
- No current litigation publicly emerging related to this patent.
- Licensing agreements or patent pools have not been reported.
How Does This Patent Influence Industry and Innovation?
- The patent covers a foundational approach to controlled-release formulations, influencing subsequent drug delivery projects.
- Firms developing extended-release formulations with similar compositions may need to consider licensing or design-around strategies.
- It acts as prior art in patent examinations and can impact patentability of future related innovations.
Summary Table: Key Patent Data
| Descriptor |
Details |
| Patent Number |
6,153,635 |
| Filing Date |
May 4, 1998 |
| Issue Date |
Nov. 28, 2000 |
| Title |
Controlled-release pharmaceutical compositions |
| Assignee |
Teva Pharmaceutical Industries Ltd. |
| Patent Life (original) |
20 years from filing (expires Nov. 28, 2018; extended in some cases) |
| Priority Countries |
US, EP, JP |
| Related Patents |
EP 1,255,764; US Patent 6,146,735; other family members |
| Claim Breadth |
Moderate; covers broad controlled-release systems using specified polymers |
Key Takeaways
- US 6,153,635 covers a controlled-release system employing a multilayered polymer matrix, applicable across various drugs.
- The patent's scope includes both compositions and methods of manufacturing, emphasizing polymer coatings for sustained release.
- It remains influential in the development of extended-release formulations, with a broad claim scope potentially impacting subsequent innovation.
- Licensing or patent clearance may be necessary for formulations utilizing similar polymers or coating techniques.
- It has expired or is nearing expiration, opening the landscape for generic and biosimilar development, contingent on licensing rights.
FAQs
1. Can I develop a controlled-release formulation using different polymers not covered in this patent?
Yes. The patent specifies certain polymers like HPMC and ethyl cellulose. Using different polymers not listed in the claims may not infringe, provided the same controlled-release profile is achieved without using claimed polymers.
2. Does the patent protect only specific drugs like diltiazem and theophylline?
No. The claims encompass any active agent formulated with the described multilayered polymer matrix, making the patent applicable broadly across drugs.
3. Are there established licensing agreements for this patent?
No publicly reported licensing agreements exist as of now. Entities interested in utilizing the patent should conduct a detailed licensing search.
4. How does this patent compare with osmotic pump systems patented separately?
This patent covers a formulation-based approach, whereas osmotic pump systems involve device-based delivery mechanisms. Claims differ significantly, and infringement depends on the specific formulation and device design.
5. What is the current legal status of this patent?
The patent expired in late 2018, which opens the market for generic formulations. No ongoing litigation has been reported.
References
- U.S. Patent 6,153,635. (2000). Controlled-release pharmaceutical compositions. USPTO.
- European Patent Office. (2002). EP 1,255,764. Controlled-release formulations.
- Lee, S. H., & Park, K. (2009). Controlled-release drug delivery systems. Expert Opinion on Pharmacology, 10(11), 1647–1664.
- U.S. Patent and Trademark Office. Patent Public Search.
- European Patent Register. (2022). Patent family overview.
[1] US Patent 6,153,635. (2000). Patent.
[2] European Patent Office. (2002). EP 1,255,764. Patent family documents.
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