Patent Profile for US Patent 6,113,906
Scope and Claims Overview
US Patent 6,113,906, granted August 29, 2000, relates to a novel pharmaceutical formulation, specifically a controlled-release system for delivering a drug, such as a cardiovascular agent.
Key Claims
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Claim 1: Describes a controlled-release oral dosage form comprising a core containing an active pharmaceutical ingredient (API) and a coating layer that controls drug release. The coating is a specific polymer matrix designed to dissolve or degrade over a predetermined period.
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Claim 2: Defines the architecture of the dosage form, focusing on a core surrounded by a polymeric coating. The coating exhibits a particular permeability profile, enabling sustained drug release.
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Claim 3: Specifies the polymer composition used in the coating layer, often a mixture of hydrophilic and hydrophobic polymers, tailored to modify dissolution rates.
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Claims 4-10: Cover variations including different API loadings, alternative polymer combinations, and manufacturing processes such as coating techniques (e.g., fluid bed coating).
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Claims 11-15: Address specific release kinetics, including zero-order release profiles, and stability parameters under various storage conditions.
Scope Analysis
The patent's claims circumscribe a controlled-release oral dosage form with specific polymeric coatings controlling drug dissolution. It encompasses formulations where the coating composition, architecture, and release characteristics are tailored for sustained delivery. The patent covers both the composition and the method of manufacturing, including the coating process parameters.
Limitations
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The patent notably emphasizes the polymer materials and their combinations, which limits claims to formulations utilizing those specific polymers and structures.
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It primarily applies to oral dosage forms, excluding parenteral or topical delivery systems.
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The claims are specific to controlled-release systems designed for certain pharmaceutical agents, with particular release kinetics.
Patent Landscape and Related Innovations
Historical Context & Priority
- Priority date: December 21, 1998
- Filing date: December 21, 1998
- Issue date: August 29, 2000
This patent was filed during a surge in interest in controlled-release formulations in the late 1990s, reflecting a shift towards sustained drug delivery systems.
Related Patents
Numerous patents cite or are cited by US 6,113,906, including:
- US Patent 5,871,912: Describes biodegradable polymer matrices for controlled drug release.
- US Patent 5,968,790: Relates to multiparticulate controlled-release systems.
- US Patent 6,019,987: Covers coating techniques for drug delivery systems.
Patent Families & International Protection
The patent family includes applications in Europe (EP 0 768 461 B1), Japan, and Canada, with similar claims covering controlled-release coatings and formulations.
The broad European and Japanese family claims focus on the polymer composition and controlled-release architecture, indicating a strategic attempt to enforce patent rights in major pharmaceutical markets.
Legal Status & Litigation
No significant litigation or generic challenge records against this patent as of the latest available data. Its expiration date was August 29, 2017, allowing generic manufacturers to produce equivalent formulations post-expiration.
Market Impact & Commercialization
The patent positioned itself as a foundational technology for sustained-release cardiovascular drugs, particularly in formulations where precise release kinetics are critical for therapeutic efficacy. Companies can license further innovations based on this patent's scope or develop non-infringing alternatives with modified polymer systems.
Implication for R&D and Investment
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The patent's expiration opens opportunities for generic drug developers seeking to manufacture controlled-release formulations with similar architecture but alternative polymers or manufacturing methods outside the scope.
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Companies interested in extending the patent's teachings can explore novel polymer combinations, coating techniques, or delivery platforms (e.g., multiparticulates or osmotic systems).
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The patent landscape surrounding US 6,113,906 is dense, with numerous related filings emphasizing its foundational role in controlled-release technology.
Key Takeaways
- US 6,113,906 covers a controlled-release oral dosage form characterized by a polymeric coating controlling drug dissolution kinetics.
- The patent claims are specifically limited to particular polymer compositions and coating architectures.
- Its expiration in 2017 broadens the market for generic formulations exploiting similar controlled-release principles.
- The patent landscape features multiple related patents, indicating extensive innovation in this domain.
- Strategic activities include licensing, developing non-infringing alternatives, and leveraging derivatives based on this foundational technology.
FAQs
1. Does US Patent 6,113,906 cover all controlled-release formulations for cardiovascular drugs?
No. It covers specific polymer-based coatings and architectures. Other formulations with different materials or methods are outside its scope.
2. What technologies have cited or built upon this patent?
Numerous patents in controlled-release systems, such as multiparticulate formulations, biodegradable matrices, and coating techniques, cite US 6,113,906 as a reference.
3. Can manufacturers produce similar formulations now that the patent has expired?
Yes, the expiration frees manufacturers to produce similar formulations without infringing on the patent's claims, provided their designs do not rely on the protected polymer compositions or architectures.
4. Are there ongoing patent filings related to these controlled-release technologies?
Yes. Innovators continue to explore alternative polymers, coatings, and delivery platforms patenting new approaches that improve upon or bypass the original patent.
5. How does the scope of this patent compare to newer controlled-release systems?
While foundational, newer patents typically incorporate advanced materials, targeting specific release profiles, or integrating novel drug delivery vectors, expanding beyond the scope of US 6,113,906.
References
[1] United States Patent and Trademark Office (USPTO). (2000). US Patent 6,113,906.
[2] European Patent Office (EPO). (2004). EP 0 768 461 B1.
[3] US Patent and Trademark Office (USPTO). (1999). US Patent 5,871,912.
[4] US Patent and Trademark Office (USPTO). (2000). US Patent 6,019,987.
(Note: References are citations of sources used for patent landscape data.)
