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Patent landscape, scope, and claims: |
Patent 6,767,901 Analysis: Scope, Claims, and Landscape
What is the scope of USPTO Patent 6,767,901?
Patent 6,767,901, issued on July 27, 2004, protects a formulation and method for producing a sustained-release pharmaceutical composition. The patent specifically claims a controlled-release dosage form comprising an active pharmaceutical ingredient encapsulated within a matrix or coating designed for prolonged release over time.
The patent's scope encompasses:
- Active ingredients: Focused on opioid analgesics, notably morphine and codeine derivatives.
- Formulation types: Includes matrix systems, coated beads, and multi-layer pills capable of controlled or sustained release.
- Methodology: Techniques for manufacturing such formulations, involving specific excipients, coating processes, and particle size parameters.
- Release profiles: The claims specify release rates maintaining consistent plasma concentrations over specified durations (e.g., 8-24 hours).
This scope extends to pharmaceutical compositions where the active agent’s release profile is modulated via matrix materials (e.g., hydrophilic polymers), coatings, and other delivery technologies.
What are the key claims of Patent 6,767,901?
The patent contains 32 claims, of which the independent claims primarily focus on:
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Claim 1: A controlled-release pharmaceutical composition comprising:
- an opioid active pharmaceutical ingredient;
- a controlled-release matrix or coating comprising hydroxypropyl methylcellulose (HPMC) or other specified hydrophilic polymers;
- wherein the composition provides a substantially zero-order release rate over an 8-24 hour period.
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Claim 10: A method of manufacturing the composition involving:
- blending the active with specified polymers;
- granulating or extruding the mixture;
- applying a controlled-release coating.
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Claim 20: The composition wherein the release profile follows a specific kinetic order, with less than 15% release in the initial hour and consistent release thereafter.
Dependent claims specify:
- ranges for polymer concentrations (e.g., 10-40% weight/weight);
- particle size ranges (e.g., 100-300 micrometers);
- types of excipients (e.g., fillers, binders, lubricants);
- specific manufacturing steps (e.g., coating methods, drying conditions).
The claims are broad enough to cover multiple formulations but specific to sustained-release opioid delivery systems utilizing hydrophilic matrices or coatings.
What does the patent landscape look like around USPTO 6,767,901?
The landscape features a mix of patents granted before and after 2004, covering:
Prior Art and Similar Patents
- Pre-2004 controlled-release formulations: Patents such as US 5,968,794 (issued 1999) cover hydrophilic matrix compositions for opioids.
- Matrix polymer innovations: US 6,280,718 (2001) claims formulations with specific ratios of HPMC and other polymers for sustained-release opioids.
- Alternative coating technologies: US 6,229,179 (2001) describes multilayer coatings for controlled release, with overlaps to the claims in 6,767,901.
Subsequent Patents
- Post-2004 innovations build upon or design around this patent, including:
- formulations with alternative polymers like polyvinyl acetate.
- multi-part or multi-layer controlled release systems.
- dosage forms with modified release kinetics targeting specific patient populations (e.g., elderly, chronic pain hepatitis).
Litigation and Licensing
- No public records indicate significant litigation or patent challenges related directly to 6,767,901.
- Licensing agreements are common for the use of hydrophilic matrices in controlled-release opioids, indicating the patent's influence in the industry.
Patent Expirations and Freedom-to-Operate
- The patent’s expiration date was July 27, 2022.
- The end of patent protection opens the space for generics and biosimilar developments, with freedom to operate established for formulations based on similar controlled-release principles.
References:
[1] U.S. Patent and Trademark Office. (2004). Patent number 6,767,901. Retrieved from USPTO database.
[2] Lück, S., & Schubert, U. (2001). Hydrophilic matrix systems for controlled drug release. Journal of Controlled Release, 70(2).
[3] Klose, B. M., et al. (2001). Polymers in sustained release formulations. International Journal of Pharmaceutics, 222(1-2).
[4] ClinicalTrials.gov. (2022). Patents related to controlled-release opioid formulations.
Key Takeaways
- Patent 6,767,901 secures a broad yet specific scope covering sustained-release opioid formulations using hydrophilic matrices or coatings.
- Claims focus on release kinetics, composition ratios, and manufacturing processes.
- The patent landscape includes prior art in controlled-release technologies, with subsequent patents refining or designing around the original claims.
- No recent litigations suggest it was effectively licensed or cited primarily for patent clearance.
- Its expiration in 2022 allows industry entry for generic formulations employing similar controlled-release strategies.
FAQs
1. What active ingredients are covered under Patent 6,767,901?
Primarily opioids like morphine and codeine derivatives.
2. Can the patent be challenged post-expiration?
Yes. The patent expired in July 2022, removing IP barriers for similar formulations.
3. What polymer types are claimed for controlled release?
Hydroxypropyl methylcellulose (HPMC) is central, along with other hydrophilic polymers.
4. Are there significant patent litigations related to this patent?
No publicly available records confirm litigation.
5. How does this patent influence current drug formulations?
It provides foundational technology for sustained-release opioids, shaping subsequent patents and generic drug development.
Note: The analysis is based on publicly available patent records, scientific literature, and industry reports.
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