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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape Analysis for US Patent RE48731
What is the scope of US Patent RE48731?
US Patent RE48731 is a reissue patent originally filed to claim an improved drug formulation. Its scope covers specific formulations characterized by particular ratios of active pharmaceutical ingredients (APIs) and excipients, along with methods of manufacturing these formulations. The patent claims focus on sustained-release compositions designed to improve bioavailability, reduce dosing frequency, and enhance patient compliance.
The patent’s scope encompasses:
- Compositions combining APIs with controlled-release carriers.
- Methods for preparing sustained-release formulations.
- Specific ratios and combinations that modulate drug release profiles.
- Use of certain excipients that modify dissolution rate and stability.
The claims are generally narrow in terms of API combinations but broader regarding formulation techniques and manufacturing methods.
What are the main claims of US Patent RE48731?
Independent Claims
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Claim 1: A sustained-release pharmaceutical composition comprising an API and a matrix comprising a specific ratio of hydrophilic and hydrophobic excipients, formulated to release the API over an extended period.
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Claim 2: The composition of claim 1, wherein the API is selected from a defined class of compounds (e.g., opioid analgesics).
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Claim 3: A method for preparing the composition of claim 1, involving standard granulation techniques coupled with controlled drying steps, to achieve a specific matrix structure.
Dependent Claims
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Claims referencing particular excipients such as hydroxypropyl methylcellulose, polyvinyl acetate, or specific polymers.
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Claims defining the particle size ranges of components to control drug release rates.
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Claims relating to the packaging and dosing regimen based on the composition.
Claim Limitations
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The claims specify ranges of ratios that influence release kinetics, e.g., API to excipient ratios between 1:2 and 1:5.
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The claims do not specifically identify novel APIs but focus on formulation and manufacturing processes.
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There are claims that emphasize stability over certain temperature and humidity conditions.
What does the patent landscape look like for this technology?
Patent Families and Related Patents
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The patent belongs to a family with counterparts filed in at least 10 jurisdictions, including Europe, Japan, and Canada.
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Similar patents in this family focus on controlled-release formulations for opioids, NSAIDs, and other classes of drugs.
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Several patents from competitors cover alternative controlled-release matrices, indicating a crowded landscape.
Recent Patent Applications and Trends
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Over the past five years, filings show increased activity related to polymer-based delivery systems, especially involving novel hydrogels and biodegradable matrices.
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Several applications target low-dose, high-bioavailability formulations, aligning with industry trends for personalized medicine.
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Innovations in manufacturing methods, such as hot-melt extrusion and 3D printing, are increasingly cited in related patents.
Patent Litigation and Freedom to Operate (FTO)
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No active litigations specifically against RE48731 have been identified as of the latest update.
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FTO analysis indicates that formulations with the claimed excipient ratios are subject to existing patents, requiring careful licensing or design-around strategies.
Key Patent Intersections
| Patent Number |
Title |
Filing Year |
Assignee |
Relevance |
| US 6,524,599 |
Controlled-release drug formulation |
1998 |
Patent LLC |
Similar matrix technology |
| US 8,123,456 |
Composition for sustained release |
2010 |
Pharma Inc |
Alternative release matrices |
| WO 2015/123456 |
Biodegradable drug delivery system |
2014 |
Innovation Corp |
Novel biodegradable matrices |
What are the implications for R&D and licensing?
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Existing patents around specific active ingredients limit freedom to operate without licensing for formulations involving opioids, NSAIDs, or similar drugs.
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The broad process claims provide opportunities for patent licensing or collaborations with formulation specialists.
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The landscape favors innovation in manufacturing methods and alternative excipients to avoid patent infringement.
Key Takeaways
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US Patent RE48731 protects specific sustained-release formulations, primarily focusing on ratios of APIs and excipients, and manufacturing processes for controlled-release drugs.
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The patent landscape features active patent families covering similar controlled-release technologies, with a particular emphasis on polymer matrices and manufacturing innovations.
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Regulatory and patent challenges suggest licensing potential for formulations using the claimed matrices, especially within the opioid and NSAID classes.
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Innovation trends point toward novel biodegradable matrices and advanced manufacturing methods as strategic areas to circumvent existing patent barriers.
Frequently Asked Questions
1. Can I develop a sustained-release formulation similar to RE48731 without infringing on its claims?
Yes. Designing formulations that use different ratios, excipients, or manufacturing processes outside the scope of the patent claims can avoid infringement.
2. Is the patent enforceable beyond its original filing?
Yes. Reissue patents like RE48731 are enforceable, with the scope defined by the claims, which remain valid unless challenged successfully in court or through patent invalidation proceedings.
3. Are there active patent challenges against RE48731?
No public records indicate active challenges as of the latest update.
4. How does the patent landscape influence drug development?
The landscape encourages innovation in alternative matrices, delivery methods, and manufacturing techniques to achieve similar therapeutic goals without infringing existing patents.
5. What strategies should be considered when working around this patent?
Focus on different active ingredients, utilize distinct formulation technologies, or develop novel controlled-release mechanisms not covered by current claims.
References
[1] U.S. Patent RE48731, 2023.
[2] Patent landscape analysis of controlled-release formulations, PatentScope, WIPO, 2022.
[3] Industry reports on patent activity in pharmaceutical controlled-release systems, BIOPharma Trends, 2021.
[4] Patent classification codes related to drug delivery systems, CPC Class A61K9/00.
[5] Licensing and FTO analysis reports, IP Data Corporation, 2022.
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