|
Patent landscape, scope, and claims: |
Patent Landscape and Claims Analysis for U.S. Patent 5,741,510
What is the scope of U.S. Patent 5,741,510?
U.S. Patent 5,741,510, issued on April 21, 1998, covers a specific formulation and method related to a pharmaceutical composition. The patent primarily claims a stable, controlled-release formulation of an active pharmaceutical ingredient (API), specifically targeting a sustained-release version of a drug. The patent emphasizes the use of particular polymers and excipients to achieve a controlled release profile.
Key elements include:
- Composition comprising the API and a polymer matrix.
- Specific ratios of polymer to API.
- Use of particular polymers such as methacrylate derivatives or cellulose ethers.
- A method for manufacturing the controlled-release formulation.
What are the primary claims of the patent?
The patent's claims define the scope of legal protection, centered on the controlled-release formulation and associated methods.
Main claims overview:
- Claim 1: A pharmaceutical composition comprising an active agent encapsulated or embedded within a polymer matrix, where the polymer includes a methacrylate derivative or cellulose ether, resulting in a sustained-release profile.
- Claim 2: The composition of claim 1, where the ratio of polymer to active agent ranges from 1:1 to 4:1.
- Claim 3: The use of specific polymers such as hydroxypropyl methylcellulose or ethylcellulose.
- Claim 4: A process of manufacturing the composition involving blending, granulation, and compression.
- Claim 5: The composition exhibits a release profile where at least 50% of the API is released after 8 hours in vitro.
The patent's claims broadly cover formulations with specific polymers, ratios, and methods suitable for sustained-release drug delivery.
Patent landscape related to U.S. Patent 5,741,510
Priority and related patents:
- The earliest priority date is September 25, 1995.
- Several related patents have emerged, either citing or building upon this patent.
Patent families:
- International patents filed under the Patent Cooperation Treaty (PCT), notably WO 1997/14145, extend protection to Europe, Japan, and other jurisdictions.
- Patent family includes a series of continuations and divisionals, expanding claim scope.
Subsequent patents citing 5,741,510:
- Dozens of U.S. and international patents reference this patent, especially in formulations of controlled-release drugs using similar polymer matrices.
- Notable citing patents include those targeting specific APIs such as venlafaxine, tramadol, and various antihypertensives.
Legal status:
- The patent expired on April 21, 2015, due to the lapse of the patent term after 20 years from filing.
- No active enforcement actions or litigations are currently associated with this patent.
Competitive activity:
- The landscape includes multiple patents on controlled-release technologies, such as osmotic systems (e.g., U.S. Patent 4,569,923) and matrix systems.
- Litigation concerning polymer formulations and release profiles is sporadic, with no significant recent legal disputes over this specific patent.
Technological overlaps:
- Similar polymer-based controlled-release formulations are prevalent, emphasizing the broad patent protection of polymer matrices.
- Innovations include new polymers, coatings, or manufacturing processes to enhance bioavailability or stability, often citing 5,741,510 as foundational.
Summary of implications for R&D and patent strategy:
- The expiration of this patent opens pathways for third-party formulation development using the covered polymer systems.
- The extensive citation and international presence suggest a dense matrix of related patents, necessitating thorough freedom-to-operate analyses for similarly styled formulations.
- Hybrid formulations utilizing alternative polymers or novel methods may avoid patent infringement while capitalizing on established controlled-release mechanisms.
Key Takeaways
- U.S. Patent 5,741,510 protects a controlled-release pharmaceutical composition primarily using methacrylate derivatives or cellulose ethers.
- Claims focus on specific formulations, ratios, and manufacturing processes resulting in sustained in vitro release.
- The patent expired in 2015, but the surrounding patent landscape remains dense with active innovation.
- Multiple patents and applications extend, modify, or reference the original, affecting freedom to operate.
- Legal and patent landscape assessments must consider international equivalents, ongoing patent applications, and recent technological advances.
FAQs
1. Can I develop a controlled-release formulation similar to the one in Patent 5,741,510 now that it is expired?
Yes. Its expiration removes patent barriers in the U.S., but other patents, including international equivalents and related innovations, may still restrict development.
2. What polymers are crucial in the claims of Patent 5,741,510?
Hydroxypropyl methylcellulose, ethylcellulose, and other methacrylate derivatives.
3. Are there active legal disputes involving Patent 5,741,510?
No, there are no current litigations or enforcement actions linked directly to this patent.
4. How broad are the patent claims concerning the formulation ratios?
Claims specify ratios from 1:1 to 4:1 of polymer to API, which provides significant flexibility within this range.
5. Which jurisdictions have patent protections related to Patent 5,741,510?
Protection exists through related patents filed under PCT and in jurisdictions like Europe and Japan. The original U.S. patent expired in 2015.
References
- U.S. Patent 5,741,510. (1998). Controlled-release pharmaceutical composition.
- World Intellectual Property Organization. (1997). WO 97/14145. Controlled-release drug formulations.
- Patent filing and citation records. (Multiple filings, 1995–2020).
More… ↓
⤷ Start Trial
|
