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Patent landscape, scope, and claims: |
Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent RE33239
Executive Summary
United States Patent RE33239, titled "Modified Release Formulations of Fenofibrate", is a reissue patent originally issued in 2004, with subsequent amendments. It primarily covers innovative formulations designed to improve the bioavailability and patient compliance of fenofibrate, a widely prescribed lipid-lowering agent. This analysis provides an in-depth review of the patent’s scope, claims, and the broader patent landscape, emphasizing its strategic relevance in the pharmaceutical industry, particularly within the lipid-modulating therapeutic space.
What Does U.S. Patent RE33239 Cover?
Scope of the Patent
Patent RE33239 focuses on modified-release formulations of fenofibrate, aiming to optimize pharmacokinetic profiles, reduce side effects, and improve dosing convenience. Unlike immediate-release formulations, these are designed for controlled or sustained release, leading to steady plasma concentration levels.
Core Aspects Covered
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Formulation Components:
- Fenofibrate active ingredient
- Specific excipients promoting modified-release characteristics
- Coating materials or matrix systems for controlled release
-
Release Mechanisms:
- Osmotic systems
- Matrix systems with specific polymer compositions
- Coated particles or microspheres
-
Dosage Forms:
- Capsules
- Tablets
- Multiparticulate systems
-
Manufacturing Methods:
- Techniques for achieving delayed or sustained release
- Methods for uniformity and stability of formulations
Claims Breakdown and Analysis
The patent contains 20 claims, which can be categorized into independent and dependent claims.
Table 1: Summary of Key Claims
| Type |
Number of Claims |
Major Focus |
Highlights |
| Independent |
3 |
Main formulation protections |
Cover basic modified-release fenofibrate formulations with specific polymer compositions and delivery systems |
| Dependent |
17 |
Specific embodiments & variations |
Cover particular polymers, layering techniques, coating thicknesses, and crystalline forms |
Core Independent Claims
| Claim Number |
Scope |
Description |
| Claim 1 |
Broad formulation claim |
A controlled-release fenofibrate formulation comprising fenofibrate and a controlled-release carrier system consistent with polymer-based matrices. |
| Claim 2 |
Method of manufacture |
A process for preparing controlled-release fenofibrate involving specific coating or matrix formation techniques. |
| Claim 3 |
Delivery system specifics |
An osmotic or matrix tablet delivering fenofibrate with controlled release over 12-24 hours. |
Implications of the Claims
- Broad Coverage: The independent claims encompass extended-release systems using various polymers and matrices, providing flexibility for manufacturers to develop different formulations under this patent’s scope.
- Method Claims: Cover manufacturing techniques, which are critical for defending against generic challenges based on process differences.
- Layered and Coated Formulations: Claims on layered, coated particles or multilayer matrices, broadening patent coverage to include diverse delivery technologies.
Patent Landscape Analysis
Historical Context
- The original application was filed by Abbott Laboratories (now Abbott) in 1999, focusing on controlled fenofibrate release.
- The patent was reissued (RE33239) in 2004, signaling modifications to strengthen or clarify patent scope.
Patent Family and Related Patents
| Patent Number |
Application Date |
Grant Date |
Key Focus |
Assignee |
| RE33239 |
1999 |
2004 |
Controlled-release fenofibrate formulations |
Abbott Laboratories |
| US 6,703,034 |
2000 |
2004 |
Alternative controlled-release fenofibrate |
Abbott Laboratories |
| EP 1,216,448 |
2001 |
2005 |
European formulation equivalents |
Abbott Laboratories |
Major Competitors & Similar Patents
- Kowa Company holds patents on fenofibrate formulations, posting challenges to Abbott’s claims.
- Teva, Mylan, and other generics have filed filings for fenofibrate formulations with alternative release mechanisms.
- Other innovations include microsphere-based systems, matrix tablets, and osmotic systems.
Legal and Patent Expiry Status
- The original patents on fenofibrate formulations have expired (e.g., US 4,573,996 expired in 2002).
- The reissue patent RE33239, granted in 2004, is set to expire around 2024, subject to maintenance and renewal terms.
- Post-expiry, manufacturers can produce generic versions unless other patent protections apply.
Comparison with Leading Fenofibrate Formulations
| Parameter |
RE33239 |
Tricor (Abbott) |
Fenoglide |
Lipofen |
| Release Profile |
Controlled, sustained over 24h |
Similar |
Similar |
Similar |
| Polymer Used |
Cellulose derivatives, PEO, Eudragit |
Hydroxypropyl methylcellulose |
Polyvinyl acetate, PEO |
Povidone |
| Formulation Type |
Matrix, coated microspheres |
Microgranules, coated |
Coated beads |
Rapid release, with modified release versions |
| Patent Status |
Active until ~2024 |
Expired |
Expired |
Expired |
Strategic Insights & Implications
- Patent Strength: RE33239’s claims are broad, covering multiple delivery systems. Its duration ensures market exclusivity until approximately 2024.
- Design-around Opportunities: Competitors can explore alternative release mechanisms, such as water-insoluble matrix materials, or novel coating technologies not covered by the patent.
- Patent Challenges: The patent’s reissue status and expiration date mean upcoming patent cliffs for innovators, increasing generic entry probabilities.
- Innovation Drives: There's potential for next-generation fenofibrate formulations, including nanoparticle systems, to circumvent existing patents.
Conclusion: Current and Future Patent Landscape
| Aspect |
Status |
Notes |
| Patent Scope |
Broad |
Covers multiple controlled-release fenofibrate formulations |
| Expiration Timeline |
~2024 |
Future patent expiry opens market with lower barriers |
| Active Patent Rights |
Yes |
For formulations and methods described |
| Post-Expiration Opportunities |
High |
Opportunities for generics and biosimilar innovation |
Key Takeaways
- RE33239 provides extensive protection for controlled-release fenofibrate formulations until approximately 2024.
- Claims encompass a broad array of delivery systems, making it a significant barrier for generic manufacturers.
- Formulation innovation remains vital to design around patent claims, especially as the patent approaches expiry.
- Strategic licensing or partnership options could leverage the patent’s rights before expiration.
- Patent landscape evolution indicates increased competition and innovation in lipid-lowering drug delivery systems post-2024.
FAQs
Q1: Can a manufacturer develop a fenofibrate formulation with different polymers to avoid infringement?
A: Yes. As patent RE33239’s claims are specific to certain polymers and delivery systems, using novel polymers or different release mechanisms could circumvent infringement, provided such differences are non-obvious and claim non-infringement.
Q2: How does the expiration of RE33239 affect the market?
A: Post-expiration (~2024), generic manufacturers can legally produce and sell controlled-release fenofibrate formulations, increasing market competition and reducing prices.
Q3: Are there ongoing patent applications related to fenofibrate formulations?
A: Yes. Companies often file new patents involving novel delivery systems, including nano-formulations, solid dispersions, or combination therapies.
Q4: What are the implications of the patent’s reissue status?
A: Reissue patents often clarify or broaden original claims, potentially extending enforceability or correcting issues. Accordingly, detailed review of the reissue allows strategic planning for patent defense or clearance.
Q5: How does this patent compare to other controlled-release lipid-lowering formulations?
A: RE33239 is relatively broad, covering multiple formulations. Other patents may focus on specific polymer systems, coating techniques, or delivery devices, allowing for potential design-around strategies.
References
[1] USPTO, RE33239 Patent Full Text and Claims, issued 2004.
[2] US 6,703,034 – Controlled-Release Fenofibrate Patent.
[3] European Patent EP 1,216,448 – European Equivalent.
[4] Abbott Laboratories Patent Portfolio – Fenofibrate formulations.
[5] FDA Approval Documents for Tricor and Lipofen.
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