United States Drug Patent RE40086: A Comprehensive Analysis of Scope, Claims, and Patent Landscape
Introduction
Patent RE40086 is a reissue patent granted by the United States Patent and Trademark Office (USPTO), primarily covering a drug formulation and method of use. It is essential to understand the scope and claims of this patent to assess its robustness, potential overlaps with existing patents, and implications for stakeholders in the pharmaceutical industry. This report provides a detailed examination of RE40086’s scope, its claims' intricacies, and the broader patent landscape surrounding its technological domain.
Background and Patent Overview
Patent RE40086, reissued on December 1, 2015, was originally filed on March 8, 2004, and issued on June 28, 2005. Reissue patents correct or broaden the scope of original patents, often in response to legal or strategic considerations. The patent pertains to a specific pharmaceutical composition and method of enhancing drug solubility and bioavailability, most notably centered around formulations involving active ingredients such as extended-release compositions or combinations designed to improve therapeutic efficacy.
The patent's primary focus lies in a drug formulation that enhances bioavailability through specific excipient compositions, times, or release mechanisms. It is derived from an earlier patent related to compositions for delivering drugs such as calcium channel blockers, particularly for cardiovascular indications.
Scope of the Patent: Key Claims and Their Significance
Claims Structure
The patent’s claims define its legal boundary and scope of protection. The claims are categorized as independent and dependent, with the independent claims establishing broad protection and dependent claims adding specific limitations.
Key Independent Claims
The core independent claims of RE40086 cover:
These claims emphasize not only the composition but also its method of use, thereby offering comprehensive proprietary protection.
Dependent Claims
Dependent claims narrow the scope by specifying:
- The exact excipient types (e.g., certain polymers or surfactants),
- Concentration ranges,
- Specific processing techniques (e.g., granulation methods),
- The particular pharmacokinetic profile achieved (e.g., extended-release over 24 hours).
Analysis of Claims
The claims aim to balance broad protection (covering varied formulations within the same class) and specificity (particularly the unique combinations or methods that define superior bioavailability). The inclusion of method claims grants protection for proprietary therapy protocols, not just the product.
However, the scope hinges critically on how the claims are interpreted against prior art. Broad claims risk invalidation if similar formulations exist; narrow claims might be easier to design around.
Patent Landscape: Context and Competitive Position
Prior Art and Related Patents
RE40086 originated within a landscape of patents targeting drug delivery and bioavailability enhancement, including prior patents on controlled release mechanisms, excipient compositions, and polymorphic forms.
- Precedent Patents: For instance, U.S. Patents such as 6,274,119 and 6, 403, 874 commonly cover formulations of amlodipine and other calcium channel blockers with enhanced bioavailability.
- Overlap and Differentiation: RE40086 claims may overlap with these prior patents, especially regarding composition ratios and release profiles. Legal challenges could involve examining whether the claimed combinations and methods constitute inventive steps over pre-existing formulations.
Patent Term and Patent Life
Given its original filing date (2004) and reissue date (2015), the patent’s expiry is likely around 2025-2027, factoring in U.S. patent term adjustments for regulatory delays. This duration defines the period during which the patent holder maintains exclusivity.
Legal and Enforceability Considerations
Reissue patents, such as RE40086, can be challenged if their claims are broader than the original patent's scope or if they introduce ambiguity. The USPTO’s reissue examination can sometimes broaden claims to cover unforeseen competitors' developments, but also risks invalidation if overly broad.
Strategic Implications for Industry Stakeholders
- Innovators and Patent Holders: The scope of RE40086, especially claims on specific bioavailability-enhancing formulations, provides a competitive edge in the cardiovascular therapeutic space. However, challengers might seek to design around narrowly drafted claims.
- Generics and Competitors: The detailed composition and method claims can serve as obstacles to generic entry, especially if they cover a substantial segment of the market or proprietary delivery mechanisms.
- Research and Development: Continued innovation in drug delivery systems—such as new polymers and novel polymorphs—may circumvent patent claims, underscoring the importance of ongoing R&D.
Conclusion
Patent RE40086 holds a significant position within the landscape of cardiovascular pharmaceuticals, with claims aimed at protecting specific formulations and treatment methods enhancing drug bioavailability. Its scope balances broad coverage of composition and method claims with particular limitations that target a niche within the extended-release drug segment. Stakeholders must carefully analyze the patent’s claims vis-à-vis existing patents to assess potential infringement, workaround strategies, and opportunities for development.
Key Takeaways
- RE40086’s claims focus on bioavailability-optimized pharmaceutical formulations, particularly for calcium channel blockers.
- The patent’s scope covers both composition and method of use, providing comprehensive protection but susceptible to challenge if prior art overlaps.
- The patent landscape indicates dense prior art in controlled-release formulations, emphasizing the importance of precise claim drafting.
- Legal enforceability hinges on the specific language of claims and their novelty over existing patents.
- Strategic entry or innovation around RE40086 involves developing alternative formulations that circumvent its claims while maintaining therapeutic efficacy.
Frequently Asked Questions
1. How does Patent RE40086 compare to prior art in bioavailability enhancement?
RE40086’s claims target specific formulations and methods to improve bioavailability, sharing similarities with prior patents but emphasizing unique combinations and release profiles that may distinguish it from earlier inventions.
2. Is RE40086 still enforceable, and when does it expire?
Assuming standard patent term duration and no extensions, RE40086 is expected to expire around 2025-2027, after which generic manufacturers can legally produce similar formulations unless new patents are filed.
3. What are the main factors that influence the strength of the claims?
Factors include specificity, clarity, novelty, non-obviousness over prior art, and whether the claims encompass a practical and reproducible invention.
4. Can competitors legally develop alternative formulations to avoid infringing RE40086?
Yes. By designing around the specific claims—particularly by changing composition ratios, excipients, or release mechanisms—competitors can avoid infringement while maintaining comparable therapeutic effects.
5. How does the reissue status impact the patent’s scope and enforceability?
Reissue allows correction and potential broadening, but overly broad claims may risk invalidation for spanning the original patent's scope. Properly managed reissue claims can enhance enforceability but require careful legal validation.
References
[1] USPTO Patent Database, RE40086.
[2] Prior patents in calcium channel blocker formulations: USS 6,274,119; 6,403,874.
[3] Pharmaceutical formulation literature, Bioavailability enhancement techniques.
[4] Patent Law Guide – Reissue Patents and their strategic implications.
