Summary
Patent 5,955,488 covers the formulation and method of use of an immediate-release oral dosage of a specific pharmaceutical compound. Its scope claims a combination of active ingredients, specific excipients, and manufacturing processes designed to optimize bioavailability and stability. The patent landscape shows substantial patent filings related to these compounds, their formulations, and methods of use, with notable activity from both originator companies and generic manufacturers. The patent’s protection is critical for exclusivity but faces potential challenges from filings focusing on alternative delivery systems or improved formulations.
Scope of Patent 5,955,488
Claims Overview
The patent claims primarily encompass a pharmaceutical composition consisting of:
- An active compound, specifically a calcium channel blocker derived from the class of dihydropyridines.
- An excipient matrix that ensures immediate release upon oral administration.
- Manufacturing process steps aimed at achieving consistent particle size and dissolution rates.
The claims can be summarized into three categories:
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Composition Claims: These define the precise ratios of active as well as excipients, including binders, fillers, and disintegrants responsible for rapid dissolution.
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Method Claims: These specify the process steps for preparing the formulation, including specific mixing, granulation, or coating techniques that result in the claimed immediate-release properties.
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Use Claims: Cover the method of administering the composition for treating conditions such as hypertension or angina, emphasizing the clinical utility.
Limitations and Specificity
While comprehensive in its scope, the patent limits claims to dosage forms containing the particular dihydropyridine compound with certain excipient compositions. The claims do not extend to sustained-release formulations or alternative delivery routes.
Patent's Core Innovation
The essence resides in the combination of the active with selected excipients to produce a stable, bioavailable, immediate-release oral medication suitable for once-daily dosing, thus improving patient compliance and therapeutic outcomes.
Patent Landscape Analysis
The patent landscape around this patent shows:
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Pre-Existing Patents: Prior patents exist for calcium channel blockers, formulation techniques, and sustained-release systems.
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Post-Patent Filings: Many generic companies and research institutions have filed Abbreviated New Drug Applications (ANDAs) seeking to challenge or design around the patent, often proposing alternative excipient combinations or modified manufacturing processes.
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Key Competitors: Major pharmaceutical firms such as Pfizer, Boehringer Ingelheim, and Actavis have filed patents targeting similar formulations, indicating strategic efforts to either defend or design around the scope of 5,955,488.
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Patent Term and Expiry: The patent was granted in 1999 and generally has 20-year patent protection from the filing date, which places expiration around 2019-2020. However, patent term extensions or supplementary protection certificates (SPCs) in specific jurisdictions can extend exclusivity.
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Litigation and Challenges: There are no publicly documented litigations directly targeting this patent, but litigation concerning competing formulations and patent validity are ongoing in related compounds and formulations.
Relevant Patent Citations
- USP patents ranging from 4,880,865 to 6,000,000 illustrate the evolution of calcium channel blocker formulations and bioavailability enhancement.
- International patents from Europe and Japan focus on similar immediate-release formulations, emphasizing global patent strategy considerations.
Implications for R&D and Market Entry
- The patent’s expiration opens the market for generic formulations, subject to court rulings or patent extensions.
- Companies developing new calcium channel blockers or innovative delivery systems need to scrutinize the patent claims to avoid infringement.
- Patent challenges often focus on invalidity via prior art or obviousness due to the extensive existing patent landscape.
Key Takeaways
- Patent 5,955,488 claims an immediate-release calcium channel blocker formulation with specific excipients and manufacturing methods.
- Its protected scope involves composition, process, and therapeutic use, primarily for cardiovascular indications.
- The patent landscape is crowded with related patents, indicating active development and potential for patent challenges.
- Expiry and legal strategies significantly influence market dynamics, particularly for generic manufacturers.
- Ongoing patent filings for alternative formulations and delivery mechanisms pose competitive threats and opportunities.
FAQs
1. What is the key innovation protected by patent 5,955,488?
It covers a specific combination of a dihydropyridine calcium channel blocker with excipients designed for immediate release, enhancing bioavailability and patient compliance.
2. How broad are the claims in this patent?
The claims focus on particular formulations with specific excipients, manufacturing procedures, and therapeutic uses. They do not extend to sustained-release forms or different active compounds.
3. When does the patent expire?
The patent was issued in 1999, with a typical expiration around 2019-2020, although extensions or SPCs in some jurisdictions may prolong exclusivity.
4. What legal or patent-based threats exist for generic entrants?
Potential challenges include design-around strategies involving alternative excipients or manufacturing steps. Patent validity could be contested based on prior art.
5. How does the landscape influence future innovation?
The densely populated patent landscape encourages development of novel formulations, delivery systems, and compounds to circumvent existing patents or improve upon current therapies.
References
- United States Patent 5,955,488.
- Patent landscape reports from the USPTO and EPO.
- FDA Orange Book entries for calcium channel blockers.
- Patent applications and filings related to calcium channel blocker formulations.
- Industry analysis reports on generic drug patent challenges.
