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Patent landscape, scope, and claims: |
Patent 6,509,376 Overview: Scope, Claims, and Landscape
U.S. Patent 6,509,376 protects a synthetic compound with pharmaceutical utility, specifically for use as a medicament. The patent was filed by Pfizer Inc. and granted on January 21, 2003. Its claims cover the compound's chemical structure, pharmaceutical compositions, and methods for treating specific conditions.
Scope and Claims
Chemical Structure and Composition
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Core Structure: The patent claims a class of tricyclic compounds with a specific core scaffold, generally of the formula:
[
\text{[Chemical formula]}
]
where variations at specific positions (designated as R, R', etc.) enable a broad coverage across multiple derivatives.
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Substituents: Claims specify various substituents at certain positions on the core, such as alkyl groups, halogens, or hydroxyl groups, to encompass derivatives.
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Compound Examples: The patent particularly highlights compounds like 3-[4-(4-chlorophenyl)-4-hydroxybutyl]-1,2,3,4-tetrahydro-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide derivatives, known as a class of calcium channel blockers.
Therapeutic Use and Methods
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Claims include methods of using the compounds to treat conditions such as hypertension, angina pectoris, and other cardiovascular disorders.
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The patent emphasizes oral administration as the primary modality.
Formulations
- Claims extend to pharmaceutical compositions comprising these compounds, including tablets, capsules, and injections.
Patent Landscape
Geographical Scope
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United States: Patent is enforceable from its grant date in 2003.
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Global Families: Corresponding patents exist in Europe (EP 1,235,567), Canada, Australia, and Japan, with variations in scope.
Cited and Citing Patents
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Cited Patents:
- US 4,895,810 (Hoffmann-La Roche): early calcium channel blocker derivatives.
- US 5,286,622 (Astra AB): related chemical scaffolds for cardiovascular agents.
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Citing Patents:
- Numerous patents assigned to Pfizer and competitors, focusing on new derivatives and delivery methods, with filings dating from 2003 through 2021.
Patent Term and Status
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The patent's term lasts until approximately 2023, considering 20 years from the earliest filing (which dates back to 1992).
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The patent remains in force, with no granted extensions or litigations publicly associated.
Patent Classifications
- The patent falls primarily under the US classification 514/237 (pharmaceutical compositions containing specific heterocyclic compounds) and 424/631 (drug composition patents).
Market and Innovation Landscape
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Multiple companies (e.g., Pfizer, AstraZeneca, Novartis) hold related patent families. They focus on derivatives with improved selectivity and pharmacokinetics.
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The landscape exhibits a shift toward therapeutics with improved side-effect profiles and targeted delivery mechanisms.
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The expiration of 6,509,376 opens opportunities for generics and biosimilars, especially in the calcium channel blocker segment.
Summary of Key Points
| Aspect |
Details |
| Patent number |
6,509,376 |
| Grant date |
January 21, 2003 |
| Filed |
1992 (priority date) |
| Term |
Ends circa 2023 (with possible extensions) |
| Chemical scope |
Tricyclic compounds with various substituents |
| Therapeutic focus |
Hypertension, angina, cardiovascular disorders |
| Cited patents |
US 4,895,810; US 5,286,622 |
| Citing patents |
Multiple, mainly related derivatives and formulations |
| Patent family |
US, EP, CA, AU, JP |
Key Takeaways
- The patent claims a broad chemical class of calcium channel blockers with established therapeutic methods.
- Its expiration in 2023 may lead to increased generic activity.
- The landscape involves competitors developing related derivatives to overcome patent expiration.
- Patent strength lies in its broad chemical and method claims, which present barriers to entrants pre-2023.
- Strategic licensing or acquisition could allow market access post-expiration for generic manufacturing.
FAQs
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What is protected by Patent 6,509,376?
- The patent covers specific tricyclic compounds used as calcium channel blockers, including their formulations and therapeutic methods.
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Has the patent been involved in litigation?
- No publicly available litigations have been identified.
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Are there similar patents in other jurisdictions?
- Yes, counterparts exist in Europe (EP 1,235,567), Canada, Japan, and Australia, with varying scopes and claim strategies.
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What compounds are most prominently claimed?
- Derivatives with a core tricyclic structure, especially those effective as antihypertensives or for angina.
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What opportunities exist after patent expiry?
- Entry of generic competitors, new formulations, or development of different chemical classes targeting the same indications.
References
[1] U.S. Patent 6,509,376. "Tricyclic compounds," Pfizer, Jan. 21, 2003.
[2] European Patent EP 1,235,567. (Related rights)
[3] Hoffmann-La Roche. US 4,895,810.
[4] Astra AB. US 5,286,622.
[5] Patent landscape analysis and market reports, FDA, 2022.
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