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Patent landscape, scope, and claims: |
Analysis of United States Patent 4,177,263: Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,177,263 (the '263 patent) was issued on December 4, 1979, and broadly pertains to a class of chemical compounds with therapeutic potential. It has historically played a significant role in the landscape of pharmaceutical patents, particularly in relation to agents used in metabolic or neurological disorders. This analysis dissects the scope and claims of the patent and evaluates its position within the current patent landscape.
Scope of the '263 Patent
The '263 patent's scope covers novel chemical compounds, their pharmacological properties, and methods of preparation aimed at treating specific conditions such as schizophrenia, depression, or other central nervous system (CNS) disorders.
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Chemical Scope:
The patent claims relate to a particular class of aryl-alkyl or aryl-alkylamine derivatives. These compounds are characterized by their structural backbone—which typically involves substitutions on a phenyl ring linked via a bridging chain to an amine group, conferring activity on various neurotransmitter receptors.
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Pharmacological Scope:
The compounds demonstrate antagonistic or agonistic activities at dopamine and serotonin receptor subtypes, offering therapeutic avenues in neuropsychological illnesses. Specifically, the patent emphasizes their antipsychotic or antidepressant capabilities.
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Method of Use:
The patent covers compositions containing these compounds, as well as methods of administering effective doses to treat relevant disorders.
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Chemical Variants and Derivatives:
Structural flexibility is embedded in the claims, encompassing substituted derivatives with variations in substituents on aromatic rings or linker chains, providing a broad patent scope.
Implication:
The scope is sufficiently broad to encompass a wide range of compounds within the chemical class, protecting not just specific molecules but also their derivatives and methods of administration.
Claims Analysis
The patent contains multiple claims—primarily independent claims (broad scope) and dependent claims (narrower scope).
Independent Claims
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Claim 1:
Describes a pharmaceutically active compound with a specified core structure, including possible substituents at certain positions, aimed at receptor activity modulation.
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Claim 2:
A pharmaceutical composition comprising the compound of Claim 1 and a suitable carrier.
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Claim 3:
A method of treating a CNS disorder, such as schizophrenia, comprising administering an effective amount of the compound of Claim 1.
Dependent Claims
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Specify particular substituents on the core structure, such as methyl, halogen, or alkyl groups.
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Cover specific compounds within the broader genus, providing protection for preferentially active variants.
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Address dosage ranges, routes of administration (oral, injectable), and formulation specifics.
Critical Evaluation of Claims
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The breadth of Claim 1 grants patent holders a wide protective scope encompassing numerous derivatives sharing the core structural features.
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Dependent claims provide fallback positions in case narrower claims are challenged, but the overarching scope remains substantial.
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The language emphasizes "comprising," which allows for additional components, and "effective amount," typical in pharmaceutical patents, safeguarding against challenges based on non-essential elements.
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The priority date (Dec 1, 1976) provides a long patent term (expiring in 1993, with potential extensions), establishing historical significance but current legal standing may be affected by subsequent patent expirations or challenges.
Patent Landscape
Historical Context and Patent Family
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The '263 patent is among pioneering filings for chemical classes used in neuropharmacology.
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It likely belongs to a patent family filed internationally, covering jurisdictions such as Europe, Japan, and Canada, reflecting commercial ambitions.
Competitor and Follow-on Patents
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Over subsequent decades, numerous later patents have been filed, claiming novel derivatives, formulation improvements, and methods of use that build upon or circumvent the '263 patent.
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Research and development driven by the initial claims prompted new compositions and combinatorial approaches targeting similar CNS pathways, often resulting in patent thickets.
Patent Term and Legal Status
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The original patent expired around the early 1990s, which means the original claims are now in the public domain.
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However, patent extensions, new formulations, or new use cases derived from the '263 compounds may be protected under subsequent patents.
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Litigation history: No known successful litigations specifically challenging the '263 patent exists, but generic companies could have potentially designed around the broad core structure once it expired.
Current Patent Landscape
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The landscape features many subsequent patents covering new chemical entities, method of use claims, polymorphs, and delivery systems.
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Active competitors include major pharmaceutical companies with newer antipsychotic agents (e.g., atypical antipsychotics), often protected via expedited patent filings or orphan drug designations.
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Generic manufacturers may have entered markets following patent expiration, though patent challenges can sometimes impede or delay such entry.
Legal and Commercial Implications
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The '263 patent historically established a foundational intellectual property position, providing competitive advantage for its assignee.
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Its expiration has led to market normalization, allowing generic competition.
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The broad claims laid the groundwork for subsequent research and development activity but have limited current enforceability.
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Newer patents related to derivatives or formulations continue to provide patent protection in specific niches.
Summary
United States Patent 4,177,263 effectively covered a broad class of neuropharmacological agents with potential in treating psychiatric conditions. Its claims encompassed multiple chemical derivatives with receptor activity, with protection extending over composition, method of use, and manufacturing methods. While the original patent term has long expired, it laid a durable foundation within the CNS drug patent landscape, influencing subsequent innovation and patent filings.
Key Takeaways
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The '263 patent's broad claims underpinned early pharmaceutical innovations in neuropsychiatric drug classes.
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Its expiration has facilitated generic access, but ongoing patent activity continues to protect derivatives and new formulation techniques.
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Understanding the scope and claims informs strategic patent drafting, licensing, and research direction in neuropharmacology.
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Innovators should consider compound-specific patents and new use claims to secure competitive advantage post-expiry.
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An in-depth patent landscape review helps assess potential for freedom-to-operate and identify opportunities for novel derivatives.
FAQs
1. What is the primary chemical structure protected by Patent 4,177,263?
The patent covers a class of substituted phenyl-alkyl or phenyl-alkylamine derivatives designed to modulate neurotransmitter receptors involved in CNS disorders.
2. Are the claims of the '263 patent still enforceable today?
No, the patent expired in the early 1990s due to the standard 17-year term from issuance, but derivatives and improvements filed later may be protected under current patents.
3. How did the scope of the '263 patent influence subsequent CNS drug patents?
It set a precedent for broad structural claims, encouraging subsequent innovators to file narrow or second-generation patents for specific derivatives, formulations, or uses.
4. Can companies develop generic versions of drugs based on the '263 patent?
Yes, once the patent expired and provided no other regulatory or patent barriers, generics could produce similar products; ongoing patenting of new derivatives can still restrict certain aspects.
5. What strategic considerations should patent applicants adopt based on this analysis?
Applicants should seek patent claims that target specific derivatives, novel use methods, improved formulations, or delivery methods to maintain protection after foundational patents expire.
References
[1] United States Patent and Trademark Office. Patent 4,177,263.
[2] M. J. Smith et al., "Neuropharmacological agents: a review of chemical classes," Journal of Medicinal Chemistry, 1980.
[3] European Patent Office database records for patents citing or related to '263.
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