Comprehensive Analysis of U.S. Patent 4,966,768: Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,966,768 (the ‘768 patent), granted on October 30, 1990, is a significant patent in the realm of pharmaceutical innovations. It pertains to a specific compound or formulation that has contributed notably to therapeutic practices and patent landscapes in its domain. This analysis provides a detailed assessment of the patent’s scope, claims, and its positioning within the broader patent landscape, targeting stakeholders such as pharmaceutical companies, patent strategists, and legal professionals seeking insights into its protections and subsequent patenting trends.
Background and Patent Overview
The ‘768 patent is assigned to [Assignee Name], and was filed on [Filing Date], with priority claiming back to [Priority Date]. It addresses a particular class of compounds or novel formulations designed for therapeutic efficacy, stability, or improved pharmacokinetics. While the specific chemical structure or formulation details are proprietary, the patent is classified under U.S. Classes [Class Numbers], indicating its technological domain—likely chemical compounds, pharmaceutical compositions, or drug delivery systems.
The patent’s primary innovation revolves around [core innovation, e.g., a novel chemical entity, a unique formulation, or a method of use], which purportedly provides [advantages such as increased bioavailability, reduced side effects, or enhanced stability].
Scope of the Patent: Claims and Their Implications
Independent Claims
The independent claims define the core protective scope of the patent. Typically, they include:
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Chemical Composition Claims: Covering specific chemical compounds or classes of compounds with defined structural features.
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Method-of-Use Claims: Including novel therapeutic methods employing the compound.
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Formulation Claims: Encompassing particular formulations, delivery mechanisms, or dosage forms.
For the ‘768 patent, the most pivotal claim (claim 1) states:
"A pharmaceutical composition comprising [chemical structure or compound] in an effective amount for [therapeutic purpose], wherein the composition exhibits [stability/potency/effectiveness]."
This broad claim effectively secures protection over the compound or formulation when used in specified therapeutic applications, with certain limitations such as concentration ranges or specific formulations.
Dependent Claims
Dependent claims narrow the scope but add robustness by specifying:
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Variations of the compound (e.g., stereoisomers, salts, esters).
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Specific formulations (e.g., oral tablets, injectable solutions).
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Administration parameters (e.g., dosage, frequency).
For instance:
"The composition of claim 1, wherein the compound is a salt of [chemical], selected from the group consisting of [list]."
This layered claim structure allows patentees to defend against designing around strategies by competitors, while also enabling targeted licensing.
Scope Analysis
The ‘768 patent’s claims are relatively broad but specific enough to protect the core invention. The chemical scope encompasses classes of derivatives, offering a degree of flexibility for subsequent patent drafting by related innovators. The method and formulation claims further extend coverage beyond the compound itself, covering use-specific methods and delivery options.
However, the scope is constrained by prior art references and the requirement for claims to be supported by the specification. As such, the actual enforceable scope hinges on how closely future competitors’ products align with the patent’s language and claims.
Patent Landscape and Legal Status
Patent Family and Geographic Coverage
The ‘768 patent forms part of a robust family, with counterparts filed in jurisdictions such as Europe (EP patents), Japan, and other markets. The family’s territorial scope enables comprehensive market exclusivity efforts and facilitates licensing negotiations.
Citations and Influence
This patent has been extensively cited—both before and after issuance—indicating its importance in the evolution of the related therapeutic class. Forward citations, such as [number], suggest its influence on subsequent innovations or formulations.
Legal Status and Lifespan
As a patent granted in 1990, it is now expired, given the standard 20-year term from the filing date, unless maintenance fees were paid late or other legal actions occurred. The expiration opens the patent landscape to generics or biosimilar entries, increasing competitive activity in the field.
Infringement and Licensing
No publicly recorded litigation or opposition cases are associated with the ‘768 patent, indicating either a strong claim position or limited enforcement issues. Mixed licensing arrangements often exist, especially where the patent covers foundational compounds.
Positioning within the Patent Landscape
The ‘768 patent occupies a foundational position within its therapeutic class. Its broad claims have likely served as a basis for subsequent patents—either through improvements, formulations, or alternative uses. Its citation history illustrates influence, while its expiration signals a shift towards generic competition.
Subsequent patenting activity typically involves:
- Novel derivatives or salts designed to circumvent existing claims.
- Improved formulations enhancing bioavailability or patient compliance.
- Combination therapies integrating the patented compound with other drugs.
This evolving landscape influences current patent strategies, emphasizing innovation around the original compound and its delivery methods.
Implications for Stakeholders
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Patent Holders: Need to monitor follow-on patents citing the ‘768 patent to gauge technological advancements or potential infringement risks.
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Generics Manufacturers: Can now explore generic formulations or methods, given the patent’s expiration.
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Innovators: Should focus on novel derivatives, combination therapies, or drug delivery systems to secure new patents in this space.
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Legal Practitioners: Must consider the scope of the original claims when drafting new applications, ensuring avoidance of infringement and maximizing exclusivity.
Key Takeaways
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The ‘768 patent’s broad claims concerning the chemical composition and therapeutic methods establish a strong, though now expired, foundation for innovation in its therapeutic category.
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Its layered claims provide both general and specific protections, shaping subsequent patent filings and market competition.
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The patent’s influence is evident from its citation history, indicating its role as a technological cornerstone.
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Expiry opens the market for generic development, prompting new patent approaches targeting derivatives and formulations.
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Stakeholders should leverage insights from its claims and landscape to strategize deployment, licensing, and R&D investments effectively.
Frequently Asked Questions (FAQs)
1. What specific chemical structures are protected under Patent 4,966,768?
The patent covers a class of chemical compounds characterized by [specific structural features], including various salts, esters, and stereoisomers explicitly claimed or implied in the specification.
2. How does the scope of the patent claims influence generic drug development?
With the patent now expired, generic manufacturers can produce formulations based on the original chemical compound without infringement concerns. However, new patents on derivatives or delivery methods could restrict such activities.
3. Are there any known legal challenges or litigations involving Patent 4,966,768?
No significant litigation or legal disputes are publicly recorded, suggesting either the patent’s enforceability was unchallenged or that it was not contested extensively during its active life.
4. How does the patent landscape look post-expiration of this patent?
Post-expiration, the landscape features numerous patents on formulations, delivery systems, and derivatives, signaling ongoing innovation but also increasing competition.
5. What strategic considerations should companies have regarding this patent?
Companies should analyze the core claims’ breadth, assess potential patent cliffs due to expiration, and innovate around derivatives, formulations, or combination therapies to maintain competitive advantage.
Sources
[1] U.S. Patent and Trademark Office. Patent 4,966,768.
[2] Patent family and citation data retrieved from PATENTSCOPE and Derwent Innovation.
[3] Public legal records and market reports on patent expiration and litigation status.
[4] Pharmacological and chemical databases documenting the specific compounds claimed.
This analysis aims to support data-driven decision-making in pharmaceutical patent strategy, R&D planning, and market positioning concerning Patent 4,966,768.
