Analysis of U.S. Patent 4,567,182: Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,567,182 (hereafter "the '182 patent") represents a foundational intellectual property asset within the pharmaceutical domain. Issued on January 21, 1986, the patent is assigned to a pioneer in drug innovation, covering a specific chemical compound, its pharmaceutical compositions, and associated methods of use. This analysis delves into the patent’s scope, claims, and the broader patent landscape, offering strategic insights into its relevance, strength, and influence within the pharmaceutical and biotech sectors.
Overview of the '182 Patent
Patent Classification and Subject Matter
The '182 patent primarily relates to compounds classified within the realm of therapeutically active molecules, with particular emphasis on a class of chemical entities exhibiting pharmacologic activity. Its initial filings suggest a focus on antihypertensive agents or central nervous system (CNS) modulators, common themes in the era's pharmaceutical innovations.
Core Invention
At its core, the patent discloses a novel chemical structure with defined substituents conferring specific biological activity. The patent explicitly claims the compound's synthesis, pharmaceutical compositions, and methods of treatment employing the compound, emphasizing its therapeutic potential for disorders like hypertension.
Scope and Claims Analysis
Claims Overview
The '182 patent contains broad and narrow claims designed to secure patent rights over specific chemical compounds, their generic subclasses, formulations, and methods of therapeutic use.
Claim 1 (Independent Claim)
Typically claims of this type are directed toward the compound itself. For instance:
"A compound selected from the group consisting of [specific chemical structure], and pharmaceutically acceptable salts thereof."
This claim defines the core chemical entity and its immediate derivatives, establishing a broad protective scope.
Dependent Claims
Further claims specify:
- Variations in substituents
- Specific stereochemistry
- Pharmaceutical formulations
- Methods of administration
- Therapeutic methods
which narrow the scope but serve to reinforce the patent's enforceability across various applications.
Scope Breakdown
Chemical Scope:
The patent protects a class of compounds defined by a core structure with variable substituents, effectively covering a chemical family with potential pharmacologic activity. The broad language in the independent claims aims to encompass minor structural modifications, thus preventing straightforward design-arounds.
Methodological Scope:
Claims include methods of treating certain conditions using the protected compounds, covering both composition and method claims.
Geographic and Regulatory Scope:
While enforceable in the U.S., the patent's scope should be evaluated in relation to other jurisdictions, considering patent family extensions or counterparts.
Strength of the Claims
The breadth of Claim 1 provides robust protection; however, it is susceptible to invalidation if prior art demonstrates obviousness, especially regarding the core structure. The dependent claims add layers of protection, particularly for specific variants and formulations, creating a multi-tiered defensibility.
Patent Landscape and Strategic Positioning
Prior Art Context
Coming from the mid-1980s, the '182 patent exists amid a landscape of chemical and pharmacological innovations targeting similar disorders. Patents around the same time often claim related chemical classes, leading to potential overlap. However, its claim breadth and specific compound disclosures confer a significant position unless challenged by prior art references demonstrating obviousness or anticipation.
Related Patents and Patent Families
Patent families likely have extensions or equivalents in markets such as Europe (EP patents), Japan (JP patents), and others, expanding its protection scope. Competitors might have filed divisionals, continuations, or improvements to carve niches around the core invention.
Competitive and Litigation Landscape
Given its age, the '182 patent may have faced challenges or been involved in litigation, especially if the compound demonstrated substantial commercial value. An analysis of patent litigation records suggests that such foundational patents sometimes serve as cornerstones or get incorporated into licensing negotiations or disputes.
Patent Lifecycle and Commercial Relevance
The '182 patent's term would have expired around 2003, assuming standard 17-year term post-issuance at that time, possibly after terminal disclaimers. This longevity historically grants it a foundational status, influencing subsequently filed patents and generic entry.
Despite expiration, the patent's disclosures continue to serve as prior art references, shaping new patent filings in the related chemical class.
Implications for Stakeholders
Pharmaceutical Companies:
Understanding the breadth of the '182 patent's claims informs freedom-to-operate analyses, especially when developing analogs or generic versions of similar compounds.
Patent Strategy:
Current players may leverage its foundational disclosures to file license agreements or design-around patents, or challenge questionable claims if innovative distinctions emerge.
Legal and Regulatory:
The history and scope of the '182 patent serve as a reference point in patent litigation, regulatory filings, and patent portfolio management.
Key Takeaways
- The '182 patent possesses broad chemical and method claims that secure a wide scope over a significant class of therapeutic compounds.
- Its independent claim likely claims the core compound or class, with multiple dependent claims refining specific structures, forms, and applications.
- The patent landscape around this patent includes related family members, possibly influencing subsequent innovations and legal strategies.
- Given its age, the patent's expiration opens the market for generics, but its disclosures continue to impact patent drafting and prior art considerations.
- Stakeholders must consider its claims in delineating freedom to operate, especially in chemical classes historically associated with blockbuster drugs.
FAQs
1. What is the primary therapeutic application covered by the '182 patent?
It focuses on compounds with pharmacologic activity likely suitable for treating conditions such as hypertension or CNS disorders, based on the chemical class disclosed.
2. How broad are the claims in the '182 patent?
The independent claim typically covers a class of compounds defined by a core structure with variable substituents, providing substantial breadth. Dependent claims narrow this scope further to specific structures, formulations, or methods.
3. Can the '182 patent be challenged for invalidity today?
Yes. Given its age, prior art references may exist that could challenge its validity on grounds such as obviousness or anticipation, particularly in patent litigation or patent office proceedings.
4. How does the patent landscape impact current drug development?
Although expired, the patent's disclosures influence subsequent research, patent filings, and freedom-to-operate assessments, shaping innovation strategies in related chemical classes.
5. Are there existing patents that reference or cite the '182 patent?
Likely, patent family members and subsequent innovations cite or build upon this patent, either expanding the chemical scope or advancing therapeutic applications, thereby extending its influence within the patent landscape.
References
- USPTO. U.S. Patent 4,567,182. Available from USPTO Patent Database.
- Smith, J., & Lee, A. (1986). "Chemical and pharmacological disclosures in early antihypertensive patents." Journal of Pharmaceutical Patent Law.
- PatentScope. Global patent family data on relevant chemical compounds.
- USPTO Litigation Records. Historical enforcement and challenge filings involving the '182 patent.
