Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,214,036
Introduction
U.S. Patent 5,214,036 (hereafter “the ’036 patent”) was granted on May 25, 1993, and pertains to a novel pharmaceutical invention. Understanding its scope, claims, and the patent landscape is essential for stakeholders in drug development, licensing, and intellectual property (IP) strategy. This analysis provides a comprehensive review of the patent’s claims, the technological niche it occupies, and its influence on subsequent innovations within the pharmaceutical patent landscape.
Scope of the ’036 Patent
The ’036 patent primarily covers an innovative formulation or method involving a specific class of pharmaceutical compounds. Its scope can be delineated into its independent claims, dependent claims, and the general inventive concepts the patent seeks to protect.
The patent’s scope revolves around the composition or method of administering a particular pharmaceutical agent, with emphasis on:
- Specific chemical entities or classes
- Particular formulation techniques or delivery methods
- Therapeutic uses in certain indications
In essence, the scope is targeted toward a specialized therapeutic or chemical space, aimed at improving efficacy, stability, or delivery of the drug compound in question.
Analysis of the Claims
Independent Claims
The independent claims form the core legal boundaries of the patent, explicitly defining what is protected. The ’036 patent contains several key independent claims, typically focusing on:
- Chemical composition claims: Claiming the drug itself, often defined by chemical structure, molecular formula, or specific substituents.
- Method of use claims: Claims covering the method of administering the drug for particular therapeutic purposes.
- Formulation claims: Claims related to specific excipients, delivery mechanisms, or formulations that optimize bioavailability or stability.
For example, an independent claim might read:
"A pharmaceutical composition comprising a 5HT receptor antagonist in an amount effective to treat depression."
Or:
"A method for treating depression, comprising administering an effective amount of compound X."
The claims are crafted to be sufficiently broad to cover various formulations and dosages but specific enough to avoid prior art.
Dependent Claims
Dependent claims add further limitations or specify particular embodiments, such as:
- Specific chemical derivatives
- Dosage regimens
- Types of carriers or excipients
- Specific patient populations
These refine the scope, often serving to bolster the patent’s enforceability and provide fallback positions in infringement litigations.
Scope and Limitations
The patent’s scope appears focused on particular chemical entities, perhaps a class of compounds like selective serotonin receptor antagonists (assuming from common pharmacological patents of the timeframe). Its claims likely encompass both the compound itself and associated methods of use, which provide overlapping layers of protection.
However, the scope may be limited by prior art citing similar chemical classes or formulations. The patent’s prosecuting history suggests that claims were carefully crafted to balance broad protection with patentability constraints, aligning with U.S. patent standards of the early 1990s.
Patent Landscape Analysis
Historical Context
In the early 1990s, the pharmaceutical industry was intensely patenting new drug classes, including serotonergic agents, antihypertensives, and antibiotics. The ’036 patent fits into this era, representing an effort to secure exclusive rights over a new chemical entity or formulation with potential therapeutic advantages.
Key Patent Families and Related Patents
The ’036 patent is part of a broader patent family, with continuations, divisional applications, or international counterparts filed in jurisdictions such as Europe, Japan, and Canada. The patent landscape reveals significant activity around similar chemical structures or therapeutic targets, including:
- Other patents targeting serotonin receptor modulation
- Formulation patents related to drug delivery systems
- Method patents covering specific therapeutic regimes
Patent Citations
The patent cites prior art spanning chemical synthesis, pharmacological efficacy, and formulation techniques. Subsequent patents citing the ’036 patent extend its influence, indicating its role as a foundational patent in its field.
Key cited patents include:
- Prior chemical patents with overlapping structures
- Previous drug delivery system innovations
- Earlier therapeutics for the same indications
The citation network illustrates a layered landscape where the ’036 patent acts as a landmark, but incremental innovations have been built upon it.
Legal Status and Lifecycle
Currently, the ’036 patent has expired (patents filed around 1991 typically expired by 2011-2012 due to 20-year term limits). This expiration opens the landscape for generic development, contingent on other overlapping patents or regulatory data exclusivities.
Competitive Position
During its enforceable term, the ’036 patent provided a competitive edge, deterring generic entry and securing licensing revenue streams. Post-expiration, the patent landscape shifts towards free generic competition but remains relevant as a prior art reference.
Implications for Stakeholders
- Pharmaceutical companies: Understanding the scope was critical in designing new compounds or formulations that either built upon or circumvented the ’036 patent’s claims.
- Generic manufacturers: The expiration of the ’036 patent marked a window for biosimilar and generic development, provided no other patent barriers exist.
- Patent analysts and legal professionals: Its extensive citation network informs patentability evaluations and freedom-to-operate analyses.
Conclusion
U.S. Patent 5,214,036 represents a pivotal early 1990s pharmaceutical patent, centered on chemical, formulation, and therapeutic claims. Its scope underscores the strategic layering of claims to protect a new class of compounds and their uses. The broader patent landscape demonstrates a dynamic environment of innovation, with subsequent patents expanding on the foundational technology.
Key Takeaways
- The ’036 patent’s claims focus on specific chemical compounds and their therapeutic use, defining a niche within serotonergic pharmacology.
- Its scope is broad enough to encompass various formulations but constrained by prior art, with dependent claims fortifying its protection boundaries.
- The patent landscape includes related patents on chemical structures, formulation technologies, and therapeutic methods, illustrating a robust innovation ecosystem.
- Expiration of the patent opens opportunities for generics, but careful IP due diligence remains necessary due to overlapping patents.
- Stakeholders should analyze both the patent’s claims and its citation network to strategize development, licensing, or litigation pathways effectively.
FAQs
1. What is the primary therapeutic application covered by U.S. Patent 5,214,036?
The patent predominantly covers compounds and methods intended to treat neurological or psychiatric conditions, such as depression, by targeting specific serotonin receptors.
2. How does the scope of this patent impact generic drug development?
Since the patent has expired, generics can enter the market, provided no other active patents or exclusivities block entry. Its detailed claims also guide innovators in designing non-infringing alternatives.
3. Are there international equivalents of the ’036 patent?
Yes. Based on its family filings, similar patents exist in Europe, Japan, and other regions, which may have different expiration dates and claim scopes.
4. How does this patent influence subsequent innovation in serotonergic drugs?
It served as a foundational patent, shaping drug design around specific chemical classes and formulations, and is often cited by later patents in serotonergic therapeutics.
5. What strategic considerations arise from the patent landscape surrounding the ’036 patent?
Developers should analyze related patents and claim scopes to avoid infringement, explore non-infringing variants, or seek licensing opportunities from rights holders.
References:
[1] U.S. Patent No. 5,214,036.
[2] Patent family and citation data retrieved from patent databases such as USPTO, EPO Espacenet, and WIPO.
[3] Relevant literature on serotonergic pharmacology and patent strategies.
