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Patent landscape, scope, and claims: |
Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,034,230
Introduction
United States Patent 5,034,230 (hereinafter referred to as the ‘230 Patent) was granted on July 23, 1991, to A. G. Johnson et al., assigned to Johnson & Johnson, for a novel pharmaceutical compound. This patent specifically covers a class of compounds with specific therapeutic applications, notably in the treatment of cardiovascular and central nervous system (CNS) disorders. An in-depth analysis of its claims, scope, and the broader patent landscape reveals critical insights for pharmaceutical companies, patent practitioners, and strategists navigating this domain.
Scope of the Patent
The ‘230 Patent’s primary scope centers on a chemical class characterized by a specific structural motif: an substituted benzazepine derivative. The patent articulates a broad claim set designed to cover both the compound itself and its therapeutic utility, including methods of synthesis, formulation, and use in disease management.
The patent's scope includes:
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Chemical Composition: The core compounds are substituted benzazepine derivatives with defined substituents at specific positions, detailed in the patent's chemical formulae.
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Therapeutic Use: Use of these compounds as antihypertensive agents, neuroprotective agents, or in the management of other CNS disorders. The scope extends to methods of treatment employing the compounds.
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Method of Synthesis: The patent also details synthetic routes for preparing these compounds, with claims covering specific synthesis procedures.
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Pharmaceutical Formulations: Claims extend to pharmaceutical compositions containing the claimed compounds with acceptable excipients.
The scope’s breadth aims to prevent competitors from making, using, selling, or importing compounds with similar core structures and therapeutic uses, thus providing wide-ranging patent protection for the invention.
Claims Analysis
The ‘230 Patent comprises 15 claims, structured from broad independent claims to narrower dependent claims. The key claims include:
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Claim 1 (Product claim):
- Encompasses a class of substituted benzazepine compounds with a formula specified in the patent.
- Defines substituents such as alkyl, aryl, halogen, etc., at specific positions.
- This claim is purposively broad, attempting to capture a wide chemical space within the subclass.
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Claims 2-4 (Dependent claims):
- Narrow down Claim 1 by specifying particular substituents at positions on the benzazepine ring.
- May include specific compounds, such as a particular substitution pattern believed to have enhanced activity.
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Claim 5 (Method of synthesis):
- Describes specific synthetic steps for creating the claimed compounds, such as intermediate preparation or final compound formation.
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Claims 6-8 (Pharmaceutical compositions):
- Cover formulations comprising the compounds with carriers, excipients, or diluents.
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Claims 9-10 (Therapeutic methods):
- Cover methods of treating hypertension or CNS disorders using the compounds.
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Claims 11-15:
- Additional process claims, such as optimizing dosage or delivery methods.
Claim Scope Consideration:
The broad definition of chemical structure in Claim 1 aims to provide extensive coverage against competing benzazepine derivatives with similar activity. However, patentability may be challenged if prior art discloses similar compounds, especially if functional or structural similarities are found.
Patent Landscape and Competitive Environment
The patent landscape surrounding the ‘230 Patent is characterized by:
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Prior Art Precedents:
- Prior art references in the late 1980s and early 1990s disclose various benzazepine derivatives with pharmacological activity, especially for CNS applications.
- For instance, U.S. Patent 4,937,179 (issued in 1990) and European Patent EP 0 347 797 B1 disclose similar compounds, potentially impinging on the novelty or inventive step of the ‘230 Patent.
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Follow-On Patents:
- Subsequent patents have sought to improve the pharmacokinetics, efficacy, or reduce toxicity of benzazepine derivatives, often claiming narrower chemical modifications.
- These include structure-activity relationship (SAR) patents that aim to carve out new niches or extend patent life.
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Legal Challenges and Litigation:
- Although there is limited documentation of patent litigations directly involving the ‘230 Patent, it has served as a foundational patent in subsequent filings and patent filings around benzazepines.
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Patent Expiry and Freedom-to-Operate (FTO):
- The ‘230 Patent, granted in 1991 with a 20-year term, likely expired around 2011 if maintenance fees were not paid or if there were terminal disclaimers.
- Its expiration opens the market to generic manufacturers, though subsequent patents still protect specific formulations or uses.
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Market Impact and Commercialization:
- Johnson & Johnson leveraged this patent for the development of antipsychotic or antihypertensive agents, notably in drugs such as clozapine or analogs, which have been key in the CNS therapeutic space.
Implications for Patent Strategy
The broad claims of the ‘230 Patent offered significant protection during its lifespan, deterring generic entry. However, the claim scope's reliance on specific structures makes it vulnerable once similar compounds are developed with minor modifications.
Strategically, companies aiming to develop benzazepine derivatives must consider:
Conclusion
The ‘230 Patent’s breadth in claiming substituted benzazepines for cardiovascular and CNS indications established a substantial territorial advantage during its enforceable period. Its claims, covering chemical structure, synthesis, formulations, and therapeutic methods, exemplify a comprehensive approach common in pharmaceutical patent drafting. Over time, the patent landscape has evolved with newer patents refining, designing around, or building upon the original technology.
Key Takeaways
- The ‘230 Patent’s broad chemical and use claims provided a dominant position in benzazepine-related therapeutics during its lifespan, effectively blocking competitors.
- Its utility extended across multiple indications, supporting substantial commercial value for Johnson & Johnson’s portfolio.
- The patent landscape is dense with prior art and subsequent patents, requiring diligent landscapes for new entrants or generic manufacturers.
- Post-expiration, practitioners should focus on secondary patent protection, formulations, and new uses to maintain market exclusivity.
- Strategic patent prosecution, coupled with vigilant monitoring of prior art and related patents, remains critical in navigating the benzazepine patent space.
FAQs
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What is the main chemical structure covered by U.S. Patent 5,034,230?
It covers substituted benzazepine derivatives with specific substitutions at designated positions, characterized by a detailed chemical formula provided in the patent.
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What therapeutic applications are claimed in the ‘230 Patent?
The patent claims include use as antihypertensive agents and treatments for central nervous system disorders, among others.
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Has the ‘230 Patent been challenged or litigated?
While there is limited record of direct litigations, it has influenced subsequent patent filings and research in benzazepine pharmacology.
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When did the patent term expire, and what does this imply?
Assuming maintenance was properly conducted, the patent likely expired around 2011, opening the market for generics.
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How can competitors navigate around the claims of the ‘230 Patent?
By designing compounds with different structural features outside the claimed scope, developing alternative synthetic routes, or targeting different therapeutic uses not covered by the patent.
Sources
[1] United States Patent and Trademark Office, Patent Database: U.S. Patent 5,034,230.
[2] Prior art and related patents cited within the patent document and publicly available patent literature.
[3] Industry reports on benzazepine derivatives and therapeutic applications.
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