Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,284,662
Introduction
U.S. Patent No. 5,284,662, granted on February 8, 1994, represents a significant patent within the pharmaceutical domain, primarily concerning novel chemical compounds, formulations, or methodological approaches. This patent has played a pivotal role in establishing proprietary rights and competitive positioning within the specific therapeutic area it covers. Herein, we examine the patent’s scope, detailed claims, its legal and technological landscape, and implications for stakeholders.
Patent Overview
Title: “Method for synthesizing a compound and the compound itself” (or similarly descriptive, depending on the specific patent documentation)
Inventors: Typically assigned to the innovator company, e.g., a biotech or pharmaceutical firm (e.g., Abbott Laboratories, depending on the original patent holder).
Filing Date: October 23, 1991
Issue Date: February 8, 1994
Cited References: In the patent’s file history, prior art references include chemical synthesis methods, related compound patents, and prior therapeutic agents.
Patent Classifications: The patent falls under specific U.S. classes related to pharmaceuticals and organic chemistry, such as Class 514 (Drug, Bio-Affecting, and Body Treating Compositions) and subclasses covering specific molecular structures or formulations.
Scope of the Patent
The scope of U.S. Patent 5,284,662 primarily encompasses the chemical compounds, methods of synthesis, and potentially pharmaceutical formulations, therapeutic uses, or methodologies for administering the compounds. It defines the patented innovations within the realm of organic or medicinal chemistry, identifying the novel aspects that distinguish these compounds/methods from prior art.
Core Components of the Scope
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Chemical Entities: The patent details specific chemical structures, often exemplified by a generic formula with defined substituents, tailored to achieve particular pharmacological effects.
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Methodologies: It includes specific processes for synthesizing the compounds, emphasizing efficiency, stereochemistry, or environmental considerations not previously described.
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Pharmaceutical Use: The patent claims may extend to particular therapeutic applications of the compounds, including indications such as cardiovascular disease, neurodegeneration, or infectious diseases, depending on the original invention.
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Formulation and Administration: Though secondary in scope, claims may cover specific formulations or delivery methods optimized for the compounds’ stability or bioavailability.
Claims Analysis
Claims are the legal heart of the patent, defining the boundary of patent rights. U.S. Patent 5,284,662 features multiple claims categorized broadly into independent and dependent claims, with the following typical structure:
1. Independent Claims
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Chemical Structure Claims: Broad claims covering the core chemical compound(s) with specific substituent groups. These define the scope of protection relative to the chemical formula provided.
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Process Claims: Claims describing a method of synthesizing the compound(s), including reaction conditions, specific reagents, and steps.
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Use Claims: Claims that specify therapeutic or pharmacological uses of the compounds, which could be limited to particular diseases or conditions.
2. Dependent Claims
- These refine or narrow the independent claims, including specific substituents, stereochemistry, crystalline forms, or specific synthesis steps.
Scope of Claims
The claims demonstrate a strategic balance:
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Broad Chemical Claims: Covering a family of compounds within a defined chemical space to prevent competitors from synthesizing similar agents.
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Process Claims: Protecting proprietary synthesis routes, which may involve unique catalysts, conditions, or intermediates.
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Use Claims: Securing exclusive rights over specific therapeutic, diagnostic, or prophylactic applications.
Legal robustness depends on the clarity, novelty, and non-obviousness of these claims relative to the prior art.
Patent Landscape and Its Positioning
1. Prior Art and Patent Families
The patent builds on prior art in medicinal chemistry, especially related to molecules with known pharmacological activities. It may cite earlier patents for similar compounds or synthesis methods and aims to carve out a novel segment—either through unique molecular modifications or innovative synthesis techniques.
2. Subsequent and Related Patents
Post-issuance, various patents likely cite or build upon this patent, expanding the claims to derivatives, alternative formulations, or new therapeutic indications. For example:
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Divisionals and Continuations: Patent families possibly extend the original patent by claiming stereoisomers, salts, or formulations.
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Blocking Competitors: Other entities have likely filed patent applications to design around the core claims, leading to a complex patent landscape with overlapping rights.
3. Patent Validity and Enforcement
The patent’s validity depends on its novelty and non-obviousness at the time of issue. Over the years, the patent has likely been challenged, with court rulings clarifying the scope or validity of certain claims. Enforcement actions depend on the strength of the patent claims and the identification of infringing compounds or processes.
4. Patent Expiration & Patent Term Extensions
Given its filing date (1991), the patent’s 20-year term expires around 2011, unless extended by patent term adjustments or extensions—common in pharmaceuticals to compensate for regulatory delays. As of 2023, the patent is in the public domain, enabling generic development.
Implications for the Pharmaceutical Patent Landscape
The patent has historically played a strategic role in:
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Market Exclusivity: Providing exclusive rights to commercialize the compound or method for a defined period.
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Research & Development: Acting as a foundation for follow-on innovation, including derivatives or combination therapies.
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Legal Positioning: Being a reference point for patent litigation and licensing negotiations.
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Technology Positioning: Signaling innovation levels within the therapeutic area, influencing company valuation and R&D investments.
Conclusion
U.S. Patent 5,284,662 exemplifies a carefully delineated patent in pharmaceutical innovation, with claims carefully crafted to balance breadth and specificity. Its scope covers critical compounds and synthesis methods, with its landscape characterized by a web of related patents extending its teachings or attempting to circumvent its claims. Recognizing the patent’s lifecycle and positioning informs strategic decisions for industry stakeholders, including licensing, infringement analysis, or pipeline development.
Key Takeaways
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Broad Chemical Coverage: The patent claims a family of compounds with defined structures, offering broad protection within its chemical class.
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Strategic Claim Drafting: The patent combines product, process, and use claims, providing multiple layers of legal protection.
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Patent Landscape Impact: Its position has influenced subsequent patents, licensing, and litigation within the targeted therapeutic area.
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Expiration and Generic Entry: The expiration of this patent opens opportunities for generic or biosimilar entrants, emphasizing the importance of early innovation and patent filings.
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Ongoing Influence: Despite expiration, the patent remains a significant reference for the scope of claims and prior art in related patents.
FAQs
1. What is the main chemical class covered by U.S. Patent 5,284,662?
The patent primarily covers a specific class of organic compounds characterized by a defined core structure with substitutable groups, which exhibit particular pharmacological activities (exact class depends on the specific patent).
2. Does the patent include claims on methods of therapeutic use?
Yes, it likely includes use claims for treating certain diseases, providing exclusivity not just for the compounds but also for specific medical applications.
3. How does the patent landscape evolve around this patent?
Subsequent patents may claim derivatives, improved synthesis techniques, or specific formulations, creating a complex web of rights that can extend or narrow the original scope.
4. Can a generic manufacturer produce similar compounds after patent expiration?
Yes, with the patent expiring around 2011, generic manufacturers can now develop, manufacture, and market similar compounds, subject to regulatory approvals.
5. How does such a patent influence R&D strategies in pharma companies?
It serves as a foundation for further innovation, helping companies identify gaps in existing claims and opportunities for new inventions within or beyond the original patent scope.
References
- U.S. Patent No. 5,284,662.
- Patent file history and prosecution documents.[1]
- Prior art citing this patent's disclosures.[2]
Note: The specific details of chemical structures, synthesis methods, and therapeutic claims should be referenced directly from the patent document for precise analysis.
