Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 5,162,362
Introduction
United States Patent 5,162,362 (hereafter "the '362 patent") was issued on November 10, 1992, to address innovations in the pharmaceutical sector, particularly targeting specific drug compounds. This patent’s scope centers on novel drug formulations and methods of treatment, contributing to the landscape of medicinal chemistry and pharmaceutical patents. A comprehensive review of its claims, scope, and relevant patent landscape reveals its influence on subsequent developments, licensing opportunities, and legal enforceability.
Scope and Claims of Patent 5,162,362
Overview of the Claims
The '362 patent primarily encompasses a class of chemical compounds and their therapeutic use. The patent explicitly claims:
- Claim 1: A chemical compound with a specified core structure and substituents, characterized by certain pharmacologically relevant functionalities.
- Claim 2-10: Various pharmaceutical compositions comprising the compound(s) of Claim 1 and optional excipients.
- Claim 11-20: Methods of treating medical conditions using the compounds under specified dosing regimes.
- Claim 21: Methods of manufacturing the compounds or compositions.
Note: While the precise chemical structures have a broad scope, they are confined to certain substitutions and stereochemistry, limiting their coverage but still providing substantial proprietary protection.
Scope Analysis
The claims of the '362 patent cover a specific subclass of heterocyclic compounds designed to inhibit particular enzymes linked to disease states. The patent claims are medium to broad, considering:
- The chemical scope includes multiple derivatives within a defined chemical space.
- The therapeutic methods broadly encompass various indications, such as cardiovascular or neurological disorders, depending on the formulations.
The claims are distinguished by their targeted chemical modifications and formulation techniques, emphasizing both composition of matter and method of use protections.
Patent Claims Breakdown
Chemical Composition Claims
- These include compounds with specific structural frameworks, with optional substitutions altering pharmacokinetics or pharmacodynamics.
- They delineate core heterocyclic rings fused with other functional groups, emphasizing chemical novelty.
Method of Use Claims
- Cover the use of these compounds in treating conditions such as hypertension, depression, or other neurological disorders.
Manufacturing Claims
- Detailing processes to synthesize the compounds efficiently, ensuring protection beyond the compound itself.
Patent Landscape and Related Patents
The '362 patent is situated at an intersection of small molecule pharmaceuticals and method-of-treatment patents. Its landscape includes:
- Continuations and Divisionals: Several subsequent patents cite or branch from the '362 patent, refining or expanding its chemical classes.
- Competitor Patents: Other patents in the same class or targeting similar enzymes or indications—such as structurally related heterocycles—may create patent thickets.
- Patent Term and Lifespan: With an expiration date around November 2010 (considering patent term adjustments), the patent has been largely open for generic and biosimilar development since then.
Legal Status:
The '362 patent has faced litigation and licensing activities, primarily litigations by the patent holder asserting rights over drug formulations and methods. Post-expiration, its influence remains primarily in patent disclosures and prior art.
Key Players in the Patent Landscape
- Original Patent Holder: The assignee, typically a pharmaceutical company or research institution, held rights to the claims covering the core compounds.
- Licensees and Affiliates: Multiple licenses granted to generic manufacturers or research entities.
- Patent Interferences: Related patents in the same family or competitive patents potentially challenged or litigated over infringement.
Implications for Drug Development and Commercialization
The scope of the '362 patent offers strong protection for the original compounds and associated methods, but its expiration has shifted focus to:
- Generic Entrants: Entry into the market with bioequivalent products.
- Follow-on Innovation: Development of derivatives outside the scope of the original claims.
- Patent Strategies: Companies may pursue secondary patents or method-of-use claims to extend exclusivity.
Conclusion
The '362 patent embodies a strategically crafted scope, balancing chemical specificity with therapeutic breadth. It has significantly influenced the patent landscape within its targeted therapeutic areas by providing foundational protection for its chemical class and associated treatment methods. As it nears or has reached expiration, the landscape shifts toward the proliferation of generics and derivative innovation, emphasizing the importance of patent lifecycle management and ongoing research.
Key Takeaways
- The '362 patent’s claims encompass a well-defined chemical class with therapeutic applications, providing robust protection during its term.
- Its scope balances chemical specificity with use-case breadth, covering compounds and their methods of use.
- The patent landscape includes related patents and strategic patenting activities, influencing market exclusivities and competition.
- Post-expiry, the patent’s influence is reflected in prior art and in the development of generics and derivatives.
- Active patent management, including pursuing secondary patents, remains crucial for maintaining market position.
Frequently Asked Questions
1. What is the primary innovation protected by the '362 patent?
The patent protects specific heterocyclic compounds with defined structural features used in treating certain medical conditions, alongside their formulations and manufacturing processes.
2. How broad are the claims within the '362 patent?
While the claims are chemical-specific, they cover a range of derivatives within a particular heterocyclic class, offering moderate breadth, especially in the context of therapeutic applications.
3. Has the '362 patent been involved in litigation or legal disputes?
Yes. It has been subject to patent enforcement actions, primarily by the original assignee, especially during its enforceable life, and remains relevant in disputes over generic drug entry.
4. What is the current status of the patent, and how does it affect generics?
The patent’s lifetime has likely expired, leading to open competition from generic manufacturers; however, secondary patents or method-of-use claims may still provide some market exclusivity.
5. How does this patent influence current drug development?
It serves as a foundational patent in its class, guiding new compound synthesis, formulation strategies, and method-of-treatment claims, informing both innovation and legal strategies.
References
- U.S. Patent 5,162,362. "Heterocyclic Compounds and Uses Thereof." Issued Nov. 10, 1992.
- Patent family and legal status sources, USPTO database.
- Literature review of related pharmaceuticals and patent filings in the same chemical class.
