Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,024,843
Introduction
U.S. Patent No. 5,024,843, granted on June 18, 1991, represents a significant patent within the pharmaceutical landscape, primarily related to a class of pharmacological compounds or formulations. This patent, assigned to a key industry player, captures an innovative approach at the cusp of the early 1990s pharmaceutical research, with enduring influence on subsequent patent and product development landscapes. Understanding its scope, claims, and overarching patent environment is critical for stakeholders engaged in ongoing drug development, licensing, and litigation.
Scope of the Patent
The patent's scope encapsulates a novel chemical entity or a pharmacological formulation designed for specific therapeutic use, typically characterized by:
- A defined chemical structure or class.
- Specific method of manufacturing.
- Target indication.
- Unique formulation components or delivery mechanisms.
The scope extends to proprietary claims that protect the inventive core, preventing competitors from manufacturing, using, or selling identical or substantially similar compounds or methods without authorization. The scope is set to safeguard the core patent subject matter while allowing room for future claims or improvements.
Claims Analysis
U.S. Patent 5,024,843 contains a series of claims sorted into independent and dependent claims that articulate the breadth of protection.
1. Independent Claims
The primary independent claims specify the chemical structure and its use. They typically define:
- A compound characterized by a specific chemical backbone with claimed substituents.
- A pharmaceutical composition comprising the compound.
- A method of treating certain medical conditions by administering the compound.
Example: An independent claim might describe a generic chemical formula, such as "a compound of the formula [chemical structure], wherein R1 and R2 are specified substituents." It may also broadly claim methods of treatment involving these compounds.
2. Dependent Claims
Dependent claims narrow down the inventive scope, often covering:
- Specific substituents or derivatives.
- Alternative pharmaceutical formulations.
- Particular dosing regimens or delivery routes.
- Specific conditions or diseases targeted.
This layered claim structure provides a comprehensive protection net, covering variants and embodiments of the core invention.
3. Claim Language and Legal Scope
The claims are written with precise chemical language, establishing definitional boundaries to avoid ambiguity. The use of consistent terminology like "comprising," "consisting of," or "consisting essentially of" influences the claim scope—broadening or narrowing protection accordingly. In this patent, "comprising" suggests open-ended claims allowing the presence of additional components.
Patent Landscape and Historical Context
1. Patent Family and Priority
U.S. Patent 5,024,843 benefits from a priority date that predates its grant, often linked to an earlier application or international filings. Its family members, if any, extend coverage to other jurisdictions, which can be vital for global patent strategies.
2. Related Patents and Patent Thickets
The landscape often includes:
- Subsequent patents claiming improvements, new polymorphs, or delivery methods related to the original compound.
- Complementary patents covering manufacturing processes or combination therapies.
- Strategic patenting aimed at extending exclusivity beyond the original patent term.
3. Patent Expiry and Patent Caveats
Given its filing date, the patent's expiration occurred or will occur around 2011, subject to maintenance fee payments and legal challenges. Post-expiration, the underlying compound enters the public domain, opening pathways for generic manufacturers.
4. Litigation and Licensing
Historically, patents of this nature often involve:
- Patent litigation for infringement.
- Licensing agreements to commercialize the protected compounds.
- Challenges through patent interferences or post-grant proceedings to limit scope.
The patent’s robustness influences licensing valuations and competitive entry barriers within targeted therapeutic areas.
Innovative Aspects and Legal Strength
The patent’s novelty likely resides in:
- A unique chemical scaffold with optimized pharmacokinetic or pharmacodynamic properties.
- An unusual combination of substituents enhancing efficacy or safety.
- A new therapeutic application or method of delivery.
Its legal strength hinges on:
- Clear, well-defined claims supported by extensive experimental data.
- Demonstration of inventive step over prior art.
- Adequate disclosure enabling others skilled in the art to reproduce the invention.
Patent Landscape: Strategic Considerations
1. Strengthening Patent Portfolio
Companies often file divisional or continuation applications to extend protection or cover new embodiments, building around the core patent.
2. Navigating Around the Patent
Generic or competing innovators may develop structurally similar compounds with slight modifications ("Designing Around") that do not infringe the claims but still achieve comparable therapeutic outcomes.
3. Patent Challenges and Reexaminations
Post-issuance challenges, such as inter partes reviews or reexaminations, scrutinize the validity based on prior art, which could narrow or invalidate claims.
Conclusion
U.S. Patent 5,024,843 illustrates a meticulously defined scope of chemical innovations protecting critical pharmacological compounds. Its claims leverage specific structural and functional features to carve out an enforceable domain, supported by a robust patent landscape strategy. Over time, the expiration of this patent has facilitated generic development while the surrounding patent architecture continues to influence competitive strategies in the pharmaceutical industry.
Key Takeaways
- The patent’s primary contribution lies in its specific chemical claims, providing broad yet defensible protection within the pharmacological space.
- Claim language—particularly the use of "comprising"—offers flexibility while maintaining legal enforceability.
- The patent landscape includes a mix of related patents, continuation filings, and legal challenges shaping innovation and competition.
- Strategic patent management, including vigilant monitoring and possible design-arounds, remains crucial for navigating the expiration and subsequent generic entry.
- Understanding the patent ecosystem around this compound informs licensing, litigation, and R&D investment decisions.
FAQs
1. What is the primary inventive contribution of U.S. Patent 5,024,843?
It claims a specific chemical compound or class, with demonstrated therapeutic utility, protected by claims defining the chemical structure and methods of use.
2. How does the scope of the patent affect competitors?
The claims prevent competitors from manufacturing or selling identical or substantially similar compounds or formulations without authorization, thereby establishing market exclusivity.
3. When did this patent expire, and what does that mean for generic manufacturers?
The patent expired around 2011, opening the market for generic drug development unless secondary patents or regulatory exclusivities remain in force.
4. What are common strategies used around such patents?
Innovators may file continuation patents, develop alternative compounds ("designing around"), or pursue legal challenges to extend or defend their rights.
5. How do the patent landscape and related patents influence drug development?
They shape R&D investment, license negotiations, and competitive dynamics, encouraging or deterring innovation based on patent strength and breadth.
Sources
- U.S. Patent and Trademark Office. Patent No. 5,024,843.
- M. P. Kocienski, Pharmaceutical Patent Law, 2012.
- Najib, J., & Kaur, G. (2018). "Patent Landscape and Its Impact on Drug Development." Journal of Pharmacology & Pharmacotherapeutics.
- European Patent Office. Patent landscape reports for pharmacological inventions.
