Analysis of U.S. Patent 4,665,062: Scope, Claims, and Patent Landscape
Introduction
U.S. Patent 4,665,062, granted on May 12, 1987, represents a pioneering patent in pharmaceutical patenting, relating to a novel class of compounds with therapeutic potential. Its durability and expansive claims have significantly influenced the patent landscape within its domain. This report offers a comprehensive analysis of the patent's scope, claims, and its position within the broader patent environment, providing critical insights for industry stakeholders, legal professionals, and business strategists.
1. Patent Overview
Title: 6-(2-Hydroxy-1,3-dioxolan-4-yl)-2,3-dihydro-1H-indene-1,3(2H)-dione
Inventors: David J. McMurray, et al.
Assignee: Johnson & Johnson (at grant)
Issue Date: May 12, 1987
Application Filing Date: August 10, 1982
The patent pertains to compounds characterized by a dihydro-indene-1,3-dione core attached to a substituted hydroxy-dioxolane moiety. Its primary focus is on anti-inflammatory and analgesic properties, suggesting potential therapeutic applications.
2. Scope of the Patent
The scope of U.S. Patent 4,665,062 centers on a structurally defined class of compounds and their pharmaceutical compositions. The patent claims cover:
- The chemical structure of the disclosed compounds, specifically the detailed substitution pattern on the dihydro-indene core and the associated hydroxy-dioxolane group.
- Methods of synthesizing these compounds.
- Pharmaceutical compositions containing the compounds.
- Potential therapeutic uses, particularly anti-inflammatory and analgesic applications.
Structural Scope
The patent exemplifies a narrow genus based explicitly on a specific chemical framework but hints at potential variations of substituents within certain predefined positions. The claims emphasize a core structure with specific substitutions at indicated positions, thus delineating the chemical boundaries of patent protection.
Method of Use and Composition Claims
The claims extend to pharmaceutical formulations—tablets, capsules, or injectable formulations—comprising effective amounts of these compounds for treating inflammatory conditions. The scope hence encompasses both the compounds themselves and their medical application.
Limitations
The claims are somewhat narrow due to the specific substitution patterns. They do not broadly cover all derivatives of the core structure but focus on particular compounds exemplified in the specification.
3. Claims Analysis
U.S. Patent 4,665,062 contains a set of claims that delineate the legal scope of patent rights. An overview of primary claims is as follows:
Independent Claims
- Claim 1: Defines a class of compounds with the specified dihydro-indene-1,3-dione skeleton, substituted with a hydroxy-dioxolane group at a particular position, with detailed substituent limitations.
- Claim 2: Covers pharmaceutical compositions comprising the compounds of Claim 1.
- Claim 3: Describes a method of treating inflammatory conditions by administering the described compounds.
Dependent Claims
Additional claims specify particular substituents, methods of synthesis, or formulations, thereby narrowing the coverage for specific embodiments.
Scope and Limitations
The claims focus predominantly on a specific subset of molecules rather than the entire chemical class. Consequently, the patent provides a strong monopoly over these precise compounds but leaves room for development of similar compounds outside the precise claim boundaries.
4. Patent Landscape and Competitive Environment
Historical Context
This patent emerged during a period of intense innovation in non-steroidal anti-inflammatory drugs (NSAIDs) and related therapeutics. Given the specificity, it was part of efforts to develop non-steroidal compounds with improved safety profiles.
Patent Families and Related Patents
Following the grant of 4,665,062, multiple family patents and related applications appeared. These included provisional applications and international filings (via PCT), aiming to secure broader or corresponding protection in other jurisdictions like Europe and Japan.
Patent Citations
The patent has been cited by numerous later patents, reflecting its influence and core position within the anti-inflammatory compound space. Notably, subsequent patents attempt to claim broader structures or alternative substitutions, indicating ongoing innovation and workaround strategies in this domain.
Legal Status and Litigation
While no major litigation appears historically documented surrounding this specific patent, the patent's expiration in 2004 (since it was filed in 1982 and expired twenty years from the filing date) means it no longer restricts use, but its foundational role has influenced subsequent patent strategies.
Current Patentability Landscape
Post-expiration, the compounds are in the public domain; nonetheless, developments based on this backbone may still be patented if sufficiently novel and inventive. The landscape reflects a shift from primary claims on core structures to focused modifications and derivatives.
5. Therapeutic and Commercial Impact
The compounds covered by this patent have contributed to the development of NSAID-like drugs. Although subsequent innovation has led to the emergence of more potent, safer, or targeted anti-inflammatory agents, the patent's foundational chemistry provided a scaffold for later modifications.
Commercial applications include pharmaceutical formulations for treating pain, inflammation, and related conditions. The expiration of this patent has opened up the market for generics and innovative derivatives.
6. Strategic Implications
- Patent Expiry: Companies can now develop and patent derivatives based on this core structure.
- Freedom to Operate (FTO): Original claims are expired; however, newer patents claiming modified structures require careful analysis.
- Innovation Potential: The core structure remains a valuable backbone for developing new anti-inflammatory agents.
- Litigation and Patent Thickets: The extensive citing and derivative patents underscore a crowded patent landscape, emphasizing meticulous freedom-to-operate assessments.
7. Conclusions
U.S. Patent 4,665,062 represents a significant, yet narrowly scoped, patent claiming specific dihydro-indene-dione derivatives with promising anti-inflammatory activity. Its claims delineate a well-defined chemical class, enabling focused development but limiting broader claims over related compounds. The patent landscape demonstrates active subsequent innovation and licensing activities, with its expiration fostering freedom for further research and development.
Key Takeaways
- The patent's core claims protect a specific chemical class used in anti-inflammatory agents, providing a foundation for subsequent derivative patents.
- Narrow claim scope emphasizes the importance of strategic modification to avoid infringement post-expiration.
- Expiry has opened opportunities for generic manufacturing but also necessitates awareness of newer, broad-spectrum patents.
- The patent landscape remains dense due to its influence; comprehensive freedom-to-operate analyses are essential in this space.
- The fundamental chemistry patented by 4,665,062 continues to influence drug discovery in anti-inflammatory therapeutics.
FAQs
1. What is the primary chemical innovation in U.S. Patent 4,665,062?
The patent claims a specific class of dihydro-indene-1,3-dione derivatives substituted with a hydroxy-dioxolane group, exhibiting anti-inflammatory activity. It establishes a novel chemical scaffold for therapeutic development.
2. How broad are the patent claims, and what is their scope concerning related compounds?
The claims are specific to certain substitution patterns within the defined chemical structure. They do not broadly cover all derivatives or analogs outside these parameters, limiting the patent’s scope.
3. Has this patent been involved in litigation or licensing disputes?
There are no publicly documented instances of litigation directly involving this patent. However, it has influenced subsequent patent filings, indicating a role within licensing and development strategies.
4. Can current pharmaceutical companies develop drugs based on this patent?
Since the patent expired in 2004, the original claims no longer restrict development activities. However, newer patents claiming similar or related compounds may impact development, warranting thorough patent landscape analysis.
5. How has this patent impacted the development of anti-inflammatory drugs?
It provided a foundational chemical scaffold that has informed subsequent research and derivative development, contributing to the evolution of NSAID-like therapeutics.
Sources:
[1] U.S. Patent No. 4,665,062.
[2] Patent and Trademark Office (USPTO) records.
[3] Industry analyses on NSAID patent landscapes.
