Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,837,111
Introduction
U.S. Patent 4,837,111, titled "Anti-inflammatory and analgesic compositions", was granted on June 6, 1989. It pertains to pharmaceutical compositions with anti-inflammatory and analgesic properties, primarily centered around a specific class of NSAIDs. This patent's scope, claims, and its position within the broader patent landscape hold significance for pharmaceutical companies, competitors, and legal entities examining patent rights related to NSAID formulations.
This analysis provides a comprehensive evaluation, focusing on the patent’s claims, scope, related patents, and the implications for patent landscape navigation and potential licensing or litigation strategies.
Scope of the Patent
Field of the Patent
The patent pertains to pharmaceutical compositions, notably those containing non-steroidal anti-inflammatory drugs (NSAIDs), designed to provide anti-inflammatory and analgesic effects. Its core innovation revolves around formulations that enhance the therapeutic profile of NSAIDs by reducing gastrointestinal side effects and increasing efficacy.
Key Technological Focus
The patent emphasizes formulations comprising indomethacin, a well-known NSAID, combined with specific carriers, stabilizers, or delivery mechanisms designed to optimize absorption and reduce adverse effects. The scope extends to the use of particular excipients and preparation methods that influence drug release and bioavailability.
Coverage Summary
The patent broadly covers:
- Pharmaceutical compositions containing indomethacin or similar NSAIDs.
- Specific formulation strategies—such as controlled-release matrices or stabilization techniques.
- Methods of preparation that yield improved anti-inflammatory and analgesic efficacy.
- Therapeutic use of such formulations in treating inflammatory conditions.
Claims Analysis
U.S. Patent 4,837,111 comprises multiple claims, ranging from broad to narrow, establishing the scope of patent protection. An overview of the primary claims reveals their strategic importance:
Independent Claims
- Claim 1: Encompasses a pharmaceutical composition comprising an NSAID (notably indomethacin) with a specific carrier matrix that modulates release characteristics, aimed at reducing gastrointestinal irritation.
- Claim 2: Encompasses a method of preparing such compositions, emphasizing preparation techniques that achieve controlled drug release.
- Claim 3: Covers the use of the composition for treating inflammatory conditions, such as rheumatoid arthritis or osteoarthritis.
Significance: These broad claims aim to secure patent rights over both formulations and their preparation methods, as well as their clinical application.
Dependent Claims
- Detail specific formulations, such as particular excipients (e.g., cellulose derivatives), ratios of drug to carrier, or manufacturing conditions.
- Describe specific controlled-release mechanisms or stabilization techniques.
- Modify the scope of independent claims to include specific embodiments, thus narrowing the claim scope but enhancing enforceability.
Significance: These claims provide fallback positions if independent claims are challenged or found invalid. They also delineate preferred formulations and methods.
Claim Scope and Potential Challenges
The broad independent claims may invite invalidity challenges based on prior art, especially considering NSAID formulations developed prior to 1989. However, the novelty appears rooted in the specific formulation strategies—such as certain carriers or preparation methods—that distinguish this invention.
Patent Landscape and Related Patents
Prior Art Context
The late 1980s and early 1990s saw extensive development of NSAID formulations, particularly controlled-release systems. Earlier patents (e.g., U.S. Patent 4,183,914 on controlled-release NSAID compositions) laid the groundwork but lacked the specific combination or preparation methods claimed in 4,837,111.
Related Patents
- U.S. Patent 4,349,463 (1982): Focused on a different controlled-release NSAID formulation.
- U.S. Patent 4,139,636 (1979): Relates to pharmaceutical compositions with NSAIDs and specific carriers.
- European Patent EP 0609121: Discloses controlled-release NSAID formulations with similar carriers.
These prior art references influence the patent’s strength, especially concerning the novelty and non-obviousness of its claims.
Competitor Patents and Ecosystem
Major pharmaceutical companies have continued to develop NSAID formulations, with subsequent patents focusing on:
- Novel delivery systems (e.g., nanoparticle carriers)
- New NSAID compounds and derivatives
- Methods to mitigate side effects (e.g., gastroprotective coatings)
While patent families around indomethacin formulations are numerous, U.S. Patent 4,837,111 remains notable for its specific compositions and methods.
Patent Term and Expiry
Filed in 1988 and granted in 1989, the patent's expiration would typically occur around 2009, considering patent term adjustments. As of 2023, the patent has likely expired, opening the landscape for generic development.
Implications for Industry and Legal Strategies
- Freedom to Operate (FTO): Given the expiration, current market entrants can utilize similar formulations without infringing this patent.
- Patent Citations and Influence: The patent is cited by subsequent patents focusing on NSAID delivery systems, indicating its influence.
- Litigation and Licensing: During its active period, the patent likely served as a basis for licensing negotiations or patent infringement litigations, especially related to controlled-release NSAID formulations.
Conclusion
U.S. Patent 4,837,111 secured broad yet defensible claims around specific pharmaceutical compositions involving NSAIDs, particularly indomethacin, and their preparation methods designed for enhanced therapeutic profiles. Its scope was sufficiently narrow to avoid prior art, but broad enough to impact subsequent formulations and delivery strategies.
The patent landscape surrounding NSAID formulations is dense, with numerous prior art references that influenced its claims. Despite its expiration, the patent contributed to shaping controlled-release NSAID development and remains a significant milestone in pharmaceutical patent history.
Key Takeaways
- The patent’s primary contribution was in specific controlled-release formulations of NSAIDs, emphasizing reduced gastrointestinal side effects.
- Its broad claims covered compositions, preparation methods, and therapeutic applications, but faced prior art limitations.
- The patent landscape is characterized by extensive prior art, yet this patent introduced specific innovations that influenced subsequent NSAID delivery patents.
- With patent expiry, the formulations and methods are now open for generic application, encouraging broader competition.
- Companies developing NSAID-based formulations should note the expired patent's teachings but remain vigilant to newer, more advanced patents.
FAQs
Q1: What is the main innovation disclosed in U.S. Patent 4,837,111?
A1: The patent primarily discloses controlled-release pharmaceutical compositions containing NSAIDs like indomethacin, utilizing specific carriers and preparation methods to reduce gastrointestinal irritation and enhance efficacy.
Q2: How does the scope of this patent compare to prior NSAID formulation patents?
A2: While building upon existing controlled-release concepts, it introduced specific formulation strategies and preparation techniques that provided novel claims, distinguishing it from earlier patents.
Q3: Is this patent still enforceable today?
A3: No. Given its filing date (1988) and typical patent term duration, it has likely expired around 2009, allowing free use of its teachings.
Q4: What does this patent's expiration mean for generic drug manufacturers?
A4: They can now develop and market similar formulations without infringing on this patent, fostering increased competition and drug accessibility.
Q5: Are there newer patents that have built upon or challenged this patent?
A5: Yes. The patent landscape includes subsequent patents focusing on advanced delivery systems, new NSAID compounds, and side-effect mitigation techniques that both build upon and differ from this early patent’s teachings.
References
[1] U.S. Patent 4,837,111. "Anti-inflammatory and analgesic compositions." Inventors: Furukawa et al., Grant Date: 1989.
[2] Prior art references and subsequent NSAID formulation patents cited in the patent file.
[3] Patent expiration and lifecycle information from the United States Patent and Trademark Office (USPTO).
