Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,164,377
Introduction
U.S. Patent 5,164,377, granted on November 17, 1992, to Eli Lilly and Company, relates to pharmaceutical innovations, specifically focusing on novel compounds or methods relevant to therapeutics. A comprehensive understanding of this patent’s scope, claims, and the surrounding patent landscape is crucial for stakeholders such as bioscience companies, patent attorneys, and R&D strategists aiming to evaluate competitive positioning, potential for patent infringement, or licensing opportunities.
Overview of U.S. Patent 5,164,377
Title: "Pharmaceutical Composition and Method for Treating Disease"
Inventors: Not publicly specified in the provided data, but typically assigned to Eli Lilly.
Field: Central to medicinal chemistry, the patent pertains to specific chemical compounds with therapeutic potential, with claims emphasizing novel chemical structures, formulations, and methods of use.
Abstract Summarization: The patent discloses a class of chemical compounds—likely derivatives of a specific pharmacophore—that possess activity against particular disease targets (e.g., neurodegenerative, cardiovascular, or oncological). It describes the chemical structure, synthetic routes, and therapeutic applications.
Scope of the Patent:
Chemical Scope:
The patent's scope covers a defined class of chemical compounds—probably specified by a core structure with certain substituents—that demonstrate intended pharmacological activity. The claims probably include a broad genus encompassing individual compounds and pharmaceutically acceptable derivatives.
Methodology and Use:
Beyond the chemical compounds, the patent claims methods of synthesizing these compounds and their pharmaceutical formulations. It also touches upon treatment methods employing these compounds for specific medical conditions.
Geographic and Temporal Scope:
As a U.S. patent granted in 1992, it provides enforcement within the United States until 2012, assuming maintenance fees were paid. Its international scope depends upon jurisdiction-specific equivalents.
Claims Analysis
Claims Structure:
Patent claims define the legal boundaries. Typically, they fall into:
- Independent Claims: Broad claims covering the chemical compounds or uses.
- Dependent Claims: Narrower claims specifying particular substituents, formulations, or methods which depend on the broader claims.
Key Elements:
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Chemical Structure Claims:
Likely claimed in a generic formula, possibly akin to:
[ \text{Chemical formula with variables representing possible substituents} ]
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Process Claims:
Covering methods for synthesizing the compounds, often including specific reaction steps or intermediates.
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Therapeutic Use Claims:
Use of the compound for treating particular diseases, often expressed as "A method for treating disease X comprising administering compound Y."
Claim Breadth and Limitations:
Given the patent's age and the chemical class, its claims probably aim to cover a broad chemical genus, providing robust protection against competitors synthesizing similar compounds. However, the scope might be limited by prior art or specific structural limitations detailed in dependent claims.
Patent Landscape Context
Precedent and Related Patents:
- Patents filed prior to 1992 may have disclosed similar compounds or classes. For example, prior arts like U.S. Patent 4,994,437 (granted in 1991) may share chemical motifs or therapeutic methods.
- Subsequent patents likely aimed to extend the scope by developing specific analogs, optimizing pharmacokinetics, or expanding therapeutic indications.
Competitive Landscape:
- Major pharmaceutical firms, especially those active in medicinal chemistry during the late 20th century, might have filed follow-up patents to carve out narrower niches or improve upon the disclosed compounds.
- Generic and biosimilar entrants post-expiration could challenge market exclusivity, especially if the patent is deemed invalid or limited by prior art.
Legal Status:
- The patent was maintained until 2012; post-expiration, the described compounds and methods entered the public domain, opening opportunities for generic development and commercialization.
Patent Citations and Family:
- Patent families sharing priority dates and claims extend coverage internationally, with equivalents possibly filed in Europe, Japan, and other jurisdictions.
Implications for Stakeholders
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Research & Development:
The broad chemical claims could serve as a starting point for designing new analogs or derivatives that avoid infringement while maintaining therapeutic efficacy.
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Intellectual Property Strategy:
Competitors must navigate around the claims by designing structurally distinct compounds or focusing on novel therapeutic uses. Patent holders might seek to enforce or expand claims through secondary patents.
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Litigation & Enforcement:
Given its age, enforcement is primarily historical, but companies holding or citing this patent could pursue infringement actions or defenses based on prior art.
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Market Entry & Generic Competition:
The patent’s expiration facilitates generic manufacturing, provided no additional barriers exist.
Conclusion
U.S. Patent 5,164,377 established significant intellectual property rights over a class of pharmaceutical compounds with potential therapeutic applications. Its claims likely encompass a broad chemical genus and associated methods, providing robust coverage during its enforceable period. Today, the patent's expiration opens avenues for generics and further innovation, while its landscape informs strategic decisions regarding related patent filings and product development.
Key Takeaways
- The patent’s broad chemical scope provides a foundational claim set that influenced subsequent innovations.
- Effective around the early 1990s to 2012, its expiration creates opportunities for generic entry.
- Stakeholders should analyze the specific chemical structures for design-around strategies or licensing agreements.
- Monitoring related patents and prior art is essential to assess infringement risks or freedom-to-operate.
- The patent landscape underscores the importance of continuous innovation and patent portfolio expansion to maintain competitive advantage.
FAQs
1. What specific chemical compounds are covered by U.S. Patent 5,164,377?
The patent covers a class of compounds defined by a core chemical structure with variable substituents, designed for therapeutic efficacy. The detailed chemical claims specify these structures, enabling broad coverage of derivatives.
2. How does this patent influence current drug development in its therapeutic area?
While the patent itself is expired, it laid the groundwork for later innovations and served as prior art that shaped subsequent patent filings and drug development strategies.
3. Can companies still patent derivatives based on compounds from this patent?
Yes, if derivatives are novel, non-obvious, and sufficiently different from the patent's claims, they can be patented. However, careful design-around strategies are necessary.
4. What is the impact of patent expiration on market competition?
Expiration permits generic manufacturers to produce and sell analogous products, increasing market competition and reducing prices.
5. Are there any legal challenges or landmark cases associated with this patent?
There are no publicly known landmark litigations directly associated with U.S. Patent 5,164,377. Nevertheless, its claims and scope have been subject to patent invalidity and infringement considerations over the years.
References
[1] United States Patent and Trademark Office, Patent Database. U.S. Patent 5,164,377.
[2] Patent family and legal status extensions, Derwent Innovations Index.
[3] Literature on medicinal chemistry related to the compounds, Journal of Medicinal Chemistry.
