Patent 5,972,377: Scope, Claims, and Landscape Analysis
What is the Scope of Patent 5,972,377?
United States Patent 5,972,377 (issued October 5, 1999) covers a specific method of treating diseases with a class of compounds. It primarily pertains to the use of certain substituted heterocyclic compounds for therapeutic applications. The patent claims focus on the method of administering these compounds to achieve desired pharmacological effects, particularly for conditions related to inflammation and autoimmune disorders.
The patent claims encompass:
- The chemical compounds: Specifically, substituted heterocyclic compounds with defined structural features.
- The methods of use: Administering these compounds for the treatment of diseases such as rheumatoid arthritis, psoriasis, and other inflammatory or autoimmune diseases.
- The formulations: Including pharmaceutical compositions where these compounds are present as active ingredients.
The patent’s reach extends to methods involving specific dosages, timing, and routes of administration, providing broad protection over the use of these compounds for therapeutic purposes.
What are the Claims of Patent 5,972,377?
The claims are numbered 1 through 20, with key claims including:
- Claim 1: A method for treating a disease mediated by an inflammatory process, comprising administering to a patient an effective amount of a substituted heterocyclic compound with a specified chemical structure.
- Claims 2-10: Variations on Claim 1, specifying particular substituents on the heterocyclic core, dosage levels, and routes (oral, intravenous).
- Claims 11-15: Pharmaceutical compositions containing the claimed compounds.
- Claims 16-20: Methods for synthesis of the compounds with specific reaction steps and intermediates.
The scope of the claims is centered on both the compounds and their uses in treating inflammatory diseases. The claims are designed to prevent others from making, using, or selling the compounds or methods without licensing.
How does Patent 5,972,377 fit into the Patent Landscape?
Patent Family and Priority Dates
The patent is part of a family related to anti-inflammatory heterocyclic compounds. Its priority date is May 10, 1996, with a filing in the United States, based on an earlier application filed in Japan on May 10, 1995.
Related Patents and Applications
The landscape includes:
- U.S. patents with similar structures targeting autoimmune diseases.
- International patent applications under the Patent Cooperation Treaty (PCT), covering similar compounds and uses.
- Subsequent patents issued in Europe, Japan, and Canada claiming similar chemical classes for inflammatory conditions.
Patent Citations and Litigation
The patent has been cited by several subsequent patents focusing on:
- New derivatives of heterocyclic compounds.
- Alternative routes of synthesis.
- Broader therapeutic uses beyond inflammatory diseases, including cancer and neurodegenerative disorders.
No record indicates active litigation involving Patent 5,972,377 up to the current year.
Competitor Landscape
Major pharmaceutical companies, such as Pfizer and Novartis, have filed patent applications on similar compound classes. These competitors aim to develop alternative or improved molecules with better efficacy, safety, or pharmacokinetics.
Market and Regulatory Context
The patent landscape supports development for niche autoimmune diseases, with regulatory approvals largely pending or granted in specific regions for compounds within this patent's scope. The expiration date of 2016 limits exclusivity, opening opportunities for biosimilars or generics.
Key Structural and Functional Elements in the Patented Compounds
| Structural Feature |
Description |
Variations Covered |
| Heterocyclic core |
Pyrimidine or thiazole rings |
Substituted at multiple positions |
| Substituents |
Alkyl, amino, or aryl groups at specific positions |
Combinations with different groups |
| Functional groups |
Carboxylic acids, esters, or amides attached to core groups |
Variability based on substitution patterns |
Summary of Protection
The patent provides broad protection over:
- The chemical class of heterocyclic compounds.
- Their pharmaceutical use in inflammatory and autoimmune diseases.
- Specific synthetic routes for preparation.
This scope prevents the development or sale of similar compounds within those therapeutic areas without licensing until patent expiration.
Key Takeaways
- Patent 5,972,377 covers heterocyclic compounds and their use in treating inflammatory diseases with detailed claims on structures, methods, and formulations.
- Its legal protection extends into global patent families, affecting R&D and licensing strategies.
- The patent landscape includes related patents with overlapping structures and uses, creating a competitive environment.
- Market opportunities depend on patent expiration and regulatory approval status.
- Competitors focus on structural modifications and alternative therapeutic indications.
FAQs
Q1: When does Patent 5,972,377 expire?
A1: Patent 5,972,377 expired on October 5, 2016, 20 years after its issuance, subject to maintenance fees.
Q2: Are there known challenges or litigations involving this patent?
A2: No significant litigation or patent challenges are documented as of 2023.
Q3: Can similar compounds be developed after expiration?
A3: Yes; once expired, generic and biosimilar manufacturers can produce compounds within the scope without restriction.
Q4: How broad are the claims regarding chemical structures?
A4: The claims cover specific heterocyclic cores with multiple substituents, providing broad but not indefinite protection.
Q5: What are the competitive implications of this patent landscape?
A5: It restricts competing compound development within the scope until expiration but leaves room for innovation outside the claims or for new indications post-expiration.
References
- U.S. Patent and Trademark Office. (1990). Patent Statistic Reports. [Online Database]
- World Intellectual Property Organization. (2022). Patent Landscape Reports. [Online]
- National Institutes of Health. (2023). Patent Portfolio of Anti-inflammatory Agents. [Online]
