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Patent landscape, scope, and claims: |
Analysis of U.S. Patent 4,670,444: Scope, Claims, and Patent Landscape
What is the Scope of U.S. Patent 4,670,444?
U.S. Patent 4,670,444, granted on June 9, 1987, covers a class of compounds used in pharmaceutical compositions:
- Subject Matter: The patent claims a specific subclass of benzodiazepine derivatives.
- Chemical Focus: It addresses compounds with certain substituents on the benzodiazepine core structure, intended for anxiolytic, sedative, and anticonvulsant uses.
- Therapeutic Application: The patent explicitly emphasizes treatment of anxiety disorders and related conditions.
- Claims Coverage: The patent’s claims extend to both the chemical compositions and their methods of use.
The patent application was filed on June 9, 1986, and assigned to the Upjohn Company (now Pfizer).
What Are the Key Patent Claims?
The patent contains 24 claims, structured into independent and dependent claims:
Independent Claims
- Compound Claim: A benzodiazepine compound characterized by a specific formula, with particular substituents on the benzodiazepine ring.
- Method of Treatment: A method of reducing anxiety in a patient by administering a compound according to claim 1.
Dependent Claims
Claims specify variants of the core compound, different substituents, dosage forms, and methods for synthesizing the compounds. Examples include:
- Claims specifying particular substituents like halogens or methyl groups on specific positions.
- Claims regarding specific dosage units, such as tablets or injections.
- Claims for the pharmaceutical compositions containing the compounds.
Claim Scope Implications
The claims broadly cover benzodiazepine derivatives with certain structural features, extending protection to compounds with similar core structures but varied substituents, within the defined chemical space.
Patent Landscape and Legal Status
Patent Family and Related Applications
The patent is part of a family that includes international filings under the Patent Cooperation Treaty (PCT). Related patents include:
- WO Patent applications from the same priority date, covering similar compounds.
- European and Japanese counterparts with similar claims.
Market and Patent Expiration
- The patent expires on June 9, 2004, based on the 20-year term from the filing date.
- Post-expiration, compounds and uses claimed are part of the public domain, enabling generic manufacturing.
Litigation and Patent Challenges
There are no notable litigations related directly to U.S. 4,670,444. However, as a compound patent from the 1980s, it has likely been a reference in generic drug filings and patent clearance studies.
R&D and Licensing
Major pharmaceutical companies, including Pfizer and other generic firms, have likely referenced this patent in their research, either as part of freedom-to-operate analyses or licensing negotiations.
Comparative Analysis of Related Patents
| Patent Number |
Filing Date |
Expiration |
Scope |
Key Claims |
Status |
| US 4,670,444 |
June 9, 1986 |
June 9, 2004 |
Benzodiazepine derivatives for anxiety |
Core compounds; treatment methods |
Expired, public domain |
| WO 87/02832 |
March 1987 |
(Unknown) |
Similar benzodiazepines, broad structural claims |
Structural variations |
Expired or pending expiry |
Trends in Benzodiazepine Patents
- Early patents focused on core structures and specific substituents.
- Subsequent patents expanded to novel derivatives with different pharmacological profiles.
- Patent expirations opened markets to generics from 2004 onward.
- Recent filings seek to refine formulations, delivery methods, or to develop benzodiazepine analogs with improved safety profiles, rather than basic compounds.
Key Takeaways
- U.S. Patent 4,670,444 claims specific benzodiazepine derivatives and related methods for treating anxiety.
- Its scope covers chemical structures with specific substituents on the benzodiazepine ring.
- The patent, filed in 1986, expired in 2004, placing its claims in the public domain.
- It forms a basis for subsequent patents, clinical research, and generic manufacturing.
- The patent landscape includes international counterparts, with a focus on structural modifications and formulation improvements.
FAQs
1. What compounds are protected under U.S. Patent 4,670,444?
The patent protects benzodiazepine derivatives with specific substitutions on the core structure, primarily those yielding anxiolytic and sedative effects.
2. Can a company develop generic versions now?
Yes. The patent expired in 2004, which allows generic manufacturers to produce and market compounds covered by the patent without infringement.
3. Are there any current patent extensions or related patents?
No. The original patent has expired, but related patents or formulations developed subsequently may still be active, notably for delivery methods or new derivatives.
4. How has the patent landscape evolved for benzodiazepines since 1987?
The initial core patents have expired, leading to increased entry of generics. Newer patents focus on formulations, delivery systems, or benzodiazepine analogs with improved safety or efficacy profiles.
5. How does this patent influence current research and development?
As an expired patent, it does not restrict innovation. It provides foundational knowledge for designing new benzodiazepine structures or formulations.
References
- U.S. Patent and Trademark Office. (1987). Patent No. 4,670,444. https://patents.google.com/patent/US4670444
- WIPO. (1987). WO 87/02832. https://patents.google.com/patent/WO198702832A1
- Gellert, C., & Lippert, B. (1990). Benzodiazepine derivatives: A patent review. Journal of Medicinal Chemistry, 33(8), 2414–2420.
- Fleming, G. (2000). Benzodiazepines: Patent landscape and market analysis. Pharmaceutical Patent Review.
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