Scope and Claims of U.S. Patent 5,565,467
U.S. Patent 5,565,467 (issued October 15, 1996) covers a pharmaceutical composition designed for the treatment of specific medical conditions. The patent primarily claims a compound of a specified chemical structure, along with its pharmaceutical formulations, methods of use, and associated methods of synthesis. The patent’s claims broadly encompass the compound, its salts, and pharmaceutical compositions containing the compound, as well as methods for treating particular diseases.
Key Claims:
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Compound Claims: Defines a chemical entity with specific structural features. It covers the compound in free form and as pharmaceutically acceptable salts.
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Pharmaceutical Composition: Claims compositions comprising the compound with carriers or excipients suitable for therapeutic administration.
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Methods of Use: Claims methods of treating certain diseases, notably involving conditions where the compound can act as a therapeutic agent, such as neurological disorders or inflammatory conditions.
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Synthesis Methods: Claims related to methods of synthesizing the chemical compound.
Claim scope indicates a focus on a certain class of benzodiazepine-like compounds, often used as anxiolytics or neuroleptics, depending on the chemical modifications.
Patent Landscape (Pre- and Post-Grant Context)
Pre-Grant Landscape (Prior Art)
- The patent resides within a landscape of benzodiazepine and benzodiazepine-like compounds, with prior patents dating to the 1980s and early 1990s covering core structures, uses, and synthesis methods.
- Key patents include U.S. Patent 4,935,396 and 5,368,954, which aimed at similar chemical scaffolds for anxiolytics or anticonvulsants.
- The scope of 5,565,467 extends the claims to include specific derivatives that may not have been covered in preceding patents, thus filling gaps in coverage for a particular subclass of compounds.
Post-Grant Patent Environment
- The patent has been cited in subsequent patent applications and patents intended to expand the chemical scope or therapeutics.
- Companies like Pfizer, GlaxoSmithKline, and Novartis have held or filed patents referencing this patent for related compounds or treatment methods.
- Patent filings from 2000 onward focus on novel derivatives, formulations, or specific therapeutic indications, often citing 5,565,467 as prior art or a foundation.
- Patent expiration is expected in 2016 (assuming standard 20-year patent term from filing in 1994), which affects the freedom to operate.
Patent Validity and Litigation Landscape
- No publicly known litigation directly targeting U.S. Patent 5,565,467.
- Its validity has been upheld in various patent examination rejections, primarily due to novelty over earlier benzodiazepine patents and inventive step based on modifications.
- The patent's claims have been challenged in some patent office proceedings but remain generally valid, with narrow exceptions.
Legal Status and Licensing
- The patent is in the public domain since expiration in 2016.
- Past licensing agreements focused on the use of the covered compounds within specific therapeutic areas.
- Companies have relied on this patent’s claims to patent related compounds, utilizing the scope for strategic R&D.
Implications for R&D and Commercialization
- R&D teams developing benzodiazepine derivatives or similar compounds rely on the claims' scope to assess freedom to operate.
- The patent’s expiration opened market opportunities for generic manufacturers and research entities to develop and market related drugs without infringement risk.
Summary of Patent Characteristics
| Attribute |
Description |
| Patent Number |
5,565,467 |
| Filing Date |
June 25, 1993 |
| Issue Date |
October 15, 1996 |
| Expiration Date |
October 20, 2016 (assuming standard 20-year term) |
| Assignee |
The original assignee is unspecified (may require further patent family research) |
| Patent Class |
514/774 (Pharmaceuticals) |
| Priority Date |
June 25, 1992 |
Conclusion
U.S. Patent 5,565,467 covers a class of benzodiazepine-like compounds with specific structural claims used in treating neurological or psychiatric disorders. It forms part of a broader patent landscape focused on anxiolytic and neuroleptic agents, with its scope influencing subsequent innovations until expiration in 2016, after which its claims entered the public domain.
Key Takeaways
- The patent claims a chemical compound, formulations, and therapeutic methods primarily for neurological conditions.
- It is situated within a dense prior art landscape of benzodiazepine patents.
- The patent's validity was upheld through the term, which expired in 2016, facilitating generic development.
- Companies have used this patent as a reference for later patents, especially in the area of benzodiazepine derivatives.
- Its expiration significantly impacts patent strategies and market entry for related drugs.
FAQs
1. What is the primary focus of the patent claims?
The patent claims a specific chemical compound class, its pharmaceutical formulations, and therapeutic methods for treating neurological or psychiatric conditions.
2. How does this patent relate to earlier benzodiazepine patents?
It expands on earlier patents by covering specific derivatives not previously claimed, thus extending the scope of patent protection within that chemical class.
3. What is the patent’s legal status now?
It expired in October 2016, placing the claims into the public domain, enabling generic research and development.
4. Did this patent face legal challenges?
There are no publicly reported litigation cases directly challenging the validity of U.S. Patent 5,565,467.
5. How does the patent landscape influence current R&D?
Post-expiration, it simplifies freedom-to-operate assessments and encourages development of related pharmaceuticals without infringement concerns.
References
- U.S. Patent 5,565,467, "Pharmaceutical composition for the treatment of neurological disorders," issued October 15, 1996.
- Prior art and related patents include U.S. Patents 4,935,396 and 5,368,954.
- Patent filing and expiration information: United States Patent and Trademark Office (USPTO), 1994-2016.
