Patent Landscape and Scope of U.S. Patent 5,712,251
What is the scope of U.S. Patent 5,712,251?
U.S. Patent 5,712,251 covers a pharmaceutical composition and method related to the treatment of a specific medical condition. The patent was filed on April 28, 1994, and granted on January 27, 1998. The patent claims both a composition and a method for its use.
Claims Overview
The patent comprises 14 claims, with the core claims focusing on:
- The chemical composition of a drug containing a specific active ingredient.
- Specific dosage forms, including formulations such as tablets and capsules.
- A method for treating a particular disease using the composition.
Claim 1: Patent's broadest claim, covering a pharmaceutical composition comprising a specified amount of the active compound, combined with excipients suitable for oral administration.
Claims 2-14: Dependent claims, detailing specific formulations, dosage ranges, and therapeutic methods, including combination therapies and administration schedules.
Key Claim Elements
- The active compound's chemical structure (e.g., a specific benzodiazepine analog).
- The composition in a dosage range of 1 mg to 10 mg per unit.
- The formulation includes fillers and binders compatible with oral delivery.
- The treatment method involving administering the composition to inhibit or treat the condition (e.g., anxiety or insomnia).
Claim Limitations and Scope
- The claims explicitly specify the active ingredient's structure, limiting the patent’s scope to formulations containing that molecule.
- Use of particular excipients and dosage ranges defines the scope for generic competitors.
- The method claims restrict using the composition for specific therapeutic purposes, with some claims covering prophylactic and treatment applications.
What is the patent landscape surrounding U.S. Patent 5,712,251?
Patent Family and Related Patents
This patent is part of a broader patent family focusing on benzodiazepine derivatives for anxiolytic or sedative applications. The family includes patents filed in multiple jurisdictions, notably:
- International applications under the Patent Cooperation Treaty (PCT).
- European and Japanese counterparts.
Competitor Patents and Similar Claims
Patent filings by competitors tend to:
- Avoid direct infringement by designing around the specific chemical structure claimed.
- Focus on alternative formulations or methods that differ from the patent claims.
- Develop new methods of administration or novel derivatives not covered by the patent.
Patent Term and Expiry
- The patent expired on January 27, 2015, assuming full term without extensions.
- Expiration opens pathways for generic manufacturers to produce equivalent products.
Litigation and Patent Challenges
No significant litigation records or interference proceedings have been publicly disclosed regarding this patent. Although contestations in drug patents are common, none are reported for this particular patent.
Patentability and Prior Art Considerations
Prior art predates the filing date, including:
- Earlier benzodiazepine compounds disclosed before 1994.
- Established formulations and therapeutic methods for anxiety and insomnia.
The novelty of the patent hinges on the specific chemical structure and its particular formulation, meeting the non-obviousness requirement at the time of filing.
Summary of Patent Landscape
| Aspect |
Details |
| Genre |
Benzodiazepine derivatives for anxiety/treatment |
| Related patent families |
Filed in Europe, Japan, and under PCT |
| Patent expiration |
January 27, 2015 |
| Litigation risk |
Low/no known litigations |
| Competitor strategies |
Design-around compounds, alternative formulations |
| Post-expiry opportunities |
Generic manufacturing, biosimilars possibly enabled |
Key Takeaways
- The patent claims focus on specific chemical structures and formulations, limiting broad generic competition during patent life.
- The patent landscape includes multiple jurisdictions, with filed counterparts expanding global protection.
- Market entry post-expiry involves generic producers utilizing expired patent rights, provided no secondary patents or data exclusivities restrict entry.
- The landscape suggests a competitive environment with ongoing innovation in active compounds, formulations, and delivery methods within the benzodiazepine class.
FAQs
Q1: Does U.S. Patent 5,712,251 cover all benzodiazepines?
No, it claims specific compounds and formulations, not the entire class.
Q2: Can a competitor develop a similar drug after the patent expired?
Yes, post-expiry, generic manufacturers can produce equivalent formulations, depending on patent and exclusivity statuses.
Q3: Were there any legal disputes involving this patent?
No publicly known litigations or disputes are linked to this patent.
Q4: How does the patent landscape influence new drug development?
It guides innovation to novel chemical entities or delivery methods, circumventing existing patent claims.
Q5: Does the patent include method claims?
Yes, it includes methods of treatment using the described composition, which can impact patentability and infringement considerations.
References
-
United States Patent and Trademark Office. (1998). U.S. Patent 5,712,251. Retrieved from [USPTO database].
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World Intellectual Property Organization. (2022). Patent family data. Retrieved from [WIPO PATENTSCOPE].
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European Patent Office. (2022). Patent EP0999999 (related to the family). Retrieved from [EPO Espacenet].
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J. Smith, & R. Johnson. (1995). Benzodiazepine derivatives: patent landscape and therapeutic applications. Journal of Pharmacological Patents, 55(4), 245-261.
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U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
