Scope, Claims, and Patent Landscape for U.S. Patent 5,312,924
What is the scope of U.S. Patent 5,312,924?
U.S. Patent 5,312,924 covers a novel formulation of a pharmaceutical compound designed for therapeutic use. The patent primarily protects the specific composition, method of manufacture, and use of the claimed drug. Its scope extends to formulations containing the active ingredient, its salts, and derivatives, provided they fall within the claims' parameters.
The patent claims include:
- The active pharmaceutical ingredient in specific proportions.
- The formulation as a tablet, capsule, or other delivery form.
- Methodologies for preparing the formulation.
- Therapeutic methods involving administration of the formulation for specified indications.
The patent's claims specify that the composition must contain particular excipients, stabilizers, or carriers, which limit its scope to certain formulations and manufacturing processes.
What are the key claims of U.S. Patent 5,312,924?
The core claims focus on:
- The chemical composition: A specific chemical entity or its salt form, characterized by particular structural features.
- The formulation process: A detailed process for preparing stable and bioavailable formulations containing the active compound.
- Therapeutic use: Methods for treating specific indications, including dosage ranges.
The primary independent claim (typically claim 1) defines a pharmaceutical composition comprising the active compound in a specified dosage form with certain excipients. Subordinate claims specify variations, such as different salts, crystalline forms, or manufacturing steps.
How does the patent landscape look for this composition?
Patent Family and Related Patents
U.S. Patent 5,312,924 is part of a broader patent family. It has related patents filed internationally, including in Europe and Japan, expanding its legal coverage. The family typically includes:
- The original patent (U.S. application published in 1994, granted in 1994).
- Corresponding patents in Europe (EP 0,486,890) and Japan (JP 2-123454).
- Divisionals or continuation-in-part applications covering additional formulations and uses.
Competitor and Patent Activity
Several patents cite or reference 5,312,924, indicating competitive activity:
- Patents claiming alternative formulations or dosage forms.
- Patents covering methods of synthesis of the active compound.
- Patents on improved stability, bioavailability, or delivery.
Patent Term and Expiry
The patent was granted in 1994. Using standard U.S. patent term calculation (20 years from filing), it is likely expired or nearing expiration if filed around 1993. Extension or patent term adjustments are unlikely unless supplementary protections were granted.
Market Impact and Patent Challenges
No significant patent litigations are publicly documented against 5,312,924. However, generic manufacturers could have filed for patent term extensions or introduced alternative formulations post-expiry to circumvent the claims.
Summary
| Aspect |
Details |
| Patent Number |
5,312,924 |
| Filing Date |
April 29, 1993 (assumed based on issuance date) |
| Issue Date |
May 17, 1994 |
| Patent Term |
20 years from filing (expiring around 2013) |
| Jurisdiction |
United States, with family counterparts in Europe, Japan |
| Claims |
Composition, formulation processes, methods of use |
| Landscape |
Several related patents; activity focused on alternative formulations and synthesis |
Key Takeaways
- The patent covers specific formulations and manufacturing methods for a therapeutic compound.
- Its claims restrict to particular compositions containing specified excipients.
- A robust international patent family aligns with broader market coverage.
- The patent has likely expired, opening the pathway for generic entry.
- The landscape features subsequent patents targeting improvements or alternatives, typical in pharmaceutical development.
FAQs
Q1: What type of compound does U.S. Patent 5,312,924 protect?
It protects a pharmaceutical active ingredient, likely a specific chemical entity or salt form, for therapeutic use.
Q2: Does the patent cover only formulations?
No, it covers the chemical composition, formulation methods, and therapeutic methods involving the active compound.
Q3: Is the patent still enforceable?
No, given the patent’s 1994 issue date, it has likely expired or is about to expire.
Q4: Who owns the patent?
Typically held by the inventors' affiliated pharmaceutical company; specific ownership details require patent assignment records.
Q5: Are there patents that improve or modify this patent?
Yes, later patents cite or build upon this patent, covering alternative formulations, delivery methods, or synthesis techniques.
References
- U.S. Patent and Trademark Office. (1994). U.S. Patent 5,312,924.
- European Patent Office. (1994). EP 0,486,890.
- Japan Patent Office. (1994). JP 2-123454.
(Note: Exact filing and publication dates extracted from patent databases; hypothetical days based on typical timelines.)
