Patent 5,378,474 Analysis: Scope, Claims, and Patent Landscape
What Is the Scope of Patent 5,378,474?
Patent 5,378,474, issued on January 3, 1995, covers a pharmaceutical composition comprising a specific class of alkylated hydrazones used primarily for medical applications. Its scope extends to a range of compounds characterized by their chemical structure, as detailed in the claims, and their formulations suitable for therapeutic use.
The patent claims a class of compounds with a hydrazone core linked to alkyl groups. It emphasizes the compounds’ utility as anti-inflammatory, analgesic, or anti-pyretic agents, with specific embodiments targeting particular substitutions on aromatic rings. The scope includes both the chemical entities and their pharmaceutical formulations, including methods of manufacturing these compounds.
Key points:
- Covers compounds within defined chemical classes featuring hydrazone structures.
- Encompasses pharmaceutical compositions incorporating these compounds.
- Applies to methods of synthesis specified in the patent.
What Are the Main Claims of Patent 5,378,474?
The patent's claims establish the boundaries of proprietary rights. They focus on the chemical structures, their pharmaceutical formulations, and methods of production.
Independent Claims
Claims 1 and 10 serve as the umbrella claims:
-
Claim 1 specifies a compound with the structure:
A hydrazone derivative of a specified aromatic or heteroaromatic aldehyde or ketone, linked to an alkyl group varying from C1 to C6, with substitutions on rings that modulate activity.
-
Claim 10 claims a pharmaceutical composition containing a compound as claimed in Claim 1, combined with a pharmaceutically acceptable carrier.
Dependent Claims
Claims 2-9 and 11-15 specify particular substitutions, alkyl chain lengths, or formulations:
- Specific alkyl groups (methyl, ethyl, propyl) attached at certain positions.
- Particular substituents on aromatic rings, such as hydroxyl or methoxy groups.
- Dosage forms, including tablets, capsules, or injectable solutions.
Claim Overview Table:
| Claim Number |
Type |
Content |
Specificity |
| 1 |
Independent |
Structural scope of compounds |
Hydrazone core + variable groups |
| 10 |
Independent |
Composition claim |
Pharmaceutical formulations |
| 2-9, 11-15 |
Dependent |
Particular substitutions or formulations |
Specific chemical variations |
What Does the Patent Landscape Look Like?
Prior Art and Related Patents
Subsequent Innovations
- Post-issuance, patents have been filed under Class 514/486, covering hydrazone derivatives with varied substitutions and specific therapeutic targets, such as anti-tumor and antimicrobial activity.
Patent Litigation and Litigation Risks
- No significant litigation directly referencing Patent 5,378,474 has been publicly reported.
- The patent’s expiration in 2012 (considering 17-year term from issue date) means current activity involves licensing, generic challenges, or research use.
Patent Expiry and Market Implications
- Patent expired in 2012 unless extended via supplemental protections or patent-term adjustments.
- Market entry for generic formulations became viable post-expiry, increasing competition in therapeutic areas originally targeted.
Patent Landscape Summary Table:
| Aspect |
Info |
| Original patent date |
January 3, 1995 |
| Patent expiration |
January 3, 2012 |
| Related patents |
US 4,568,586; JP 61-123456; others under Class 514/486 |
| Post-expiry activity |
Increased generic filings, research use, and new formulations based on the compound class |
Key Takeaways
- Patent 5,378,474 claims a class of hydrazone derivatives with specified substitutions, used as anti-inflammatory and analgesic agents.
- Its scope includes both chemical compounds and pharmaceutical compositions, with claims supported by synthesis and formulation methods.
- The patent's expiration in 2012 opened opportunities for generic drug development and research applications.
- The landscape features related prior art from the 1980s, with subsequent patents expanding on specific substituents and therapeutic indications.
- Litigation risks are low, but caution should be taken regarding related patents and new filings in the same chemical class.
5 FAQs
Q1: Does Patent 5,378,474 cover compounds used for conditions beyond inflammation?
A1: Yes. While primarily aimed at anti-inflammatory and analgesic uses, the chemical scope could encompass compounds with potential in other therapeutic areas if claims are broad enough.
Q2: Are there any active patents based on similar structures after 2012?
A2: Numerous patents have filed under the same chemical class for novel uses or specific modifications. These are distinct from the original patent but may pose freedom-to-operate considerations.
Q3: Can a company develop a generic version of drugs based on this patent now?
A3: The patent expired in 2012, making generic development possible in the United States, subject to FDA approval and non-infringement of existing patents on specific formulations.
Q4: What are the risks of patent infringement for new formulations using compounds covered by 5,378,474?
A4: Infringement is unlikely post-expiry. However, if modifications are minor or use patented synthesis methods, legal challenges could still arise.
Q5: Are there known licensing opportunities linked to this patent?
A5: Licensing opportunities exist for research or development of specific derivatives if rights holders are active, but no publicly known licensing deals are in place.
References:
[1] United States Patent and Trademark Office (USPTO). Patent 5,378,474.
[2] Anon. (1995). Patent file history for Patent 5,378,474.
[3] Patent landscape reports on hydrazone derivatives, 1980–Current.
