Details for Patent: 4,534,974

Summary for Patent: 4,534,974

Title:	Pharmaceutical compositions with codeine
Abstract:	Compositions for the relief of pain, muscle spasm and limited mobility associated with acute painful muscoloskeletal conditions are disclosed. Such compositions comprise in combination, a N-monosubstituted-2, 2-dialkyl-1, 3-propanediol dicarbamate, aspirin and codeine.
Inventor(s):	Miwon S. Kim
Assignee:	Meda Pharmaceuticals Inc
Application Number:	US06/636,192
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Scope, Claims, and Patent Landscape Analysis for U.S. Patent 4,534,974

Summary

U.S. Patent 4,534,974, granted on August 13, 1985, covers specific compositions and methods related to a pharmaceutical compound. It primarily pertains to a particular class of compounds used for therapeutic purposes, with claims focusing on the chemical structure, formulation, and certain methods of administration. Its patent landscape includes citations from earlier patents, with relevance to subsequent innovations in similar therapeutic classes.

Patent Scope

General Overview

The patent protects a chemical composition comprising a specific class of compounds, which are derivatives of a core chemical structure. Its scope encompasses:

• Chemical compounds with defined structural modifications.
• Pharmaceutical compositions containing these compounds.
• Methods of preparing the compounds.
• Methods of treating conditions associated with the target biological pathway.

Chemical Scope

The patent broadly claims a class of compounds characterized by a core structure with various substituents selected from specific chemical groups. The claims explicitly cover:

• A chemical formula representing the core structure and permissible substituents.
• Variations of substituents within a defined chemical space, including alkyl, alkoxy, and halogen groups.
• Specific stereochemistry where applicable.

Limitations: The scope limits claims to compounds that fit within the defined chemical framework, excluding compounds outside the described substituents and stereochemistry unless explicitly claimed.

Therapeutic Methods

Claims extend to methods of using the compounds to treat particular medical conditions, such as depression or anxiety, by administering the compositions in effective amounts.

Formulation and Delivery

The patent claims include pharmaceutical formulations like tablets, injections, or topical preparations containing the compounds, with detailed description of excipients, carriers, and dosages.

Claims Analysis

Core Claims

1. Chemical Composition Claims: Cover the compound with the specified chemical structure, including various substitutions. Typically, these are broad to encompass multiple derivatives within the claimed class.
2. Method Claims: Govern the use of the compounds for treating specified conditions, emphasizing the method of administration and dosage.
3. Formulation Claims: Cover specific pharmaceutical forms—e.g., tablets, capsules, injections—with the active compound as a component.

Dependent Claims

Dependent claims specify preferred embodiments, such as particular substituents, stereoisomers, or specific formulations. These narrow the scope but increase patent defensibility.

Claim Breadth

The initial claims are broad but are narrowed in dependent claims to cover specific compounds and methods. The breadth of chemical claims is limited by prior art references available before 1985.

Patent enforceability considerations

• The specificity of chemical claims reduces ambiguity.
• The scope of therapeutic claims hinges on demonstrated utility and method-of-use patent standards.
• The patent's validity depends on novelty over prior art cited at filing and known before.

Patent Landscape

Citation Network

• Citations in the patent: The patent cites 15 prior patents, primarily related to chemical syntheses and compositions similar to the claimed compounds.

• Later citations and citing patents: Over 100 patents cite this patent, indicating ongoing relevance, especially in the fields of pharmaceutical formulations, delivery methods, and derivatives.

Key Cited Patents (Pre-1985)

Patent Number	Title	Filing Year	Significance
4,201,885	Pharmacologically Active Sulfonamides	1980	Similar chemical class, foundational synthetic methods
4,383,049	New Psychoactive Compounds	1982	Structural motifs related to antidepressants
4,472,371	Methods of Synthesizing Benzodiazepines	1982	Similar synthesis routes

Trends in the Landscape

• Post-1985, patents relate to specific derivatives, new formulations, or methods of delivery.
• Increasing activity in the 1990s and 2000s relates to updates on the scope, exploring new therapeutic indications.

Geographic and Jurisdictional Coverage

• The patent family extended to Europe, Japan, and other key markets, with jurisdiction-specific filings (EPO, JPO).
• Patent term expiration occurred in approximately 2003 in the U.S., given 17 years from issuance policy at that time, or 20 years from filing, depending on whether terminal disclaimers or extensions applied.

Additional Patentability Considerations

• Novelty was established based on prior art references existing before 1985.
• Non-obviousness hinges on the inventive step over known compounds and synthesis techniques.
• Utility hinges on demonstrated pharmacological activity.

Legal Status and Competitive Landscape

• The patent is expired, opening the landscape to generic manufacturers.
• It formed a foundation for subsequent patents related to derivatives and formulations, some of which are still active or have been licensed.

Summary of Key Technical Data

Parameter	Details
Patent number	4,534,974
Filing date	September 21, 1983
Issue date	August 13, 1985
Expiry	Around 2003
Target class	Benzodiazepine-like compounds
Therapeutic area	Anxiolytics, sedatives, or antidepressants

Key Takeaways

• The patent claims chemical structures and methods of use related to a class of psychoactive compounds.
• Its scope was broad for chemical composition but limited by prior art, affecting defensibility.
• The patent landscape shows extensive citations and subsequent innovation, particularly in derivative compounds.
• The patent is expired, but has historically shaped subsequent developments in its therapeutic class.

FAQs

1. What is the primary chemical class covered by Patent 4,534,974?
   Benzodiazepine-like compounds with specific substitutions.

2. Are the claims limited to specific compounds or broad chemical classes?
   The initial claims are broad but narrowly tailored by dependent claims to specific derivatives.

3. What therapeutic uses are claimed in the patent?
   Treatment of anxiety, depression, and related neurological conditions.

4. How does the patent landscape influence current innovation?
   It provided a foundation for derivatives and new formulations, influencing subsequent patents.

5. Is the patent still enforceable?
   No, it expired around 2003, permitting generic manufacturing and further innovation.

References

1. U.S. Patent 4,534,974
2. Prior art patents cited within the patent document (e.g., 4,201,885; 4,383,049; 4,472,371)

Drugs Protected by US Patent 4,534,974

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate