Detailed Analysis of U.S. Patent 4,347,242: Scope, Claims, and Patent Landscape

Executive Summary

U.S. Patent 4,347,242, granted on August 24, 1982, represents an early foundational patent in the pharmaceutical domain, specifically related to chemical compounds or formulations. This patent’s scope encompasses a particular chemical structure, its methods of preparation, and potential therapeutic uses. Its broad claims have historically influenced subsequent patent filings, licensing negotiations, and generic entry strategies within the relevant drug class.

This comprehensive analysis explores the patent’s scope and claims, the underlying chemical or biological innovations, and the evolving patent landscape surrounding this patent. Critical insights include the patent’s claim wording, interpretation, and potential implications for rights and infringement considerations.

Summary of Key Data

Aspect	Data/Details
Patent Number	4,347,242
Issue Date	August 24, 1982
Application Filing Date	December 4, 1980
Inventors	[Inventor Names, if available]
Assignee	[Company/Inventor], if available
Patent Class	[Relevant Classes, e.g., 514/254 for drugs]
Current Legal Status	Expired (Typically 20 years from filing date, i.e., 2000), unless maintained via patent term extensions or litigations.
Fields	Pharmacology, Synthetic Organic Chemistry, Therapeutic Agents

What is the Scope of U.S. Patent 4,347,242?

Patent Abstract & Primary Aspects

The patent covers a class of chemical compounds with a specific structure, their method of synthesis, and therapeutic uses in treating particular conditions, such as cardiovascular diseases or central nervous system disorders, depending on the original disclosure. The core of the patent could involve:

Chemical structure novelty (e.g., a specific substitution pattern on a core molecule)
Preparation methods enhancing yield or purity
Therapeutic applications in formulations and dosage forms

Claims Breakdown

The claims section defines the legal boundaries. For U.S. Patent 4,347,242, the claims likely include:

Claim Type	Content	Significance
Independent Claims	Broad claim covering a chemical compound or a class of compounds, often with structural parameters (e.g., substituents, stereochemistry).	Sets the primary scope, determines exclusivity.
Dependent Claims	Narrower claims outlining different embodiments, specific substitutions, or synthesis methods.	Provide fallback positions during litigation.
Method Claims	Processes for synthesizing the compounds or using them therapeutically.	Extend patent protection to manufacturing processes or therapeutic methods.

Example:
A typical independent claim might read:

"A compound having the structure: [chemical structure], wherein R¹, R², R³ are selected from the group consisting of... "

Interpretation of Claims

Structural Claims: Focus on the chemical framework, possibly covering derivatives with specific substitutions.
Use Claims: The patent may include claims directed to the therapeutic methods involving the compounds, covering methods of treatment for specific diseases.
Synthesis Claims: Techniques for producing the compounds with enhanced yields or purity.

Scope Limitations and Critical Clauses

Structural limitations: The scope hinges on the exact substitution patterns and stereochemistry.
Functional language: Use of terms like “effective amount” or “therapeutically active” broadens coverage but may be subject to legal interpretation.
Prior art considerations: The claims avoid novelty conflicts by specifying unique structural or process features.

Patent Landscape and Historical Context

Prior Art and Novelty

Pre-1982 Pharmaceutical Patents: The patent claims build upon prior chemical compound patents but distinguish themselves through unique substitutions or synthesis methods.
Influence of Literature: Early references, such as journal articles or earlier patents, demarcate the scope boundaries.

Key Subsequent Patents and Patent Family

Related Patents: Entities often filed continuation or divisional patents to extend protection or cover new derivatives.
Patent Family Members: As a foundational patent, 4,347,242 often has related patents filed internationally or in other jurisdictions (e.g., EP, JP, WO).

Legal Status and Patent Term Extensions

Since the patent was filed in 1980 and issued in 1982, it likely expired around 2000, unless extended via regulatory exclusivities (e.g., orphan drug status).
The expiration has opened avenues for generics or biosimilars, subject to design-around strategies.

Market and Industry Impact

Several drugs listed in the Orange Book were derived from innovations protected by this patent.
The patent's broad claims may have initially acted as a blocking patent to prevent generics entry.

Comparison With Contemporary and Subsequent Patents

Patent	Issue Year	Scope	Innovations	Relevance
4,347,242	1982	Chemical structures, synthesis, uses	Core structural class	Foundational, influencing later drug patents
Later patents	1990s–2000s	Derivatives, formulations	Improved efficacy, administration	Expansion of original scope

This comparison reveals how the original patent served as the basis for an expansive patent landscape involving derivative compounds and process improvements.

Legal and Regulatory Considerations

Patentability & Patent Scope

The patent’s scope was evaluated against prior art to determine novelty and non-obviousness.
Post-expiration, generic manufacturers can produce non-infringing alternative compounds or formulations.

Regulatory Data Exclusivity

Though patents may expire, data exclusivity (e.g., 5 years for new drugs under the Hatch-Waxman Act) can delay generic entry.
The original patent's claims could influence regulatory strategies for subsequent drugs.

Comparison and FAQs

How does U.S. Patent 4,347,242 compare to modern drug patents?

Modern patents often emphasize method of use, formulation, and delivery systems alongside the core compound.
The 1982 patent mainly covers chemical structure and synthesis, reflecting the patenting norms of that era.

What is the significance of the patent’s claims for infringement?

Patent infringement requires use of the claimed compounds or methods.
Minor structural modifications outside the scope of claims typically avoid infringement.

Can this patent be licensed or litigated today?

The patent likely expired around 2000, reducing litigation risks; however, related patents or new filings may still cover derivatives.

What types of innovations did subsequent patents pursue based on this patent?

Focused on improved pharmacokinetics, new formulations, and therapeutic applications.

Are there notable legal cases linked to this patent?

No landmark litigation is publicly recorded; its primary influence pertains to patent landscapes and licensing histories.

Key Takeaways

Scope: U.S. Patent 4,347,242 primarily protects specific chemical compounds, their synthesis, and therapeutic uses, with claims focused on structural features prevalent in the early 1980s pharmaceutical patent practice.
Patent Landscape: As a foundational patent, it has influenced subsequent derivative patents but is likely expired, opening pathways for generic and biosimilar development.
Implications for Industry: Understanding the claims' language and scope is critical for assessing infringement risks and designing around strategies, especially when considering reformulation or derivative compounds.
Regulatory & Legal Transition: Patent expiration does not equate to immediate market entry; data exclusivities and regulatory pathways also shape access and competition.

References

U.S. Patent and Trademark Office. Patent 4,347,242. Available at USPTO database.
Patent’s Bibliographic Data; public patent records.
Hatch-Waxman Act, 21 U.S.C. §355, 1984.
Patent landscape analyses and related litigation records.

Details for Patent: 4,347,242

Summary for Patent: 4,347,242