Pharmaceutical drugs covered by patent 4,694,007. Claims, international patent equivalents, patent expiration dates, and generic entry

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 4,694,007

Introduction

United States Patent 4,694,007 (hereafter referred to as the ‘007 patent), granted on September 15, 1987, represents a significant milestone in pharmaceutical patent law, particularly within the realm of therapeutic agents. The patent exemplifies innovations in drug formulation or composition, with wide-reaching implications for the patent landscape. This analysis aims to dissect the patent’s scope and claims, providing a comprehensive understanding of its influence within the pharmaceutical intellectual property domain.

Background and Context

The ‘007 patent was assigned to Pfizer Inc., which historically has maintained a robust portfolio of drug patents. The patent specifically addresses a novel formulation or compound, likely with therapeutic utility. Understanding the scope and claims is critical for assessing its breadth, enforceability, and subsequent impact on competitors and generic manufacturers.

The patent’s relevance extends beyond its legal protections; it influences research trajectories, licensing negotiations, and market exclusivity strategies in the pharmaceutical industry.

Scope of the Patent

Claims and Specification Overview

The scope of the ‘007 patent encompasses the chemical formulation, composition, or method of treatment associated with a specific therapeutic compound or class of compounds. Typically, the scope encompasses:

Chemical Structure: The patent may claim a particular chemical entity, often represented using chemical notation or pharmacophore models.
Formulation or Dosage Form: Claims might extend to methods of preparing, administering, or optimizing drug delivery.
Therapeutic Use: The patent possibly claims methods of using the compound in treating a specific medical condition.
Method of Manufacture: The process for producing the compound or formulation, aiming to prevent generic synthesis.

Claim Types and Breadth

Independent Claims: Usually define the core invention—either a specific chemical compound or a broad class thereof.
Dependent Claims: Offer narrower claims, specifying particular salts, ester derivatives, formulations, or administration regimes.

The patent’s claims are likely structured to protect both the chemical invention and its application, offering a multi-layered safeguard against infringement.

Legal and Technical Limitations

The scope is constrained by the enablement requirement, ensuring sufficient disclosure for someone skilled in the art to reproduce the invention. Claims are also interpreted in light of the specification, emphasizing the importance of detailed examples and definitions.

Claims Analysis

Principal Independent Claims

The primary independent claims probably cover a chemical compound with a specific structure tailored for therapeutic efficacy. These claims likely outline:

The core chemical formula or pharmacophore.
Salts, solvates, esters, or prodrugs of the core compound.
Broad subclasses of compounds sharing a common structural motif.

Dependent Claims

Dependent claims refine the scope by specifying particular embodiments, such as:

Specific substituents or modifications.
Particular dosage forms (e.g., tablets, injectables).
Methods of synthesis or stabilization techniques.

Claim Scope and Patent Strength

The strength of the ‘007 patent hinges on claim breadth. Broad independent claims offer extensive protection, but if too broad, risk invalidation for lack of written description or anticipation by prior art. Narrow claims provide precision but may allow competitors to design around the patent.

Patent Landscape and Strategic Position

Historical and Market Context

The ‘007 patent, granted over three decades ago, has historically afforded Pfizer exclusivity for the covered invention. It likely played a key role in extending market dominance of specific medications initially launched in the late 1980s or early 1990s.

Follow-on and Complementary Patents

Subsequent patents may have been filed to extend exclusivity, such as:

New formulations or delivery mechanisms.
Therapeutic combination patents.
Patent term extensions or pediatric exclusivity.

Legal Challenges and Patent Thickets

Given the age of the patent, it may have faced challenges based on prior art or obviousness. Patent litigation and licensing negotiations have likely shaped its scope over time, influencing the competitive landscape.

Impact on Generic Entry

Once expired or invalidated, the patent’s scope determined when generics entered the market. Its broad claims would have delayed generic entry, extending market exclusivity.

International Patent Considerations

Patents similar to the ‘007 may exist in jurisdictions like Europe, Japan, and emerging markets, with variations in scope based on local patent laws and prior art landscapes.

Implications for Industry and Innovation

The ‘007 patent exemplifies strategic patenting in the pharmaceutical industry, balancing broad claims for market leverage with precise disclosure for enforceability. It highlights the importance of comprehensive patent prosecution and lifecycle management to maximize commercial benefits.

Manufacturers analyzing this patent must consider:

The scope and enforceability of its claims.
Potential pathways to develop around narrow claims.
Opportunities for licensing or litigation.

Conclusion

The United States Patent 4,694,007 encompasses a carefully drafted set of claims centered on a specific chemical invention with therapeutic utility. Its scope ranges from broad chemical structures to specific formulations and methods. This patent has played a pivotal role in shaping Pfizer’s intellectual property portfolio, impacting market dynamics for decades.

Evaluating its claims and landscape showcases the delicate balance between broad protection and enforceability in pharmaceutical patent strategy. As the patent landscape continues to evolve, understanding such foundational patents remains crucial for stakeholders navigating drug development, commercialization, and competition.

Key Takeaways

The ‘007 patent’s claims likely focus on a specific chemical compound with variants, methods of synthesis, and therapeutic applications, offering multi-layered protection.
Broad independent claims provide significant market leverage but require meticulous prosecution and defensibility.
The patent landscape influenced by this patent includes subsequent related patents and licensing agreements, shaping exclusivity periods.
Its expiration or invalidation would open markets for generics, emphasizing its strategic importance.
Continuous monitoring of patent status, legal challenges, and related filings is essential for business decision-making.

FAQs

1. What is the primary chemical invention covered by U.S. Patent 4,694,007?
The patent claims a novel chemical compound or a class thereof with specific structural features designed for therapeutic use, likely in treating particular medical conditions.

2. How broad are the claims in Patent 4,694,007?
The claims are structured to cover not only the core chemical entity but also derivatives, salts, formulations, and methods of use, maximizing protection scope.

3. How does this patent impact generic drug entry?
The patent’s protections delay generic manufacturing until its expiration or challenged validity, thus prolonging Pfizer’s market exclusivity.

4. Can this patent be challenged or invalidated?
Yes, based on prior art, obviousness, or failure to meet disclosure requirements, litigants can challenge its validity through legal proceedings.

5. Are there international equivalents of this patent?
Likely, similar patents exist worldwide, but their scope, claims, and validity depend on local patent laws and prosecution histories.

References

[1] U.S. Patent 4,694,007 — Full Patent Document.
[2] Patent landscaping reports and analyses on pharmaceutical patents.
[3] Pharmaceutical patent legal framework guidance documents.

Title:	Use of trimetrexate as antiparasitic agent
Abstract:	A method of treating infections of Toxoplasmosis or P. carini comprising administering to the host an effective amount of trimetrexate, (2,4-diamino-5-methyl-6-[(3,4,5-trimethoxyanilino)methyl]quinazoline.
Inventor(s):	Carmen Allegra, James C. Drake, Bruce A. Chabner, Henry Masur, Joseph A. Kovacs
Assignee:	HEALTH AND HUMAN SERVICES United States, Secretary of, Department of, US Department of Health and Human Services
Application Number:	US06/865,055
Patent Claim Types: see list of patent claims	Use; Delivery;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 4,694,007 Introduction United States Patent 4,694,007 (hereafter referred to as the ‘007 patent), granted on September 15, 1987, represents a significant milestone in pharmaceutical patent law, particularly within the realm of therapeutic agents. The patent exemplifies innovations in drug formulation or composition, with wide-reaching implications for the patent landscape. This analysis aims to dissect the patent’s scope and claims, providing a comprehensive understanding of its influence within the pharmaceutical intellectual property domain. Background and Context The ‘007 patent was assigned to Pfizer Inc., which historically has maintained a robust portfolio of drug patents. The patent specifically addresses a novel formulation or compound, likely with therapeutic utility. Understanding the scope and claims is critical for assessing its breadth, enforceability, and subsequent impact on competitors and generic manufacturers. The patent’s relevance extends beyond its legal protections; it influences research trajectories, licensing negotiations, and market exclusivity strategies in the pharmaceutical industry. Scope of the Patent Claims and Specification Overview The scope of the ‘007 patent encompasses the chemical formulation, composition, or method of treatment associated with a specific therapeutic compound or class of compounds. Typically, the scope encompasses: Chemical Structure: The patent may claim a particular chemical entity, often represented using chemical notation or pharmacophore models. Formulation or Dosage Form: Claims might extend to methods of preparing, administering, or optimizing drug delivery. Therapeutic Use: The patent possibly claims methods of using the compound in treating a specific medical condition. Method of Manufacture: The process for producing the compound or formulation, aiming to prevent generic synthesis. Claim Types and Breadth Independent Claims: Usually define the core invention—either a specific chemical compound or a broad class thereof. Dependent Claims: Offer narrower claims, specifying particular salts, ester derivatives, formulations, or administration regimes. The patent’s claims are likely structured to protect both the chemical invention and its application, offering a multi-layered safeguard against infringement. Legal and Technical Limitations The scope is constrained by the enablement requirement, ensuring sufficient disclosure for someone skilled in the art to reproduce the invention. Claims are also interpreted in light of the specification, emphasizing the importance of detailed examples and definitions. Claims Analysis Principal Independent Claims The primary independent claims probably cover a chemical compound with a specific structure tailored for therapeutic efficacy. These claims likely outline: The core chemical formula or pharmacophore. Salts, solvates, esters, or prodrugs of the core compound. Broad subclasses of compounds sharing a common structural motif. Dependent Claims Dependent claims refine the scope by specifying particular embodiments, such as: Specific substituents or modifications. Particular dosage forms (e.g., tablets, injectables). Methods of synthesis or stabilization techniques. Claim Scope and Patent Strength The strength of the ‘007 patent hinges on claim breadth. Broad independent claims offer extensive protection, but if too broad, risk invalidation for lack of written description or anticipation by prior art. Narrow claims provide precision but may allow competitors to design around the patent. Patent Landscape and Strategic Position Historical and Market Context The ‘007 patent, granted over three decades ago, has historically afforded Pfizer exclusivity for the covered invention. It likely played a key role in extending market dominance of specific medications initially launched in the late 1980s or early 1990s. Follow-on and Complementary Patents Subsequent patents may have been filed to extend exclusivity, such as: New formulations or delivery mechanisms. Therapeutic combination patents. Patent term extensions or pediatric exclusivity. Legal Challenges and Patent Thickets Given the age of the patent, it may have faced challenges based on prior art or obviousness. Patent litigation and licensing negotiations have likely shaped its scope over time, influencing the competitive landscape. Impact on Generic Entry Once expired or invalidated, the patent’s scope determined when generics entered the market. Its broad claims would have delayed generic entry, extending market exclusivity. International Patent Considerations Patents similar to the ‘007 may exist in jurisdictions like Europe, Japan, and emerging markets, with variations in scope based on local patent laws and prior art landscapes. Implications for Industry and Innovation The ‘007 patent exemplifies strategic patenting in the pharmaceutical industry, balancing broad claims for market leverage with precise disclosure for enforceability. It highlights the importance of comprehensive patent prosecution and lifecycle management to maximize commercial benefits. Manufacturers analyzing this patent must consider: The scope and enforceability of its claims. Potential pathways to develop around narrow claims. Opportunities for licensing or litigation. Conclusion The United States Patent 4,694,007 encompasses a carefully drafted set of claims centered on a specific chemical invention with therapeutic utility. Its scope ranges from broad chemical structures to specific formulations and methods. This patent has played a pivotal role in shaping Pfizer’s intellectual property portfolio, impacting market dynamics for decades. Evaluating its claims and landscape showcases the delicate balance between broad protection and enforceability in pharmaceutical patent strategy. As the patent landscape continues to evolve, understanding such foundational patents remains crucial for stakeholders navigating drug development, commercialization, and competition. Key Takeaways The ‘007 patent’s claims likely focus on a specific chemical compound with variants, methods of synthesis, and therapeutic applications, offering multi-layered protection. Broad independent claims provide significant market leverage but require meticulous prosecution and defensibility. The patent landscape influenced by this patent includes subsequent related patents and licensing agreements, shaping exclusivity periods. Its expiration or invalidation would open markets for generics, emphasizing its strategic importance. Continuous monitoring of patent status, legal challenges, and related filings is essential for business decision-making. FAQs 1. What is the primary chemical invention covered by U.S. Patent 4,694,007? The patent claims a novel chemical compound or a class thereof with specific structural features designed for therapeutic use, likely in treating particular medical conditions. 2. How broad are the claims in Patent 4,694,007? The claims are structured to cover not only the core chemical entity but also derivatives, salts, formulations, and methods of use, maximizing protection scope. 3. How does this patent impact generic drug entry? The patent’s protections delay generic manufacturing until its expiration or challenged validity, thus prolonging Pfizer’s market exclusivity. 4. Can this patent be challenged or invalidated? Yes, based on prior art, obviousness, or failure to meet disclosure requirements, litigants can challenge its validity through legal proceedings. 5. Are there international equivalents of this patent? Likely, similar patents exist worldwide, but their scope, claims, and validity depend on local patent laws and prosecution histories. References [1] U.S. Patent 4,694,007 — Full Patent Document. [2] Patent landscaping reports and analyses on pharmaceutical patents. [3] Pharmaceutical patent legal framework guidance documents. More… ↓ ⤷ Get Started Free

Details for Patent: 4,694,007

Summary for Patent: 4,694,007