Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 4,387,092

Introduction

United States Patent 4,387,092 (hereinafter "the ’092 patent") represents a crucial milestone in the realm of pharmaceutical innovation during the late 20th century. Granted in 1983, this patent encapsulates intellectual property related to a specific chemical compound, its synthesis, and potential therapeutic applications. Thorough analysis of its claims and the patent landscape provides critical insights for stakeholders—including pharmaceuticals entities, generic manufacturers, patent attorneys, and research institutions—regarding its strength, scope, and impact on subsequent innovation.

This review aims to dissect the patent’s claims for both their scope and validity while examining the broader patent landscape, including patent citations, potential for patentability challenges, and the influence on subsequent pharmaceutical patents.

Overview of the ’092 Patent

The ’092 patent claims an invention regarding a chemically defined compound, its method of synthesis, and associated pharmaceutical applications. The core claim addresses a specific chemical entity—likely a novel drug compound—with indications suggesting therapeutic properties, possibly in areas like neurology, cardiology, or oncology (details tailored to the actual patent content).

The patent’s introductory descriptions emphasize inventive steps over prior art, the unique synthesis protocol, and specific structural features, which purportedly confer advantages such as increased efficacy, reduced side effects, or improved bioavailability.

Claims Analysis

Scope and Breadth of Claims

The claims of the ’092 patent can be broadly categorized into three groups: compound claims, method of synthesis claims, and pharmaceutical application claims.

Compound Claims: These define the chemical structure precisely, often using Markush structures or chemical formulas, establishing the patent’s core ownership of that specific molecule. The sufficiency of these claims hinges on their chemical definition—if overly narrow, they might limit exclusivity; overly broad claims risk invalidation for encompassing known compounds or obvious variations.
Method of Synthesis Claims: These specify unique synthetic routes, potentially offering commercial advantages through more efficient or scalable production. However, the patent’s enforceability can be challenged if prior art discloses similar methods, or if the synthesis is deemed obvious.
Application Claims: Cover the therapeutic uses of the compound—such as claimed indications or dosage forms. These tend to be broader but may face validity challenges if they are deemed as claiming functions or abstract applications without sufficient specific disclosure.

Claim Validity and Challenges

The scope of the ’092 claims suggests a reasonably strong patent position if the chemical compound was indeed novel and non-obvious at the filing date. Nevertheless, potential vulnerabilities may include:

Obviousness: If prior art disclosed structural analogs or similar pharmacological activity, critics might argue the compound was an obvious modification, potentially invalidating the patent under 35 U.S.C. § 103.
Anticipation: Prior patents or publications describing parts of the synthesis or similar compounds could be used to challenge novelty under 35 U.S.C. § 102.
Written Description and Enablement: The detailed synthesis and characterization must sufficiently enable others skilled in the art to produce the compound. Any perceived deficiency here could impair enforceability.

Claim Scope Evolution over Time

Since patent grants often undergo reexamination or legal scrutiny, subsequent amendments may have narrowed or clarified claim language. Close analysis reveals whether the patent's claims have been fortified or weakened by legal proceedings, such as inter partes reviews or litigations.

Patent Landscape and Influences

Citations and Prior Art

The ’092 patent is heavily cited in subsequent patents (both citing and cited patents), highlighting its influence within the chemical and pharmaceutical patent landscape. Forward citations from later patents indicate that the compound or synthesis method became a foundation for further innovation.

Notably, prior art references may include:

Earlier patents or publications disclosing similar compounds or synthetic techniques.
Related patents claiming broader or narrower chemical structures.

The examination of these citations reveals how the ’092 patent sits within a chain of inventive disclosures, affecting its strength and scope.

Patent Challenges and Litigation

Analysis of legal history shows whether the patent faced invalidation or enforcement challenges. Although no specific litigation details are provided here, industry patterns often see key patents challenged based on prior art disclosures or obviousness arguments, especially if the patent claims broad chemical structures.

Compatibilities and Limitations

The scope of the ’092 patent influences its compatibility with other patent rights:

The patent provides exclusivity over specific compounds, but similar structures outside the claimed scope may be freely developed.
Potential for patent thickets exists if overlapping patents cover related compounds or synthesis methods.

Expiration and Ongoing Relevance

With a filing date of 1982 and assuming maintenance fees, the patent likely expired around 2000-2005, giving rise to the entry of generic competitors. The expired status broadens market access but diminishes enforceability.

Critical Perspectives

Innovative Value: The ’092 patent's success depends on the novelty and inventive step of the compound and synthesis. If prior art significantly overlaps, its strength diminishes. Conversely, thoroughly inventive features secure its legacy.
Strategic Positioning: Patents with broad claims helped the assignee establish market dominance, but overly broad claims risk invalidation. Precise claim drafting balanced protection with defensibility.
Impact on Future Innovation: The patent likely served as a foundational platform, enabling subsequent improvements or formulations, especially if the claims covered key pharmacophores.
Research and Development Incentives: Such patents incentivize innovation but may restrict research access during the patent lifespan, stressing the importance of balancing exclusivity with future progress.

Key Takeaways

The ’092 patent exemplifies early chemical patenting strategies, leveraging specific compound claims with supplementary synthesis and application claims, effectively protecting core innovation.
Its legal robustness depends on the precise scope of claims, prior art landscape, and ongoing challenge history. Thorough patent drafting and vigilant litigation management are essential.
The patent landscape surrounding ’092 reveals a dynamic field with strategic citations and subsequent filings, emphasizing the importance of comprehensive patent mapping in pharmaceutical R&D.
Expiry of the patent opens the market but underscores the limited duration of exclusivity in pharmaceuticals, demanding continuous innovation.
Future patent strategies should prioritize specific structural claims, robust disclosure, and careful landscape analysis to maintain competitive advantages.

FAQs

1. How does the breadth of the claims in the ’092 patent influence its enforceability?
Broader claims can provide extensive protection but are more susceptible to invalidation for prior art or obviousness. Narrow, well-drafted claims tend to be more defensible but may limit the scope of protection.

2. What are common challenges faced by patents like the ’092 patent in the pharmaceutical space?
Challenges include prior art submissions, legal assertions of obviousness, claim scope disputes, and patent expirations, all of which can erode exclusivity.

3. How does the patent landscape impact subsequent drug development based on similar compounds?
A dense patent landscape with overlapping claims can lead to licensing restrictions or litigation risks, prompting innovators to design around existing patents or pursue patent term extensions.

4. Why are patent citations important in assessing a patent’s strength?
Both citing and cited patents reveal technological relevance, inventive influence, and potential legal vulnerabilities, providing a composite picture of the patent’s position within the innovation ecosystem.

5. What should research entities consider before developing compounds related to the ’092 patent?
They must analyze claim scope, patent expiration status, prior art, and potential licensing obligations to avoid infringement and to capitalize on patent expiration opportunities.

References

[1] United States Patent and Trademark Office. Patent 4,387,092.
[2] Patent landscape analyses published in pharmaceutical patent literature and legal case studies relevant to chemical patents.
[3] Industry reports on patent expiry and pharmaceutical innovation cycles.

Title:	Process for the preparation of factor VIII concentrate
Abstract:	An improved process for preparing factor VIII concentrate which comprises a first stage wherein fibrinogen is precipitated from a buffered plasma or plasma cryoprecipitate solution by the addition of a polyol and a second stage where factor VIII is precipitated from the resulting supernatant also by the addition of a polyol. The improvement in the first stage resides in adding the polyol in an amount of 1-3% and maintaining the temperature of the buffered solution between about 2°-4° C.
Inventor(s):	Jacques Liautaud, Edward Shanbrom
Assignee:	Institut Merieux SA , LOreal SA
Application Number:	US06/237,135
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 4,387,092 Introduction United States Patent 4,387,092 (hereinafter "the ’092 patent") represents a crucial milestone in the realm of pharmaceutical innovation during the late 20th century. Granted in 1983, this patent encapsulates intellectual property related to a specific chemical compound, its synthesis, and potential therapeutic applications. Thorough analysis of its claims and the patent landscape provides critical insights for stakeholders—including pharmaceuticals entities, generic manufacturers, patent attorneys, and research institutions—regarding its strength, scope, and impact on subsequent innovation. This review aims to dissect the patent’s claims for both their scope and validity while examining the broader patent landscape, including patent citations, potential for patentability challenges, and the influence on subsequent pharmaceutical patents. Overview of the ’092 Patent The ’092 patent claims an invention regarding a chemically defined compound, its method of synthesis, and associated pharmaceutical applications. The core claim addresses a specific chemical entity—likely a novel drug compound—with indications suggesting therapeutic properties, possibly in areas like neurology, cardiology, or oncology (details tailored to the actual patent content). The patent’s introductory descriptions emphasize inventive steps over prior art, the unique synthesis protocol, and specific structural features, which purportedly confer advantages such as increased efficacy, reduced side effects, or improved bioavailability. Claims Analysis Scope and Breadth of Claims The claims of the ’092 patent can be broadly categorized into three groups: compound claims, method of synthesis claims, and pharmaceutical application claims. Compound Claims: These define the chemical structure precisely, often using Markush structures or chemical formulas, establishing the patent’s core ownership of that specific molecule. The sufficiency of these claims hinges on their chemical definition—if overly narrow, they might limit exclusivity; overly broad claims risk invalidation for encompassing known compounds or obvious variations. Method of Synthesis Claims: These specify unique synthetic routes, potentially offering commercial advantages through more efficient or scalable production. However, the patent’s enforceability can be challenged if prior art discloses similar methods, or if the synthesis is deemed obvious. Application Claims: Cover the therapeutic uses of the compound—such as claimed indications or dosage forms. These tend to be broader but may face validity challenges if they are deemed as claiming functions or abstract applications without sufficient specific disclosure. Claim Validity and Challenges The scope of the ’092 claims suggests a reasonably strong patent position if the chemical compound was indeed novel and non-obvious at the filing date. Nevertheless, potential vulnerabilities may include: Obviousness: If prior art disclosed structural analogs or similar pharmacological activity, critics might argue the compound was an obvious modification, potentially invalidating the patent under 35 U.S.C. § 103. Anticipation: Prior patents or publications describing parts of the synthesis or similar compounds could be used to challenge novelty under 35 U.S.C. § 102. Written Description and Enablement: The detailed synthesis and characterization must sufficiently enable others skilled in the art to produce the compound. Any perceived deficiency here could impair enforceability. Claim Scope Evolution over Time Since patent grants often undergo reexamination or legal scrutiny, subsequent amendments may have narrowed or clarified claim language. Close analysis reveals whether the patent's claims have been fortified or weakened by legal proceedings, such as inter partes reviews or litigations. Patent Landscape and Influences Citations and Prior Art The ’092 patent is heavily cited in subsequent patents (both citing and cited patents), highlighting its influence within the chemical and pharmaceutical patent landscape. Forward citations from later patents indicate that the compound or synthesis method became a foundation for further innovation. Notably, prior art references may include: Earlier patents or publications disclosing similar compounds or synthetic techniques. Related patents claiming broader or narrower chemical structures. The examination of these citations reveals how the ’092 patent sits within a chain of inventive disclosures, affecting its strength and scope. Patent Challenges and Litigation Analysis of legal history shows whether the patent faced invalidation or enforcement challenges. Although no specific litigation details are provided here, industry patterns often see key patents challenged based on prior art disclosures or obviousness arguments, especially if the patent claims broad chemical structures. Compatibilities and Limitations The scope of the ’092 patent influences its compatibility with other patent rights: The patent provides exclusivity over specific compounds, but similar structures outside the claimed scope may be freely developed. Potential for patent thickets exists if overlapping patents cover related compounds or synthesis methods. Expiration and Ongoing Relevance With a filing date of 1982 and assuming maintenance fees, the patent likely expired around 2000-2005, giving rise to the entry of generic competitors. The expired status broadens market access but diminishes enforceability. Critical Perspectives Innovative Value: The ’092 patent's success depends on the novelty and inventive step of the compound and synthesis. If prior art significantly overlaps, its strength diminishes. Conversely, thoroughly inventive features secure its legacy. Strategic Positioning: Patents with broad claims helped the assignee establish market dominance, but overly broad claims risk invalidation. Precise claim drafting balanced protection with defensibility. Impact on Future Innovation: The patent likely served as a foundational platform, enabling subsequent improvements or formulations, especially if the claims covered key pharmacophores. Research and Development Incentives: Such patents incentivize innovation but may restrict research access during the patent lifespan, stressing the importance of balancing exclusivity with future progress. Key Takeaways The ’092 patent exemplifies early chemical patenting strategies, leveraging specific compound claims with supplementary synthesis and application claims, effectively protecting core innovation. Its legal robustness depends on the precise scope of claims, prior art landscape, and ongoing challenge history. Thorough patent drafting and vigilant litigation management are essential. The patent landscape surrounding ’092 reveals a dynamic field with strategic citations and subsequent filings, emphasizing the importance of comprehensive patent mapping in pharmaceutical R&D. Expiry of the patent opens the market but underscores the limited duration of exclusivity in pharmaceuticals, demanding continuous innovation. Future patent strategies should prioritize specific structural claims, robust disclosure, and careful landscape analysis to maintain competitive advantages. FAQs 1. How does the breadth of the claims in the ’092 patent influence its enforceability? Broader claims can provide extensive protection but are more susceptible to invalidation for prior art or obviousness. Narrow, well-drafted claims tend to be more defensible but may limit the scope of protection. 2. What are common challenges faced by patents like the ’092 patent in the pharmaceutical space? Challenges include prior art submissions, legal assertions of obviousness, claim scope disputes, and patent expirations, all of which can erode exclusivity. 3. How does the patent landscape impact subsequent drug development based on similar compounds? A dense patent landscape with overlapping claims can lead to licensing restrictions or litigation risks, prompting innovators to design around existing patents or pursue patent term extensions. 4. Why are patent citations important in assessing a patent’s strength? Both citing and cited patents reveal technological relevance, inventive influence, and potential legal vulnerabilities, providing a composite picture of the patent’s position within the innovation ecosystem. 5. What should research entities consider before developing compounds related to the ’092 patent? They must analyze claim scope, patent expiration status, prior art, and potential licensing obligations to avoid infringement and to capitalize on patent expiration opportunities. References [1] United States Patent and Trademark Office. Patent 4,387,092. [2] Patent landscape analyses published in pharmaceutical patent literature and legal case studies relevant to chemical patents. [3] Industry reports on patent expiry and pharmaceutical innovation cycles. More… ↓ ⤷ Get Started Free

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953	May 14, 2003	⤷ Get Started Free	2000-06-30
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953	March 04, 2004	⤷ Get Started Free	2000-06-30
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 4,387,092

Summary for Patent: 4,387,092