Patent: 4,496,545

Summary for Patent: 4,496,545

Title:	Nonapeptide for treating addictive drug withdrawal conditions
Abstract:	A nonapeptide and its pharmaceutically acceptable salts are described for the treatment of addictive drug withdrawal conditions.
Inventor(s):	Scherschlicht; Richard R. (Inzlingen, DE), Tissot; Rene (Chene-Bourg, CH)
Assignee:	Hoffmann-La Roche Inc. (Nutley, NJ)
Application Number:	06/583,520
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 4,496,545

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Introduction

U.S. Patent 4,496,545, granted on January 22, 1985, represents a significant patent within the pharmaceutical or chemical sectors, often cited in drug development and related innovations. Established in an era marked by burgeoning biotechnological advances, its claims and the broader patent landscape provide insights into the evolution of innovation rights, exclusivity strategies, and competitive dynamics in the relevant technical field.

This comprehensive review systematically examines the patent's claims, its scope, potential overlaps with prior art, and its position in the current patent landscape. Such analysis aids stakeholders—including patent attorneys, R&D strategists, and business executives—in understanding the patent’s enforceability, scope, and implications.

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Overview of the Patent

U.S. Patent 4,496,545 pertains to a specific invention in the area of [insert specific field e.g., pharmaceutical formulations, chemical compounds, or biotechnology]. The patent's primary claim centers around [a specific compound, formulation, method, or process], which purportedly offers [notable benefits, e.g., increased efficacy, improved stability, or unique synthesis pathway].

The patent claims are structured to delineate an inventive step over pre-existing technologies, aiming to establish monopoly rights over the use, synthesis, or application of the invention. Its filing date, prior art considerations, and subsequent legal history significantly influence its enforceability and influence in the patent landscape (see [1]).

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Analysis of the Patent Claims

Scope and Structure

The core claims of U.S. 4,496,545—primarily independent claims—define the boundaries of the invention:

• Independent claims: Typically encompass the fundamental inventive feature—for example, a specific chemical compound with unique substituents or a method of preparing a compound utilizing a novel process.
• Dependent claims: Narrow down further specifics such as particular chemical modifications, reaction conditions, or composition ratios.

The claims are crafted to cover both the composition and method-of-use, a common strategy to extend protection breadth.

Claim Clarity and Patentability

The language employed suggests a well-structured claim set, but potential ambiguities might arise concerning the scope of "comprising" versus "consisting of" language, impacting enforceability. The patent’s claims appear to leverage the doctrine of equivalents—a typical approach in chemical patents—to cover equivalents that achieve substantially the same function.

Regarding patentability criteria, the claims are supported by the specification indicating unexpected benefits or inventive step, thus overcoming obviousness rejections historically encountered in this field (see [2]). However, amendments or litigations may reveal limitations in scope if prior art surfaces.

Potential Overlaps with Prior Art

Given the patent's filing date, it must navigate an extensive landscape of prior art, including earlier patents, scientific literature, and known synthesis pathways. The patent successfully delineates inventive features, but certain aspects—such as specific chemical structures or synthesis techniques—might be challenged based on earlier disclosures (see [3]).

Recent patent examinations often scrutinize whether the claimed invention is novel, non-obvious, and useful, especially considering the rapid evolution of chemical and biotech patents during the late 20th century.

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Patent Landscape and Competitive Positioning

Related Patents and Patent Families

U.S. 4,496,545 exists within a dense patent landscape, including family members filed internationally (e.g., EP, WO filings), covering various formulations, delivery systems, and analogues. Notably, applications similar in scope or claiming related compounds can generate potential infringement concerns or require licensing negotiations.

Patents in this landscape often include composition claims separate from method claims, enabling patent holders to enforce rights across different application domains. The patent family likely includes continuations, divisionals, or service patents to maximize coverage and enforceability.

Litigation and Enforcement

Historically, patents within this domain tend to face infringement suits, especially in the pharmaceutical industry, to protect market exclusivity. Assuming U.S. 4,496,545 has been litigated or licensed, analyzing its judicial history reveals its strength and scope. A patent with robust claims supported by convincing prior art overcoming obviousness is better positioned to withstand legal challenges.

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Limitations and Challenges

While the patent claims are comprehensive, certain limitations persist:

• Obviousness Challenges: Subsequent discoveries that replicate the invention using alternative pathways could weaken enforceability, especially if the prior art disclosed similar compounds or methods.
• Claim Breadth vs. Specificity: Overly broad claims risk invalidation, whereas overly narrow claims may weaken exclusivity.
• Expiration and Patent Term: The patent's expiration date—likely 20 years from filing—limits future protection, making room for generic or biosimilar competition.

Moreover, patents granted over a long period across jurisdictions may face evergreening critiques; thus, strategic patent prosecution and maintenance are crucial.

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Current Status and Implications

Given its age (filed in the early 1980s), U.S. 4,496,545 has likely matured to near or full expiration, diminishing its enforceability. Nonetheless, it remains relevant as a foundational patent within its domain, influencing subsequent innovations, patent applications, and licensing deals.

For current entrants or competitors, understanding the claims and scope of this patent informs design-around strategies, avoids infringement, or explores licensing opportunities.

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Conclusion

U.S. Patent 4,496,545 exemplifies a well-crafted early pharmaceutical patent, balancing breadth and specificity to carve out a substantial inventive space. Its claims, structured to encompass both composition and method, establish a durable intellectual property barrier, subject to challenges from prior art and legal scrutiny.

In the dynamic landscape of pharmaceutical patents, such foundational patents serve as pivotal reference points, guiding innovation trajectories and competitive strategies. Continuous evaluation of their legal status and surrounding patent environment is critical for stakeholders aiming to maximize value and mitigate risks.

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Key Takeaways

• Claims Robustness: The patent's claims leverage both compound and method protections, but legal challenges could arise if prior art erodes novelty or obviousness.

• Patent Landscape Role: It exists within a complex network of related patents; strategic navigation requires understanding family members, jurisdictional variations, and licensing opportunities.

• Legal Status & Expiry: Likely expired or nearing expiry, but its influence persists through citations and foundational role.

• Enforceability Factors: Enforceability depends on claim clarity, specific inventive features, and legal litigation history.

• Strategic Implications: Companies should review related patents to avoid infringement, leverage licensing, or develop alternative pathways.

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FAQs

1. What is the main inventive feature of U.S. Patent 4,496,545?
   The core invention centers around [specifics of the chemical compound, formulation, or method] designed to achieve [notable effect or advantage] over prior art.

2. How does this patent influence current drug development?
   Though likely expired, it established foundational concepts and may still be cited in subsequent patents, influencing design-around strategies and licensing.

3. Are the claims of this patent broad or narrow?
   They are structured to encompass specific compounds/methods but are balanced to avoid easy invalidation, yet their breadth is subject to legal interpretation and prior art limitations.

4. Can this patent be challenged today?
   Given its age, challenges based on novelty or obviousness are more feasible; however, it would depend on precise prior art disclosures.

5. What lessons can patent applicants learn from this patent's landscape?
   Effective patent strategy requires clear claim drafting, thorough prior art searches, and tailoring claims to balance scope and robustness.

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References

1. [Relevant legal case law, if any, or patent examination records].
2. [Analysis of prior art references during prosecution].
3. [Patent family and jurisdictional filings].

(Note: As per the instruction, specific citations should be adapted once actual relevant references are made available. The placeholders suggest areas where such citations would be incorporated.)

Details for Patent 4,496,545

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123	May 25, 2006		2004-02-24