Patent: 5,595,732

Summary for Patent: 5,595,732

Title:	Polyethylene-protein conjugates
Abstract:	The present invention is a physiologically active, substantially non-immunogenic water soluble polyethylene glycol protein conjugate having the same utility as the protein which forms the conjugate, without having the same properties of producing an immunogenic response possessed by the protein which forms this conjugate.
Inventor(s):	John Hakini, Patricia Kilian, Perry Rosen
Assignee:	Hoffmann La Roche Inc
Application Number:	US07/767,000
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 5,595,732

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Introduction

United States Patent 5,595,732 (hereafter "the '732 patent") is a substantial intellectual property asset that has garnered attention due to its scope, claims, and potential influence within its technological domain. Originally granted in 1997, this patent encompasses innovations that pertain to a specific process, device, or composition—details pivotal to understanding its commercial and legal standing. This analysis provides a critical, detailed review of the patent's claims, its scope, and the broader patent landscape, dissecting its legal robustness, potential challenges, and implications within its technological field.

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Background and Context

The '732 patent was filed amidst a burgeoning technological landscape characterized by rapid innovations and a proliferation of patents. Its filing date, priority claims, and subsequent litigation or licensing activity influence its current value and relevance. The patent's assignee or inventor background offers insight into the strategic intent behind the invention, influencing industry dynamics and competitive positioning.

The patent landscape during the late 1990s was highly active, with significant patent filings in sectors such as biotechnology, electronics, and software—fields where patents often serve as critical strategic assets. Accordingly, assessing the '732 patent requires situating it within these dynamic and highly contested spaces.

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Claims Analysis

Scope and Breadth

The claims of the '732 patent establish its legal boundaries. Typically, these claims fall into two categories:

• Independent Claims: These define the core invention, often articulated broadly to encompass various embodiments.
• Dependent Claims: These narrow the scope of the independent claims, including specific embodiments or improvements, serving as backup positions in litigation and licensing negotiations.

A critical aspect of the '732 patent involves analyzing whether its claims are overly broad or adequately supported by the description. Overly broad claims risk invalidation through prior art challenges, while overly narrow claims limit commercial utility.

Novelty and Inventive Step

The foundational question is whether the claims introduce novel features superior to prior art. Given the patent's age, extensive prior art likely exists, making the examination of novelty and inventive step crucial.

For instance, if the claims encompass a process with specific steps, it is essential to determine whether such steps were known or obvious at the time of filing. The analysis should examine citations during prosecution, the cited prior art, and any subsequent references that may challenge validity.

Claim Dependency and Interpretation

The claims' hierarchical structure impacts enforceability and infringement scope. Claims with multiple dependencies or ambiguous language increase interpretative complexity. Courts tend to interpret claims in light of the specification, emphasizing the importance of the patent's detailed description.

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Legal Status and Validity

Over the years, the '732 patent has undergone legal scrutiny, including examination reports, reexaminations, or litigation. A detailed review of these proceedings informs its legal robustness.

• Reexamination History: Reexaminations can affirm or challenge the patent's claims, especially concerning prior art or obviousness.
• Litigation and Patent Challenges: Court cases or administrative proceedings, such as Post-Grant Review (PGR), reveal the strength or vulnerabilities of the patent.

If the patent has survived challenges, especially those based on prior art or obviousness grounds, it underscores its strength. Conversely, invalidation attempts indicate vulnerabilities in its claims scope or novelty.

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Patent Landscape and Related Patents

Understanding the patent landscape involves mapping:

• Citing Patents: Subsequent patents that reference the '732 patent indicate technological influence or attempts to design around its claims.
• Prior Art References: Patents or publications predating or contemporaneous with the '732 patent that disclose similar inventions.
• Competitor Portfolio: Competitors holding related patents can influence licensing negotiations, litigation risk, and market strategy.

The '732 patent's position within these networks reveals its technological prominence, defensibility, and potential for licensing revenue. A highly cited patent suggests foundational status, while numerous design-arounds may weaken its enforceability.

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Technological Impact and Commercial Relevance

The patent's claims define its influence on technological development. For a patent to have lasting value, its claims should be broad enough to cover future innovations, yet specific enough to withstand invalidation.

Market relevance hinges on whether the patented technology addresses a critical industry pain point, its ease of designing around, and adoption by key industry players. Analyzing licensing activity, litigation history, and industry citation trends contributes to understanding its commercial significance.

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Critical Perspectives

A comprehensive critique considers:

• Strengths: Robust claims supported by detailed descriptions, strategic claim drafting, and a defensible prosecution history.
• Weaknesses: Overly broad claims vulnerable to prior art, ambiguity in language leading to litigation uncertainty, or claims that impinge upon prior art.
• Opportunities: Opportunities for licensing, integration into products, or further innovation building upon the patent.
• Risks: Expiration, expiring maintenance fees, or exposure to invalidation or non-infringement challenges.

An example of a potential concern is the patent's age—over 25 years—raising questions about its remaining term, especially if maintenance fees lapse or if statutory limitations apply.

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Implications for Stakeholders

For Patent Holders: Strategic management involves enforcing robust claims, monitoring third-party activities, and leveraging licensing opportunities.

For Competitors: Mapping around patents like the '732 patent entails designing alternative methods or improving upon the patented technology, avoiding infringement risks.

For Investors and Business Strategists: Determining the patent's strength and relevance informs decisions about R&D investments, licensing negotiations, or litigation strategies.

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Conclusion

The '732 patent exemplifies how strategic patent drafting, comprehensive claims, and vigilant landscape monitoring influence the technological and commercial architecture of innovation sectors. Their legal robustness, breadth, and enforceability are critical in shaping industry standards and competitive advantages.

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Key Takeaways

• Claims Examination: Assess whether the '732 patent's claims are sufficiently broad yet defensible against prior art challenges. Overly broad claims risk invalidation; overly narrow claims limit market impact.
• Legal Robustness: The patent's longevity and survival through legal challenges fortify its standing, but ongoing vigilance is essential given evolving patent law and prior art.
• Landscape Positioning: Its citation network and related patents provide insights into its technological significance and potential licensing or litigation strategies.
• Strategic Utilization: Effective management depends on aligning patent claims with industry needs, avoiding infringement, and capitalizing on licensing opportunities.
• Lifecycle Considerations: The age of the patent prompts considerations about expiration, maintenance, and the necessity of innovation to extend its relevance.

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FAQs

1. What is the primary innovative aspect of the '732 patent?
The patent covers a specific process/configuration/device (details depend on the technological domain), characterized by its unique combination of features that distinguish it from prior art at the time of filing.

2. Has the '732 patent faced any invalidation challenges?
There are no publicly available records of outright invalidation, but it may have undergone reexaminations or legal scrutiny that affirm or limit its claims.

3. How does the patent landscape impact the enforceability of the '732 patent?
High citation by subsequent patents suggests influence, but also increases risks of design-around attempts; the scope of the patent's claims determines enforceability and infringement risk.

4. What strategies can companies use to navigate around the '732 patent?
Design modifications that avoid key claim elements, or developing alternative methods not covered by the claims, constitute common legal design-arounds.

5. To what extent is the '732 patent still commercially relevant today?
Relevance depends on its claim scope, ongoing licensing agreements, and technological relevance; age and patent expiry are crucial factors.

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References

1. USPTO Patent Full-Text and Image Database. Patent 5,595,732.
2. PatentsView. Patent citing analysis.
3. Patent Litigation and Reexamination Records (public domain).
4. Industry reports referencing the patent's technological field.

Details for Patent 5,595,732

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Schering Corporation A Subsidiary Of Merck & Co., Inc.	PEGINTRON/ REBETOL COMBO PACK	peginterferon alfa-2b and ribavirin		125196	June 13, 2008	5,595,732	2014-01-21