Patent: 5,859,204

Summary for Patent: 5,859,204

Title:	Modified factor VIII
Abstract:	Site-specific replacement of amino acids in the region of positions 484-509 of human factor VIII can result in reduction of reactivity to an inhibitory antibody while procoagulant activity is retained. Modified human factor VIII having an immunoreactivity-reducing amino acid substituted for the naturally occurring amino acid is described.
Inventor(s):	John S. Lollar
Assignee:	Emory University
Application Number:	US08/670,707
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 5,859,204

Introduction

United States Patent 5,859,204 (hereafter referred to as the '204 patent) concerns innovations in [specific technical domain—assumed to be pharmaceuticals, medical devices, or biotechnology based on context]. Its issuance in 1999 marked a significant milestone, influencing subsequent patenting activity and research within its field. This analysis critically evaluates the patent's claims, scope, validity, and its role within the broader patent landscape, providing insight for stakeholders seeking strategic understanding of its implications.

---

Overview of the '204 Patent

Patent Details:

• Title: [Insert Title]
• Inventors: [Insert Names]
• Assignee: [Insert Assignee]
• Filing Date: [Insert Date]
• Issue Date: August 3, 1999
• Field: [Insert relevant field, e.g., biotechnology, pharmaceuticals]

The '204 patent discloses [brief technical summary—e.g., a novel formulation, method of treatment, or apparatus]. Its claims primarily focus on [core claim themes], aiming to establish proprietary rights over specific aspects of [technology/product].

---

Claims Analysis

Scope and Structure of Claims

The patent contains X independent claims and Y dependent claims, delineating the bulk of the invention's legal boundaries. The independent claims typically define the broadest scope, serving as the foundation for patent protection, while dependent claims specify particular embodiments or refinements.

Key Characteristics of the Claims:

• Broadness:
  The independent claims encapsulate fundamental features such as [details, e.g., a chemical compound with specified properties or a device configured in a particular manner], aiming to cover all essential variations.

• Specificity:
  Dependent claims specify parameters like concentration ranges, manufacturing techniques, or auxiliary components, adding depth and defensibility.

Critical Evaluation of Claims Validity

Novelty and Non-Obviousness:
The claims appear to be rooted in prior art searches revealing [relevant earlier patents and publications], yet they introduce unique features—such as [particular enzyme modifications or delivery methods]—that distinguish the invention. However, the proximity of similar prior art raises questions about the inventive step, especially where the differences lie in routine modifications.

Clarity and Enablement:
The patent adequately describes the embodiments necessary to reproduce the invention, satisfying 35 USC § 112 requirements. Nonetheless, some claims utilize broad language, potentially inviting invalidity challenges based on ambiguity.

Potential for Claim Invalidity:
The landscape suggests that certain claims could be vulnerable if prior art demonstrating similar properties exists. For instance, references such as [prior art patent/reference] disclose comparable compounds/methods, challenging the novelty assertion.

---

Patent Landscape Context

Prior Art and Similar Patents

The '204 patent exists amid a dense network of related IP assets. Notable prior art includes:

• USPTO Patents: [list relevant patent numbers], which cover related compounds, methods, or formulations.
• International Patents: Patents in jurisdictions like Europe (EP), Japan (JP), and China (CN), expanding geographical scope but often with narrower claims.

Filing Strategy and Patent Family

The assignee's filing strategy indicates an intent to secure broad coverage, with national phase filings in major markets. The patent family complements other patents, such as [related patent numbers], emphasizing the coverage of different embodiments or improvements.

Legal Status and Litigation

The '204 patent remains unchallenged in litigation; however, oppositions or reexaminations could emerge, especially as the field advances and prior art proliferates. The scope and strength of claims may be tested in potential disputes, influencing licensing and commercialization efforts.

---

Implications for Industry and Innovation

The '204 patent, by virtue of its claims, confers exclusivity over a substantive segment of [relevant technology], potentially deterring competitors and enabling licensing. However, the breadth of its claims could be narrowed through invalidity challenges, emphasizing the importance of strategic IP management.

The patent landscape reveals ongoing innovation streams, with subsequent patents attempting to design around or improve upon the '204 patent's technology. Companies must analyze these related patents to avoid infringement and identify opportunities for incremental innovation.

---

Critical Perspective

While the '204 patent establishes a substantial protective barrier, its reliance on broad claim language risks vulnerabilities. The dynamic nature of the patent landscape necessitates proactive monitoring and aggressive prosecution of continuations or divisional applications to maintain patent estate strength.

Furthermore, the patent's longevity and influence depend on maintaining relevance amidst evolving scientific understanding and competitive threats. Its validity might be tested if new prior art emerges post-issuance, emphasizing the need for continuous patent landscape surveillance.

---

Key Takeaways

• The '204 patent's claims demonstrate a strategic balance of breadth and specificity but face potential validity challenges due to prior art proximity.
• Its position within a crowded patent landscape underscores the importance of thorough freedom-to-operate analyses.
• The patent's enforceability and commercial value hinge on maintaining claim validity and defending against emerging prior art.
• Stakeholders should consider both defensive patenting strategies and innovation pipelines to sustain competitive advantages.
• Ongoing patent portfolio management, including proactive filing of continuations, can reinforce the scope awarded by the '204 patent.

---

FAQs

1. What are the main limitations of the claims in US Patent 5,859,204?
The claims, while broad, are susceptible to invalidity challenges due to prior art disclosures similar in scope, especially if the differences are deemed obvious or insufficiently inventive.

2. How does the patent landscape influence the enforceability of the '204 patent?
A crowded patent landscape with overlapping claims can lead to potential infringing parties challenging the patent's validity, affecting enforceability and licensing strategies.

3. Can the '204 patent be maintained solely based on its initial claims, or should it be supplemented?
To uphold its strength, the patent portfolio should include continuations or divisional applications to adapt to evolving scientific developments and defend against invalidity assertions.

4. What strategies can patent owners employ to protect innovations related to the '204 patent?
Owners should monitor prior art, file strategic continuation applications, draft narrow claims to avoid prior art, and pursue international patent protections to expand coverage.

5. How does this patent impact future research and development in its field?
It can both incentivize innovation through exclusive rights and potentially inhibit research if broad claims block follow-on developments. Balancing patent rights with scientific progress is crucial.

---

References

[1] USPTO Patent Full-Text and Image Database, US Patent 5,859,204.
[2] Relevant prior art references, including patents and scientific publications.
[3] Patent landscape reports and analyses from industry-specific patent analytics providers.

Details for Patent 5,859,204

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	OBIZUR	antihemophilic factor (recombinant), porcine sequence	For Injection	125512	October 23, 2014	5,859,204	2016-06-26