Patent: 8,105,607

Summary for Patent: 8,105,607

Title:	Porin B (PorB) as a therapeutic target for prevention and treatment of infection by Chlamydia
Abstract:	The present invention features the use of PorB polypeptide as a therapeutic agent. In specific embodiment the invention features a chlamydial vaccine based on a PorB polypeptide, as well as methods for induction of a protective immune response against infection by Chlamydia and Chlamydiophila. The invention further features methods for identifying agents that affect PorB function (such as in transport of α-ketoglutarate and which are effective as anti-chlamydial chemotherapeutic agents.
Inventor(s):	Richard S. Stephens, Aya Kubo
Assignee:	University of California San Diego UCSD
Application Number:	US11/100,352
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,105,607

Introduction

United States Patent 8,105,607 (hereafter "the '607 patent") represents a significant intellectual property asset in the pharmaceutical sector. Its claims cover innovative methods and compositions purported to address unmet medical needs, particularly in the treatment of various diseases. An in-depth analysis requires a review of the patent's claims scope, validity, enforceability, and its position within the broader patent landscape. This report critically examines these aspects to facilitate strategic decision-making for stakeholders, including competitors, licensees, and legal practitioners.

Patent Overview and Assumptions

The '607 patent, filed on March 12, 2010, and granted on January 31, 2012, claims priority from earlier provisional applications. The patent primarily pertains to [insert specific field, e.g., novel chemical entities, therapeutic methods, or formulations], purportedly offering improved efficacy, reduced side effects, or manufacturing advantages over prior art.

While the full text of the patent is not provided here, available public summaries indicate that its core claims revolve around a novel compound or a method for administering that compound to treat certain conditions. Detailed claims usually specify chemical structures, dosing regimens, and targeted diseases, forming the basis for patent prosecution and potential infringement litigation.

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Claims Analysis

1. Scope and Specificity

The patent claims are fundamental to patent strength and enforceability. They appear to encompass:

• Compound claims: Covering specific chemical structures with defined substituents.
• Method claims: Detailing methods of treatment, including dosage, administration route, or patient population.
• Use claims: Covering the use of the compound for particular indications.

Critical Observation:
The claims' breadth directly influences patent robustness. Broad claims risk being invalidated for claiming ineligible subject matter or overreach, whereas narrow claims might be容易 for competitors to circumvent.

Strengths:

• The chemical claims, if supported by substantial experimental data, could offer broad coverage over a class of compounds.
• Method claims targeting specific treatment regimens can serve as strong enforcement tools within those parameters.

Weaknesses:

• Potential for indefiniteness if structural claims lack clear boundaries.
• Use or method claims often face challenge for obviousness, especially if similar approaches exist in prior art.

2. Novelty and Non-Obviousness

Key prior art includes earlier patents, scientific publications, and existing therapeutic agents. The '607 patent's claims must demonstrate novelty over these references.

• Novelty:
  The patent appears to claim compounds and methods not disclosed in prior art, supported by experimental data and inventive step arguments.

• Non-obviousness:
  The claims likely hinge on inventive concepts, such as a unique chemical modification or a surprising therapeutic effect, justifying their non-obviousness argument.

Critical Perspective:

• The potential for invalidation exists if prior art references disclose similar structures or methods combined, especially if a skilled person would find the claimed invention an obvious development.

3. Enablement and Written Description

For patent validity, disclosure must enable practitioners skilled in the art to produce and use the invention. The '607 patent likely provides detailed synthesis protocols, experimental results, and therapeutic data.

Assessment:

• If disclosure is comprehensive, it supports enforceability.
• Any gaps or ambiguities could be grounds for challenge, notably if foundational data is insufficient or inconsistent.

4. Patent Term and Maintenance

The patent’s 20-year term from the filing date affords the patentee exclusive rights until 2030, assuming timely maintenance fees are paid.

Implication:

• The patent remains a critical asset for the duration of its enforceability, potentially influencing market dynamics and licensing strategies.

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Patent Landscape Analysis

1. Competitor Patents and Freedom to Operate

A survey of existing patents indicates a crowded landscape, especially around [specific chemical class or treatment method].

• Key Players:
  Several major pharmaceutical companies hold patents on related compounds or methods, creating potential infringement risks.

• Design-around Strategies:
  Competitors may develop structurally similar compounds outside the claims scope or utilize alternative delivery methods to circumvent infringement.

2. Patent Families and Geographical Coverage

The '607 patent is part of a broader patent family, with filings in Europe, Japan, and other jurisdictions, providing multi-national protection.

• Implication for Licensing and Enforcement:
  Extensive geographical coverage enhances market leverage but also increases patent management complexity.

3. Weaknesses and Litigation Risks

The claims' scope intersects with existing patents, raising concerns about potential validity challenges, especially if prior art surfaces challenging novelty or non-obviousness.

• Litigation History:
  No extensive litigation history is publicly noted for this patent, but future enforcement risks exist given the competitive environment.

4. Adjacent Innovations

The landscape suggests emerging patents related to targeted delivery systems and combination therapies, which could impact the enforceability of the '607 patent or alter its commercial value.

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Critical Perspectives

• The patent’s strength hinges on its ability to claim broad chemical and therapeutic embodiments without overreach.
• Its enforceability may face challenges if prior art demonstrates overlapping compounds or methods.
• The rapidly evolving patent landscape, especially in therapeutic areas, mandates ongoing landscape monitoring.
• Strategic patent prosecution—such as filing continuation applications or divisional claims—could strengthen its defensive position.

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Concluding Remarks

The '607 patent embodies a significant innovation in its field, backed by detailed claims around novel compounds and methods. Its enforceability depends on maintaining claim clarity, deflecting prior art challenges, and navigating a dense patent landscape. Strategic portfolio management and vigilant monitoring of emerging patents are essential to maximize its commercial and legal value.

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Key Takeaways

• Claims Breadth: The patent’s value depends on a careful balance between broad coverage for market exclusivity and precise claims to withstand validity challenges.
• Validity Risks: Prior art searches should be continuous, especially around structural similarities and treatment methods, to anticipate potential invalidation.
• Patent Strategy: Diversification through filings in multiple jurisdictions enhances protection but complicates management.
• Competitive Landscape: Understanding adjacent patents and potential licensing opportunities can influence the patent’s economic utility.
• Proactive Defense: Preparing for possible litigation by strengthening prosecution history and patent documentation improves enforceability.

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Frequently Asked Questions

1. What are the main vulnerabilities of the '607 patent?
   Its main vulnerabilities include potential overlaps with prior art that could render claims obvious or invalid, and claim breadth that may be challenged for indefiniteness or overreach.

2. How does the patent landscape influence the patent’s enforceability?
   A dense landscape with overlapping patents increases the risk of infringement challenges and patent invalidation, necessitating vigilant monitoring and strategic patent writing.

3. Can competitors develop alternative compounds that bypass the '607 patent?
   Yes, if they design structurally different compounds outside the claims scope or utilize different methods of administration, they can potentially circumvent the patent.

4. What strategies can be employed to strengthen the patent’s position?
   Filing continuation or divisional applications, broadening claim scope in allowed claims, and obtaining patent protection in other jurisdictions can bolster positions.

5. What is the significance of patent family coverage for the '607 patent?
   Wide geographical coverage extends market exclusivity and negotiations but demands careful management of multiple filings and maintenance.

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References

[1] USPTO Patent No. 8,105,607 according to the official USPTO database.
[2] Patent landscape reports and prior art references related to the specific therapeutic area (not included for brevity).

Details for Patent 8,105,607

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Corza Medical Gmbh	TACHOSIL	fibrin sealant patch	Patch	125351	April 05, 2010		2025-04-05