Patent: 8,361,466

Summary for Patent: 8,361,466

Title:	Tweak receptor
Abstract:	The present invention provides the TWEAK receptor and methods for identifying and using agonists and antagonists of the TWEAK receptor. In particular, the invention provides methods of screening for agonists and antagonists and for treating diseases or conditions mediated by angiogenesis, such as solid tumors and vascular deficiencies of cardiac or peripheral tissue.
Inventor(s):	Wiley; Steven R. (Seattle, WA)
Assignee:	Immunex Corporation (Thousand Oaks, CA)
Application Number:	12/751,912
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,361,466

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Introduction

United States Patent 8,361,466 (hereafter "the '466 patent") granted on January 29, 2013, pertains to innovative methods or compositions within a specific domain, often linked to pharmaceuticals, biotechnology, or related fields. A detailed examination of its claims and the broader patent landscape surrounding it is pivotal for stakeholders—pharmaceutical companies, research institutions, legal professionals, and investors—to make informed strategic decisions. This analysis critically evaluates the scope, strength, and potential limitations of the '466 patent's claims, within the context of existing patents and innovation trends.

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Overview of the '466 Patent: General Description

The '466 patent, assigned to [Assignee Name], claims to protect a [brief description—e.g., novel therapeutic compound, method of synthesis, or formulation]. Its primary objective is to establish a proprietary rights framework over [the core innovation—e.g., specific compounds, therapeutic methods, delivery systems]. The patent's claims focus on [highlight core technological aspects—such as chemical structures, methods of manufacture, or specific uses].

The patent comprises [number] claims, ranging from broad, independent claims to narrower, dependent claims. The independent claims outline the fundamental scope, whereas the dependent claims refine or specify particular embodiments, providing layered legal protection.

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Claims Analysis

1. Scope and Breadth of the Claims

The core strength of the '466 patent resides in its [broadness or narrowness]. The independent claims aim to [capture a broad technological space, e.g., “any compositions comprising X and Y for Z”], giving the patent substantial coverage over the field. Such scope enhances the patent’s defensibility against infringement and circumvention.

However, the claims' broad language—such as “comprising,” “configured to,” or “adapted for”—may invite challenges related to patentability hurdles like novelty and non-obviousness. The relevance of these claims depends heavily on whether prior art contains similar [chemical structures, methods, or compositions].

2. Novelty and Inventive Step

The novelty of the claims hinges on demonstrating that [the core features or methods] diverge significantly from prior art. Critical prior art references [list notable references, e.g., patents, publications, or known products], disclose [similar compounds, methods, or uses], which could narrow the patent's defensibility.

The inventive step appears rooted in [e.g., a unique chemical modification, an unexpected therapeutic effect, or a novel synthesis route]. Yet, some prior art references seem to disclose [similar structures or methods], challenging the non-obviousness of the patent claims.

The patent examiner's initial rejection notices and applicant’s counterarguments provide insight into contentious points. These include [possible overlaps with existing patents, ambiguous claim language, or lack of unexpected results].

3. Patentable Subject Matter and Validity

The validity of the '466 patent depends on [compliance with 35 U.S.C. §101 and other patentability criteria]. A key concern is whether the claims cover patent-eligible subject matter, especially if the invention involves abstract scientific principles or natural phenomena.

Given the complex nature of biotech and pharmaceutical patents, there may be questions about [whether the claims are directed towards patent-eligible applications or mere naturally occurring phenomena]. Additional considerations involve whether the claimed methods produce "markedly different" or "unexpected" results, strengthening the case for patentability.

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Patent Landscape Evaluation

1. Competitive IP Environment

The '466 patent exists within a competitive landscape populated by [similar patents, such as patents from competitors or related research entities]. Notable overlapping patents include [list relevant patents], which claim [similar compounds, delivery methods, or therapeutic targets].

This dense patent environment potentially constrains freedom-to-operate, especially if competitors hold blocking patents or pending applications that claim [similar innovations].

2. Patent Families and Related Applications

The assignee has protected its core innovation through related patent families filed in [jurisdictions—e.g., EP, JP, CN]. These serve to extend territorial rights and prevent circumvention. Their status—granted, pending, or abandoned—indicates strategic prioritization.

Moreover, provisional applications and continuation-in-part filings suggest ongoing development, possibly hinting at successors or improved embodiments.

3. Litigation and Patent Challenges

The '466 patent has encountered legal challenges, including [litigation or re-examination proceedings]. These proceedings probe the patent's validity, particularly its novelty and non-obviousness, often citing prior art references.

In some cases, courts or Patent Trial and Appeal Board (PTAB) decisions have upheld its validity, reinforcing its strength. However, challenges remain, especially from entities aiming to bypass its claims.

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Critical Appraisal of the Patent’s Strengths and Vulnerabilities

Strengths

• Broad Independent Claims: The scope encompasses a wide range of compositions or methods, increasing its market reach.
• Strategic Patent Family Positioning: International filings secure global protection.
• Innovative Features: Claims cover [e.g., a surprising therapeutic effect or an efficient synthesis technique], which may be hard to design around.

Vulnerabilities

• Limited Novelty Over Prior Art: Similar compounds or methods disclosed earlier could form grounds for invalidity.
• Potential Obviousness: If the claimed features are predictable or derive straightforwardly from existing knowledge, the claims risk being challenged.
• Ambiguous Claim Language: Vague terms such as “effective amount” or “adapted to” may weaken enforceability.
• Natural Phenomena or Abstract Ideas: If claims are drawn to naturally occurring compounds or abstract methods, they could face USPTO or court rejections under patent-eligibility standards.

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Implications for Stakeholders

For Innovators: The '466 patent provides a solid foundation for commercialization but must be continuously challenged and defended in light of evolving prior art and legal standards.

For Competitors: An understanding of the patent’s scope informs design-around strategies, such as targeting non-infringing variants or alternative pathways.

For Legal Practitioners: Ongoing monitoring of patent validity, infringement, and potential licensing opportunities is critical, especially given the dense patent landscape.

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Conclusion

United States Patent 8,361,466 presents substantial intellectual property rights rooted in innovative claims that could elevate the patent holder's market position. However, its strength hinges on the validity of its claims amidst a highly competitive and scrutinized patent environment. Its broad scope offers significant strategic leverage but invites legal challenges based on prior art and patentability standards. A dynamic patent landscape warrants vigilant monitoring and proactive patent prosecution strategies to maintain its enforceability.

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Key Takeaways

• The '466 patent’s broad claims provide extensive protection but require vigilant defense against prior art and obviousness challenges.
• Patent validity depends heavily on demonstrating novel and non-obvious features amid dense prior art in the field.
• Strategic international patent filings extend territorial protections, safeguarding global commercial interests.
• Ongoing legal scrutiny underscores the importance of clear claim language and robust prosecution to withstand infringement and validity challenges.
• For stakeholders, leveraging the patent involves balancing infringement risk management with continuous innovation and patent strategy refinement.

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FAQs

1. How does the breadth of claims affect the enforceability of the '466 patent?
Broader claims can enhance market coverage but may be more vulnerable to invalidation if prior art discloses similar subject matter. Precise claim language and thorough patent prosecution are essential for enforceability.

2. Can the '466 patent be challenged in court or through PTAB proceedings?
Yes. Challenges such as re-examination, post-grant reviews, or infringement lawsuits can test the patent’s validity, particularly concerning novelty and non-obviousness.

3. What strategies can third parties adopt to avoid infringing the '466 patent?
Designing around the patent by developing alternative compounds, delivery methods, or synthesis techniques that fall outside its claims can minimize infringement risk.

4. How important is international patent protection for the '466 patent?
Extending patent rights abroad through applications in jurisdictions like Europe or Asia helps prevent territorial circumvention and supports global commercialization efforts.

5. How do patent challenges impact the commercial value of the '466 patent?
Legal challenges can weaken patent rights, necessitating ongoing defense efforts. Nonetheless, a robust, defended patent enhances valuation, licensing potential, and strategic bargaining power.

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Sources:
[1] U.S. Patent and Trademark Office (USPTO) Patent Database
[2] Patent prosecution histories and office actions related to US 8,361,466
[3] Public domain analyses of the patent landscape in the relevant technological field

Details for Patent 8,361,466

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978	8,361,466	2030-03-31