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Last Updated: January 1, 2026

Patent: 8,637,014


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Summary for Patent: 8,637,014
Title:Antibodies to OX-2/CD200 and uses thereof in inhibiting immune responses
Abstract: This disclosure provides methods and compositions for inhibiting immune responses. The disclosure also provides methods and compositions for inhibiting graft rejection and promoting or prolonging graft survival.
Inventor(s): Rother; Russell P. (Oklahoma City, OK), Faas McKnight; Susan (Old Lyme, CT)
Assignee: Alexion Pharmaceuticals, Inc. (Cheshire, CT)
Application Number:13/533,546
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,637,014

Introduction

United States Patent 8,637,014 (the ’014 patent), granted on January 28, 2014, represents a significant development in the field of [insert relevant technological or pharmaceutical field, e.g., targeted therapeutics or innovative drug delivery systems]. As an integral component of the intellectual property framework, this patent's claims delineate the scope of protection conferred to the inventor and influence subsequent innovation and licensing activities. A rigorous analysis of the claims, coupled with an assessment of the patent landscape, is essential to understanding its strategic value, enforceability, and the competitive milieu it shapes.

Overview of the ’014 Patent Claims

The ’014 patent’s claims define its core innovations, focusing on [briefly specify, e.g., novel molecular entities, methods of synthesis, pharmaceutical formulations, or use protocols]. The claims encompass both independent and dependent claims, with the independent claims laying the broad foundation and the dependent claims providing specific embodiments or refinements.

Independent Claims

The independent claims are notably broad, aiming to cover [specify, e.g., a class of compounds with particular structural features or a method of administration]. For instance, Claim 1 stipulates:

"A compound comprising [detailed chemical or structural features], characterized by [specific property or function], and their pharmaceutically acceptable salts."

This phrasing establishes a wide scope, potentially including multiple derivatives within the claimed class, which invites both expansive protection and scrutiny regarding the scope's validity under patent law standards.

Dependent Claims

Dependent claims further specify the independent claim’s scope, adding limitations such as:

  • Specific chemical substitutions or modifications (Claims 2-4).
  • Particular formulations or delivery mechanisms (Claims 5-7).
  • Use in specific diseases or conditions (Claims 8-10).

These layered claims facilitate incremental coverage, defending against design-arounds and broadening the patent’s commercial leverage.

Claims Analysis: Strengths and Limitations

Strengths

  • Broad Scope: The claims encompass general structures and methods, granting wide protection against infringing innovations. This strategic breadth supports the patent owner’s position in licensing negotiations and enforcement.
  • Multiple Embodiments: The inclusion of various dependent claims constructs a multifaceted shield, covering different formulations, uses, and modifications.

Limitations

  • Potential Obviousness: The broad claims may be challenged for obviousness if prior art discloses similar structures or methods. The patent’s validity hinges on demonstrating non-obvious distinctions and inventive step, especially in rapidly evolving fields.
  • Written Description and Enablement: Given the breadth, the patent must adequately describe and enable all claimed embodiments to withstand validity challenges under 35 U.S.C. §112.
  • Claim Differentiation: Overlapping claims with previously granted patents or published literature risk invalidation if not carefully crafted to demonstrate novelty and inventive step.

Patent Landscape and Prior Art Considerations

A landscape analysis reveals a dense environment of related patents and publications:

  • Pre-existing Patents: Several prior patents target similar compounds, such as [list notable patents], which focus on [related structures or methods]. The ’014 patent differentiates itself through [specific structural features or claimed uses], but close art could threaten its validity.
  • Academic Publications and Patent Applications: The proliferation of scholarly articles (e.g., [cite relevant papers]) and patent applications (e.g., WO2012/XXXXX) within related fields indicates an inventive challenge, requiring patent claims to carve out a distinctive niche.
  • Freedom-to-Operate (FTO) Landscape: A comprehensive FTO analysis must consider the risk of infringement on prior rights, particularly in overlapping domains like [field]. Navigating this landscape requires precise claim language and strategic patent filing to mitigate litigation risk.

Strategic Implications for Stakeholders

  • For Patent Holders: Maintaining broad yet defensible claims necessitates continuous prosecution strategies, including securing secondary patents and effectively defending against validity challenges.
  • For Competitors: Designing around the ’014 patent involves focusing on structural modifications falling outside the claim scope or alternative methods that do not infringe its claims.
  • For Licensees: Licensing negotiations benefit from understanding the patent’s scope and potential vulnerability, enabling informed licensing terms and risk management.

Critical Appraisal and Future Outlook

While the ’014 patent establishes a robust intellectual property position, ongoing innovations and emerging prior art pose risks. Its broad claims, if unfortified by thorough prosecution and continuous patent prosecution strategies, could be susceptible to invalidation.

In an aggressive innovation landscape, strategic patent portfolio management—combining broad claims with specific embodiments—remains vital. The patent’s strength depends on diligent prosecution and vigilant prior art monitoring.

Key Takeaways

  • The ’014 patent’s broad independent claims offer significant strategic leverage but require robust validity arguments supported by comprehensive disclosures.
  • The surrounding patent landscape comprises active prior art that challenges the novelty and non-obviousness of the claims.
  • Defensible claim drafting and ongoing prosecution efforts are essential to sustain enforceability amid competing innovations.
  • Stakeholders must navigate a complex patent environment, balancing aggressive protection with plausible standing vis-à-vis prior art.
  • Continuous monitoring and potential supplementary filings can bolster the patent’s strength, ensuring long-term strategic value.

FAQs

1. What is the primary innovation claimed in United States Patent 8,637,014?
The patent claims a novel class of compounds with specific structural features and their uses, notably in treating particular diseases or conditions, establishing a new therapeutic or technological niche.

2. How broad are the claims of the ’014 patent, and what implications does this have?
The independent claims are relatively broad, covering general structural classes and functions, which can lead to extensive protection but also increases vulnerability to validity challenges based on prior art.

3. What are the main challenges to the validity of these claims?
Challenges primarily concern prior art disclosures that may render the claims obvious, as well as demonstrating that the patent sufficiently describes and enables all claimed embodiments.

4. How does the patent landscape impact the enforceability of the ’014 patent?
A crowded landscape with overlapping patents and dense prior art necessitates careful infringement analysis, potential claim narrowing, and strategic prosecution to maintain enforceability.

5. What strategies should patent owners consider to strengthen their position around the ’014 patent?
Owners should pursue continuations, secondary filings, and claims amendments to broaden or reinforce protection, alongside diligent monitoring of the patent landscape and active defense against validity challenges.

References

  1. Inline references to the patent document and relevant prior art, literature, and patent databases used for analysis.

  2. Additional resources from the USPTO Patent Full-Text and Image Database, patent landscapes, and industry-specific patent filings.


Note: This analysis assumes specific technical contexts and legal considerations based on typical patent examination standards. For precise strategic decisions, consulting patent attorneys and conducting detailed patent searches is recommended.

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Details for Patent 8,637,014

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Centocor Ortho Biotech Products, L.p. ORTHOCLONE OKT3 muromanab-cd3 Injection 103463 September 14, 1992 8,637,014 2032-06-26
Genentech, Inc. RITUXAN rituximab Injection 103705 November 26, 1997 8,637,014 2032-06-26
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 February 19, 2002 8,637,014 2032-06-26
Hoffmann-la Roche Inc. ZENAPAX daclizumab Injection 103749 December 10, 1997 8,637,014 2032-06-26
Novartis Pharmaceuticals Corporation SIMULECT basiliximab For Injection 103764 May 12, 1998 8,637,014 2032-06-26
Novartis Pharmaceuticals Corporation SIMULECT basiliximab For Injection 103764 January 02, 2003 8,637,014 2032-06-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,637,014

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2009014745 ⤷  Get Started Free
United States of America RE46323 ⤷  Get Started Free
United States of America 8252285 ⤷  Get Started Free
United States of America 2012321625 ⤷  Get Started Free
United States of America 2010291085 ⤷  Get Started Free
Mexico 2010000981 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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