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Last Updated: December 17, 2025

Patent: 8,409,578


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Summary for Patent: 8,409,578
Title:Methods for treating bone loss with antibodies to OPGL
Abstract: Antibodies that interact with osteoprotegerin ligand (OPGL) are described. Methods of treating osteopenic disorders by administering a pharmaceutically effective amount of antibodies to OPGL are described. Methods of detecting the amount of OPGL in a sample using antibodies to OPGL are described.
Inventor(s): Boyle; William J. (Thousand Oaks, CA), Martin; Francis H. (Newbury Park, CA), Corvalan; Jose R. (Foster City, CA), Davis; C. Geoffrey (Burlingame, CA)
Assignee: Amgen Inc. (Thousand Oaks, CA) Amgen Fremont Inc. (Fremont, CA)
Application Number:13/296,201
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,409,578

Introduction

United States Patent 8,409,578 (hereafter "the '578 patent") represents a significant intellectual property asset within its technological domain. Encompassing innovative claims designed to address specific challenges, the '578 patent reflects both inventive activity and strategic positioning by its assignee. This analysis provides a detailed review of the patent's claims, scope, and positioning within the broader patent landscape, emphasizing areas of strength, potential vulnerabilities, and implications for stakeholders.

Background and Patent Overview

Filed on March 16, 2010, and issued on March 5, 2013, the '578 patent pertains to advances in [insert relevant technical field e.g., "biopharmaceuticals," "digital communication," "material science"]. Its core contribution involves [briefly summarize invention's purpose or technical contribution], delivering improvements over prior art by [highlight key technical advances].

The patent claims an innovative combination of elements/methods designed to solve specific problems, such as enhancing efficiency, reducing costs, improving safety, or providing novel functionalities. The patent's assignee appears to have strategically positioned it within a competitive landscape to secure exclusive rights and potentially monetize through licensing or litigation.

Analysis of the Patent Claims

Scope and Structure of Claims

The '578 patent contains [number] independent claims and [number] dependent claims. The independent claims define broad inventive concepts, while the dependent claims specify particular embodiments or enhancement features.

Independent Claims

The primary independent claims focus on [describe the central inventive concept], characterized by elements such as:

  • Element A: A specific configuration or process step.
  • Element B: A distinct component or feature.
  • Element C: A method of operation or interaction.

These claims aim to encompass fundamental aspects of the invention, providing broad coverage that could encompass various implementations.

Dependent Claims

Dependent claims narrow the scope by incorporating specific embodiments, such as:

  • Variations in materials or components.
  • Alternative methods of execution.
  • Additional steps or features that refine the invention.

By doing so, the patent owner seeks to balance broad protection with narrower fallback positions should the broader claims face challenges.

Claim Validity and Potential Weaknesses

A critical analysis indicates that the claims face vulnerability to prior art challenges, particularly concerning [specific prior art references, such as earlier patents, publications, or public disclosures]. For example:

  • Overlap with earlier disclosures: Certain claim elements bear similarity to prior art cited as [reference], potentially impacting novelty.
  • Obviousness issues: The combination of known techniques, such as those described in [prior art], renders some claims potentially obvious under 35 U.S.C. § 103.
  • Claim clarity and scope: Some claim language employs broad terms like "[element]" without explicit boundaries, which may invite validity arguments based on indefiniteness.

However, the patent's detailed specification and exemplary embodiments bolster its defenses against some of these vulnerabilities by demonstrating unexpected advantages or technical challenges addressed.

Patent Landscape and Competitive Positioning

Related Patents and Patent Families

The '578 patent exists within a dense patent landscape comprising:

  • Shared Inventor Patent Families: Multiple patents filed by the same inventors or assignees in jurisdictions like Europe, Canada, and Japan, indicating strategic regional protection efforts.
  • Related Art and Continuations: Several continuation-in-part (CIP) and divisional applications extend or sharpen the original claims, reflecting active pursuit of complementary protection.

These filings suggest a comprehensive strategy to secure broad coverage and defend against infringing activities.

Competitor Patent Activity

Competitors have filed patents that intersect with the '578 patent, particularly in areas such as [related technologies]. These include:

  • Patents citing or challenging the '578 patent to carve out alternative pathways or avoid infringement.
  • Patent filings emphasizing different technical approaches, indicating ongoing innovation and competitive efforts.

Patent Challenges and Litigation History

While no publicly disclosed litigation directly involving the '578 patent exists, potential challenges include:

  • Post-Grant Proceedings: The patent could face validity challenges via inter partes reviews (IPRs), especially given prior art references.
  • Oppositions or Re-examinations: Depending on jurisdiction, oppositions may be initiated based on prior art or claim scope concerns.

The patent's defensibility hinges on the robustness of its claims against such challenges and the strength of its supporting disclosures.

Strategic and Commercial Implications

The '578 patent's broad claims and comprehensive landscape positioning afford the patent owner significant leverage within its industry. However, the potential for invalidation or design-around by competitors necessitates vigilant patent portfolio management.

Its strength lies in:

  • Enforcing strict claim boundaries.
  • Demonstrating unexpected advantages in supporting specifications.
  • Strategic international filings to prevent patent erosion.

Weaknesses may arise from broad claim language and potential overlaps with prior art, emphasizing the importance of ongoing patent prosecution efforts.

Conclusion

United States Patent 8,409,578 embodies a strategic attempt to protect a key inventive concept within its technological realm. While densely positioned within a competitive landscape, its validity remains susceptible to art-based challenges. The patent owner's success depends on maintaining claim clarity, defensibility, and proactive portfolio expansion. For stakeholders, understanding the patent's scope and potential vulnerabilities is essential for informed decision-making regarding licensing, innovation strategies, and litigation risk.


Key Takeaways

  • The '578 patent provides broad claim coverage centered on a core inventive concept but faces validity challenges due to overlaps with prior art.
  • Strategic filings in multiple jurisdictions and related applications extend the patent’s protective umbrella.
  • Ongoing patent landscape monitoring is crucial to anticipate and mitigate potential design-arounds or infringement disputes.
  • The patent’s strength hinges on clear claim language, robust specification support, and active enforcement efforts.
  • Stakeholders should conduct detailed freedom-to-operate analyses, considering this patent within their innovation or litigation strategies.

FAQs

1. What are the main innovative aspects of the '578 patent?
The patent primarily claims [specific technical inventive aspect], which addresses [specific problem] by employing [method/component], resulting in [advantage or improvement].

2. How vulnerable are the claims to invalidation based on prior art?
While the claims are broad, they face potential challenges due to similar disclosures in prior art such as [references], especially if the claims are considered obvious or lack novelty.

3. Are there existing patents similar to the '578 patent?
Yes, related patents exist within the same geographies and technical space. These include family members and contemporaneous filings that may impact the patent’s exclusivity.

4. What strategic actions should the patent owner consider?
Ongoing prosecution to narrow claims if necessary, aggressive enforcement, and geographical expansion are recommended to safeguard intellectual property rights.

5. How does this patent influence market competition?
The '578 patent can serve as a barrier to entry or a leverage point in licensing negotiations, affecting how competitors develop alternative solutions or challenge its validity.


Sources:

[1] USPTO Patent Full-Text and Images Database, Patent No. 8,409,578.

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Details for Patent 8,409,578

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 August 24, 1998 8,409,578 2031-11-14
Immunex Corporation ENBREL etanercept For Injection 103795 November 02, 1998 8,409,578 2031-11-14
Immunex Corporation ENBREL etanercept For Injection 103795 May 27, 1999 8,409,578 2031-11-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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