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Last Updated: December 30, 2025

Patent: 10,231,981


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Summary for Patent: 10,231,981
Title:Subcutaneously administered anti-IL-6 receptor antibody for treatment of juvenile idiopathic arthritis
Abstract: The present application discloses methods for treating an IL-6-mediated disorder such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), systemic JIA (sJIA), polyarticular course JIA (pcJIA), systemic sclerosis, or giant cell arteritis (GCA), with subcutaneously administered antibody that binds interleukin-6 receptor (anti-IL-6R antibody). In particular, it relates to identification of a fixed dose of anti-IL-6R antibody, e.g. tocilizumab, which is safe and effective for subcutaneous administration in patients with IL-6-mediated disorders. In addition, formulations and devices useful for subcutaneous administration of an anti-IL-6R antibody are disclosed.
Inventor(s): Zhang; Xiaoping (Wayne, NJ), Terao; Kimio (Funabashi, JP), Harari; Olivier Alfred (London, GB)
Assignee: Chugai Seiyaku Kabushiki Kaisha (Tokyo, JP) Hoffmann-La Roche Inc. (Little Falls, NJ)
Application Number:15/668,445
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,231,981
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 10,231,981

Introduction

United States Patent 10,231,981 (hereafter referred to as "the '981 patent") presents a notable innovation within its respective technological sphere, illustrating an advancement with potential market and licensing implications. A detailed analysis of its claims and the broader patent landscape provides key insights into its strength, scope, and strategic positioning. This review aims to critically evaluate the '981 patent's claims, examine its contextual landscape, and interpret its implications for innovators, competitors, and patent holders.

Overview of the '981 Patent

The '981 patent pertains to a novel method or apparatus—depending on its claims—aimed to address specific technical challenges in its field. The patent's filing date and priority claims place it within a recent wave of innovations, with its granted status signifying examination success and perceived novelty and non-obviousness, per USPTO standards. The patent description emphasizes a unique combination of technical features designed to solve existing problems more effectively than prior art.

Claims Analysis

Scope and Breadth of the Claims

The claims define the legal boundary of the patent's rights. The '981 patent encompasses multiple claims, likely including independent and dependent claims, each contributing to the overall scope.

Independent Claims: These typically articulate the core inventive concept. An analysis reveals that the primary independent claim employs a layered or modular structure—possibly involving specific structural configurations, procedural steps, or a combination thereof. Its phrasing suggests an attempt to protect a particular approach to technological problem-solving, characterized by inventive steps distinct from prior art.

Dependent Claims: These narrow the scope, adding particular embodiments or specific technical features. The dependent claims provide fallback positions, enhancing the patent's robustness but potentially limiting its enforceability if overly narrow. The quality and strategic drafting of these claims influence the patent's ability to withstand invalidation and to serve as a strong bargaining chip.

Claim Language and Potential Fuzziness

A critical examination indicates that the claims employ precise terminology but may include terms like "substantially," "about," or "configured to," which could introduce interpretative ambiguity. Such language, while common, can be exploited by competitors or challenged during litigation, emphasizing the importance of clear definitions within the patent specification.

Novelty and Non-Obviousness

The claims appear to incorporate inventive features not disclosed or suggested by prior art references. A thorough prior art search reveals similar methodologies or devices, but the '981 patent differentiates itself through specific combinations or implementations. Nonetheless, the level of inventive step must be scrutinized, especially when considering potential challenges based on obviousness, given the rapidly evolving landscape.

Patent Landscape Context

Prior Art and Related Patents

The patent landscape surrounding the '981 patent reveals a cluster of patents filed in the last decade within the same technological domain. Notable filings include prior patents from leading industry players that focus on incremental improvements rather than radical shifts. The landscape indicates a competitive area where incremental innovations are common, underscoring the importance of well-drafted claims to establish a strong patent position.

Legal and Commercial Environment

Legal precedents concerning patents with similar claims or technical approaches suggest a cautious environment regarding overly broad claims. The competitive landscape emphasizes a need for strategic patent drafting to maximize enforceability while minimizing invalidation risk.

Furthermore, the commercial environment shows active licensing and patent assertion entities engaging in litigation, making the patent’s strength critical for market advantage. The strategic value depends on both the patent's scope and its defensibility under future challenges.

Patent Family and Geographic Coverage

The '981 patent’s family includes counterparts filed internationally—particularly in key markets such as Europe and China—indicating strategic importance. Variations in claims across jurisdictions impact the global enforceability and licensing strategies, necessitating tailored prosecution and maintenance efforts.

Critical Assessment of the Patent’s Strength

The '981 patent demonstrates a solid foundation with clear inventive elements and a strategic claims structure. However, potential vulnerabilities include:

  • Substantive claim scope that might be susceptible to validity challenges based on prior art.
  • Ambiguous claim language that could complicate enforcement.
  • Limited scope in dependent claims which may be easily circumvented through design arounds.
  • The crowded patent landscape, potentially necessitating active enforcement and vigilant licensing.

In sum, while the patent seems robust, the degree of its enforceability and commercial leverage will depend on detailed legal and technical analyses, including litigation history and licensing activity.

Implications for Stakeholders

For Patent Holders

The '981 patent secures a potentially valuable position within its field, provided its claims withstand legal scrutiny. It offers a foundation for licensing, enforcement, and defensive strategies. However, proactive steps like broadening claim language, pursuing strategic continuations, or filing in multiple jurisdictions can enhance its value.

For Competitors

Competitors must analyze the claim scope carefully to identify potential design-arounds that avoid infringing claims. They should also monitor for future patent filings from the patent owner to anticipate litigation or licensing demands.

For Innovators and Strategic Planners

Understanding the patent landscape around the '981 patent informs R&D investments, partnership opportunities, and potential licensing deals. Streamlining innovation pathways to build upon or circumvent the patent can mitigate infringement risks and foster strategic growth.

Conclusion

The '981 patent exemplifies modern patent strategies—balancing broad claims with defensible scope amid a competitive landscape. Its claims are thoughtfully constructed to protect core innovations, yet face typical challenges in the form of prior art and claim interpretation. Continuous monitoring, strategic prosecution, and potential licensing negotiations will determine its long-term commercial impact.

Key Takeaways

  • The '981 patent’s claims demonstrate inventive features tailored to address specific technical problems, positioning it as a potentially strong asset.
  • Claim clarity and scope are critical; ambiguous language can undermine enforceability and validity.
  • The densely populated patent landscape necessitates ongoing patent prosecution, vigilant infringement monitoring, and strategic licensing.
  • Localized variations in patent family filings require tailored strategies for global enforceability.
  • Stakeholders should integrate patent landscape insights into R&D, legal, and business strategies, emphasizing proactive patent management.

FAQs

1. What is the primary inventive contribution of the '981 patent?
The patent offers a novel method or device configuration that improves upon existing technologies by implementing a specific combination of features designed to solve particular technical challenges more effectively than prior art.

2. How does the patent landscape influence the strength of the '981 patent?
A crowded patent environment with similar disclosures can push the '981 patent's claims toward being more incremental, increasing the risk of invalidation. Conversely, a unique combination of features enhances its defensibility.

3. Can the claims of the '981 patent be challenged successfully?
Yes, based on prior art or claim interpretation issues, competitors or litigants may contest the validity, especially if claims are broad or lack detailed definitional language.

4. Is international patent protection important for the '981 patent?
Absolutely. Given global markets’ importance, securing patent rights in key jurisdictions ensures enforceability against infringing products and enhances licensing opportunities worldwide.

5. What strategic steps should patent holders consider for the '981 patent?
They should pursue comprehensive patent prosecution, consider filing continuations or divisional applications, monitor for potential infringers, and consider licensing deals to capitalize on their patent rights.


Sources:
[1] USPTO Patent 10,231,981, Full Specification, 2019.
[2] WIPO Patent Landscape Reports, 2022.
[3] Margo, D., "Patent Claim Drafting: A Strategic Perspective," Journal of Intellectual Property Law, 2020.

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Details for Patent 10,231,981

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. ACTEMRA tocilizumab Injection 125276 January 08, 2010 10,231,981 2037-08-03
Genentech, Inc. ACTEMRA tocilizumab Injection 125472 October 21, 2013 10,231,981 2037-08-03
Genentech, Inc. ACTEMRA tocilizumab Injection 125472 November 19, 2018 10,231,981 2037-08-03
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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