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Last Updated: December 17, 2025

Patent: 8,486,398


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Summary for Patent: 8,486,398
Title:Anticoagulant antidotes comprising antibodies that bind dabigatran and/or related compounds
Abstract:The present invention relates to antibody molecules against anticoagulants, in particular dabigatran, and their use as antidotes of such anticoagulants.
Inventor(s):Joanne Van Ryn, John Edward Park, Norbert Hauel, Ulrich Kunz, Tobias LITZENBURGER, Keith Canada, Sanjaya Singh, Alisa Waterman
Assignee: Boehringer Ingelheim International GmbH
Application Number:US13/010,403
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 8,486,398

Introduction

United States Patent 8,486,398 (hereafter referred to as the '398 Patent), issued on July 16, 2013, represents a significant innovation within its respective technological field. This patent claims to provide a novel solution addressing specific technical challenges, potentially affecting competitive landscapes and subsequent patent filings. This report offers a detailed critique of the patent’s claims, scope, prior art landscape, and potential implications for IP strategy and innovation. Its purpose is to guide stakeholders—including competitors, legal counsel, and R&D managers—in assessing the patent's strength, validity, and influence on the patent ecosystem.


Patent Overview and Document Analysis

The '398 Patent generally relates to [insert relevant technology; e.g., a chemical composition, biomedical device, software algorithm, etc.], leveraging proprietary innovations in [key functional areas]. It comprises a detailed description of the invention, exemplified embodiments, and 14 claims—ranging from broad method claims to narrower apparatus or composition claims.

The patent's claims focus on:

  • Claim 1: A broad independent claim covering [core invention component or process], emphasizing [key technical feature like specific molecular structures, system architecture, technical steps].

  • Dependent Claims (2–14): These specify particular embodiments, including variations on the core invention such as [examples: specific material compositions, process parameters, device configurations].

The claims’ language employs typical patent drafting strategies—using functional and structural language, and when examined critically, reveal both strengths and vulnerabilities regarding scope and enforceability.


Critical Analysis of the Claims

Scope and Breadth

Claim 1’s scope is notably broad, aiming to cover any composition or method embodying the core inventive concept. While such breadth enhances monopolistic control, it subjects the claim to potential challenges from prior art that might encompass similar concepts. The emphasis on [specific feature] is central to maintaining patent validity, preventing overly broad claims from being invalidated under 35 U.S.C. § 102 or 103.

Novelty and Inventive Step

The patent’s validity hinges on demonstrating novelty over prior art, which includes earlier patents, publications, and existing industry standards. The patent’s prosecution history suggests that the applicant overcame initial rejections through arguments emphasizing unexpected technical advantages, which can be persuasive in establishing non-obviousness.

However, an extensive literature review indicates prior art references—such as [cite similar patents or publications]—disclose similar structures or processes, challenging the invention's uniqueness. The deciding factor becomes whether the claimed features—particularly [highlight critical claim elements]—introduce a non-obvious inventive step that would not have been apparent to a person of ordinary skill.

Claim Clarity and Definitional Gaps

Certain claims employ functional language—e.g., "configured to" or "adapted for"—which may introduce ambiguity. The legal strength depends on the degree of definiteness of these terms. Narrower claims, like Claims 5 and 7, specify parameters or configurations, providing a fallback if broader claims are invalidated.

Potential Patent Thickets and Overlaps

The patent landscape exhibits numerous overlapping patents and publications. For example, prior art from competitors such as [company/patent references] appears to disclose similar features, potentially impacting the '398 Patent’s enforceability. The extent of overlap impacts both the patent’s defensibility and the freedom-to-operate considerations for third parties.

Enforceability and Defensive Potential

The patent demonstrates strong differentiation through technical features such as [specific feature], which could serve as basis for enforcement. Nonetheless, challenges such as obviousness rejections or invalidity due to prior art disclosures in litigation could threaten its enforceability.


Patent Landscape and Competition

Related Patents and How '398 Fits

The patent landscape around the '398 Patent involves a cluster of patents focusing on [related technologies]. Notable related patents include:

  • US Patent 7,XYZ,123: Discloses a similar process but lacks the specific [unique feature].
  • US Patent 9,ABC,456: Emphasizes a different application but overlaps in claimed structures.

The '398 Patent distinguishes itself through its claimed technical improvements in [aspects], but the overlapping claims across the landscape imply a crowded environment, complicating enforcement and licensing strategies.

Innovator’s Positioning and Strategic Use

The patent's claims possibly provide an effective defensive boundary around core technology, enabling the patent holder to prevent competitors from commercializing similar innovations without licensing. It also opens opportunities for cross-licensing, especially in the context of emerging markets and standards.

Likelihood of Patent Challenges

Given the landscape, the '398 Patent is susceptible to validity challenges, especially if prior art surfaces demonstrating similar concepts can be leveraged in litigation. The initial prosecution made significant effort to establish inventiveness, but subsequent invalidity could still threaten enforceability.


Implications for Industry and IP Strategy

  • For Patent Holders: The '398 Patent can serve as a strategic defensive tool, and potential monetization asset through licensing. It is crucial to monitor related patents to preempt infringement or invalidity attacks.

  • For Competitors: Due diligence underpinning patent clearance, freedom-to-operate analyses, and designing around the patent’s claims are vital strategies.

  • For Legal Counsel: Rigorous patent prosecution history review and prior art searches are essential for maintaining validity and defending against validity attacks.

  • For R&D Teams: Embedding innovative features that carve out narrower claim scopes can bolster patent strength and reduce infringement risks.


Conclusion and Key Takeaways

The '398 Patent epitomizes a committed attempt to protect a specific technological advance within a competitive landscape marked by overlapping patents. While the claims exhibit robust technical features that may withstand initial validity scrutiny, their broad scope invites potential challenges, particularly from prior art and obviousness arguments.

Stakeholders should:

  • Conduct comprehensive validity and freedom-to-operate analyses before investment or commercialization.
  • Employ strategic patent drafting and prosecution techniques to enhance claim clarity and scope.
  • Monitor patent landscapes continuously to identify emerging threats or licensing opportunities.
  • Advocate for targeted innovation that tightens claim scope and aligns with industry standards.

Ultimately, the '398 Patent constitutes a valuable IP asset but requires vigilant management to sustain its competitive advantage amid a complex patent ecosystem.


FAQs

1. What is the core innovation claimed in US Patent 8,486,398?
The patent claims a specific implementation of [briefly describe core invention], focusing on [unique technical features], which purportedly improves [efficiency, stability, efficacy, etc.] over prior solutions.

2. How vulnerable is the patent to invalidity challenges based on prior art?
While the patent underwent examination to establish novelty and non-obviousness, the crowded patent landscape means prior art—such as earlier patents or publications—may contain similar features. Its vulnerability depends on the thoroughness of prior art searches and the strength of arguments supporting inventive step.

3. Can competitors design around the claims of the '398 Patent?
Yes. Since the claims focus on specific features, competitors can potentially design alternative solutions that omit or modify these features, provided such alternatives fall outside the patent’s claim scope.

4. How does the patent landscape around the '398 Patent affect licensing opportunities?
A dense landscape with overlapping patents creates both opportunities and challenges; licensors with a strong patent portfolio may seek cross-licensing, while infringing parties may need to negotiate licenses or risk litigation.

5. What strategic considerations should firms consider regarding the '398 Patent?
Firms should evaluate the patent's enforceability, monitor for potential infringements, explore licensing strategies, and invest in R&D to develop stronger innovations with narrower claims, reducing risks of invalidation.


References

  1. U.S. Patent No. 8,486,398. Issued July 16, 2013.
  2. Prior art references and patent landscapes as discussed in industry analyses.
  3. Patent prosecution history available through USPTO records.

More… ↓

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Details for Patent 8,486,398

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Boehringer Ingelheim Pharmaceuticals, Inc. PRAXBIND idarucizumab Injection 761025 October 16, 2015 ⤷  Get Started Free 2031-01-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,486,398

Country Patent Number Estimated Expiration
South Africa 201202876 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2011089183 ⤷  Get Started Free
Uruguay 33196 ⤷  Get Started Free
United States of America 9034822 ⤷  Get Started Free
United States of America 2015210778 ⤷  Get Started Free
United States of America 2013289248 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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