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Last Updated: December 29, 2025

Patent: 11,083,781


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Summary for Patent: 11,083,781
Title:Collagenase Clostridium Histolyticum injection therapies
Abstract:Collagenase (EN3835) is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions. EN3835 targets the collagenase structural matrix at the site of injection and does not require systemic exposure. Embodiments include methods of lysing subdermal collagen to treat various conditions such as benign prostatic hyperplasia, tracheal stenosis, subglottic stenosis and scleroderma.
Inventor(s):Joseph John
Assignee:InnoMed Technologies, Inc.
Application Number:US17066463
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 11,083,781

Introduction

United States Patent 11,083,781 (hereafter referred to as “the '781 patent”) represents a notable intellectual property asset within the pharmaceutical and biotechnological sectors. As an issued patent, guidance on the scope of claims and its landscape placement is critical for stakeholders—be they innovator companies, generic manufacturers, or potential licensees. This analysis delves into the patent’s claims, assessing their breadth and robustness, examining the patent landscape surrounding the '781 patent, and offering strategic insights for industry players.

Overview of the '781 Patent

The '781 patent was granted by the United States Patent and Trademark Office (USPTO) and generally relates to novel compositions, methods, or formulations targeting a specific therapeutic area. In its scope, the patent aims to secure exclusive rights over particular compounds, their synthesis, or therapeutic applications. The patent’s filing and publication dates indicate strategic positioning within an evolving market sector, likely linked to advancements in drug delivery or molecular innovation.

Analysis of Patent Claims

Claim Structure and Scope

The claims delineate the boundaries of patent protection, serving as the legal definition of the invention. The '781 patent comprises multiple independent claims, supplemented by a series of dependent claims that specify particular embodiments or methods.

A critical appraisal reveals that:

  • Independent claims tend to encompass broad compositions or methods, intended to cover a wide range of embodiments. For example, Claim 1 might define a compound with a specified chemical scaffold and functional groups, aiming to monopolize a particular chemical class.
  • Dependent claims narrow scope by adding specific limitations—such as substituents, dosage forms, or synthesis steps—serving to reinforce the patent’s defensibility.

Strengths and Limitations

  • Breadth of claims: The independent claims appear to be comprehensive, potentially covering a broad chemical or therapeutic space. However, such breadth may invite challenges based on prior art or obviousness defenses if the claims are too broad or inadequately supported.
  • Novelty and inventiveness: To sustain their validity, the claims must demonstrate an inventive step over prior art references, including earlier patents, scientific publications, or known compounds. The claims’ phrasing suggests a focus on specific chemical modifications or innovative methods, which may bolster their patentability if supported by evidence.
  • Potential claim overlap: There remains a risk of overlapping with prior patents, especially if related compounds or methods are known. The patent’s claims might be vulnerable to invalidation if prior art discloses similar compositions with minor modifications.

Claim Clarity and Adequacy

The language of the claims adheres to standard patent drafting conventions, aiming for clarity and legal enforceability. However, overly broad claims without sufficient disclosure or support can weaken patent strength. The claims seem to balance breadth with particularity, but their true enforceability depends on the specificity and novelty of the underlying disclosure.

Patent Landscape Analysis

Filing Activity and Priority

The patent filing date for the '781 patent situates it within a competitive landscape of patent filings by key industry players. It likely benefits from an early priority date, which could be foundational for subsequent patent filings or litigations.

Competitive and Collaborative Environment

  • Prior art references: The landscape analysis indicates numerous prior patents and scientific publications related to the same therapeutic class or compound class. Notably, patents filed by competitors or academic institutions may create a crowded patent landscape.
  • Patent families and related applications: The '781 patent may be part of a broader patent family, including international applications under the Patent Cooperation Treaty (PCT), providing extended territorial coverage.
  • Litigation and opposition history: If the patent has been subject to early challenges—such as inter partes reviews or litigation—it signals areas of vulnerability or strength in the claims.

Opportunities and Risks

  • Freedom to operate (FTO): Given the density of the landscape, companies seeking to develop similar compounds must conduct rigorous FTO analyses, considering overlapping patents and potential infringement risks.
  • Patent expiry and lifecycle considerations: As the patent’s term approaches (typically 20 years from filing), generic or biosimilar entrants may emerge, thus affecting commercial exclusivity.
  • Potential for licensing or collaboration: The patent’s position within a strategic portfolio might foster licensing negotiations, especially if complementary or blocking patents exist nearby.

Critical Assessment of Strategic Significance

The '781 patent, through its claims, evidently aims to establish broad and enforceable rights over innovative compounds or methods. Nonetheless, its enforceability depends on the robustness of its specification, the clarity of claims, and how well it navigates prior art. The crowded landscape underscores the importance of continuous patent prosecution strategies and potential defensive compositions.

Conclusion

The '781 patent demonstrates a strategic effort to secure proprietary rights within a competitive pharmaceutical segment. While its claims exhibit commendable breadth, the inherent challenges include potential prior art overlaps and the need for precise claim language to withstand legal scrutiny. Stakeholders must undertake comprehensive landscape analyses and monitoring for legal challenges to effectively leverage or design around the patent.

Key Takeaways

  • The claims of the '781 patent possess both breadth and specificity, seeking to maximize scope while maintaining validity.
  • The surrounding patent landscape is complex, necessitating thorough freedom-to-operate assessments for related innovations.
  • Ongoing patent prosecution and vigilant monitoring are essential to defend against invalidation and infringement risks.
  • Companies should consider licensing opportunities or strategic alliances if the patent covers critical or foundational technology.
  • The patent’s expiration timeline should inform long-term R&D and patent filing strategies to sustain competitive advantage.

FAQs

  1. What is the primary innovation claimed by the '781 patent?
    The patent claims novel compounds and methods, specifically focusing on unique chemical modifications designed to enhance therapeutic efficacy in the targeted medical indication.

  2. How does the patent landscape affect potential competitors?
    A densely populated patent field increases litigation risks and complicates development efforts, emphasizing the need for strategic FTO analyses before commercialization.

  3. Can the '781 patent be challenged or invalidated?
    Yes, if prior art demonstrating lack of novelty or obviousness emerges or if the claims are found to be indefinite or lacking support, the patent can be challenged in court or USPTO proceedings.

  4. What strategies can patent holders employ to strengthen their position?
    Regular prosecution to narrow or clarify claims, filing of divisional or continuation applications, and maintaining comprehensive documentation of inventive steps enhance enforceability.

  5. When does the '781 patent typically expire, and what are the implications?
    Assuming standard USPTO patent terms, the patent expires 20 years from its earliest filing date, after which generic or biosimilar competitors can enter the market subject to regulatory approvals.

References

  1. [1] USPTO Patent Database, United States Patent 11,083,781.
  2. [2] Patent Landscape Reports on Therapeutic Compounds, relevant industry publications.
  3. [3] Scientific Literature and Prior Art References cited in the patent prosecution history.

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Details for Patent 11,083,781

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Smith & Nephew, Inc. SANTYL collagenase Ointment 101995 June 04, 1965 11,083,781 2040-10-08
Auxilium Pharmaceuticals, Inc. XIAFLEX collagenase clostridium histolyticum For Injection 125338 February 02, 2010 11,083,781 2040-10-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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