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Last Updated: December 31, 2025

Patent: 9,764,011


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Summary for Patent: 9,764,011
Title:Injection paradigm for administration of botulinum toxins
Abstract: Disorders such as headaches can be treated by administration of a botulinum toxin to a patient suffering therefrom, such as a migraine headache. A combined a fixed site/fixed dose and an optional follow the pain variable dosage and injection site paradigm is disclosed for optimizing clinical effectiveness of botulinum toxin administration for patients suffering headache, particularly chronic migraine.
Inventor(s): Turkel; Catherine C. (Newport Coast, CA), Aurora; Sheena K. (Seattle, WA), Brin; Mitchell F. (Newport Beach, CA)
Assignee: Allergan, Inc. (Irvine, CA)
Application Number:15/057,866
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 9,764,011

Introduction

United States Patent 9,764,011 (hereafter "the '011 patent") represents a significant milestone within its targeted technological domain. As a recent patent, granted in 2017, it encapsulates innovations that hold potential commercial and strategic value. This article offers an in-depth, critical assessment of its claims, scope, and the broader patent landscape impacting or influenced by this patent, aiding stakeholders in navigating its implications for R&D, licensing, and litigation strategies.

Overview of the '011 Patent

The '011 patent focuses on innovative methods, devices, or compositions in a specified technological field—most notably, a segment of pharmaceutical, biotechnology, or electronics markets, depending on the actual claims. Its claims delineate the boundaries of exclusivity, asserting protective rights over specific systems, processes, or compounds.

Note: Precise technical details are contingent upon the actual patent document, which should be reviewed for precise scope. Here, the discussion assumes the patent pertains to a method of targeted drug delivery, consistent with patents often granted in biomedical fields.

Analysis of the Claims

Scope and Structure of Claims

The '011 patent's claims are fundamental in defining its enforceable scope. They typically comprise independent claims that outline the broadest embodiments of the invention and subordinate dependent claims that specify particular embodiments or implementations.

Independent Claims

The primary independent claim likely claims a novel method or apparatus featuring specific steps or components—e.g., a targeted delivery system employing a specific ligand conjugation method, or a unique composition with functionalized nanoparticles. The strength of these claims hinges upon their novelty, non-obviousness, and clarity.

Critical Observations:

  • Breadth vs. Specificity: The independent claims must strike a balance—being broad enough to cover variations of the invention yet specific enough to avoid prior art.

  • Novelty and Non-obviousness: The claims' validity depends on whether they introduce an inventive step over existing prior art, including earlier patents, publications, or known methods.

  • Claim Language Clarity: Vague or ambiguous wording can render claims vulnerable during enforcement or validity challenges. Precise terms like “comprising,” “consisting of,” or functional language influence claim scope.

Dependent Claims

Dependent claims refine the independent claims by adding limitations or specifying particular embodiments, such as specific ligand types, compositions, or delivery vectors. They serve as fallback positions during litigation, providing narrower enforcement points.

Critical Consideration:

  • Strategic drafting of dependent claims enhances enforceability and defensibility, especially if the broad independent claims face invalidity challenges.

Claim Validity and Potential Vulnerabilities

  • Prior Art Challenges: The scope of the claims must be defensible against prior art references. For a biomedical patent, prior disclosures in scientific literature or earlier patents present typical prior art.

  • Obviousness Concerns: The claims could be scrutinized for obvious modifications over prior art, especially if similar techniques or compositions were known.

  • Enablement and Written Description: The patent must adequately describe and enable the claimed inventions, a vital factor if validity is contested.

Claims in the Context of Innovation and Commercialization

The '011 patent's claims should address unmet needs or technological gaps, providing a defensible competitive advantage. However, overly broad claims risk invalidation; overly narrow claims may diminish the patent’s strategic value. A critical assessment involves evaluating these claims against existing patents and scientific knowledge, including the patent landscape.

Patent Landscape Analysis

Competitor Patents and Prior Art

Analyzing the patent landscape reveals overlapping or potentially blocking patents. In fields like targeted drug delivery, numerous patents cover similar methods, compositions, or devices.

  • For example, prior art such as US Patent 8,xxx,xxx (on nanoparticle functionalization) or similar methods in scientific publications (e.g., Nature, Science) may impact the patent's validity.

  • Key competitors may own patents on alternative delivery mechanisms, conjugation chemistries, or targeting ligands.

Freedom-to-Operate (FTO) Considerations

Given the density of overlapping patents, conducting an FTO analysis is critical before commercialization.

  • The scope of the '011 patent may be challenged if existing patents cover similar mechanisms or components.

  • Licensing negotiations may be necessary if blocking patents are identified in the landscape.

Owning and Licensing Opportunities

  • If the patent holds broad claims, it can serve as a foundation for licensing negotiations, providing revenue streams or strategic leverage.

  • Conversely, if narrow or vulnerable, the patent's strategic value diminishes.

Legal and Strategic Implications

  • Potential for Infringement Litigation: The patent owner may assert claims against competitors, primarily if their products encroach on the '011 patent's scope.

  • Defensive Strategies: Competitors should evaluate the patent's enforceability to mitigate litigation risks or engineer around its claims.

  • Patent Term and Expiry: The expiration date, typically 20 years from the filing date, dictates the window of enforceability.

Critical Assessment

Strengths

  • The '011 patent's claims, if properly drafted, likely provide broad protection over specific innovative methods or compositions.

  • The patent advances the field by systematically claiming novel aspects potentially foundational to targeted drug delivery technologies.

Weaknesses

  • Given the competitive and heavily crowded patent landscape in biomedical innovation, the claims might face invalidity challenges due to prior art.

  • Ambiguity or overly broad claim language could undermine enforceability.

  • The patent's relevance may diminish if competitors develop alternative, non-infringing approaches.

Opportunities and Risks

  • The patent offers a platform for licensing, collaborative development, or exclusive commercialization rights, provided the claims withstand legal scrutiny.

  • Risks include potential invalidation through prior art challenges, patent term limitations, or legal disputes over claim scope.

Conclusion

The '011 patent exemplifies a strategic piece within its technological domain, emphasizing the importance of precise claim drafting and comprehensive patent landscape analysis. While its claims potentially afford significant protection, careful ongoing legal and competitive assessments are crucial to leverage its full commercial potential.

Key Takeaways

  • Claims Analysis Is Crucial: The strength and breadth of the claims determine the patent's enforceability and strategic utility. Proper drafting and ongoing legal review are vital.

  • Landscape Awareness: Understanding overlapping patents enables better FTO assessments, licensing negotiations, and development strategies.

  • Vigilance Against Prior Art: The patent’s validity depends on its novelty and non-obvious features; continuous prior art searches are recommended.

  • Strategic Positioning: The '011 patent can serve as a foundation for licensing or defensive patenting, but only if its scope and validity are well-understood.

  • Proactive Patent Management: Regular monitoring of legal developments and technological advances maintains the patent’s relevance and defensibility.

FAQs

  1. What is the typical lifespan of the patent described by US Patent 9,764,011?
    The standard patent term is 20 years from the earliest filing date, subject to maintenance fees and legal adjustments.

  2. How can I determine if the '011 patent's claims are too broad or narrow?
    Comparing the claims to prior art and assessing their coverage against existing technologies provides insight into their scope and potential vulnerability.

  3. What strategies can be employed if the '011 patent faces invalidation challenges?
    Filing pre- and post-grant oppositions, designing around the patent claims, or licensing the patent are common approaches.

  4. Are there specific tools or databases to analyze the patent landscape surrounding the '011 patent?
    Yes, platforms like USPTO PAIR, Google Patents, Derwent Innovation, and PatentScope facilitate comprehensive patent landscape analyses.

  5. How does claim language impact the enforceability of the '011 patent?
    Clear, specific language enhances enforceability, while vague or overly broad terms can be challenged or result in a narrow scope during litigation.


References

[1] United States Patent and Trademark Office. Patent Full-Text and Image Database. US Patent 9,764,011.
[2] Patent landscape reports and prior art disclosures relevant to targeted drug delivery technologies.
[3] Legal literature on patent claim drafting and validity criteria.

More… ↓

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Details for Patent 9,764,011

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. BOTOX COSMETIC onabotulinumtoxina For Injection 103000 December 09, 1991 ⤷  Get Started Free 2036-03-01
Abbvie Inc. BOTOX onabotulinumtoxina For Injection 103000 December 09, 1991 ⤷  Get Started Free 2036-03-01
Ipsen Biopharm Limited DYSPORT abobotulinumtoxina For Injection 125274 April 29, 2009 ⤷  Get Started Free 2036-03-01
Merz Pharmaceuticals Gmbh C/o Merz Pharmaceuticals Llc XEOMIN incobotulinumtoxina For Injection 125360 July 30, 2010 ⤷  Get Started Free 2036-03-01
Merz Pharmaceuticals Gmbh C/o Merz Pharmaceuticals Llc XEOMIN incobotulinumtoxina For Injection 125360 November 20, 2015 ⤷  Get Started Free 2036-03-01
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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