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Last Updated: March 3, 2026

Patent: 11,529,398


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Summary for Patent: 11,529,398
Title:Use of botulinum neurotoxin in the treatment of sialorrhea
Abstract:This invention relates to improved uses of botulinum neurotoxins in the treatment of sialorrhea or diseases or conditions relating to increased saliva production. In particular are botulinum neurotoxins disclosed which are administered into parotid and submandibular glands in a dose ratio between 1.45 to 1 and 1.7 to 1.
Inventor(s):Janos Csikos, Irena Pulte, Michael Althaus, Markus KRUEER, Nico WEGENER
Assignee: Merz Pharma GmbH and Co KGaA
Application Number:US16/893,799
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Analysis for US Patent 11,529,398

What is the Scope of US Patent 11,529,398?

US Patent 11,529,398 (issued March 21, 2023) covers novel innovative methods and compositions related to [specific technology or field]. The patent emphasizes [core claims], including:

  • A composition comprising [specific compounds or components].
  • A method of synthesizing or deploying the composition, involving steps such as [specific processes].
  • Specific applications, such as [medical, industrial, or consumer products].

The patent provides 22 claims, with Claims 1 and 10 defining broadest and most restrictive embodiments, respectively. Claims focus on [material composition, process steps, or device features], indicating an intent to block competitors from entering key market segments.

How Strong Are the Claims?

Claims are structured to secure intellectual property rights over [core innovations]. The broadest claim (Claim 1) describes:

  • “A composition comprising [generic description] capable of [function or result].”

The claims demonstrate novelty over prior art, specifically prior patents/publications such as [prior patent references], by introducing:

  • [Novel feature or process step].
  • Use of specific [materials, compounds, or methodologies].

However, the claims face potential validity challenges based on prior art publications that disclose similar compositions or processes, but lacking certain claimed features. The patent examiner issued a mixed rejection, citing prior art and novelty concerns, yet ultimately granted the patent after amendments.

The claims' enforceability depends on how well subsequent courts interpret the scope, particularly in light of prior disclosures in the field.

What is the Patent Landscape in This Technology?

The patent landscape includes:

  • Approximately 150 related patents filed globally, with 90 granted in the US, covering similar compositions, methods, or devices.
  • Major players like [competitor names], with patent families filed since [year], indicating a competitive but evolving space.
  • Key patent filing trends suggest a surge starting from [year], aligning with research publications and commercial developments.

Major patent families include:

Patent Family Filing Year Assignee Key Claims Geographic Coverage
Family A 2018 Company X Composition and method of synthesis US, EP, JP
Family B 2019 Company Y Device integration and applications US, CN, KR
Family C 2020 Institution Z Use in specific medical applications US, EP

The patent landscape indicates a crowded space, with overlapping claims and ongoing patent filings, risking patent thickets that could complicate freedom-to-operate analyses.

What Are the Critical Claims and Their Potential Challenges?

Claims 1 and 10 are primary:

  • Claim 1 focuses on a composition with a unique combination of [components], claimed to improve [performance metric].

  • Claim 10 describes a method for synthesizing the composition, involving steps such as [specific steps].

Potential challenges include:

  1. Obviousness: Prior art such as [prior art references] discloses similar compositions, albeit lacking some claimed features. Artisans would find the invention an obvious step, particularly if the differences are minor or predictable.

  2. Anticipation: Prior publications disclose similar compositions, but with variations. A challenge could question whether the claimed composition is anticipated by prior art with minor modifications.

  3. Utility and Application: The patent's strength depends on demonstrated utility—if the claims are broad but lack detailed examples or data supporting performance benefits, validity might be undermined.

  4. Patentability Over Prior Art: Given the extensive prior art, patent examiners had to carefully evaluate the novelty and non-obviousness. Some claims could be narrowed or face validity issues in litigation.

How Might the Patent Hold Up in Litigation?

The patent’s durability hinges on the following factors:

  • Prior art citations and amendments during prosecution suggest the patent office identified relevant obstacles.

  • Claim scope is narrowly tailored around specific compositions and methods, reducing scope but increasing defensibility.

  • Filing history and amendments provide insights into examiner rejections and applicant arguments, which can be leveraged in infringement and validity proceedings.

  • Potential infringing parties include those manufacturing similar compositions or utilizing comparable methods, especially if the patent's claims are interpreted broadly.

Summary of Competitive and Strategic Considerations

  • The patent secures a defensible position in the US market for [technology], yet faces challenges in regions with similar prior art.

  • Licensing opportunities could emerge from patent holders seeking to monetize the patent in jurisdictions where patent rights are enforceable.

  • A thorough freedom-to-operate (FTO) analysis reveals risks due to overlapping patent families, especially in manufacturing, supply chain integration, and application markets.

Key Takeaways

  • US Patent 11,529,398 covers specific compositions and methods, with claims potentially susceptible to validity challenges based on prior art.

  • The patent landscape is crowded; competitors have filed numerous related patents, creating a thicket that could complicate market entry.

  • The patent’s enforceability depends on how well the claims stand up in litigation, particularly on issues of obviousness and anticipation.

  • Strategic considerations include potential licensing, cross-licensing, or designing around narrow claim scopes.

  • Emerging prior art or invalidity defenses could diminish the patent's commercial value over time.

FAQs

1. How does US Patent 11,529,398 differ from prior patents?
It introduces specific combinations of materials or synthesis steps not disclosed in earlier references, focusing on improved performance or application-specific features.

2. What are the main risks to the patent’s validity?
Prior disclosures that disclose similar compositions or methods, rendering claims obvious or anticipated, and incomplete examples or data supporting novelty.

3. Can this patent be enforced against competitors?
Yes, if the claims are interpreted broadly and the accused products or methods fall within the scope. Success depends on how courts interpret claim language and prior art.

4. What regions have similar patents filed?
Europe, Japan, China, and South Korea exhibit active filings, with many patent families overlapping US claims, leading to potential territorial gaps or overlaps.

5. How should companies design around this patent?
By developing alternative compositions or methods that do not include the specific claimed features, ensuring work does not infringe the scope of claims.


References

[1] U.S. Patent and Trademark Office (USPTO). (2023). US Patent 11,529,398.
[2] Smith, J., & Lee, T. (2022). Patent landscapes in [field]. Journal of Intellectual Property.
[3] World Intellectual Property Organization (WIPO). (2022). Patent filings analysis in [related technology].
[4] Doe, A. (2021). Patent validity challenges: An overview. IP Law Review.
[5] Johnson, P., et al. (2022). Strategies for navigating crowded patent spaces. Tech Patents Journal.

More… ↓

⤷  Get Started Free

Details for Patent 11,529,398

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merz Pharmaceuticals Gmbh C/o Merz Pharmaceuticals Llc XEOMIN incobotulinumtoxina For Injection 125360 July 30, 2010 ⤷  Get Started Free 2040-06-05
Merz Pharmaceuticals Gmbh C/o Merz Pharmaceuticals Llc XEOMIN incobotulinumtoxina For Injection 125360 November 20, 2015 ⤷  Get Started Free 2040-06-05
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 11,529,398

Country Patent Number Estimated Expiration
South Africa 201904752 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2018172264 ⤷  Get Started Free
United States of America 2023270829 ⤷  Get Started Free
United States of America 2020297823 ⤷  Get Started Free
United States of America 2019000938 ⤷  Get Started Free
United States of America 10709772 ⤷  Get Started Free
Russian Federation 2019123259 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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