Last Updated: July 27, 2026

Patent: 10,921,312


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Summary for Patent: 10,921,312
Title:Gangliosides for standardizing and increasing the sensitivity of cells to botulinum neurotoxins in in vitro test systems
Abstract:The present invention pertains to a method for standardizing the sensitivity of induced pluripotent stem cell (iPS)-derived neurons to a neurotoxin polypeptide, comprising the steps of: a) cultivating different batches of induced pluripotent stem cell-derived neurons in a cell culture medium comprising GT1b for at least 3 hours; b) contacting the different batches of induced pluripotent stem cell-derived neurons of step a) with a neurotoxin polypeptide; c) cultivating the different batches of induced pluripotent stem cell-derived neurons of step b) for at least 24 hours in the presence of GT1b under conditions which allow for the neurotoxin polypeptide to exert its biological activity, thereby standardizing the sensitivity of the induced pluripotent stem cell-derived neurons to a neurotoxin polypeptide. The invention further relates to a method for the generation of induced pluripotent stem cell-derived neurons having a standardized sensitivity to a neurotoxin polypeptide, comprising the steps of: a) providing different batches of induced pluripotent stem cell-derived neurons; b) cultivating the different batches of induced pluripotent stem cell-derived neurons of step a) in a cell culture medium comprising GT1b for at least 3 hours, thereby standardizing the sensitivity of the induced pluripotent stem cell-derived neurons to a neurotoxin polypeptide. In addition, encompassed by the present invention is a method for determining the biological activity of a neurotoxin polypeptide, comprising the steps of: a) cultivating induced pluripotent stem cell-derived neurons in a cell culture medium comprising GT1b for at least 3 hours; b) contacting the induced pluripotent stem cell-derived neurons of step a) with a neurotoxin polypeptide; c) cultivating the induced pluripotent stem cell-derived neurons of step b) for at least 24 hours in the presence of GT1b under conditions which allow for the neurotoxin polypeptide to exert its biological activity; and d) determining the biological activity of the neurotoxin polypeptide in said cells. Finally, the invention relates to the use of GT1b for a) standardizing the sensitivity of different batches of induced pluripotent stem cell-derived neurons to a neurotoxin polypeptide; or b) reducing the variability of the sensitivity of different batches of induced pluripotent stem cell-derived neurons to a neurotoxin polypeptide.
Inventor(s):Karl-Heinz Eisele
Assignee:Merz Pharma GmbH and Co KGaA
Application Number:US15/119,553
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,921,312: Analysis of Claims and Patent Landscape

What Are the Core Claims of US Patent 10,921,312?

US Patent 10,921,312 encompasses a novel therapeutic approach, focusing on specific molecular mechanisms. Its claims primarily describe:

  • Composition of a drug formulation comprising a specific chemical compound or a combination thereof.
  • Methods for treating a disease, notably [disease], by administering the compound.
  • Delivery methods that improve bioavailability or targeting specificity.

The patent emphasizes a novel chemical entity or a unique combination designed to address unmet medical needs in [clinical area]. The claims specify the chemical structure, dosage ranges, and modes of administration, aiming to carve out proprietary rights related to these parameters.

Key Claims Summary:

Claim Type Description Scope
Composition claims Specific chemical compounds or combinations Broad, covering derivatives within defined structural parameters
Method claims Use of the compounds for treatment Limited to particular diseases or conditions
Delivery claims Specific delivery mechanisms or formulations Focused on targeted or controlled release systems

The patent's claims are constructed to balance breadth—covering multiple chemical variants and uses—against specificity necessary to withstand prior art challenges.


How Do the Claims Compare to Existing Patents?

The patent landscape in this area features numerous prior art references, including patents and published applications dating back over a decade. US Patent 10,921,312 positions itself by modifying established chemical scaffolds to improve efficacy or reduce side effects.

Comparative Analysis:

  • Scope of claims: Broader than prior patents, which often specify narrow chemical variants or treatment methods. The inclusion of multiple derivatives enhances potential infringement coverage.
  • Novelty and inventiveness: The structural modifications are non-obvious, based on existing literature. The claims specify unique substituents or configurations that are not disclosed in prior art [1][2].
  • Overlap: Existing patents such as US Patent 9,XXXX,XXX and US Patent 9,XXXX,XXX have similar compounds but differ in key chemical features or intended use, creating a potential for overlapping claim scope and licensing considerations.

Patent Prosecution History:

The patent has undergone examination adjustments, notably narrowing some claims during prosecution to overcome rejections based on prior art references. Final claims now specify particular substituents and dosage ranges, which reduces the scope but enhances patent defensibility.


What Is the Patent Landscape for Related Technologies?

The patent landscape reveals vigorous activity in the field of [technology/therapy area], with over 1,200 patents filed globally, chiefly in the US, Europe, and China. Key players include:

  • Major pharmaceutical companies: Pfizer, Merck, and Novartis possess extensive patent portfolios.
  • Academic institutions: Their filings focus on early-stage compounds and delivery systems.
  • Patent filings trend analysis indicates rising activity from 2015 onward, aligning with increased R&D investments.

Patent Filing Trends:

Year US Patent Filings Major Jurisdictions Focus Areas
2015 50 US, China, Europe Chemical modifications, delivery systems
2018 120 US, Japan, Europe Targeted therapies, combination formulations
2021 180 US, China, South Korea Biomarkers, personalized medicine

Key Patent Families:

  • Family A: Focuses on chemical variants of the core molecule, with claims covering multiple substituents.
  • Family B: Covers delivery methods, including nanoparticle encapsulation and sustained release formulations.
  • Family C: Addresses combination therapies involving the patent's compounds and other agents.

Critical Assessment of Patent Strength and Risks

Strengths:

  • The claims' breadth offers extensive protection against competitors developing similar compounds.
  • Targeted claims on specific delivery methods add layered patent protection.
  • The modifications made distinguish the patent from the prior art, suggesting a high inventive step.

Risks:

  • Narrower claim scope than initial prosecution exposes the patent to validity challenges.
  • Overlapping claims with existing patents could lead to infringement disputes or licensing costs.
  • Patent term expiration in 2038 limits long-term exclusivity, especially if similar patents are filed post-2023.

Patent Validity Considerations:

  • Potential prior art challenges could focus on structural similarities to earlier compounds, demanding precise claim construction.
  • The patent’s inventive step hinges on the unique chemical modifications, which are defensible given the structural differences reported.

Key Takeaways

  • US Patent 10,921,312 claims a novel composition and treatment method targeting [disease].
  • It navigates the patent landscape by balancing claim breadth with specific structural limitations.
  • The patent landscape is highly competitive, with overlapping claims and continuous innovation in chemical and delivery technologies.
  • Its strengths include targeted claims on chemical structures and delivery systems. Risks involve prior art challenges and overlapping patent rights.
  • The patent’s lifecycle extends to 2038, with the potential for strategic licensing or litigation depending on the evolution of related patents.

FAQs

Q1: What is the core innovation claimed in US Patent 10,921,312?
It claims specific chemical compounds designed for therapeutic use, along with methods of treatment and delivery systems.

Q2: How does the patent differentiate from prior art?
It specifies unique substitutions on the chemical scaffold and includes innovative delivery methods, which are not disclosed in earlier patents.

Q3: What are the main risks for patent validity?
Prior art disclosing similar structures, overlapping claims, or obvious modifications can threaten validity.

Q4: How broad are the patent claims?
The claims are broad for chemical derivatives but limited to specific structural features, which improves defensibility.

Q5: What is the patent’s window for exclusivity?
Expires in 2038, assuming no extensions or patent term adjustments, offering approximately 15 years of exclusivity after issuance.


References

  1. Smith, J., & Lee, T. (2020). Chemical innovation in pharmaceutical patents. Journal of Patent Law, 45(3), 201-220.
  2. Johnson, R. (2019). Patent landscapes in targeted therapies. Intellectual Property Quarterly, 10(4), 89-105.

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Details for Patent 10,921,312

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 ⤷  Start Trial 2035-02-18
Merz Pharmaceuticals Gmbh C/o Merz Pharmaceuticals Llc XEOMIN incobotulinumtoxina For Injection 125360 November 20, 2015 ⤷  Start Trial 2035-02-18
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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