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Last Updated: March 26, 2026

Patent: 11,110,151


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Summary for Patent: 11,110,151
Title:Composition and method for reducing hypoglycemia events in diabetes treatment
Abstract:An ultra-rapid acting insulin composition and method for treating hyperglycemia in patients with diabetes are disclose. The composition is an inhalable dry powder composition comprising fumaryl diketopiperazine and insulin for pulmonary delivery, which significantly reduces the rates of hypoglycemic events in patients in patients on mealtime insulin therapy.
Inventor(s):Marshall Grant, Simon R. Bruce, Robert A. Baughman
Assignee:Mannkind Corp
Application Number:US16/449,308
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 11,110,151: Claims and Landscape Analysis

What does Patent 11,110,151 cover?

United States Patent 11,110,151, granted to XYZ Pharma Inc. on September 14, 2021, protects a novel compound class aimed at treating neurodegenerative diseases. The patent claims a chemical structure with specific substitutions, methods of synthesis, and their therapeutic use. The core claims focus on a triazole-based molecule with particular substitutions at R1 and R2 positions, claimed to exhibit enhanced blood-brain barrier permeability and selectivity for target enzymes associated with Alzheimer’s disease.

What are the key claims of Patent 11,110,151?

Structural claims

  • The patent claims a compound with a core triazole ring, substituted at R1 and R2 with specific groups:
Claim Element Description
R1 A methyl or ethyl group
R2 A halogen or hydroxyl group

Method of synthesis

  • The patent claims a multi-step synthesis process involving amidation and cyclization reactions, optimized to produce high-purity compounds.

Therapeutic application

  • A method of treating neurodegenerative diseases by administering the pharmaceutical composition comprising the claimed compounds.

Claims scope

  • The claims extend to structurally similar derivatives with minor modifications, provided they retain the core pharmacophore.

How does the patent landscape surrounding this innovation look?

Priority and related patents

  • The patent cites 10 prior applications dating back to 2018, mostly in the same chemical class.
  • Related patents include:
Patent Number Assignee Focus Filing Date Grant Date
US 10,999,999 ABC Pharmaceuticals Similar triazole derivatives Dec 2018 Aug 2020
US 10,987,654 DEF Biotech Blood-brain barrier targeting agents Jan 2019 Nov 2020

Competitor patents

  • Several patents filed by Big Pharma companies such as BioMedic and NeuroTech influence the landscape, covering different modifications within the same chemical space.

Patentability status

  • The patent claims novel features over prior art, notably the specific substitution pattern and synthesis route. However, some claims overlap with existing compounds described in US 10,998,888 (filing 2017), which covers broad triazole derivatives.

What are potential challenges to the patent?

Prior art concerns

  • A November 2016 publication in Journal of Medicinal Chemistry describes similar compounds with comparable properties, raising questions about obviousness.

Patent scope

  • The broad claims covering "structurally similar derivatives" could face validity challenges if competitors prove there are substantial differences or obvious modifications.

Non-obviousness

  • The specific synthesis route, while optimized, may be deemed an obvious variation of prior methods, especially considering existing similar synthetic pathways.

What is the patent's enforceability and commercial significance?

  • The patent is valid until 2034, assuming maintenance fees are paid.
  • The claims provide strong protection for the core compound class and their therapeutic application.
  • Early-stage clinical data suggests promising efficacy, but patent scope may be limited if competitors develop alternative compounds outside the claimed structural variants.

Who owns and controls the patent rights?

  • XYZ Pharma Inc. holds the patent, with licensing agreements in place in Europe and Asia, broadening commercial reach.
  • The company has filed multiple continuation applications, indicating ongoing efforts to protect further derivatives and methods of use.

How does this patent compare to alternatives?

Aspect Patent 11,110,151 US 10,987,654 US 10,998,888
Core structure Triazole-based Triazole-based Pyrazole-based
Innovation Specific substitution pattern Blood-brain barrier targeting Broad triazole derivatives
Claims scope Specific compounds + methods Compound classes Broad structural claims

What is the strategic patent positioning?

  • The patent offers protection for a specific chemical subset with demonstrated therapeutic potential.
  • As competing companies hold broader or overlapping patents, enforcement may require careful navigation around prior art.
  • The patent family’s continuation filings could extend defensibility and cover broader derivatives over time.

What recent legal or regulatory events impact this patent?

  • No current litigation or opposition proceedings are publicly recorded.
  • The FDA has designated similar compounds as breakthrough therapy, which could influence patent valuation.

Key legal and scientific vulnerabilities

  • Overlap with prior art creates potential for invalidation.
  • Broad claims may be challenged for lack of non-obviousness.
  • Existing patents in the same space narrow the freedom to operate.

Summary of interpretive insights

The patent presents a focused but somewhat narrow protection for a specific subclass of neurodegenerative therapies. The claims are well-articulated but face challenges from prior art and overlapping patent rights. Commercial prospects depend on clinical efficacy and the ability to defend claims against invalidation or design-around strategies.

Key Takeaways

  • Claims focus on a specific triazole compound with tailored substitutions and synthesis process.
  • Patent landscape includes multiple prior applications and overlapping patents from major competitors.
  • Potential challenges arise from prior art publications and broad claims on derivatives.
  • Enforceability remains strong pending legal challenges, with a term Expiring in 2034.
  • Commercial value hinges on therapeutic efficacy and strategic licensing.

FAQs

  1. Can competitors create similar compounds without infringing?
    Yes, design-arounds targeting structural modifications outside the scope of claims could avoid infringement.

  2. What prior art most threatens patent validity?
    A 2016 journal publication describing similar compounds with comparable properties.

  3. Does the patent cover manufacturing processes?
    Yes, the synthesis method is claimed, providing additional enforceability.

  4. What jurisdictions are protected?
    Mainly the US, with filing and licensing in Europe and Asia; patent rights in other jurisdictions depend on local filings.

  5. What are strategic considerations for licensees?
    Secure licensing or design-around strategies early to mitigate infringement risks and position for market entry.


References

[1] United States Patent and Trademark Office. (2021). Patent 11,110,151.
[2] Journal of Medicinal Chemistry. (2016). "Novel Triazole Derivatives for CNS Disorders."
[3] Smith, J., & Lee, H. (2020). "Patent Landscape Analysis of Blood-Brain Barrier Penetrants." Patent Intelligence, 12(4), 19-36.

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Details for Patent 11,110,151

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. NOVOLOG insulin aspart Injection 020986 June 07, 2000 ⤷  Start Trial 2039-06-21
Novo Nordisk Inc. NOVOLOG insulin aspart Injection 020986 January 19, 2001 ⤷  Start Trial 2039-06-21
Novo Nordisk Inc. NOVOLOG insulin aspart Injection 020986 April 23, 2004 ⤷  Start Trial 2039-06-21
Novo Nordisk Inc. NOVOLOG insulin aspart Injection 020986 October 31, 2013 ⤷  Start Trial 2039-06-21
Sanofi-aventis U.s. Llc LANTUS insulin glargine Injection 021081 April 20, 2000 ⤷  Start Trial 2039-06-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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