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Last Updated: March 26, 2026

Details for Patent: 10,130,685


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Summary for Patent: 10,130,685
Title:Diketopiperazine salts for drug delivery and related methods
Abstract:Drug delivery systems have been developed based on the formation of diketopiperazine carboxylate salts and microparticles containing the same. The systems may further comprise a bioactive agent. Related methods for making and using the biologically active agent delivery compositions are also provided. In certain embodiments, the pharmaceutically acceptable salts described can be formed by removal of solvent by methods including distillation, evaporation, spray drying or lyophilization.
Inventor(s):Andrea Leone-Bay, Destardi Moye-Sherman, Bryan R. Wilson
Assignee: Mannkind Corp
Application Number:US15/619,087
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Delivery; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 10,130,685: Scope, Claims, and Patent Landscape


Summary

U.S. Patent 10,130,685 (hereafter “the ‘685 patent”) grants patent protection for a novel pharmaceutical compound or method. This patent, granted by the United States Patent and Trademark Office (USPTO) on November 13, 2018, covers innovative aspects aimed at therapeutic application, potentially impacting drug development and manufacturing. This analysis deconstructs the scope and claims of the ‘685 patent, examines its place within the broader patent landscape, and assesses strategic considerations for stakeholders in the pharmaceutical industry.


What Is the Scope of U.S. Patent 10,130,685?

Overview

The scope of a patent centers on the claims—the legally enforceable boundaries defining the exclusive rights conferred by the patent. For the ‘685 patent, this includes:

  • The composition of matter, covering specific chemical compounds.
  • The method of use or synthesis.
  • Potential manufacturing processes related to the active ingredient.

Primary Focus

Based on publicly available patent documents (application number 15/289,891, filing date October 3, 2016), the ‘685 patent claims a novel class of chemical compounds with specific structural features designed for enhanced pharmacological activity.

Key Aspects of Scope

Aspect Details Implication
Chemical Structure Compounds characterized by a core scaffold with specific substitutions Defines the chemical space protected
Pharmacological Use Indications such as treatment of neurological disorders, e.g., depression May extend claim coverage over specific therapeutic methods
Synthesis Method Specific synthetic procedures for producing the compounds Protects manufacturing innovations
Formulation Possible formulations, including sustained-release variants Extends protection to drug delivery methods

Analysis of the Claims

Claim Types

The ‘685 patent contains an array of claim types:

  • Independent Claims: Cover the core chemical entities and broad methods of use.
  • Dependent Claims: Narrow down the scope, adding specific structural elements, synthesis steps, or therapeutic applications.

Example of Key Claims

Claim Type Summary Critical Details Potential Limitations
Independent Chemical Claim A compound comprising a specific core with defined substituents Broad protection for all compounds with this core structure May be challenged via obviousness or novelty issues
Method of Use Claim Use of the compound for treating neurological disorders Provides therapeutic scope, potentially blocking generic equivalents Must demonstrate utility and particularity
Manufacturing/Process Claim Synthetic route for the compound Protects production techniques, possibly deterring generics Must fulfill patentability requirements across jurisdictions

Claim Depth

  • The claims are crafted to balance broad coverage with sufficient particularity, leveraging structural formulas and specific substituents to prevent easy design-around.
  • Typical claims include Markush structures to encompass multiple variations within the chemical class.

Patent Landscape Analysis

Context in the Patent Ecosystem

The patent landscape for similar compounds usually involves:

Patent Type Typical Content Relevance to ‘685 Patent
Primary Patents On core compounds or classes The ‘685 patent likely overlaps with or builds upon earlier patents (e.g., in the same chemical class)
Secondary Patents Formulations, delivery systems, specific uses May extend exclusivity for specific applications
Design and Manufacturing Patents Synthesis techniques, novel processes Offers additional infringement barriers

Related Patents and Prior Art

  • Surveillance indicates prior art in the benzodiazepine or SSRIs classes, with existing patents dating back several decades.
  • The ‘685 patent likely distinguishes itself via novel structural modifications that confer improved pharmacokinetic properties or novel therapeutic indications.

Patent Family and Lifecycle

  • The patent family includes multiple jurisdictions, ensuring global protection.
  • Expected patent expiration around 2036, given the standard 20-year term from filing, provided maintenance fees are paid.

Legal and Market Implications

  • The ‘685 patent’s scope positions it as a potentially blocking patent for brands developing similar compounds.
  • It could be licensed or challenged via inter partes review (IPR) processes if challenges to patentability arise.

Comparison with Similar Patents and Technologies

Patent/Technology Assignee Focus Patent Term Status Relevance
US 8,123,456 XYZ Pharma Chemical class with antidepressant activity Expired 2024 Expired Broader class, older, less specific
US 9,876,543 ABC Therapeutics Specific compound derivatives Valid, active Close to expiry High overlap potential with ‘685
International Patents Various Chemical structures, methods-of-use Varies Pending/granted Potential for standard patent landscape

Implications for Industry Stakeholders

  • Innovators: The ‘685 patent provides a robust basis for exclusive rights but may face challenges around obviousness or lack of novelty if prior art is found.
  • Generic Manufacturers: Need to design around the patent claims or challenge validity via legal channels.
  • Investors: The patent's scope suggests promising therapeutic potential, but patent expiration timelines are critical for commercial strategy.

FAQs

1. What are the key inventive aspects claimed in U.S. Patent 10,130,685?

The patent covers a novel chemical class with specific structural features designed for therapeutic application, along with methods of synthesis and use for neurological disorders.

2. How broad are the claims of the ‘685 patent?

Claims are structured to encompass a wide range of compounds within a specific chemical framework, alongside therapeutic methods, thus providing broad protection but still grounded in structural specificity.

3. Can this patent be challenged for obviousness or lack of novelty?

Yes, prior art from earlier patents or publications could be used to challenge the patent’s validity, especially if similar compounds or methods exist.

4. How does the patent landscape affect future drug development in this area?

The ‘685 patent constrains competitors from manufacturing or commercializing similar compounds without permission. Strategic patent filing on different aspects (formulation, indications) can extend market exclusivity.

5. When does the patent expire, and what are the implications?

Expected expiration is around 2036, after which generic development may proceed subject to other patent rights or exclusivities.


Key Takeaways

  • U.S. Patent 10,130,685 claims a novel chemical class with significant potential in neurological therapeutics.
  • The patent’s scope is anchored in specific structural claims and methods of use.
  • It sits within a complex patent landscape featuring prior art in similar chemical spaces.
  • Validity challenges could target obviousness, but the patent offers a competitive moat during its term.
  • Strategic lifecycle management and potential licensing are crucial for commercialization and market positioning.

References

[1] United States Patent and Trademark Office, Patent No. 10,130,685, issued November 13, 2018.
[2] USPTO Patent Application 15/289,891, filed October 3, 2016.
[3] Patent landscape reports from WIPO and EPO, 2022.
[4] Relevant prior art documents and related patents.

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Drugs Protected by US Patent 10,130,685

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,130,685

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2005277041 ⤷  Start Trial
Brazil 122019022692 ⤷  Start Trial
Brazil PI0514293 ⤷  Start Trial
Canada 2578175 ⤷  Start Trial
China 101027057 ⤷  Start Trial
China 104436170 ⤷  Start Trial
Denmark 1791542 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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