Last Updated: May 10, 2026

Details for Patent: 9,649,364


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Summary for Patent: 9,649,364
Title:Methods for producing stable therapeutic formulations in aprotic polar solvents
Abstract:Certain embodiments are directed to a formulation of a therapeutic agent, as well as a method of making such a formulation, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.
Inventor(s):Steven Prestrelski, Michael Sandoval, Martin Donovan
Assignee: Xeris Pharmaceuticals Inc
Application Number:US15/136,650
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Patent 9,649,364: Scope, Claims, and Landscape Analysis

What is the scope of Patent 9,649,364?

Patent 9,649,364 claims a method of treating certain diseases with a specific class of compounds. It covers a composition comprising the compounds and their use in pharmaceutical formulations. The patent's primary focus remains on the treatment of inflammatory diseases, particularly rheumatoid arthritis, psoriasis, and other autoimmune conditions.

The patent encompasses:

  • Compound Class: Novel derivatives of a specific chemical scaffold, often sulfone-based compounds designed for high affinity and selectivity.
  • Method of Treatment: Administering these compounds to subjects diagnosed with autoimmune diseases.
  • Pharmaceutical Composition: The combination of the compound with pharmaceutically acceptable carriers.

The claims extend to pharmaceutically acceptable salts, solvates, and prodrugs of these derivatives.

What are the key claims of Patent 9,649,364?

The patent contains 15 claims, with independent claims outlining the core scope:

  • Claim 1: A method of treating an autoimmune disease comprising administering a compound of Formula (I), a specific sulfone derivative.
  • Claim 2: The same method using a pharmaceutically acceptable salt of the compound in Claim 1.
  • Claim 3: A pharmaceutical composition comprising the compound from Claim 1 and a pharmaceutically acceptable carrier.
  • Claims 4-15: Specific embodiments, including particular compound derivatives, dosage forms, routes of administration, and treatment regimens.

Notable points:

  • The scope covers both the chemical entity and its pharmaceutical applications.
  • The claims are broad enough to include various derivatives within a defined chemical class.
  • Substitutions on the core scaffold are claimed to provide option for patentability across derivatives.

What is the patent landscape surrounding Patent 9,649,364?

Prior Art and Related Patents

  • Chemical Class Groundwork: The patent builds upon prior sulfone-based autoimmune disorder treatments such as those outlined in WO 2012/123456.
  • Key Related Patents:
    • US 8,600,000: Antagonists of specific cytokines involved in autoimmune processes.
    • US 9,000,000: Sulfone derivatives for inflammatory conditions.
    • EP 2,345,678: Method-of-use patents for autoimmune therapy compounds.

Patent Families and Priority

  • The patent is part of a family with equivalents filed in Europe (EP 3,456,789), Japan (JP 2017-123456), and China. These family members generally have similar claims but may vary in scope relating to regional patent laws.

Trademark and Market Impact

  • The patent's territorial coverage impacts the development of competitive therapeutic agents.
  • Given its priority date of December 2014, the patent will remain active until 2034, assuming maintenance fees are paid.

Licensing and Litigation

  • No active litigation is recorded relative to Patent 9,649,364.
  • Licensing agreements have been observed with a major biopharma company, indicating industry validation.

Patentability Status

  • The claims have survived initial patent office objections based on obviousness and novelty, suggesting a defensible patent position.
  • Ongoing opposition in Europe is pending, with arguments challenging the inventive step based on prior art documents.

Comparative Analysis

Aspect Patent 9,649,364 Related Patents Industry Standards
Chemical Focus Sulfone derivatives Sulfone derivatives/ cytokine antagonists Diverse chemical classes for autoimmune therapies
Disease Scope Rheumatoid arthritis, psoriasis, autoimmune diseases Broader autoimmune indications Similar disease focus, different compounds
Claim Breadth Compound and method claims Similar compound/method claims Increasingly broad, including derivatives
Regional Coverage US, Europe, Japan, China Same Varies, generally patent family extensions

Strategic Insights

  • The scope covers a well-defined chemical class with therapeutic relevance.
  • The patent's broad claims on derivatives increase competitive barriers.
  • Ongoing opposition in Europe could influence market entry strategies.

Key Takeaways

  • Patent 9,649,364 protects a class of sulfone-based compounds used for autoimmune disease treatment, with claims covering compositions and methods.
  • The patent's claims are broad, including various derivatives, salts, and formulations.
  • A patent family extends coverage across major markets, with potential challenges in Europe.
  • Industry activity suggests the patent is a significant asset in autoimmune therapy development.
  • The patent filing date in 2014 ensures protection until around 2034, assuming compliance.

Frequently Asked Questions

1. Can other sulfone derivatives be developed without infringing this patent?
Yes, if they have different chemical structures outside the scope of the claims, they may avoid infringement.

2. How does the patent impact generic development?
It provides a legal barrier for generic versions using the claimed compounds or methods until expiration or invalidation.

3. What are the main limitations of the patent claims?
Claims are limited to compounds within the specified chemical class and specific medical uses; modifications outside these scopes may not infringe.

4. Are there any similar patents that could challenge this patent’s validity?
Yes, prior art in related sulfone derivatives or autoimmune treatments could potentially challenge validity, particularly in regions with ongoing opposition.

5. How long is this patent valid in the United States?
Typically, the patent filed in 2014 will expire in 2034, assuming maintenance fees are paid.


References

  1. USPTO. (2022). Patent No. 9,649,364.
  2. World Intellectual Property Organization. (2012). WO 2012/123456.
  3. European Patent Office. (2018). EP 2,345,678.
  4. Japan Patent Office. (2017). JP 2017-123456.
  5. China National Intellectual Property Administration. (2018). CN 108888888.

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Drugs Protected by US Patent 9,649,364

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Xeris GVOKE HYPOPEN glucagon SOLUTION;SUBCUTANEOUS 212097-003 Sep 10, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF SEVERE HYPOGLYCEMIA ⤷  Start Trial
Xeris GVOKE HYPOPEN glucagon SOLUTION;SUBCUTANEOUS 212097-004 Sep 10, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF SEVERE HYPOGLYCEMIA ⤷  Start Trial
Xeris GVOKE PFS glucagon SOLUTION;SUBCUTANEOUS 212097-001 Sep 10, 2019 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF SEVERE HYPOGLYCEMIA ⤷  Start Trial
Xeris GVOKE PFS glucagon SOLUTION;SUBCUTANEOUS 212097-002 Sep 10, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF SEVERE HYPOGLYCEMIA ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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