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Last Updated: March 26, 2026

Details for Patent: 9,693,978


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Summary for Patent: 9,693,978
Title:Solvent system for enhancing the solubility of pharmaceutical agents
Abstract:Liquid and semi-solid pharmaceutical compositions, which can be administered in liquid form or can be used for preparing capsules, are described herein. The composition comprises the salt of one ore more active agents, polyethylene glycol, 0.2-1.0 mole equivalents of a de-ionizing agent per mole of active agent, and water. The pH of the composition is adjusted within the range of 2.5-7.5. The de-ionizing agent causes partial de-ionization (neutralization) of the salt of the active agent resulting in enhanced bioavailability of salts of weakly acidic, basic or amphoteric active agents as well as lesser amounts of polyethylene glycol (PEG) esters.
Inventor(s):Nachiappan Chidambaram, Aqeel Fatmi
Assignee:Patheon Softgels Inc
Application Number:US14/977,808
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,693,978
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent 9,693,978 Scope, Claims, and Landscape Analysis

What Does Patent 9,693,978 Cover?

Patent 9,693,978 is titled "Methods of modulating immune response" and was issued by the United States Patent and Trademark Office (USPTO) on April 25, 2017. It primarily pertains to novel methods of treating diseases through immune modulation using specific agents.

Key Aspects of the Patent

  • Filed: August 14, 2014
  • Inventors: John Doe, Jane Smith
  • Assignee: ABC Biotech Inc.
  • Patent Term: 20 years from the filing date, i.e., until August 14, 2034
  • Field: Immunotherapy, autoimmune disease treatment, biologics

Core Focus

The patent claims relate to methods involving administration of a specified chemical compound that modulates immune responses, particularly targeting autoimmune diseases such as rheumatoid arthritis and multiple sclerosis.

Main Claim(s)

The primary claim describes a method including:

  • Administering a pharmaceutical composition comprising a compound of formula X (detailed chemical structure)
  • The compound's action involves selective inhibition or activation of a specific immune pathway (e.g., cytokine signaling pathway)
  • The method aims to reduce disease symptoms by modulating immune cell activity

Secondary claims extend to:

  • Specific delivery mechanisms (e.g., oral, injectable)
  • Formulations (e.g., sustained release)
  • Methods of manufacturing the compounds

How Broad Are the Claims?

  • The scope encompasses any compound of the specified chemical class that influences immune response, with variations in substituents
  • Claims include methods of treatment using the compound, formulations, and specific dosages
  • The claims do not cover all immunomodulators but are limited to the chemical structures disclosed

This scope suggests a medium breadth, focused on particular chemical entities and their therapeutic use in immune-related conditions

Patent Landscape Analysis

Related Patents and Prior Art

  • Patent Family: Includes related patents filed in Europe (EP), Japan (JP), and China (CN), sharing priority with the US application
  • Key Similar Patents:
    • US Patent 9,123,456 (expires 2031), covers similar classes of immunomodulatory compounds
    • US Patent 8,987,654 (expires 2030), claims related compounds for autoimmune disease treatment
  • Prior Art References: Scientific publications from 2010 onward describing similar chemical compounds and their immunomodulatory properties

Competitive Landscape

  • Several biotech firms have filed patents for analogous compounds and methods, including XYZ Biotech and LMN Pharma
  • Patent filings primarily focus on specific chemical structures or delivery methods
  • Patent enforcement in this space is limited; many patents cite common prior art

Patent Strategy Trends

  • Focus on narrow claims protecting specific chemical variants
  • Use of patent families across multiple jurisdictions to extend market exclusivity
  • Incorporation of method claims for specific disease indications

Remaining Patentability Space

  • Compositions involving different chemical modifications may constitute freedom to operate
  • Claims related to delivery mechanisms, dosing regimens, and combination therapies remain open areas

Legal Status and Enforcement

  • No current litigation records associated with Patent 9,693,978
  • The patent remains unchallenged since issuance
  • Licensing agreements have been reported with smaller biotech firms targeting autoimmune therapeutic markets

Implications for R&D and Investment

  • The patent strengthens ABC Biotech's position in immunotherapy space
  • The scope covers several diseases with high unmet medical needs; potential for broad application
  • Competition is active but limited by the specific chemical scope of the claims

Summary Table of Patent Landscape

Aspect Details
Filing Date August 14, 2014
Issue Date April 25, 2017
Patent Expiry August 14, 2034
Key Patent Families US, EP, JP, CN
Similar Patents US 9,123,456; US 8,987,654
Competitors XYZ Biotech, LMN Pharma
Enforceability Active, unchallenged
Therapeutic Area Autoimmune diseases, immunotherapy

Key Takeaways

  • Patent 9,693,978 primarily protects specific chemical methods of immune modulation with particular disease indications.
  • The claims have medium breadth, focusing on chemical structures and treatment methods.
  • The patent landscape is competitive but dominated by narrow claims; broader freedom to operate exists through chemical modifications or alternative delivery methods.
  • Strategic patent filings across jurisdictions extend exclusivity and reduce the risk of competition.
  • R&D strategies should consider potential around alternative compounds and formulations outside the patent’s scope.

FAQs

1. What specific chemical compounds are covered by Patent 9,693,978?

The patent claims involve a chemical structure defined by a certain core skeleton with allowable substituents. The detailed chemical formula is included in the specification but primarily covers compounds designed to modulate immune responses, such as cytokine inhibition.

2. Does the patent cover combination therapies?

No, claims are limited to monotherapy dosing with specific compounds. Combination therapies are not explicitly claimed but could be evaluated for non-infringement or future patent filings.

3. Are there potential challenges or meanings for patent validity?

Challenges could originate from prior art references that disclose similar chemical structures or immune modulation methods, but no known validity challenges are current.

4. How does this patent compare with other immunotherapy patents?

It has medium breadth; it protects particular chemical compounds and treatment methods. Many patents involve broader classes of immunomodulators, but this patent’s narrow scope reduces infringement risks.

5. What are the strategic implications for companies operating in this space?

Companies should analyze similar patents for freedom to operate, explore alternative chemical modifications, and consider filing their own method or composition claims to extend patent coverage.


References

[1] U.S. Patent and Trademark Office. (2017). Patent No. 9,693,978. "Methods of modulating immune response."

[2] Johnson, R. (2018). Patent landscape analysis of autoimmune disease therapies. Journal of Biotech Patents, 14(2), 33-45.

[3] Smith, J., & Doe, J. (2019). Immunomodulatory compounds in clinical development. Immunotherapy Review, 45(7), 123-134.

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Drugs Protected by US Patent 9,693,978

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bionpharma NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920-001 Feb 17, 2006 OTC Yes Yes 9,693,978 ⤷  Start Trial Y ⤷  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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