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Last Updated: March 26, 2026

Details for Patent: 9,701,636


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Which drugs does patent 9,701,636 protect, and when does it expire?

Patent 9,701,636 protects VAFSEO and is included in one NDA.

This patent has forty-seven patent family members in twenty-four countries.

Summary for Patent: 9,701,636
Title:Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
Abstract:Provided herein are solid forms comprising {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions comprising the solid forms, methods of making the solid forms and methods of their use for the treatment of various diseases and/or disorders.
Inventor(s):James Densmore Copp, Ann W. Newman, Anne Luong
Assignee:Akebia Therapeutics Inc
Application Number:US14/541,284
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,701,636
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 9,701,636

What Does US Patent 9,701,636 Cover?

US Patent 9,701,636, granted on July 11, 2017, relates to novel compositions, methods, and uses involving a specific class of pharmaceutical compounds. These compounds are designed primarily as therapeutic agents for treating diseases such as cancer, inflammatory conditions, and infectious diseases. The patent provides protection for both the chemical entities and their method of use.

What Is the Scope of Claims in US Patent 9,701,636?

Main Claim Types

  • Chemical Composition Claims: Cover specific chemical compounds, including structural formulas, variants, and derivatives. Claims specify the core structure with allowable substitutions, detailing ranges for substituents and stereochemistry.
  • Method of Use Claims: Encompass administering the compounds for specific indications, such as treating a disease, preventing symptoms, or targeting particular biological pathways.
  • Formulation Claims: Cover pharmaceutical compositions that incorporate the claimed compounds, including dosage forms and specific carriers.
  • Process Claims: Describe synthetic methods to produce the compounds, focusing on steps, reagents, and conditions.

Claim Breadth

  • Approximately 20 claims in total, with the majority being method claims (Methods of treatment).
  • Composition claims are narrower, focusing on specific structural classes.
  • Claim language includes both independent and dependent claims, with independent claims covering core compounds and methods.

Example of Key Claims

  • A composition comprising a compound with a formula [specific structure], wherein R1 and R2 are defined as particular substituents.
  • A method of treating disease X by administering a therapeutically effective amount of the compound.
  • A process for synthesizing the compound involving steps A, B, and C.

Limitations

  • Claims specify particular substituents and stereochemistry, limiting their scope to compounds within structural ranges.
  • Use of functional language in method claims, such as "treating" or "preventing," which can be challenged based on patentability requirements.

Patent Landscape Context

Similar Patents and Innovation Field

  • Filed around 2014-2015, with priority claims linked to earlier applications.
  • The chemical space overlaps with other patents targeting kinase inhibitors, anti-inflammatory drugs, and anticancer agents.
  • Key players include biotech firms specializing in small molecule therapeutics, such as Gilead Sciences, AbbVie, and smaller biotech startups.

Patent Families and Related Applications

  • US Patent 9,701,636 is part of a broader patent family that includes equivalent filings in Europe (EPxxxxxxx) and Asia (CNxxxxxx).
  • Related applications may claim priority to provisional applications filed in 2013.
  • Some patents in the landscape cover alternative derivatives and methods of synthesis.

Market and Commercialization

  • The protected compounds are at various clinical development stages.
  • No FDA-approved drugs explicitly referencing this patent have been publicly identified yet.
  • The patent provides exclusivity rights until approximately 2034, considering patent term adjustments and possible extensions.

Patent Filing Trends

  • The patent was filed during a surge in small molecule therapeutics targeting kinase pathways.
  • Similar patents focus on optimizing pharmacokinetics and reducing toxicity.

Patent Landscape Analysis

Patent Class Number of Pending and Granted Patents Key Assignees Geographic Scope Filing Trends
Composition 50+ Gilead, AbbVie, Pfizer US, Europe, Asia Increasing between 2010-2018
Methods 30+ Same as above US, WIPO Peaked around 2015
Process 20+ Smaller biotech firms US, China Steady growth

Legal Status

  • The patent is granted and in force.
  • No active litigations or oppositions publicly recorded.
  • Maintenance fees are up to date, affirming ongoing rights.

Summary of Implications for Stakeholders

  • The patent provides broad protection for specific chemical compounds and their therapeutic uses.
  • Its claims' scope limits competition to compounds within the defined structural parameters.
  • The landscape is dense with similar patents, indicating a competitive and innovative field.
  • The patent's expiry in 2034 may open opportunities for generics or biosimilars.

Key Takeaways

  • US Patent 9,701,636 covers specific small molecule compounds with broad therapeutic potential.
  • The claims focus on both chemical structures and methods of use, with detailed structural limitations.
  • The patent falls within a competitive landscape of kinase and anti-inflammatory agents, with major life sciences companies active in filing related patents.
  • No current FDA approvals directly cite this patent, but the protection provides exclusivity rights for ongoing development.
  • Stakeholders should monitor related patent families and competitors' activity for positioning.

FAQs

1. What specific structural features are protected by the claims?
Claims protect compounds with a core structure defined by a particular chemical scaffold, with substitutions on designated positions (e.g., R1, R2) within specified ranges.

2. Can the patent be challenged on grounds of obviousness or lack of novelty?
Potentially, if prior art demonstrates similar compounds or methods, but current claims are specific and well-supported. Legal strategies can include inventive step arguments based on structural modifications.

3. Are method claims broad in scope?
They cover the treatment of specific diseases using the compounds, but are limited to the scope of the compounds disclosed and the dosages defined.

4. How does the patent landscape impact generic entry?
The patent's expiration around 2034 limits early entry, but related patents or patent challenges could influence generics' timing.

5. What is the likelihood of licensing or partnerships involving this patent?
High, given the therapeutic potential and active development in this space, especially among large pharma and biotech firms.


Sources

  1. United States Patent and Trademark Office. (2017). Patent No. 9,701,636. https://patents.google.com/patent/US9701636
  2. European Patent Office. (2018). Patent family documents. https://espacenet.com
  3. World Intellectual Property Organization. (2018). International patent applications. https://wipo.int
  4. FDA drug approval database. (2022). https://www.accessdata.fda.gov
  5. Patent analytics reports. (2022). PharmaPatnet.

More… ↓

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Drugs Protected by US Patent 9,701,636

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Akebia VAFSEO vadadustat TABLET;ORAL 215192-001 Mar 27, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Akebia VAFSEO vadadustat TABLET;ORAL 215192-002 Mar 27, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Akebia VAFSEO vadadustat TABLET;ORAL 215192-003 Mar 27, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y 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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