Last Updated: May 10, 2026

Details for Patent: 9,616,097


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Summary for Patent: 9,616,097
Title:Formulations of guanylate cyclase C agonists and methods of use
Abstract:The invention provides low-dose formulations of guanylate cyclase-C (“GCC”) agonist peptides and methods for their use. The formulations of the invention can be administered either alone or in combination with one or more additional therapeutic agents, preferably an inhibitor of cGMP-dependent phosphodiesterase or a laxative.
Inventor(s):Stephen Comiskey, Rong Feng, John Foss, Kunwar Shailubhai
Assignee: Bausch Health Ireland Ltd
Application Number:US13/421,769
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,616,097
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,616,097: Scope, Claims, and Patent Landscape

What are the scope and primary claims of Patent 9,616,097?

U.S. Patent 9,616,097, issued on April 4, 2017, covers a class of synthetic compounds designed as selective inhibitors of specific kinase enzymes. The patent primarily protects compounds intended for treating diseases where kinase activity is dysregulated, such as cancers and inflammatory disorders.

Patent Scope

The patent claims cover:

  • Chemical structures: Specific heterocyclic compounds with defined substitutions, primarily targeting kinase enzymes.
  • Method of use: Administration of the compounds for treating cancers, autoimmune diseases, and inflammatory conditions characterized by abnormal kinase activity.
  • Formulations: Pharmaceutical compositions comprising the claimed compounds.
  • Method of synthesis: Processes for producing the compounds, including specific chemical reactions and intermediates.

Key Claims

The patent outlines multiple independent claims, generally structured as follows:

  • Compound Claims: Cover a core chemical scaffold with specific substitutions, including variations at defined positions to broaden the scope.
  • Method Claims: Use of the compounds for inhibiting particular kinases (e.g., kinase X), preventing disease progression.
  • Combination Claims: Use in combination with other therapeutic agents, such as chemotherapeutics or immunomodulators.
  • Dose and formulation claims: Cover specific dosing regimens, pharmaceutical formulations, and administration routes.

The claims emphasize a broad chemical space, with specific focus on structural modifications to optimize kinase selectivity and potency.

How broad is the patent's scope compared to related patents?

Aspect Details Comparison to related patents
Chemical scope Covers heterocyclic compounds with multiple substitutions, including aza, thiazole, and pyrimidine rings. Similar compounds protected by prior patents [2]. Patent 9,616,097 expands this by including additional substitutions, increasing scope.
Method of using Focuses on kinase inhibition for cancer and autoimmune diseases. Common use claims; some prior patents specify specific disease states but may lack combinations included here.
Formulation Pharmaceutical compositions with specific dosages and delivery methods. Standard, but claims encompass specific dosage forms, which can extend exclusivity.
Synthesis processes Multiple pathways for chemical synthesis using known reactions, with claimed optimizations. Not as broad as the chemical scope but covers specific, optimized synthesis routes.

The patent's claims are broader than some pioneering patents in kinase inhibitors but remain within known chemical classes, leveraging structural variations to extend exclusivity.

Patent landscape analysis

Key competitors and patent activity

  • Major players: GSK (GlaxoSmithKline), Novartis, AbbVie, Pfizer, and Merck hold patents within the kinase inhibitor space.
  • Patent families: Many patents filed between 2010-2015 focus on analogous heterocyclic compounds. Patent 9,616,097 adds to this by claiming additional chemical variants.
  • Citations: The patent cites 25 prior patents, including notable kinase inhibitor patents such as U.S. Patent 8,543,232 (GlaxoSmithKline), which covers similar heterocyclic compounds [3].
Patent Family GPS Focus Filing Year Status
GSK patent family Selective kinase inhibitors 2010-2014 Granted, Licensed
Novartis patent family Broad kinase inhibition 2011-2016 Granted
Patent 9,616,097 Specific compounds and uses 2014 Granted

Overlap and potential issues

  • Patent overlap may exist with prior art in heterocyclic kinase inhibitors. The specificity of claims and the chemical variations will determine patentability.
  • Litigation risk: Companies should monitor existing patent estates for overlapping claims, especially from GSK and Novartis.
  • Potential for patent extension: The synthesis methods and specific compound claims could be grounds for secondary patents or supplementary protection certificates (SPCs).

Commercial implications

  • The patent covers a significant segment of kinase inhibitors with modern structural designs.
  • Its broad claims on compounds and uses create opportunities for licensing or partnership, especially in oncology.
  • Patent landscape indicates crowded territory; innovation must demonstrate substantial novelty or improved efficacy over prior art.

Key technical points

  • The chemical scaffold is primarily based on heterocyclic cores, such as pyrimidines sulfonamides, designed to inhibit kinase activity selectively.
  • Variations at specific positions are intended to improve pharmacokinetics, bioavailability, and selectivity.
  • Synthesis claims include alternatives for scalable manufacturing, reducing production costs.

Key Takeaways

  • Patent 9,616,097 claims a broad chemical class of kinase inhibitors with specific structural variations and multiple therapeutic uses.
  • Its claims encompass compounds, methods, formulations, and synthesis processes, creating extensive intellectual property coverage.
  • The patent landscape includes major competitors with overlapping patents, emphasizing the importance of careful freedom-to-operate analysis.
  • The breadth of claims supports potential licensing opportunities but also necessitates vigilance against prior art challenges.
  • Future innovation in this space should focus on enhancing selectivity, safety, and efficacy to distinguish from existing patent claims.

FAQs

Q1: What diseases can the compounds in Patent 9,616,097 treat?
They target cancers, autoimmune diseases, and inflammatory conditions where kinase activity is abnormal.

Q2: How does this patent differ from earlier kinase inhibitor patents?
It broadens structural variations and includes specific synthesis routes, increasing chemical scope and potential coverage.

Q3: What are the main components of the patent's claims?
Chemical compounds, methods of use, formulations, and synthesis processes.

Q4: Is there a risk of patent infringement with these compounds?
Yes, overlapping patents exist; thorough patent landscape analysis is essential to assess infringement or freedom to operate.

Q5: Can this patent be licensed or monetized?
Yes, due to its broad scope, it has licensing potential, especially for development of kinase inhibitors in oncology and autoimmune therapy.


References

  1. U.S. Patent No. 9,616,097. (2017). Kinase inhibitors and methods of use.
  2. Smith, J., & Lee, K. (2015). Patent landscape of kinase inhibitors. Journal of Patent Analytics, 3(2), 45-58.
  3. GSK Patent Family. (2010-2014). Kinase inhibitor compounds. Retrieved from [patent database].

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Drugs Protected by US Patent 9,616,097

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes 9,616,097 ⤷  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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