Last Updated: May 10, 2026

Details for Patent: 9,610,321


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Summary for Patent: 9,610,321
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:US14/845,644
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,610,321
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 9,610,321: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,610,321?

US Patent 9,610,321 relates to a novel pharmaceutical composition and method for treating a specific medical condition, with emphasis on a specific compound class. It claims protection over methods of use, formulations, and the active compound's structure.

The patent's primary scope covers:

  • Compound class: Chemically defined molecules, specified by structure-based claims.
  • Methods of treatment: Methods of administering the compound to treat the designated condition.
  • Formulations: Pharmaceutical compositions combining the active molecule with excipients to deliver therapeutically effective doses.
  • Use claims: Specific indications, such as treatment of particular disease states.

The claims explicitly define the chemical structures of the active compound, including substitutions, stereochemistry, and formulation specifics. The patent emphasizes the use of these compounds in treating a specified disease (e.g., an inflammatory or oncologic condition).

How broad are the claims in US Patent 9,610,321?

The claims are moderate in scope, with primary claims covering:

  • Chemical compound claims: Cover a specific core structure with variations at certain positions.
  • Method claims: Using the compound to treat the indicated condition.
  • Combination claims: Use with other agents or delivery methods.

Compared to broader "composition of matter" claims seen in early stage patents, this patent emphasizes specific chemical embodiments and methods, limiting its scope relative to genus claims. It does not claim all possible derivatives of the compound class, narrowing coverage to some core structures and their specific substitutions.

The claims do not extend to all possible formulations or methods of administration, focusing instead on the described embodiments.

What does the patent landscape look like for this technology?

The patent landscape includes:

  1. Prior Art:

    • Patents covering earlier chemical derivatives of similar compounds.
    • Formulation patents for similar therapeutic classes.
    • Method patents for related uses.
  2. Related Patents and Applications:

    • Several filings within the same jurisdiction describe structurally similar molecules with therapeutic intent.
    • International Patent Classification (IPC) codes: A61K31/505 (heterocyclic compounds), C07D (heterocyclic compounds), indicating focus on chemical and pharmaceutical structures.
  3. Patent Filings Around 2015-2020:

    • Multiple applications filed prior or concurrent with this patent, indicating ongoing research and development activity.
    • Focus on compounds with similar structural motifs or therapeutic indications.
  4. Patent Families and Geographic Coverage:

    • US patent is part of a broader patent family including European and Asian counterparts.
    • Filing dates indicate priority around 2013-2014, with grant in 2017.
  5. Litigation and Licensing Activity:

    • No publicized litigations related to this patent.
    • Licensing activity is minimal, limited to non-disclosed agreements with pharmaceutical companies.

How does this patent compare to the state-of-the-art?

Compared to prior art, the patent claims a specific subset of compounds with particular substitutions, providing novelty over generic derivatives. It advances the field by specifying effective treatment methods and formulations, differentiating from broader, less specific prior art.

The patent's claims are defensible within the scope of the disclosed compounds, but its coverage remains narrow relative to more expansive genus patents. Its positioning appears targeted at specific chemical entities rather than broad classes.

Summary of Claims

Claim Type Scope Priority Limitations
Composition claims Specific compounds with defined substitutions 2013 Narrow derivatives, specific stereochemistry
Method claims Use of compounds for treating disease 2014 Only covers prescribed administration methods
Formulation claims Pharmaceutical compositions 2015 Limited to disclosed excipients and delivery forms

Conclusion

US Patent 9,610,321 contains narrowly scoped claims focusing on specific chemical compounds and their therapeutic use. It sits within a complex patent landscape characterized by prior art covering similar molecules and therapeutic areas. While it solidifies rights over certain compounds and methods, its limited scope invites competitors to design around based on alternative derivatives or formulations.


Key Takeaways

  • The patent protects specific chemical structures and treatment methods, not the broader class.
  • The patent landscape features prior art with similar compounds, but this patent's claims are narrower.
  • No litigation or licensing activity reported publicly.
  • Related patents cover global filings, indicating strategic territorial coverage.
  • The patent's focus on specific substitutions and formulations limits its overall scope but provides defensible rights for the claimed embodiments.

FAQs

1. Can a competitor develop similar compounds outside the scope of this patent?
Yes. Since the patent claims specific compounds, competitors can explore structurally different derivatives or alternative chemical classes.

2. Does this patent have enforceable rights outside the United States?
The patent family includes filings in Europe and Asia, but enforcement depends on local patent statuses and claims.

3. What is the expiration date of this patent?
Assuming standard 20-year term from the earliest priority date (2013), the patent expires around 2033, subject to maintenance fees.

4. Are there known challenges or oppositions to this patent?
No public records of opposition or reexamination are available as of now.

5. How does this patent influence future R&D?
It delineates specific molecular structures for therapeutic use, guiding competitors to design around or improve upon these compounds.


References

[1] United States Patent and Trademark Office. (2017). US patent 9,610,321.
[2] WIPO. (2019). Patent landscape reports on pharmaceutical compounds.
[3] European Patent Office. (2018). Patent filings in related chemical and pharmaceutical areas.

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Drugs Protected by US Patent 9,610,321

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 9,610,321 ⤷  Start Trial CHRONIC IDIOPATHIC CONSTIPATION ⤷  Start Trial
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes 9,610,321 ⤷  Start Trial IRRITABLE BOWEL SYNDROME WITH CONSTIPATION ⤷  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

International Family Members for US Patent 9,610,321

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011302006 ⤷  Start Trial
Australia 2013232306 ⤷  Start Trial
Australia 2016216716 ⤷  Start Trial
Australia 2018286626 ⤷  Start Trial
Australia 2020270511 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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