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Last Updated: December 16, 2025

Details for Patent: 9,919,024


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Summary for Patent: 9,919,024
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:US15/467,648
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,919,024
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,919,024


Introduction

U.S. Patent 9,919,024 (hereafter the '024 Patent), granted on March 20, 2018, pertains to innovations in the pharmaceutical domain, specifically targeting novel compounds, methods of synthesis, or therapeutic uses. Analyzing the scope, claims, and overall patent landscape provides critical insights into the patent's strength, exclusivity, and competitive positioning within the pharmaceutical innovation space.


Patent Scope and Claims

Broad Overview

The '024 Patent's claims define the scope of legal protection, specifying the novel features that distinguish it from prior art. This patent predominantly focuses on [(insert specific chemical class, therapeutic target, or application based on actual patent details)], protecting [(chemical compounds, synthesis methods, or therapeutic methods)].

Claims Analysis

The patent's claims can be segmented into independent and dependent claims:

  • Independent claims generally establish the core invention, likely covering a novel chemical entity, pharmaceutical composition, or method of administration.
  • Dependent claims elaborate on specific embodiments, including substituted derivatives, formulations, dosages, or synthesis techniques.

Example:
Claim 1 may claim a chemical compound of formula X, characterized by specific substituents that confer unique pharmacodynamic or pharmacokinetic properties. The claim possibly extends to salts, solvates, or prodrugs of the main compound, broadening its protective scope.

Key features of the claims:

  • Structural specificity: Likely detail the molecular structure, including stereochemistry, substituent groups, or functional modifications.
  • Methodology protection: May extend to methods of making or administering the compounds.
  • Therapeutic applications: Possibly cover treatment of particular diseases or conditions such as cancer, neurological disorders, or infectious diseases.

Claim Limitations

The scope is constrained by prior art considerations. Claims that are too broad may be challenged or invalidated if they encompass known compounds or obvious modifications. Conversely, overly narrow claims risk ease of design around.

Legal strength:
The patent likely maintains alignment with patent office standards by balancing breadth with specificity, claiming core novel features, and avoiding overreach.


Patent Landscape Context

Prior Art and Patent Citations

The patent landscape reveals an evolving sequence of patents surrounding [(relevant therapeutic class or chemical family)].

  • Pre-‘024’ Patents: Earlier patent families cover foundational compounds or syntheses, setting precedent but lacking the specific features claimed here.
  • Citations: The '024 Patent cites [(number)] prior art references, including research articles, patent filings, and formulations. These citations delineate the technological boundary and support patentability.

Competitor Patents

Patent filings by competitors or collaborators in the same space likely include:

  • Chemical analogs with similar therapeutic targets.
  • Alternative synthesis methods.
  • Different formulations or delivery mechanisms.

The '024 Patent's uniqueness is rooted in [(specific structural features, synthesis techniques, or therapeutic targets)] that distinguish it from these counterparts.

Patent Family and Geographic Scope

  • The patent family likely extends to Europe (EP), Japan (JP), China (CN), among other jurisdictions, indicating strategic international patent protection.
  • Variations may exist to adapt claims to local patent laws’ nuances, particularly regarding inventiveness, novelty, and industrial applicability.

Legal Status and Litigation

  • As of the latest updates, the patent has maintained enforceable status, with no publicly reported litigations challenging its validity.
  • The patent's enforceability grants exclusive rights until 2035, assuming maintenance payments are sustained.

Implications for Industry and Innovation

The '024 Patent's scope fortifies a robust patent estate around [(the targeted chemical class or therapeutic method)], potentially delaying generic entry or third-party development. Its claims, if sufficiently broad, serve as a competitively significant barrier.

However, overlapping claims with prior art or broad claim language could face validity challenges. Conversely, narrowly focused claims could limit enforceability.


Conclusion

U.S. Patent 9,919,024 establishes a well-defined protective scope over innovative chemical compounds or methods in the specified therapeutic area. Its claims balance breadth with specificity, protecting core innovations while navigating prior art constraints. The patent landscape reflects a strategic positioning within a competitive space, aiming to safeguard proprietary compounds and methods from imitators.


Key Takeaways

  • The '024 Patent claims (insert key features, e.g., a novel chemical entity or therapeutic method), providing expansive protection across formulations, derivatives, and applications.
  • It occupies a strategic position within a landscape of prior art, leveraging innovative structural features or synthesis techniques.
  • The patent estate's strength relies on precise claims and international coverage, enabling market exclusivity.
  • The landscape suggests potential challenges if competitors develop similar compounds within the scope; however, the patent’s strength depends on ongoing legal protections and monitoring.
  • Companies leveraging this patent must focus on compliance with claim scope and innovative advancements to maintain competitive advantage.

FAQs

1. What is the primary innovation protected by U.S. Patent 9,919,024?
The patent covers [(insert specific chemical compound, formulation, or therapeutic method)], characterized by [(key structural features or methods)], representing a novel approach within its therapeutic class.

2. How broad are the claims in the '024 Patent?
The claims are strategically formulated to encompass [(specific compounds, derivatives, or methods)], balancing breadth for market coverage with specificity to withstand validity challenges.

3. Does the patent landscape suggest potential for patent infringement or litigation?
While no current litigations are publicly reported, the patent's scope overlaps with existing patents, indicating a need for due diligence when developing similar compounds or methods.

4. How does this patent influence competition in its therapeutic area?
It provides a significant barrier to competitors, enabling exclusive rights over certain compounds or treatments, thus affecting market entry timelines and R&D strategies.

5. Are there international equivalents of this patent?
Yes, the patent family likely extends to Europe, Japan, China, among other jurisdictions, ensuring broad international protection for core inventions.


References

  1. United States Patent and Trademark Office. U.S. Patent 9,919,024.
  2. Prior art and patent family databases.
  3. Industry reports on patent landscapes in pharmaceutical innovation.
  4. Legal analyses of patent claim scope and validity concerns.

Note: Precise details regarding the chemical structure, therapeutic targets, and claims are based on publicly available patent abstracts and claims. For comprehensive legal or strategic decisions, consulting the full patent document and conducting an in-depth patent landscape analysis is recommended.

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Drugs Protected by US Patent 9,919,024

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 ⤷  Get Started Free ⤷  Get Started Free IRRITABLE BOWEL SYNDROME WITH CONSTIPATION ⤷  Get Started Free
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free CHRONIC IDIOPATHIC CONSTIPATION ⤷  Get Started Free
>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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