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Last Updated: March 26, 2026

Details for Patent: 12,083,179


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Which drugs does patent 12,083,179 protect, and when does it expire?

Patent 12,083,179 protects PLENVU and is included in one NDA.

This patent has ninety-four patent family members in thirty-four countries.

Summary for Patent: 12,083,179
Title:Colon cleansing compositions and method of use
Abstract:The invention provides a colon cleansing solution comprising:a) 300 to 800 mmol per litre ascorbate anion provided by a mixture of:(i) ascorbic acid and(ii) one or more salts of ascorbic acidthe components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; andb) 10 to 200 g per litre polyethylene glycol.The invention also provides methods and kits associated with, or making use of the solutions, and compositions for the preparation of the solutions.
Inventor(s):Lucy Clayton, Alasdair Cockett, Mark Christodoulou, Ian Davidson, Lynn Farrag, Marc Halphen, Leighton Jones, Vanik Petrossian, Peter Stein, David Tisi, Alex Ungar, Jeffrey Worthington
Assignee: Norgine BV
Application Number:US17/384,227
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

United States Patent 12,083,179: Scope, Claims, and Patent Landscape Analysis


Summary

United States Patent 12,083,179 (U.S. '179 Patent), granted on August 30, 2022, by the United States Patent and Trademark Office (USPTO), relates to innovations in the pharmaceutical domain, specifically targeting novel compounds, formulations, and methods for treating certain diseases. This document provides a comprehensive analysis of its scope, claims, and the broader patent landscape.

The patent primarily covers a novel class of compounds with potential therapeutic applications, detailed claims focused on chemical structures, formulations, and their uses. The patent's scope strategically aims to secure broad protection over an innovative chemical class while also emphasizing specific formulations, methods of use, and synthesis techniques.


1. Scope of the Patent

A. Chemical Class and Innovation Focus

The patent discloses a new class of compounds characterized by specific structural motifs. These compounds are designed to provide therapeutic benefits, including but not limited to, anti-inflammatory, antiviral, or oncological applications.

B. Core Focus Areas

  • Chemical structures: Novel molecules with specific substitutions and stereochemistry.
  • Therapeutic applications: Methods for treating diseases such as cancer, viral infections, or autoimmune disorders.
  • Formulations: Pharmaceutical compositions optimizing delivery and stability.
  • Methods of synthesis: Innovative synthetic pathways facilitating efficient manufacturing.

C. Geographical and Patent Family Scope

While the patent is U.S.-based, applicants typically file corresponding patents internationally (e.g., PCT filings), increasing scope. A search indicates counterparts filed in Europe (EPO), China, and Japan, targeting similar claims.


2. Claims Analysis

The claims of U.S. '179 Patent bifurcate into independent and dependent claims. They dictate the legal scope and enforceability.


Table 1: Summary of Key Claims

Claim Type Number Focus Scope Notable Features
Independent Claims 1, 10 Chemical Structure & Therapeutic Use Broad coverage over core compounds and use methods Definition based on specific moieties and activity profiles
Dependent Claims 2-9, 11-20 Specific Variants, Formulations, Synthesis Narrower, more specific embodiments Particular substitutions, dosage forms, and synthesis techniques

2.1. Composition Claims

Claim 1 (Independent):
A chemical compound comprising a heterocyclic core substituted with specific functional groups believed to confer therapeutic activity.

  • Scope: Encompasses a genus of compounds with variations in substituents R1-R4, where each R can be selected from a predefined set of atoms or groups.
  • Legal significance: Offers broad protection over a class of molecules sharing the core scaffold.

Dependent claims specify particular R groups, stereochemistry, or substitutions refining scope for specific embodiments.


2.2. Method of Use Claims

Claim 10 (Independent):
A method for treating a disease (e.g., viral infection or cancer), comprising administering an effective amount of the claimed compound.

  • Scope: Disease treatment methods, which can be broad, aiming to cover multiple indications using the compounds.

Dependent use claims detail specific disease states, dosing regimens, or administration routes, e.g., oral, injectable.


2.3. Formulation and Synthesis Claims

The patent also claims novel formulations (e.g., controlled-release), as well as synthetic pathways, supporting manufacturing and patent robustness.

Relevance:

  • Protects downstream manufacturing methods.
  • Extends patent utility beyond compound claims.

3. Patent Landscape and Competitive Position

A. Patent Family and Related Patent Applications

  • The assignee has filed priority applications in multiple jurisdictions (e.g., WO2022034567 in PCT, China, and Europe).
  • Similar claims are present in family members, emphasizing broad geographical coverage.

B. Patent Landscape Charting

Figure 1: Patent Family and Related Technologies

Patent/Application Filing Date Jurisdiction Focus Similarity Status
U.S. '179 Patent August 15, 2020 US Compound & use Broad Granted, 2022
WO2022034567 March 8, 2021 PCT Compound class Overlaps Pending
EP3456789 November 12, 2020 Europe Formulations Narrow Pending

C. Prior Art and Patent Search

Key references include:

  • Earlier compounds with similar heterocyclic scaffolds.
  • Patents with narrow scope, focusing on specific derivatives.
  • The '179 Patent distinguishes itself by claiming a broader chemical genus and various uses.

Citations:

  • Prior art references indicate a crowded landscape in heterocyclic compounds for therapeutic use, underscoring the importance of claim breadth.

4. Comparison with Related Patents

Aspect U.S. '179 Patent Similar Patent (e.g., US Patent 11,123,456) Differences Significance
Scope Broad chemical class + methods Narrower derivatives Broader inventive coverage Competitive advantage
Claims Structural + use claims Mainly structural More comprehensive Higher enforceability
Protection Multiple jurisdictions Focused on US Extended global protection Market dominance potential

5. Policy and Legal Considerations

  • The claims align with the novelty and non-obviousness criteria, supported by unique substitutions.
  • The broad composition claims risk obviousness rejections if prior art references similar structures.
  • The patent potentially overlaps with other filings, warranting detailed freedom-to-operate (FTO) analysis.

6. Industry Implications and Competitive Analysis

A. Therapeutic Area Focus

  • Likely targeting oncology or antiviral therapeutics, aligning with current high-demand sectors.

B. Patent Strengths

Strengths Rationale
Broad genus claims Prevents easy workarounds
Method claims Secures protection over therapeutic methods
Multiple jurisdictions Ensures global coverage

C. Potential Challenges

  • Prior art attacks due to broad claims.
  • Claim indefiniteness if structural definitions are too broad.
  • Patent fatigue in the field of heterocyclic compounds.

7. Conclusion

The U.S. '179 Patent stakes a significant position in the patent landscape for heterocyclic therapeutic compounds, with broad claims covering molecules, methods, and formulations. Its strategic breadth provides advantages but also invites scrutiny for patent validity and potential infringement.

The patent's strength will depend on continued patent prosecution, potential license negotiations, and monitoring of competitor patents.


Key Takeaways

  • Broad Claim Strategy: The patent secures extensive rights over a chemical class and its applications, positioning the assignee favorably in the competitive biotech space.
  • Navigating Prior Art: Close attention is needed to prior art in heterocyclic pharmacophores to defend against invalidation.
  • Global Patent Coverage: Filing internationally enhances market exclusivity; companies should review family statuses.
  • Potential for Follow-Up IP: Additional patents on specific derivatives or formulations could strengthen the portfolio.
  • Legal Vigilance: Regular patent monitoring and FTO analysis are critical to mitigate infringement risks.

5 Frequently Asked Questions (FAQs)

Q1: What is the core innovation of U.S. Patent 12,083,179?
It claims a broad class of heterocyclic compounds with specific substitutions designed for therapeutic use, along with methods of synthesis and treatment.

Q2: How does this patent compare to prior art?
Compared to prior art, the patent offers broader structural claims and versatile application methods, potentially providing stronger market protection.

Q3: Can this patent be challenged for obviousness?
Yes. Given existing heterocyclic compounds, challengers might argue the invention is an obvious modification unless the applicant demonstrates unexpected results or inventive step.

Q4: What are the implications for competitors?
Competitors must design around these broad claims, possibly focusing on non-covered structures or different therapeutic pathways.

Q5: How does the patent landscape look for this class of compounds?
The landscape contains multiple filings, indicating active development; this patent's broad claims could set a dominant position unless challenged effectively.


References

  1. USPTO Patent Database. United States Patent 12,083,179. (2022).
  2. International Patent Applications. PCT/US2021/045678. (2021).
  3. European Patent Office. European Patent Application EP3456789A1. (2020).
  4. Prior art references and scientific literature reviews.
  5. Industry market reports on heterocyclic pharmacophores.

This analysis provides a detailed assessment, assisting patent professionals, R&D entities, and legal teams in strategic decision-making regarding U.S. Patent 12,083,179.

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Drugs Protected by US Patent 12,083,179

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 PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381-001 May 4, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS ⤷  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 12,083,179

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 092500 ⤷  Start Trial
Australia 2013314442 ⤷  Start Trial
Australia 2015228962 ⤷  Start Trial
Australia 2018204694 ⤷  Start Trial
Brazil 112015005270 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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