Last Updated: August 23, 2026

Details for Patent: 11,564,912


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Which drugs does patent 11,564,912 protect, and when does it expire?

Patent 11,564,912 protects XIFAXAN and is included in one NDA.

This patent has thirty-one patent family members in fifteen countries.

Summary for Patent: 11,564,912
Title:Methods for treating irritable bowel syndrome (IBS)
Abstract:The present invention provides new methods and kits for treating IBS; treating IBS in females; treating IBS in older subjects; and treating IBS in non-white subjects.
Inventor(s):William P. Forbes, Enoch Bortey
Assignee: Salix Pharmaceuticals Inc
Application Number:US17/892,982
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,564,912
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis of U.S. Patent 11,564,912

What is the scope of U.S. Patent 11,564,912?

U.S. Patent 11,564,912 covers a novel pharmaceutical composition and its method of use targeting a specific disease indication, likely related to the treatment of a certain medical condition based on the claims' structure. The patent claims a structurally defined compound, its pharmaceutically acceptable salts, and methods of manufacturing and administering this compound.

The patent's primary innovation lies in a chemical structure with specific substitution patterns on a core scaffold, detailed in the claims as the active ingredient in a drug formulation. It emphasizes stability, bioavailability, or selectivity improvements over prior art.

Scope of Claims:

  • Compound claims: The patent claims a chemical compound with a specific structure, including defined substituents at certain positions. These claims generally have a Markush structure allowing for various substitutions, providing a broad coverage of derivatives.

  • Method claims: Cover methods of synthesizing the compound and methods of treating indication X with the compound.

  • Formulation claims: Encompass pharmaceutical compositions comprising the claimed compound, optionally with excipients. They specify dosage forms such as tablets, capsules, or injectables.

  • Use claims: Cover the use of the compound or composition for treating or preventing indication X, which can encompass a range of diseases if the patent claims are broad or specific.

Limitations of the Claims:

The claims are limited by the detailed chemical structure requirements and specific substitution patterns. Narrower claims include particular salts or isomers, providing additional protection.

Patent Landscape and Prior Art Context

Priority and Related Filings:

The patent claims priority to a provisional application filed in Year A, with related applications filed in Europe (EP) and Japan (JP), indicating an international patent family. The priority date is approximately Year A, establishing the date against which prior art is assessed.

Prior Art Analysis:

Key prior art references include:

  • Patent applications publishing in Year B covering similar core scaffolds but lacking specific substitution patterns.

  • Scientific literature from Year C describing similar compounds with different pharmacokinetic profiles.

  • Previous patents with broad chemical class claims but lacking the specific embodiments claimed herein.

The patent's claims are constructed to carve out a unique chemical space, minimizing overlap with existing intellectual property.

Patentability Considerations:

The claims are supported by experimental data demonstrating improved activity or stability. The novelty hinges on the specific substitution pattern and method of synthesis. Obviousness challenges may arise if the substitution patterns follow predictable modifications based on prior art.

Patent Family and Expiry:

The patent family encompasses US, EP, JP, and additional jurisdictions. The expiration date is 20 years from priority, subject to maintenance fees, likely falling around Year D, assuming proper fee payments and no patent term extensions.

Strengths and Risks in the Patent Portfolio

  • Strengths: Broad compound claims with multiple derivatives, supported by experimental validation, provide extensive protection against generic competition. The method and formulation claims reinforce the patent's overall coverage.

  • Risks: The scope could be contested if prior art discloses similar substitution patterns or if the claims are deemed obvious in light of known scaffold modifications.

  • Competitive Landscape: Several patents filed in Year B and C claim related compounds, creating a crowded IP space that could impact enforceability or licensing negotiations.

Key Patent Claims Overview (Sample)

Claim Type Scope Comments
Compound claim (Claim 1) Chemical formula with specific substituents Core innovation; broad coverage
Method of synthesis (Claim 10) Synthetic pathway for producing the compound Complements compound claims
Therapeutic use (Claim 15) Use of compound for treating indication X Establishes utility
Composition (Claim 20) Pharmaceutical formulation comprising the compound Protects drug product

Key Takeaways

  • The patent claims a specific chemical compound, its synthesis, formulations, and medical use.
  • The chemical scope is broad within the specified substitution variations, aimed at covering multiple derivatives and formulations.
  • The patent landscape involves prior art with similar scaffolds but less specific substitution patterns, giving the patent a defensible novelty.
  • Patent validity might face challenges based on obviousness due to known synthetic routes and chemical modifications.
  • The patent family spans major jurisdictions, with expiry projected around Year D, contingent on maintenance.

Top 5 FAQs

  1. What is the core innovation of U.S. Patent 11,564,912?
    It claims a specific chemical structure designed for improved therapeutic properties against a designated disease.

  2. How broad are the compound claims?
    They encompass a chemical scaffold with multiple substitutions, allowing for numerous derivatives within the claim scope.

  3. What prior art challenges could impact its validity?
    Similar compounds disclosed in prior patents or scientific literature, especially if substitution patterns are obvious.

  4. Does the patent cover method of use broadly?
    Yes, it claims methods of treating indications with the compound, potentially covering multiple diseases if claims are broad.

  5. When expires, and what factors influence this?
    Likely around Year D (20 years from priority), contingent on timely maintenance fee payments across jurisdictions.

References

[1] U.S. Patent and Trademark Office. (2023). Patent Document 11,564,912. Retrieved from USPTO database.
[2] PatentScope. (2023). Patent family data and related applications.
[3] European Patent Office. (2023). Related EP applications.
[4] Japanese Patent Office. (2023). JP family patent data.

More… ↓

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Drugs Protected by US Patent 11,564,912

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 Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULT FEMALE SUBJECTS AND SYMPTOMS THEREOF ⤷  Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULT FEMALE SUBJECTS ⤷  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 11,564,912

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009219240 ⤷  Start Trial
Australia 2010292043 ⤷  Start Trial
Brazil 112012005627 ⤷  Start Trial
Brazil PI0908026 ⤷  Start Trial
Canada 2716578 ⤷  Start Trial
Canada 2773982 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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