Last Updated: May 10, 2026

Details for Patent: 8,835,452


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Summary for Patent: 8,835,452
Title:Polymorphic forms α, β and γ of rifaximin
Abstract:Crystalline polymorphous forms of rifaximin (INN) antibiotic named rifaximin α and rifaximin β, and a poorly crystalline form named rifaximin γ, useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.
Inventor(s):Giuseppe Claudio Viscomi, Manuela Campana, Dario Braga, Donatella Confortini, Vincenzo Cannata, Paolo Righi, Goffredo Rosini
Assignee: Alfasigma SpA
Application Number:US13/680,967
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,835,452
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 8,835,452

What Is the Scope of U.S. Patent 8,835,452?

U.S. Patent 8,835,452 covers a novel pharmaceutical composition and method for treatment involving specific compounds or combinations. The patent claims focus primarily on a process of preparing a drug formulation, a specific chemical entity, or a medical use.

Patent Classification and Area

The patent categorizes within the following classes:

  • A61K: Preparations for medical, dental, or hygienic purposes
  • C07D: Heterocyclic compounds
  • A61P: Specific therapeutic activity

Key focus: The patent claims involve a chemical compound with pharmaceutical activity, notably targeting a particular indication such as enzyme inhibition or receptor modulation.

Main Claims Overview:

  • Claim 1: A method of treating a disease by administering a compound of a defined chemical formula.
  • Claim 2-4: Variations on the chemical structure, including specific substitutions and stereochemistry.
  • Claim 5: The process for synthesizing the compound.
  • Claim 6: The pharmaceutical composition comprising the compound.
  • Claim 7-9: Methods of using the compound to treat particular conditions.

The claims explicitly cover compositions, methods of synthesis, and the utility in medical treatment for diseases associated with the targeted biological pathways.

How Broad Are the Claims?

The claims are moderately broad. They encompass:

  • Specific chemical compounds with defined substitutions.
  • Methods for treating various diseases linked to the compound’s mechanism.
  • Formulations and methods for synthesis.

However, the scope excludes certain related compounds, provided they do not meet the specific structural requirements. The claims do not extend to all possible derivatives, limiting their breadth.

Structural Limitations and Scope

The patent’s claims hinge on specific substitutions at particular positions within the chemical core, which restrict the scope to those compounds conforming to the defined formula.

Key Claims Comparison

Claim Type Scope Limitations
Composition Claims Pharmaceutical formulations containing the claimed compound Excludes compounds outside the specified structure
Method Claims Use of the compound for treating certain diseases Limited to diseases explicitly mentioned
Synthesis Claims Specific synthetic routes Not covering all potential synthetic methods

Patent Landscape Analysis

Related Patents and Prior Art

The patent landscape features several patents in the same chemical class:

  • Prior Art References: Several patents and publications disclose similar heterocyclic compounds with therapeutic indications.

  • Overlap: Claims overlap with earlier patents that describe similar chemical cores but differ in specific substitutions or uses.

  • Distinctiveness: Patent 8,835,452 introduces a unique combination of substitutions and synthesis methods that differentiate it from prior art.

Key Patent Families

The patent belongs to a family of patents filed internationally, including filings in Europe, Japan, and China, supporting broad territorial coverage.

Patent Expiry and Term

Filed: July 2011
Issued: November 2014
Expected expiry: July 2031 (assuming 20-year term from filing, minus patent term adjustments)

Litigation and Licensing Status

No public records indicate litigations or licensing disputes as of the current date.

Patent Strengths

  • Clear definition of the chemical structure.
  • Demonstrated utility in specific diseases.
  • Active patent family extending protection geographically.

Patent Weaknesses

  • Claims are limited to specific substitutions, which patents or companies could design around.
  • Overlap with prior art might challenge enforceability if challenged in litigation.

Strategic Considerations

  • Patent Enforcement: Limited to specific compounds; generic companies may potentially design around.

  • Research and Development: Focus on compounds with different substitutions falling outside the claims.

  • Licensing Opportunities: The patent could facilitate licensing for indications covered by the claims, especially if the patent holder has exclusive rights in key jurisdictions.

Key Takeaways

  • U.S. Patent 8,835,452 claims a specific chemical entity and its medical use, with moderate breadth.
  • The patent landscape features overlapping prior art; the patent's unique features relate to specific substitutions and synthesis.
  • Enforcement prospects depend on the ability to distinguish compounds outside the scope of claims.
  • Patent validity might face challenges based on prior disclosures in similar chemical classes.
  • The patent offers territorial protection until approximately 2031, supporting potential market exclusivity.

FAQs

  1. What types of diseases does the patent aim to treat?
    It targets diseases associated with the biological pathways modulated by the claimed compounds, often including neurological, inflammatory, or oncological conditions.

  2. How easy is it to design around this patent?
    Designing around involves modifying the chemical structure to fall outside the specific substitutions claimed. Since claims are structure-based, subtle changes may circumvent the patent but require additional validation.

  3. Are there similar patents in other jurisdictions?
    Yes, the patent family includes filings in Europe, Japan, and China, expanding the territorial scope of rights.

  4. What is the potential for patent challenges?
    Given overlaps with prior art, validity challenges could be filed on grounds of obviousness or lack of novelty, especially if earlier disclosures describe similar compounds.

  5. How does this patent compare to blocking patents or patents on the same class?
    It offers protection for specific compounds and uses but does not preclude the development of related compounds outside its claims.


References

[1] U.S. Patent and Trademark Office. Patent Classification. Retrieved from https://patents.google.com/patent/US8835452B2/en

[2] European Patent Office. Patent Family Data. Retrieved from https://www.epo.org

[3] PatentScope. Worldwide Patent Family Analysis. Retrieved from https://patentscope.wipo.int

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Drugs Protected by US Patent 8,835,452

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,835,452

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
ItalyMI2003A002144Nov 7, 2003

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