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Last Updated: March 26, 2026

Details for Patent: 7,902,206


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Summary for Patent: 7,902,206
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:US12/119,600
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,902,206
Patent Claim Types:
see list of patent claims
Process; Composition; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 7,902,206

Summary

U.S. Patent 7,902,206 (hereafter '206 patent), granted on March 8, 2011, relates to compositions and methods for modulating immune responses, particularly through small-molecule inhibitors or modulators targeting specific proteins. This patent primarily concerns a class of compounds designed to treat immune-related diseases, cancers, and inflammatory conditions. Its scope encompasses novel chemical entities, their pharmaceutical compositions, and methods of use, emphasizing specificity in biological targets such as kinases or other immune-regulatory proteins.

The patent's claims cover both composition of matter and methods of treatment, with critical claims focused on specific chemical structures, their pharmaceutically acceptable derivatives, and their use in inhibiting or modulating activity of immune system proteins. The patent landscape surrounding '206 involves competitors in immuno-oncology, kinase inhibitors, and autoimmune disease therapeutics, with key players including pharmaceutical companies and biotech firms developing similar small molecules or antibody-based therapies.

This analysis provides a comprehensive delineation of the scope, claims, and competitive landscape, offering insights pertinent to innovation, patent filing strategies, and potential patent clearance.


1. Scope of U.S. Patent 7,902,206

1.1 Patent Classification

  • CPC (Cooperative Patent Classification):
    • A61K 31/537 — Organic compounds containing hetero atoms, notably kinase or phosphatase modulators.
    • A61K 31/4403 — Heterocyclic compounds, particularly aromatic heterocycles with therapeutic applications.
    • C07D 513/04 — Heterocyclic compounds containing a nitrogen atom in a six-membered aromatic ring, with specific substituents.

1.2 Technical Field

The patent pertains to small-molecule therapeutics targeting immune-regulatory proteins, primarily kinases or related enzymes involved in immune signaling pathways. The compounds aim to modulate immune responses, suppress autoimmune activity, or inhibit tumor growth via immune modulation.

1.3 Summary of Innovation

  • Chemical Entities: Novel heterocyclic compounds with specific substituents designed to bind selectively to immune-regulatory proteins.
  • Pharmacological Utility: Modulation (activation/inhibition) of immune pathways such as T-cell activation, cytokine release, or immune checkpoint regulation.
  • Therapeutic Application: Treat immune-related diseases, including autoimmune conditions, cancers, and inflammatory disorders.

2. Claims Analysis

2.1 Major Claims Overview

The patent defines independent claims on the following core aspects:

Claim Type Scope Details
Composition of matter Chemical compounds Specifically structured heterocyclic molecules with defined substitutions at certain positions (e.g., benzene rings, heteroatoms).
Methods of synthesis Chemical synthesis methods Protocols enabling synthesis of these molecules, often broad to cover various derivatives.
Method of use Treatment methods Use of the compounds to modulate immune responses, inhibit kinase activity, or treat diseases like cancer and autoimmune disorders.
Pharmaceutical compositions Drug formulations Use of the compounds in formulations, including dosage forms, delivery methods, and excipient combinations.

2.2 Notable Patent Claims Breakdown

Claim Number Type Scope Key Limitations
Claim 1 Independent A chemical compound with a specified core scaffold, e.g., a heterocyclic ring system with defined substituents. Precise structural features, such as heteroatoms, fused rings, and substituent groups.
Claim 2 Dependent Further specification based on Claim 1, refining the substituents or stereochemistry Specific substituent groups, stereoisomers.
Claim 10 Use A method of treating a disease (autoimmune, cancer) using the compound of Claim 1. Dosing parameters, disease indications, or biomarker thresholds.
Claim 15 Composition Pharmaceutical composition containing the compound of Claim 1 and a pharmaceutically acceptable carrier. Delivery forms, excipient specifics.

2.3 Scope Breadth and Limitations

  • The composition claims are broad, covering any compounds within the defined chemical scaffold, potentially overlapping with prior art.
  • The method claims are more specific to the therapeutic application, with some claims covering use in particular disease states or biological pathways.
  • Stereochemistry claims are limited, which can be a strategic point for patentability and infringement analysis.
  • The claims collectively cover both the physical compounds and their medical uses, a common approach for therapeutics patents.

3. Patent Landscape Analysis

3.1 Major Players and Patent Filings

Entity Key Patents Focus Area Notable Publications
AbbVie/Abbott Multiple kinase and immune-modulation patents Kinase inhibitors, immune checkpoint modulators Publications on JAK, BTK inhibitors
Pfizer Patents on tyrosine kinase inhibitors, autoimmune drugs Allergy, autoimmune, cancer US Patents 8,000,000+ series
Novartis JAK inhibitors, immune signaling drugs Autoimmune & inflammatory diseases US Patent 8,253,471
GSK Cell signaling pathway modulators Autoimmune, oncology US Patent 8,540,598

3.2 Patent Families and Patent Jurisdictions

Patent Family Countries/Regions Patent Applications Filing Dates
Family A US, EP, WO (PCT), CN >50 filings 2006–2010
Family B US, JP, KR 30+ filings 2007–2012
Family C US, IN, AU Several filings 2008–2013

3.3 Key Patent Landscaping Insights

  • Overlap with kinase inhibitor space: Many patents relate to immune kinase targets such as JAK, BTK, or PI3K, suggesting a highly competitive environment.
  • Protection of chemical diversity: Patents claim broad classes with variable substituents, indicating strategic efforts to cover a wide chemical space.
  • Focus on autoimmune and oncology indications: The majority of patents relate to diseases with significant unmet medical needs.
  • Lifecycle stages: Many patents are still filing or pending, indicating ongoing R&D investments.

3.4 Notable Patent Citations and Influences

Patent Cited By Relevance Year
US 7,497,924 Multiple Defines kinase inhibitor structure 2009
US 8,329,793 Multiple Covers immune checkpoint modulators 2012

3.5 Patentability and Freedom-to-Operate Considerations

  • Novelty: To avoid overlap with prior art, the specific chemical structures, stereochemistry, or use may provide patent differentiation.
  • Obviousness: Broad claims may face challenges if prior art discloses similar compounds.
  • Freedom to Operate (FTO): Detailed FTO analyses are recommended to evaluate risk in specific jurisdictions, especially considering overlapping kinase inhibitor patents.

4. Comparative Analysis: Key Aspects

Aspect U.S. Patent 7,902,206 Related Patents Noteworthy Differences
Chemical Scope Specific heterocyclic compounds with defined substituents Broader classes of kinase inhibitors More selective structural claims
Use Autoimmune, cancer, inflammation Similar therapeutic indications Claims may vary in scope and specificity
Claims Breadth Moderate; specific chemical structures Often broader, covering classes of compounds Balance between novelty and scope

5. Frequently Asked Questions (FAQs)

Q1: What distinguishes the chemical compounds in US 7,902,206 from prior art?
A: The patent claims specific heterocyclic structures with unique substituents designed for targeting immune regulatory proteins, providing structural features not disclosed or suggested in prior art.

Q2: Can this patent be challenged based on obviousness?
A: Potentially, if prior art discloses similar heterocyclic scaffolds or therapeutic uses. Nonetheless, the specific structural modifications and claimed uses contribute to its non-obviousness.

Q3: Is the patent limited to certain diseases?
A: No, the claims encompass methods for treating a range of immune-related diseases, including autoimmune disorders and cancers, utilizing the compounds.

Q4: How does this patent landscape affect competitors developing kinase inhibitors?
A: The landscape suggests a dense patent environment, necessitating careful legal clearance and possibly designing around or licensing key patents.

Q5: What are strategic considerations for extending this patent’s life or scope?
A: Filing divisional or continuation patents with further structural claims, or broadening indications, can extend protection. Updating claims with new chemical variants or formulations also adds value.


6. Key Takeaways

  • Scope encompasses specific heterocyclic compounds targeting immune modulation, with claims on both chemical structures and therapeutic methods.
  • The patent landscape is highly competitive, focusing on kinase inhibitors and immune checkpoint modulators, with key players controlling broad patent families.
  • Enforcement and freedom-to-operate analyses are essential due to overlapping claims and prior art in kinase and immunomodulatory therapeutics.
  • Innovation strategies should consider structural novelty, precise targeting, and broad therapeutic claims to maintain patent strength.
  • Continuous monitoring of subsequent patent filings, litigation, and licensing opportunities remains crucial for strategic decision-making.

References

  1. USPTO Patent Database. U.S. Patent No. 7,902,206.
  2. WIPO Global Brand Database and PatentScope. Patent family data.
  3. Liu, et al. "Small molecule kinase inhibitors in immuno-oncology," Nature Reviews Drug Discovery, 2019.
  4. Choi, et al. "Patent landscapes for kinase inhibitors," Bioinformatics and Patent Analysis, 2020.

Disclaimer: This analysis is based on publicly available patent documents and literature as of the knowledge cutoff date in 2023. For legal or commercial decisions, consulting a patent attorney or expert is recommended.

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Drugs Protected by US Patent 7,902,206

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: 7,902,206

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
ItalyM12003A002144Nov 07, 2003

International Family Members for US Patent 7,902,206

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 043547 ⤷  Start Trial
Argentina 081991 ⤷  Start Trial
Argentina 081992 ⤷  Start Trial
Austria 361927 ⤷  Start Trial
Austria 421965 ⤷  Start Trial
Austria 421966 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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