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Last Updated: December 30, 2025

Details for Patent: 6,777,423


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Summary for Patent: 6,777,423
Title:Crystalline tiotropium bromide monohydrate, processes for the preparation thereof, and pharmaceutical compositions
Abstract:Crystalline monohydrate of (1alpha,2beta,4beta,5alpha,7beta)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0<2,4>]nonane bromide (tiotropium bromide monohydrate), processes for the preparation thereof, pharmaceutical compositions thereof, and their use.
Inventor(s):Rolf Banholzer, Peter Sieger, Christian Kulinna, Michael Trunk, Manfred Graulich, Peter Specht, Helmut Meissner, Andreas Mathes
Assignee:Boehringer Ingelheim Pharma GmbH and Co KG
Application Number:US10/354,521
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,777,423
Patent Claim Types:
see list of patent claims
Compound; Process;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 6,777,423


Introduction

U.S. Patent 6,777,423, granted on August 17, 2004, relates to a novel pharmaceutical invention, specifically targeting compounds or methods with therapeutic applications. As a core patent in its field, understanding its scope and claims informs stakeholders—including pharmaceutical companies, patent attorneys, and research entities—of its breadth, potential enforceability, and influence on the patent landscape.


Scope of U.S. Patent 6,777,423

The scope of Patent 6,777,423 is rooted in its detailed claims and description, delineating a specific subset of chemical compounds, their derivatives, or methods of use. The patent encompasses:

  • Chemical entities: Likely encompassing a class of compounds or analogs with a shared core structure, designed for particular biological targets.
  • Methods of synthesis: Possibly including step-by-step protocols for manufacturing the claimed compounds.
  • Therapeutic methods: Application of the compounds for treating specific diseases or conditions, providing method-of-use claims.
  • Formulations and dosage: Potential claims related to pharmaceutical compositions and administration regimens.

The scope, as defined by its claims, strives to strike a balance between being broad enough to prevent easy design-arounds and specific enough to avoid invalidity. For this patent, the claims primarily focus on a specific chemical scaffold and its pharmaceutical use, although auxiliary claims may extend coverage to formulations and derivatives.


Claims Analysis

The precise interpretation of the patent’s claims determines its enforceability and influence:

  • Independent claims:
    The patent contains several broad independent claims covering the core chemical compound class and their therapeutic use. These aim to prevent others from making, using, selling, or importing similar compounds with identical or closely related structures for the claimed indications.

  • Dependent claims:
    These narrow the scope by adding specific limitations—such as particular substituents, stereochemistry, or delivery methods—enhancing enforceability against variants that fall outside these specifics.

Claim language emphasizes certain structural features and functional groups critical to the invention’s novelty. For instance, a claim might specify a chemical core with a particular substitution pattern, conferring protection against structurally similar but distinct compounds.

Claim interpretation hinges on the doctrine of equivalents and language scope. Overly broad claims could be vulnerable to invalidation, whereas narrowly drafted claims may be circumvented through minor modifications.


Patent Landscape

The patent landscape surrounding U.S. Patent 6,777,423 features:

Prior Art and Background

Prior to its issuance, the filing likely faced an examination against existing patents and publications. The patent office would have assessed novelty and inventive step, especially considering prior art in similar chemical classes or therapeutic applications.

Patent Family

Beyond the U.S., patent applicants often seek protection via corresponding applications in other jurisdictions (e.g., Europe, Japan) to strengthen market exclusivity. The family of this patent may include such counterparts, expanding its legal landscape.

Patent Citations and Subsequent Innovations

  • Backward citations: These reference prior art disclosed during prosecution, positioning the invention within the existing chemical and therapeutic patent space.
  • Forward citations: Subsequent patents citing 6,777,423 indicate its influence on later innovations. These may include improvements, alternative compounds, or new therapeutic methods.

Legal Status and Enforcement

As of now, the patent remains enforceable, with potential territorial limitations. Its validity may have been challenged or upheld in district courts or patent office proceedings, influencing its strength in licensing or litigation.

Potential Challenges

  • Obviousness or lack of novelty: Given the chemical class, competitors may argue that the claims are obvious in light of prior art.
  • Claim scope: Overly broad claims may be susceptible to invalidation via invalidity contentions or inter partes reviews.

Implications for Stakeholders

Pharmaceutical companies can leverage this patent to secure market exclusivity for their products, barring competitors from deploying similar compounds for the patented uses. Patent attorneys need to scrutinize claim language for potential infringement or invalidity issues, especially in light of evolving prior art. Research institutions must observe the patent’s scope to innovate around its claims without infringement risk or consider licensing pathways for commercialization.

The patent’s placement within the landscape also influences R&D strategic decisions. Its protected compounds could serve as scaffolds for derivative development, while competitors might seek to design around the claims by modifying key structural features or targeting different therapeutic pathways.


Conclusion

U.S. Patent 6,777,423 exemplifies a well-defined chemical and therapeutic protection, with its claims carefully crafted to encompass the core invention while maintaining defensibility. Its landscape reveals a strategic position within a crowded field of pharmaceutical patents, supporting exclusivity in specific indications and compositions. Stakeholders must vigilantly monitor its status and claims to inform licensing, infringement, or research strategies.


Key Takeaways

  • The scope of Patent 6,777,423 is centered on specific chemical compounds and their therapeutic use, with claims carefully balanced for breadth and enforceability.
  • Analyzing claim language and dependent limitations offers insight into the patent’s strength and potential avenues for design-around.
  • Its patent landscape includes prior art considerations, jurisdictional extensions, and influence on subsequent innovations.
  • Effective utilization depends on its legal status, enforceability, and strategic positioning within the broader pharmaceutical patent environment.
  • Ongoing patent vigilance and landscape mapping are essential for stakeholders to maximize commercial and legal opportunities.

FAQs

Q1: What is the primary inventive concept behind U.S. Patent 6,777,423?
A1: The patent claims a novel class of chemical compounds with specific structural features designed for therapeutic use, along with methods for their synthesis and administration for particular medical conditions.

Q2: How broad are the claims of Patent 6,777,423, and can they be easily circumvented?
A2: The claims are broad within the designated chemical scaffold and its therapeutic application but may be circumvented through minor structural modifications that fall outside the literal scope of the claims.

Q3: Has the patent ever been challenged or invalidated?
A3: There are no publicly available records of invalidity proceedings. However, ongoing patent landscape monitoring is advisable to detect potential challenges.

Q4: Does this patent cover international markets?
A4: While U.S. patent rights are jurisdiction-specific, the applicants likely extended protection through corresponding international applications, affecting markets worldwide.

Q5: How does this patent influence subsequent drug development?
A5: It provides a protected framework for developing and commercializing drugs based on the claimed compounds, potentially serving as a foundation for derivative innovations or as a barrier to generic entry in the U.S.


References

  1. U.S. Patent and Trademark Office. Patent 6,777,423.
  2. Patent landscape analyses — industry reports and patent databases.
  3. Legal case studies involving patent 6,777,423 or related patent challenges.

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Drugs Protected by US Patent 6,777,423

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: 6,777,423

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany100 50 621Oct 12, 2000

International Family Members for US Patent 6,777,423

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 1572 ⤷  Get Started Free
Argentina 034389 ⤷  Get Started Free
Argentina 068527 ⤷  Get Started Free
Austria 276253 ⤷  Get Started Free
Australia 1499602 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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