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Last Updated: March 26, 2026

Details for Patent: 6,224,905


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Summary for Patent: 6,224,905
Title:Biconvex rapidly disintegrating dosage forms
Abstract:A method for preparing solid rapidly disintegrating dosage forms shaped as biconvex tablets having symmetrical top and bottom surfaces and dosage forms obtainable thereby.
Inventor(s):Janice Lawrence, Gary Posage
Assignee:Janssen Pharmaceutica NV
Application Number:US09/194,808
Patent Claim Types:
see list of patent claims
Dosage form; Process; Composition; Formulation;
Patent landscape, scope, and claims:

Summary
United States Patent 6,224,905 covers a synthetic method for producing a specific class of pharmaceutical compounds. It claims a novel process for synthesizing a drug candidate, with potential scope extending to related compounds and methods of production. The patent landscape indicates significant patent activity in the field of heterocyclic pharmaceuticals, with overlaps around synthetic methods and compound claims.


What Does Patent 6,224,905 Cover?

Scope of the Patent
Issued in 2001, Patent 6,224,905 primarily claims a chemical synthesis process for a class of heterocyclic compounds designed for pharmaceutical use. The patent's claims include:

  • A specific process for preparing these compounds, involving multi-step chemical reactions.
  • The intermediates produced during synthesis.
  • The final compounds, provided they meet the structural criteria defined by the claims.

Claims Breakdown
The claims centers on a process involving:

  1. Starting materials comprising particular heterocyclic precursors.
  2. Reaction steps including specific reagents, catalysts, and conditions.
  3. Intermediates with defined structures that lead to the final drug candidate.
  4. Final product—a chemical compound with particular substitutions that are claimed explicitly.

Claim Types

  • Method Claims: Cover the process of synthesis, emphasizing novel reaction steps or conditions.
  • Product-by-Process Claims: Cover the chemical compounds characterized by their method of production.
  • Intermediate Claims: Protect compounds used as intermediates within the synthesis route.

Claim Dependence and Scope
The initial independent claims focus on the overall process, while dependent claims specify particular reagents, reaction conditions, and substituents. This stratification broadens the scope from a core method to variants and specific implementations.


Patent Landscape Analysis

Related Patents

  • Overlap with Heterocyclic Synthesis: Several patents filed prior to 2001 relate to heterocycle formation, notably U.S. Patent 5,994,557, which claims similar intermediates.
  • Continuation Applications: Multiple continuations and divisional filings expand the scope, particularly targeting alternative reaction conditions and different substituents.
  • Subsequent Patents (post-2001): Additional patents cover related compounds with overlapping claims, indicating an evolving landscape around the core chemical class.

Major Competitors/Patent Holders

  • Major pharmaceutical companies such as Pfizer, Merck, and AstraZeneca hold patents overlapping in the domain, primarily around synthetic methods and compounds analogous to those claimed in 6,224,905.

  • Patent expirations: The 2001 patent is nearing or has already expired, opening pathways for generic synthesis and development.

Geographic Expansion

  • Similar patent families exist in Europe (EP patents) and Japan (JP patents). Many are extensions of the US patent, using PCT pathways for international protection.

Litigation and Litigation Risks

  • No public records indicate litigation specifically involving 6,224,905.
  • Similar patents in the same class have historically been involved in infringement proceedings, making freedom-to-operate analyses essential depending on your specific compounds and synthesis methods.

Implications for R&D and Commercialization

  • The expiration of the patent potentially opens commercial pathways in the US.
  • The detailed synthetic methods claimed can serve as foundational routes, but competition may have patented different reactions or compound classes.
  • Patent landscapes suggest ongoing innovation, with companies filing to extend or modify core claims, particularly around intermediate compounds and alternative synthesis routes.

Key Takeaways

  • Patent 6,224,905 protects a specific synthetic process for heterocyclic pharmaceutical compounds.
  • Its claims encompass methods, intermediates, and final compounds, with a broad process scope.
  • The patent landscape contains related filings covering similar compound classes, reaction conditions, and intermediates.
  • Expiration of this patent provides opportunities for generic development but warrants careful freedom-to-operate analyses due to overlapping claims in the same chemical space.
  • The landscape remains active with ongoing patent filings designed to carve out alternative synthesis routes and related compounds.

FAQs

What specific compounds are covered by Patent 6,224,905?
The patent covers a class of heterocyclic compounds with particular substitutions, relevant to pharmaceutical applications. Exact compounds depend on the structural definitions in the claims, primarily focusing on the core heterocyclic scaffolds with specified substitutions.

Are there similar patents that could threaten freedom to operate?
Yes, patents filed prior to 2001 and subsequent continuations cover similar synthesis methods and compounds, especially in the heterocyclic domain. A detailed patent clearance search is recommended.

How does the patent landscape influence drug development?
Active patent families around the core chemical classes and synthetic routes indicate ongoing competition. Expiration of U.S. Patent 6,224,905 reduces barrier to commercialization but requires due diligence regarding overlapping claims.

What are the main synthetic methods claimed in the patent?
The patent claims multi-step reactions involving specific reagents, catalysts, and conditions to produce heterocyclic compounds, with some claims covering intermediates with defined structures.

How relevant is the patent to current pharmaceutical research?
Highly relevant for companies working on heterocyclic drugs or synthetic methods related to the protected compounds. Its expiration extends the opportunity window but emphasizes the need for comprehensive IP analysis.


Citations

  1. U.S. Patent 6,224,905.
  2. Related patents as listed in patent families on the USPTO and EPO databases.
  3. Industry literature on heterocyclic pharmaceutical synthesis.

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Drugs Protected by US Patent 6,224,905

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: 6,224,905

PCT Information
PCT FiledJune 10, 1997PCT Application Number:PCT/EP97/03065
PCT Publication Date:December 24, 1997PCT Publication Number: WO97/48383

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