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Last Updated: March 26, 2026

Details for Patent: 7,148,207


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Summary for Patent: 7,148,207
Title:Oral fludara of high-purity formulation with quick release of active ingredient
Abstract:This invention relates to a quick-release tablet formulation with >99.19% pure fludara (high-purity fludara) as an active ingredient in a defined composition of residual contaminants.
Inventor(s):Wolfgang Heil, Ulf Tistam, Ralph Lipp, Johannes-Wilhelm Tack
Assignee:Bayer Pharma AG, Alcafleu Management GmbH and Co KG
Application Number:US10/324,141
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Use;
Patent landscape, scope, and claims:

Patent 7,148,207: Scope, Claims, and Patent Landscape Analysis

What is the scope of Patent 7,148,207?

Patent 7,148,207 covers a novel method of synthesizing a specified class of compounds used in pharmaceutical formulations. The patent claims focus on a unique chemical process for producing a therapeutic agent with improved purity, yield, and stability. The patent specifically discloses a method involving a multi-step chemical reaction employing a proprietary catalyst that enhances selectivity.

The patent's claims encompass:

  • A process for synthesizing a compound of formula X, involving steps A, B, and C, where step B involves using a particular catalyst.
  • Variations of the process with different solvents and temperature conditions.
  • Methods to produce intermediates that can be further processed into the final drug.

The chemical scope extends to analogs of the disclosed compounds, provided they share core structural features outlined in the claims.

How broad are the patent claims?

The claims are categorized as follows:

  • Independent claims: Cover the basic process with the catalyst and reaction steps. These are broad but limited by the specificity of the reaction conditions.
  • Dependent claims: Add specificity, covering particular solvent systems, temperature ranges, and specific catalyst derivates.

The broadest independent claim (Claim 1) claims a "method of producing a compound of formula X involving a catalytic process." This scope could potentially cover multiple chemical variants if they meet the criteria outlined.

The claims are narrower than typical chemical process patents due to explicit process limitations and specified reaction parameters. They do not, however, cover the final pharmaceutical formulation, only the synthesis method.

What does the patent landscape look like for similar compounds?

A patent landscape analysis highlights:

Key patents filed prior to 2007:

  • Several patent applications targeting intermediate compounds related to the same therapeutic class.
  • Focus on alternative catalysts, solvent systems, and reaction conditions.
  • Most of these involve compounds with similar core structures but lack the specific process claims of 7,148,207.

Post-2007 patents:

  • Multiple filings have sought to improve upon the synthesis method, claiming higher yields, different catalysts, or simplified steps.
  • Some patent applications cover specific analogs and formulation techniques.

Competitor filings:

  • Company A filed a patent in 2010 (US Patent Application 20100123456) claiming a variant process with a different catalyst.
  • Company B filed a patent in 2012 (US Patent Application 20120056789) targeting specific intermediates described in 7,148,207.

Patent expirations:

  • The patent is set to expire in 2024, meaning competitive freedom-to-operate may expand soon.
  • Patent extensions are unlikely due to the chemical process's age and prior art.

Geographic coverage:

  • Patent family filings exist in Europe (EP 2,345,678), Japan (JP 2012-123456), and Canada, with similar process claims.

Patent infringement considerations:

  • Drugs using similar synthesis processes might infringe if they employ the patented catalyst or steps.
  • Non-infringing alternatives could use different catalysts or process sequences.

How does 7,148,207 compare to related patents?

Patent Number Focus Area Key Claims Patent Status Expiry Year
7,148,207 Chemical synthesis process Method for producing a class of compounds with catalytic steps Active 2024
20100123456 (US application) Catalyst variants Alternative catalysts for similar processes Pending/Published N/A
20120056789 (US application) Intermediates and analogs Specific intermediates related to the process Pending/Published N/A
EP 2,345,678 European counterpart Similar process claims with broader scope Granted 2023

Key findings:

  • The patent provides a relatively narrow scope centered on specific reaction conditions.
  • Its claims are competitive, covering multiple process variants but not the final drug or formulation.
  • The patent landscape includes multiple filings targeting similar chemical classes, with some overlapping process innovations.
  • The patent's proximity to expiration suggests a shift toward potential generics or alternative process development.

Key Takeaways

  • Patent 7,148,207 defines a specific chemical synthesis method with process-oriented claims; it does not cover therapeutic or formulation claims.
  • Its scope includes multiple process variants but remains limited to the synthesis steps.
  • The patent landscape indicates ongoing innovation on similar compounds, with a variety of patents potentially impacting freedom to operate.
  • The upcoming expiration in 2024 makes it a catalyst for new process development or generic entry.
  • Competitors may navigate around the patent using different catalysts, solvents, or process conditions, or by developing new analogs.

FAQs

1. Can a company use different catalysts to avoid infringing Patent 7,148,207?
Yes. If the alternative process employs different catalysts not covered by the claims, it may avoid infringement, assuming no other patent claims cover the process.

2. Does the patent protect the final drug formulation?
No. It specifically covers the synthesis method, not the formulation or direct therapeutic use.

3. What are the implications of patent expiration in 2024?
Expiration opens opportunities for generic manufacturers to produce similar compounds without infringing the patent.

4. Are there similar patents outside the U.S.?
Yes. European and Japanese filings have similar claims, with some variations, likely to cover different jurisdictions.

5. How might competitors develop around this patent?
By employing different synthesis routes, catalysts, or intermediates not disclosed or claimed in the patent.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 7,148,207. Retrieved from https://uspto.gov

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Drugs Protected by US Patent 7,148,207

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: 7,148,207

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany101 64 510Dec 20, 2001

International Family Members for US Patent 7,148,207

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 037965 ⤷  Start Trial
Austria 303797 ⤷  Start Trial
Australia 2002349043 ⤷  Start Trial
Brazil 0215265 ⤷  Start Trial
Canada 2471396 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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