Last Updated: June 27, 2026

Details for Patent: 6,376,515


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Summary for Patent: 6,376,515
Title:Benzamides and related inhibitors of factor Xa
Abstract:Novel benzamide compounds including their pharmaceutically acceptable isomers, salts, hydrates, solvates and prodrug derivatives having activity against mammalian factor Xa are described. Compositions containing such compounds are also described. The compounds and compositions are useful in vitro or in vivo for preventing or treating coagulation disorders.
Inventor(s):Bing-Yan Zhu, Penglie Zhang, Lingyan Wang, Wenrong Huang, Erick A. Goldman, Wenhao Li, Jingmei Zuckett, Yonghong Song, Robert M. Scarborough
Assignee: Millennium Pharmaceuticals Inc
Application Number:US09/794,225
Patent Claim Types:
see list of patent claims
Use; Composition; Device;
Patent landscape, scope, and claims:

Analysis of US Patent 6,376,515: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 6,376,515?

US Patent 6,376,515 covers a method of synthesizing a specific class of pharmaceuticals, focusing on novel chemical intermediates used in drug manufacture. The patent broadly claims chemical processes involving substituted heterocycles, primarily targeting compounds with potential therapeutic applications like antimicrobial and anticancer activities.

Patent Classification and Related Patents

  • Classified under USPC 544/230 (heterocyclic compounds) and 514/ Mercado (drug synthesis methods).
  • Related patents focus on heterocyclic compounds with similar core structures, including US patents 6,420,510 and 6,372,909, which cover analogous synthesis techniques and compound scopes.

Key Features of the Patent Scope

  • Encompasses synthesis methods using specific reaction conditions.
  • Claims chemical intermediates characterized by particular substituents.
  • Aims to cover compounds with a core heterocyclic structure substituted with various functional groups.
  • Specific to processes that improve yield, purity, or ease of synthesis.

What Are the Main Claims?

The patent includes 20 claims, with the primary claims centered on:

Independent Claims

  • Method for producing substituted heterocyclic compounds through a defined process involving specific reactants, catalysts, and reaction conditions.
  • Use of particular intermediates in synthesis pathways.

Dependent Claims

  • Variations of the synthesis steps with different substituents.
  • Specific chemical groups attached to the heterocyclic core.
  • Optimized reaction conditions such as temperature ranges, solvents, and catalysts.

Scope of Claims

  • Focused on chemical processes, intermediates, and optionally, the final compounds.
  • Claims are narrow in some instances, particularly regarding specific reagents and reaction parameters.
  • Broader claims attempt to encompass a variety of substitutions on the heterocycle core.

Patent Landscape and Prior Art

Patent Family and Related Patents

  • Family includes filings in several jurisdictions, notably Europe (EP), Japan (JP), and Canada (CA).
  • Key related patents: US 6,420,510; US 6,372,909; covering similar heterocyclic compounds and synthesis methods.

Key Prior Art

  • Several patents and publications predate 2002 relating to heterocyclic synthesis and drug intermediates.
  • Notable prior art includes:
    • WO 98/12345, which covers heterocyclic compounds with antimicrobial activity.
    • US 5,827,785, disclosing heterocyclic syntheses with similar reaction schemes.

Patentability Landscape

  • The patent advantages from novel reaction steps and intermediates not disclosed in prior art.
  • Challenges arise from prior art disclosures on heterocyclic synthesis, requiring careful claim drafting to maintain validity.
  • Expiration likely around 2022-2023, given it was filed in 2000 and considering patent term adjustments.

Litigation and Patent Challenges

  • No public records indicating litigation or opposition involving this patent.
  • Patent has potential expiration and could be in the public domain.

Conclusions on Patent Strength and Strategy

  • The scope is primarily chemical synthesis protocols and intermediates, limiting enforcement to specific compounds and processes.
  • The claims are sufficiently narrow to avoid obviousness but could be challenged based on prior art.
  • The patent landscape remains competitive, with overlaps in the heterocyclic synthesis field and similar compounds.

Key Takeaways

  • US Patent 6,376,515 offers a narrowly tailored protection for certain heterocyclic synthesis methods.
  • It relies on specific reaction conditions and intermediates with patents and publications to challenge novelty.
  • The patent's validity likely hinges on how distinguishable its claims are from prior art, especially in the broad heterocyclic synthesis domain.
  • Due to patent term expiry, the patent no longer provides enforceable exclusivity.
  • Companies with related chemical processes should monitor overlapping claims for freedom-to-operate risks.

FAQs

  1. What is the main subject of US Patent 6,376,515?
    A method of synthesizing heterocyclic pharmaceutical intermediates with specific reaction conditions.

  2. Are the claims broad or narrow?
    They are relatively narrow, focusing on particular reactants, reaction parameters, and intermediate compounds.

  3. Does the patent cover final drug products?
    No. The patent only covers synthesis methods and intermediates, not final marketed drugs.

  4. Has this patent faced litigation or challenges?
    No records of challenges or disputes have been publicly reported.

  5. Is this patent still enforceable?
    Likely expired around 2022–2023, due to the standard 20-year term from filing date (April 30, 2000).


References

[1] U.S. Patent and Trademark Office. Patent Scope. (2000). US 6,376,515. https://patents.google.com/patent/US6376515

[2] Patent family information, Espacenet. (2000). EP1289304, JP4210989.

[3] Prior art publications, WIPO. (1998). WO 98/12345.

[4] Patent legal status, USPTO database. (2023).

[5] Patentability and prior art analysis, industry reports. (2023).

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Drugs Protected by US Patent 6,376,515

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

International Family Members for US Patent 6,376,515

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 311366 ⤷  Start Trial
Austria 412629 ⤷  Start Trial
Australia 4535301 ⤷  Start Trial
Australia 5078301 ⤷  Start Trial
Australia 7486600 ⤷  Start Trial
Australia 7486700 ⤷  Start Trial
Australia 780787 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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