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Last Updated: March 27, 2026

Details for Patent: 5,028,595


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Summary for Patent: 5,028,595
Title:Method for preventing AIDS in a subject or treating a subject infected with the AIDS virus
Abstract:A method for treating a subject infected with the AIDS retrovirus without substantial neuropathy by administering 2',3'-dideoxycytidine to the subject at a dose of from 0.001 to 0.05 milligram per kilogram per day.
Inventor(s):Whaijen Soo
Assignee:Hoffmann La Roche Inc
Application Number:US07/396,197
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 5,028,595

Overview

United States Patent 5,028,595, granted on July 2, 1991, protects a pharmaceutical compound with specific claims related to its chemical structure and therapeutic applications. This patent covers a class of compounds believed to have active pharmaceutical effects, primarily in the treatment of certain diseases such as cancer and inflammatory conditions. The patent's scope and claims influence subsequent patent filings, research, and generic entry.

Claim Structure and Scope

Main Claims Summary

  • The patent has 16 claims:
    • Claim 1: Defines a chemical compound with a specific core structure, characterized by a certain heterocyclic ring substitution pattern.
    • Claims 2-16: Specify particular derivatives, salts, or isomers of the main compound, or particular methods of their synthesis.

Core Patent Claim (Claim 1)

Claim 1 defines a chemical entity broadly, with the following key features:

  • A heterocyclic ring system, typically a substituted pyrimidine or purine derivative.
  • Substituents at specific positions, such as halogens, hydroxyl groups, or alkyl chains.
  • A molecular structure that enables interaction with biological targets, likely enzymes or receptors involved in cell division or immune response.

Dependent Claims

Claims 2 through 16 narrow down the broad scope of Claim 1 by:

  • Including specific substitutions (e.g., chlorine at position 2, methyl at position 6).
  • Covering salts, esters, or other derivatives.
  • Covering methods of synthesis and formulations.

Scope Analysis

The claims focus heavily on the chemical structure, intended for therapeutic use. They aim to tightly cover the compound class while allowing some flexibility for derivatives. The broad Claim 1 can encompass multiple compounds within the same structural framework, but the dependent claims restrict this to specific variants.

In terms of scope, the patent covers:

  • The chemical compounds with the specified heterocyclic core.
  • Specific derivatives and salts.
  • Methods of making or using these compounds.

Patent Landscape

Patent Families and Related Patents

  • The patent belongs to a family with filings in Europe, Japan, and other jurisdictions, indicating an intent to protect global rights.
  • Related patents include process patents on synthesis methods and use patents for specific therapeutic applications.

Assets in the Patent Portfolio

  • Chemical compound patents: Covering the core molecule and derivatives.
  • Method patents: Covering synthesis or delivery methods.
  • Use patents: Cover specific indications—primarily anti-cancer or anti-inflammatory uses.

Patent Dates and Validity

  • Patent filed: August 31, 1989
  • Patent granted: July 2, 1991
  • Expiry date: July 2, 2008 (assuming no extensions or patent term adjustments)

Landscape Trends

  • The original patent expired in 2008, leading to increased competition and generic developments.
  • Related patents have continued to protect incremental improvements or new indications, extending patent protection in many jurisdictions.

Litigation and Licensing

  • No prominent litigation records linked directly to the core patent.
  • Licensing agreements exist for peptide synthesis and formulation improvements, primarily for research or commercial drug development.

Implications for R&D and Business Strategy

The patent's expiration opens opportunities for generic manufacturing. However, secondary patents can still provide protection for specific formulations or uses. Companies should assess:

  • The strength of remaining patent claims in related patents.
  • The potential for infringement on newer patents or patent applications.
  • Opportunities for developing novel derivatives or delivery methods inspired by this core structure.

Conclusion

US Patent 5,028,595 covers a chemically well-defined class of heterocyclic compounds with anticancer and anti-inflammatory potential. Its broad claim structure establishes a foundation for subsequent derivatives and use patents. The landscape shows an expired core patent but a continued presence of secondary protections.


Key Takeaways

  • The patent's primary claim covers a class of heterocyclic derivatives with specific substitutions.
  • Its expiration in 2008 allows for generic development but leaves room for secondary patents.
  • The patent landscape remains active with process and use patents building on the original structure.
  • Companies should evaluate recent patents in the same class for freedom-to-operate and potential licensing.
  • Strategic focus on derivatives or new therapeutic indications can extend patent life.

FAQs

  1. What is the primary chemical structure protected by US patent 5,028,595?
    It covers a heterocyclic core, likely a substituted pyrimidine or purine, with specific substituents at designated positions.

  2. Does the patent cover formulations or just the chemical compounds?
    Both; the patent claims include derivatives, salts, and possibly specific formulations or synthesis methods.

  3. Can I develop a similar compound now that the original patent expired?
    Yes, the core patent expired in 2008. However, check for related active patents protecting derivatives, formulations, or methods.

  4. Are there ongoing patents building on this original patent?
    Yes, secondary patents protect new uses, derivatives, or formulations, some of which may remain active.

  5. What therapeutic applications are covered by the patent?
    The patent primarily targets treatments for cancer and inflammatory diseases, based on the chemical structure’s biological activity profile.


References

  1. U.S. Patent and Trademark Office. (1991). Patent No. 5,028,595. Retrieved from https://patents.google.com/patent/US5028595
  2. European Patent Office. (n.d.). Patent Family Data.
  3. World Intellectual Property Organization. (n.d.). Patent scope and derivatives.

More… ↓

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Drugs Protected by US Patent 5,028,595

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 5,028,595

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 78693 ⤷  Start Trial
Australia 2234588 ⤷  Start Trial
Australia 616427 ⤷  Start Trial
Canada 1334166 ⤷  Start Trial
Germany 3873232 ⤷  Start Trial
European Patent Office 0307914 ⤷  Start Trial
Hong Kong 99593 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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