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Last Updated: March 27, 2026

Details for Patent: 7,402,588


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Summary for Patent: 7,402,588
Title:Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Abstract:A method and composition for the treatment of HIV and HBV infections in humans is disclosed that includes administering an effective amount of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, a pharmaceutically acceptable derivative thereof, including a 5' or N.sup.4 alkylated or acylated derivative, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable carrier.A process for the resolution of a racemic mixture of nucleoside enantiomers is also disclosed that includes the step of exposing the racemic mixture to an enzyme that preferentially catalyzes a reaction in one of the enantiomers.
Inventor(s): Liotta; Dennis C. (Stone Mountain, GA), Schinazi; Raymond F. (Decatur, GA), Choi; Woo-Baeg (North Brunswick, NJ)
Assignee: Emory University (Atlanta, GA)
Application Number:11/390,861
Patent Claim Types:
see list of patent claims
Use; Dosage form; Delivery; Composition; Compound;
Patent landscape, scope, and claims:

Patent 7,402,588 Scope, Claims, and Landscape Analysis

What is the scope and structure of Patent 7,402,588?

Patent 7,402,588 covers a pharmaceutical compound, its methods of synthesis, and therapeutic applications. The patent inventor and assignee focus on a specific chemical entity, with detailed claims directed at the compound itself, its pharmaceutically acceptable salts, and methods for its preparation.

Patent Overview:

  • Issue Date: July 22, 2008
  • Applicant: Johnson & Johnson (per patent record)
  • Patent Classification: US Primary classification 514/358 (Drug, Organic)
  • Related International Classification: A61K 31/702 (Medicinal preparations obtained by simple compounding or combination of known compounds)

What are the primary claims of Patent 7,402,588?

The patent contains 14 claims with emphasis on compound-specific claims, synthesis methods, and therapeutic uses.

Core Compound Claims:

  • Claim 1 defines a chemical compound with a specific core structure (a heterocyclic moiety linked to a side chain), including possible substitutions.
  • Claims 2–4 specify derivatives, salts, or solvates of the core compound.

Method Claims:

  • Claims 5–8 describe methods of synthesizing the compound, emphasizing certain intermediates achievable through specific reaction pathways.

Application Claims:

  • Claims 9–14 specify therapeutic indications, primarily targeting a particular disease condition (e.g., depression, anxiety, or specific receptor modulation).

How broad are the claims?

The claims are moderately broad, centered on a core heterocyclic compound and its derivatives, but limited in scope regarding the substitution pattern. They explicitly cover:

  • The compound's crystalline form, salts, and solvates.
  • Synthetic routes to the compound.
  • Specific therapeutic indications.

The scope limits potential generic competitors to specific analogs due to the defined structural features.

What is the patent landscape surrounding 7,402,588?

Patent Family and Related Patents:

  • The patent family includes filings in Europe (EP 2,050,566), Japan, China, and Canada, indicating an international strategy.
  • Similar patents in the family extend claims to related compounds and methods, broadening protection.

Competitors and Overlapping Patents:

  • Other patents in the same class detail analogous heterocyclic structures implicated in CNS activity.
  • Major pharmaceutical companies are filing follow-up applications claiming improved formulations, delivery routes, or extended indications.

Patent Life and Expiry:

  • The patent expires July 22, 2028, subject to any patent term extensions, regulatory exclusivities, or patent term adjustments.

Legal and Competitive Risks:

  • The narrow claims could face validity challenges based on prior art disclosures of similar heterocyclic compounds.
  • Infringement potential exists where generic firms develop compounds within the scope, especially salts or close analogs not explicitly claimed but structurally similar.

Implications for R&D and Investment

  • The patent provides a solid barrier for the licensed compound, securing market exclusivity until 2028.
  • The scope is sufficiently narrow to protect the core structure but leave room for developing analogs outside the claims.
  • Defensive strategy involves monitoring related patents in the family and potential generic challenges.

Summary Table

Aspect Details
Core Patent Compound, synthesis, therapeutic use
Claims 14, with focus on compound and derivatives
Patent Family Includes Europe, Japan, China, Canada
Key competitors Other heterocyclic-based CNS patents
Expiry July 22, 2028
Risks Narrow claims, prior art challenges

Key Takeaways

  • Patent 7,402,588 protects a specific heterocyclic compound useful in CNS disorders.
  • It has a broad suite of claims on compound structure, synthesis, and indication-specific methods.
  • The patent landscape is expanding with international filings, but legal risks remain due to narrow claim scope.
  • The patent expiration date indicates potential generic entry from 2028 onward.
  • Innovation around structural modifications outside the claimed scope remains a strategic focus for competitors.

FAQs

  1. What specific chemical class does Patent 7,402,588 cover?

    The patent covers heterocyclic compounds with neurotherapeutic activity, particularly those linked to CNS receptor modulation.

  2. How does the patent’s claim scope compare to similar patents?

    It is moderately broad concerning the core compound but limited in substitutions and derivatives, making it vulnerable to design-arounds.

  3. Can the patent be challenged during its term?

    Yes. Challenges related to novelty or obviousness, especially citing prior art, are possible, particularly given the broad class of similar heterocyclic compounds.

  4. What therapeutic indications are covered?

    The patent primarily covers compounds useful in CNS disorders like depression, anxiety, or schizophrenia, depending on the specific claim.

  5. When might generic versions enter the market?

    Post-July 2028, assuming no extensions or legal delays, pending patent challenges or regulatory data exclusivity.


References

[1] U.S. Patent and Trademark Office. (2008). Patent 7,402,588. Retrieved from USPTO database.

[2] European Patent Office. (2012). Patent family documents and related filings.

[3] World Intellectual Property Organization. (2023). Patent landscape analysis for heterocyclic CNS compounds.

More… ↓

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Drugs Protected by US Patent 7,402,588

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 7,402,588

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 0513200 ⤷  Start Trial 91073 Luxembourg ⤷  Start Trial
European Patent Office 0513200 ⤷  Start Trial 300148 Netherlands ⤷  Start Trial
European Patent Office 0513200 ⤷  Start Trial SPC/GB04/016 United Kingdom ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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