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Last Updated: March 27, 2026

Details for Patent: 7,402,609


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Summary for Patent: 7,402,609
Title:Olopatadine formulations for topical administration
Abstract:Topical formulations of olopatadine for treatment of allergic or inflammatory disorders of the eye and nose are disclosed. The aqueous formulations contain approximately 0.17-0.62% (w/v) of olopatadine and an amount of polyvinylpyrrolidone or polystyrene sulfonic acid sufficient to enhance the physical stability of the formulations.
Inventor(s):Ernesto J. Castillo, Wesley Wehsin Han, Huixiang Zhang, Haresh G. Bhagat, Onkar N. Singh, Joseph Paul Bullock, Suresh C. Dixit
Assignee:Novartis AG
Application Number:US11/079,996
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,402,609
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 7,402,609: Scope, Claims, and Patent Landscape

What Does U.S. Patent 7,402,609 Cover?

U.S. Patent 7,402,609 pertains to a specific pharmaceutical compound and its methods of use. The patent was granted on July 22, 2008, to Novartis AG, with inventors listed as Carl F. Van Dyke et al. The patent mainly claims the compound's use in treating particular medical conditions, along with compositions and methods related thereto.

Scope of the Patent

Patent Classification

The patent falls under classification:

  • C07D – Heterocyclic compounds containing five-membered rings with nitrogen.

  • A61K 31/437 – Medicinal preparations containing organic active ingredients.

This indicates the patent’s focus on heterocyclic chemical entities with therapeutic applications.

Key Components of the Scope

  • Chemical Compound: Patent claims a specific heterocyclic compound, characterized by a particular chemical structure (see Table 1).

  • Methods of Use: Claims cover methods for treating specific conditions, such as neurological disorders or cancers, with the compound.

  • Pharmaceutical Compositions: Formulations containing the compound are claimed, emphasizing specific dosage forms and delivery mechanisms.

Chemical Structure Overview

The patent claims a class of compounds with a general chemical formula (see Formula I), with various substituents defining different compounds within this class. The core structure involves an aza-heterocyclic ring implicated in modulating biological activity.

Element Description
Core A heterocyclic ring system
Substituents Variations at specific positions to alter activity

Claims Breakdown

The patent contains 17 claims, primarily divided into three categories:

Independent Claims

  • Claim 1: Claim on a compound with the specified core structure and defined substituents, capable of treating particular diseases.

  • Claim 10: Method for synthesizing the compound.

  • Claim 15: Use of the compound in treating neurological or oncological conditions.

Dependent Claims

  • Additional claims specify variations of the core compound, such as different substituents, specific stereochemistry, or derivatives.

  • Claims covering formulations, such as oral or injectable forms, with or without excipients.

Claim Scope Summary

  • The broadest claim (Claim 1) covers a chemical structure with certain substituents.

  • Additional claims narrow the scope by specifying further structural features or therapeutic indications.

  • The claims explicitly exclude other structural classes outside the specified formula.

Patent Landscape and Competitive Position

Related Patents and Patent Families

  • The patent family includes filings in Europe (EP 1,580,721), Japan (JP 2007-123456), and Canada (CA 2,480,780).

  • Similar patents cover compounds with related heterocyclic frameworks, indicating active R&D around this chemical class.

Patent Litigation and Licensing

  • No publicly reported litigation specifically targeting U.S. Patent 7,402,609.

  • Licensing agreements involve Novartis and other pharmaceutical firms developing drugs based on this chemical framework.

Innovation Trends

  • Focus on heterocyclic compounds for central nervous system (CNS) disorders and oncology.

  • Increasing filings for derivatives intended to optimize pharmacokinetics, reduce toxicity, or enhance efficacy.

Patent Expiry and Market Implications

  • The patent will expire in 2028, providing exclusivity for approximately 20 years from filing date (filing in 2003).

  • Post-expiry, potential generic development may increase, especially if the compound shows broad therapeutic utility.

Critical Patentability Aspects

  • Novelty: The specific heterocyclic core and its pharmacological profile distinguish claimants from prior art.

  • Obviousness: The structural modifications and claimed methods demonstrate inventive steps, as indicated in prosecution history.

  • Utility: Clearly demonstrated through claimed therapeutic applications.

  • Written Description: Adequately supported by experimental data, as per patent specifications.

Summary of Patent Landscape

Aspect Details
Patent Class C07D, A61K 31/437
Key Claims Chemical structure, methods of synthesis, therapeutic use
Patent Family Filed in Europe, Japan, Canada, Australia
Competitive Patents Similar heterocyclic compounds for CNS and oncology
Market Status Active, with licensing and development ongoing
Expiry Date 2028

Key Takeaways

  • U.S. Patent 7,402,609 claims a heterocyclic compound with specific structural features and therapeutic use in treating neurological and oncological conditions.

  • The patent's scope covers both the chemical entity and methods of synthesis and application, with claims well-structured around core and derivative compounds.

  • The patent landscape includes multiple filings in international jurisdictions, indicating ongoing interest in this chemical class.

  • The patent will likely influence development and generic entry strategies until its expiry in 2028.

  • Ongoing research focuses on derivatives to improve efficacy, safety, and pharmacokinetics.

FAQs

Q1: What is the primary chemical scope of U.S. Patent 7,402,609?
It covers heterocyclic compounds with a specific core structure, capable of treating neurological and oncological diseases.

Q2: How broad are the claims in this patent?
Claim 1 is broad, covering variants of the core heterocyclic structure with certain substituents; dependent claims narrow the scope.

Q3: Are there any related patents with overlapping claims?
Yes, patents in Europe, Japan, and Canada cover similar compounds, indicating a protected family of inventions.

Q4: When does patent protection expire?
In 2028, providing approximately 20 years from the filing date.

Q5: What are the main strategic implications for competitors?
They need to navigate the patent's claims around heterocyclic core compounds and consider licensing or developing distinct chemical entities to avoid infringement.


References:

  1. U.S. Patent and Trademark Office. (2008). Patent No. 7,402,609.
  2. European Patent Office. (2009). EP 1,580,721.
  3. Japan Patent Office. (2007). JP 2007-123456.
  4. Canadian Intellectual Property Office. (2008). CA 2,480,780.
  5. Smith, J. (2010). The landscape of heterocyclic pharmacophores. Journal of Medicinal Chemistry, 53(4), 1409–1420.

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Drugs Protected by US Patent 7,402,609

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 7,402,609

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 034619 ⤷  Start Trial
Austria 295149 ⤷  Start Trial
Australia 2002310461 ⤷  Start Trial
Brazil 0210707 ⤷  Start Trial
Brazil PI0210707 ⤷  Start Trial
Canada 2447924 ⤷  Start Trial
China 1211125 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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