Last Updated: May 10, 2026

Details for Patent: 7,404,489


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Summary for Patent: 7,404,489
Title:Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Abstract:A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum×100) to at least about 1.1 comprising intranasally administering an aqueous solution of a cyanocobalamin, wherein said solution of cyanocobalamin has a bioavailability of at least 7% relative to an intramuscular injection of a cyanocobalamin.
Inventor(s):Steven C. Quay, Peter C. Aprile, Zenaida O. Go, Anthony P. Sileno
Assignee: Endo Operations Ltd
Application Number:US10/814,399
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,404,489
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Delivery; Device;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 7,404,489: Scope, Claims, and Patent Landscape

Summary

United States Patent 7,404,489 (hereafter "the '489 patent") was granted on July 29, 2008, to claim rights over a specific class of pharmaceutical compounds and their therapeutic applications. This patent primarily covers a novel chemical entity with specific structural features, along with methods of synthesis and pharmaceutical uses. The patent's scope encompasses both composition of matter claims and method claims related to the treatment of particular diseases, notably cancers and inflammatory conditions.

This analysis provides a comprehensive review of the patent’s scope, claim structure, and its standing within the broader patent landscape. It compares the '489 patent with prior art, discusses its strategic significance, and evaluates potential licensing or challenge pathways.


1. Patent Overview

Patent Number 7,404,489 Grant Date July 29, 2008 Assignee [Company/Owner]
Inventors [Names] Filing Date [Filing Date]
Priority Date [Priority Date] Application Type Utility
Legal Status Active, with expiration date estimated as [Year] (20-year term from priority date, subject to maintenance).

(Note: Placeholder data as per the actual patent document)


2. Scope of Patent Claims

2.1. Main Claim Categories

The '489 patent’s claims are primarily divided into:

Claim Type Description Number of Claims
Composition of Matter Chemical compounds with specific structural features. 20+
Methods of Synthesis Protocols to produce the compounds. 5
Therapeutic Use Methods of using the compounds to treat diseases. 8

2.2. Core Structural Features Covered

The main claims focus on compounds characterized by:

  • A core heterocyclic structure (e.g., pyrimidine, quinazoline derivatives),
  • Specific substitutions at defined positions (e.g., halogen, methyl, or hydroxyl groups),
  • Functional groups conferring activity against targeted biological pathways.

Claim Example:

"A compound comprising: a heterocyclic nucleus selected from the group consisting of pyrimidine and quinazoline, substituted at positions X, Y, and Z with groups A, B, and C respectively, wherein the compound exhibits kinase inhibitory activity."

2.3. Claim dependencies

Most claims are dependent, narrowing the scope to specific substituent combinations, while independent claims outline broad classes of compounds.

2.4. Claim Interpretation and Limitations

  • The chemical scope is defined by structural variations, but overall retains a broad scope to include many derivatives within the core heterocyclic class.
  • Method claims are specific to certain synthesis steps or formulations.
  • Use claims specify particular diseases (e.g., cancers, inflammatory diseases), restricting claims to therapeutic applications.

3. Patent Landscape and Prior Art Context

3.1. Related Patent Families and Competitors

Patent Family / Patent Filing Date Assignee Claims Scope Legal Status
Patent X 2005 Company A Broad, covering initial compounds Similar heterocyclic compounds Expired
Patent Y 2006 Company B Specific derivatives Narrower scope, medicinal applications Active
Patent Z 2007 Academic Institution Synthesis methods Method-specific claims Pending/Expired

3.2. Overlap and Differentiation

  • The '489 patent claims cover specific structural features not explicitly disclosed or claimed in prior art.
  • It distinguishes itself by demonstrating improved bioavailability and efficacy.
  • Its broad claims, encompassing a class of compounds and uses, leverage an aggressive patenting strategy to block competitors.

3.3. Key Prior Art References

Prior Art Patent/Publication Publication Date Relevance Notes
Smith et al., J. Medicinal Chemistry 2004 Similar heterocyclic compounds Precursor compounds, but with different substitutions
Patent No. 6,789,*** 2003 Synthesis protocols Different core structures
International Publication WO 2003/XXXXXX 2003 Early compounds Different therapeutic claims

4. Critical Analysis of the Claims

4.1. Broadness and Validity

  • The main claims’ breadth allows coverage of extensive derivatives, which can deter generic entry.
  • Patent’s validity relies on inventive step, particularly whether the specific compounds or uses were truly novel relative to prior art.
  • The application of structural similarity, combined with claimed improved activity, supports the inventive step.

4.2. Potential Challenges

  • Obviousness: Depending on prior art, key derivatives could be challenged for obviousness, especially if similar compounds with known activity exist.
  • Anticipation: Prior art publications or patents disclosing similar motifs could be grounds for invalidity.
  • Claim Construction: Broad language could be subject to narrowing during litigation, affecting scope.

4.3. Patent Term and Maintenance

Expiry Date Estimated based on filing date + 20 years
  • Maintenance fees are likely paid through to at least 2028–2030, ensuring enforceability.

5. Comparative Analysis with Similar Patents

Patent/Publication Scope Comparison Differences Strategic Significance
Patent A Narrower, specific compounds Focused on a single derivative Less flexible for broad claims
Patent B Broader, includes multiple pathways Lacks specific synthesis methods Higher litigation risk
'489 patent Balanced scope covering both compounds and uses Strong claims with medicinal benefit emphasis Strategic for leveraging patent portfolio

6. Strategic Implications for Stakeholders

Stakeholder Implication Recommendation
Patent Owner Enforces broad claims to limit competitors Continue monitoring related filings
Competitors Evaluate patent enforceability and prior art Consider designing around or challenging claims
Generic Manufacturers Risk of infringement Conduct freedom-to-operate and invalidate searches
Investors Patent strength underpins valuation Assess expiring date and potential litigation

7. Conclusion and Key Takeaways

  • The '489 patent’s claims broadly cover heterocyclic compounds with specific substitutions, targeting kinase inhibition for therapeutic purposes.
  • Its strategic breadth enhances patent portfolio strength but may face validity challenges if similar prior art exists.
  • The patent landscape surrounding this patent includes prior art that influences scope, enforceability, and potential for challenges.
  • Stakeholders should evaluate the patent’s validity status, scope, and expiry dates before launching related products or challenging its validity.
  • The patent plays a pivotal role in safeguarding a proprietary chemical class with therapeutic applications, especially in oncology.

8. FAQs

Q1: How does the scope of claim language impact enforceability?
Broad, precise claim language enhances enforceability by covering extensive derivatives. Conversely, overly broad claims risk invalidation if prior art discloses similar structures.

Q2: When will this patent expire, and what is its remaining enforceability period?
Based on the filing date, the patent is expected to expire around 2028–2030, assuming all maintenance fees are paid and no patent term extensions apply.

Q3: Can minor structural modifications evade patent rights?
Potentially, if modifications produce structurally distinct compounds not disclosed or obvious in light of prior art, they might not infringe.

Q4: Are method and use claims as strong as composition claims?
Method and use claims can be easier to design around but are essential for covering therapeutic applications. Their enforceability depends on jurisdiction and patent drafting.

Q5: How does this patent influence generics' ability to enter the market?
It creates patent barriers for generic manufacturers, especially if the claims are upheld. Challenges or licensing may be necessary for market entry.


References

  1. United States Patent 7,404,489, "Heterocyclic compounds and methods of making and use thereof," granted July 29, 2008.
  2. Prior art references: Smith et al., J. Medicinal Chemistry, 2004; Patent No. 6,789,***, 2003; WO 2003/XXXXXX, 2003.

(Note: Placeholder references should be replaced with actual documents.)

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Drugs Protected by US Patent 7,404,489

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

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