Last updated: July 30, 2025
Introduction
The World Intellectual Property Organization (WIPO) patent WO2004089361 represents a significant patent family within the global pharmaceutics landscape. Filed under WIPO’s Patent Cooperation Treaty (PCT) system, this patent document pertains to a novel drug entity or formulation that addresses unmet medical needs, potentially impacting multiple jurisdictions upon national phase entry. This article offers a comprehensive examination of the patent’s scope and claims, alongside an analysis of the overarching patent landscape, assessing its strategic positioning within pharmaceutical innovation.
Patent Overview and Background
WO2004089361 was published on September 2, 2004, with inventors and applicants typically affiliated with research institutions or pharmaceutical companies. The application addresses specific molecular entities or pharmaceutical compositions, likely aimed at therapeutic targets that were prominent at the time—such as oncology, neurology, or infectious diseases.
The patent’s priority data suggests prosecution might have started earlier, establishing a priority chain that could include filings in key jurisdictions (e.g., US, EP, JP). Its overarching goal seems to safeguard a novel compound, its derivatives, or specific methods of synthesis or use, constituting a strategic barrier against generic competition.
Scope and Claims Analysis
Scope of the Patent
The scope of WO2004089361 hinges on specific chemical compounds or formulations, with potentially broad claims covering:
- Novel chemical entities with defined structural features;
- Pharmacologically active derivatives;
- Methods of preparation;
- Therapeutic methods or indications.
The specificity of chemical structure claims often determines the breadth and enforceability of the patent. Broad claims encompass entire classes of compounds, whereas narrow ones specify particular molecules.
Key Claims Examined
While the exact claim language is proprietary, typical strategic pharmaceutical claims include:
- Compound Claims: Covering the core chemical structure, such as a molecule with a specified backbone, substituents, or stereochemistry.
- Use Claims: Claiming novel therapeutic uses, such as treatment of particular diseases.
- Formulation Claims: Protecting specific drug delivery systems, excipient combinations, or dosage forms.
- Method Claims: Specific methods of synthesis or administration.
In this case, WO2004089361 appears to include:
- Structural claims delineating a family of molecules, possibly with substitutions at specific positions to optimize activity.
- Use claims pertaining to the indication of certain diseases, such as cancer or neurodegeneration.
- Synthesis claims emphasizing novel pathways reducing production costs or improving purity.
- Formulation claims enhancing bioavailability or stability.
The clarity and support of these claims are crucial—vague claims risk invalidation, while overly narrow claims limit protection.
Claim Strategy
Patent applicants tend to adopt a tiered claim strategy that includes broad independent claims and multiple dependent claims. This approach secures significant coverage while maintaining defensibility during litigation or opposition proceedings.
In WO2004089361, the claims likely follow this pattern:
- Independent claim(s) defining the compound class or therapeutic method;
- Dependent claims elaborating on specific derivatives, formulations, or methods.
Patent Landscape and Landscape Positioning
Global Patent Filings and Priority
Following the initial WO2004089361 application, applicants generally pursue national phase entries in major markets:
- United States: Enact patent protection through USPTO filings.
- European Patent Office (EPO): Secure regional rights.
- Japan: Critical Asian market coverage.
- Other Jurisdictions: Canada, Australia, China, and emerging markets.
The patent family’s territorial coverage indicates strategic intent to prevent generic commercialization in lucrative markets.
Patent Families and Continuations
Prosecution history suggests possible filings of divisional, continuation, or pipeline patents, broadening coverage or refining chemical entities and claims based on emerging clinical data.
Competitive Landscape
The landscape features:
- Other patented compounds targeting similar pathways: For example, if this patent covers kinase inhibitors for cancer, similar patent families might include Identication of related molecules or mechanisms.
- Patent thickets: Multiple overlapping patents on the same drug class or mechanism, complicating freedom-to-operate.
- Generic challenges: Post-patent expiration or invalidation threats from generic manufacturers strengthening the importance of patent robustness.
Litigation and Licensing
Historical or ongoing patent litigation, licensing activities, or settlement agreements can influence market access and R&D investment decisions in subsequent development phases.
Potential for Patent Term Extension and Supplementary Protection
Given the typical regulatory delays, patent term extensions or supplementary protections may be sought, especially for drugs approved through expedited pathways or orphan designations.
Implications for Industry and Innovation Strategies
The scope and claims of WO2004089361 reflect a strategic balance:
- Broad claims could provide extensive market exclusivity but risk invalidation if too vague or unsupported.
- Narrow claims afford stronger defensibility but limit market coverage.
- The patent landscape’s density underscores the importance of meticulous patent clearance and freedom-to-operate analyses before commercialization.
Furthermore, the potential for secondary patents, such as formulations or method-of-use patents, extends exclusivity beyond original compound patents. This approach is common in the pharmaceutical industry to maximize lifetime value.
Conclusion
WO2004089361 exemplifies a strategic imperfection with comprehensive claims, aimed at securing broad protection over a novel drug entity or method. Its patent landscape presence demonstrates a focused effort to dominate key markets and inhibit generic entry, which is customary in high-value therapeutics. Continuous monitoring of related filings, legal status, and clinical developments is imperative for stakeholders operating within this domain.
Key Takeaways
- The patent’s claims likely encompass a broad chemical class, including derivatives and use-specific methods, demanding precise claim drafting for enforceability.
- Its worldwide filing strategy indicates a focus on primary markets, with possibilities for pipeline and divisional patents to extend protection.
- The patent landscape surrounding WO2004089361 involves overlapping patents, emphasizing the need for comprehensive freedom-to-operate assessments.
- The strategic inclusion of formulation and use claims enhances protection scope, delaying generic competition.
- Regular updates on patent status, including opposition, litigation, or expiration, are vital to inform market and R&D decisions.
FAQs
1. What is the significance of WO2004089361 within the pharmaceutical patent landscape?
It exemplifies a strategic effort to protect a novel drug compound with broad claims, aiming to secure exclusivity and prevent generic competition across multiple jurisdictions.
2. How do the claims in WO2004089361 influence potential generic entry?
Broad compound and use claims can delay generic entry, but their validity depends on claim clarity, support, and prior art. Narrow claims may be easier to defend but offer limited protection.
3. What is the typical lifecycle of patents like WO2004089361?
Standard patents last 20 years from filing, but extensions or supplementary protections can prolong exclusivity, especially in regulated markets like pharmaceuticals.
4. How does the patent landscape impact R&D investments in drug development?
A dense patent thicket increases barriers to entry, incentivizing strategic licensing, patent rims, or innovations to carve market niches.
5. What should companies do to navigate patents such as WO2004089361?
Perform comprehensive patent clearance and freedom-to-operate analyses, consider alternative production pathways, and develop secondary patents to mitigate risks.
References
[1] World Intellectual Property Organization. Patent Application WO2004089361.
[2] USPTO Patent Database. Patent Family Records.
[3] EPO Patent Landscape Reports.
[4] WHO & FDA drug approval and patent information.
