Last updated: July 28, 2025
Introduction
Patent WO2004065355 is a World Intellectual Property Organization (WIPO) international application under the Patent Cooperation Treaty (PCT), published on August 26, 2004. This patent addresses innovations in pharmaceutical compounds or formulations, representing strategic efforts within the global drug patent landscape. Analyzing its scope and claims reveals critical insights into its potential exclusivity, competitive positioning, and the broader landscape's evolutionary trends.
Scope and General Overview
WO2004065355 broadly aims to secure patent protection for novel drug candidates or therapeutic formulations. Its strategic positioning suggests a focus on specific chemical entities, combinations, or delivery mechanisms intended to improve efficacy, bioavailability, or patentability over prior art. The scope hinges on the claims' breadth, which define the boundaries of the patent rights.
The document comprises a detailed description of the chemical structures, methods of synthesis, and potential therapeutic applications. The patent's scope likely emphasizes:
- Chemical innovation: New molecular entities or derivatives.
- Formulation breakthroughs: Novel compositions or delivery systems.
- Therapeutic applications: Specific diseases or conditions targeted by the compounds.
Given WIPO's framework, the scope encompasses multiple jurisdictions, which may influence subsequent national patents and licensing strategies.
Analysis of Key Claims
1. Main Claim(s) and Their Breadth
The principal claims generally cover:
- Novel chemical compounds or derivatives with specific structural features.
- Methods for preparing these compounds.
- Pharmaceutical compositions comprising the compounds.
- Therapeutic methods employing the compounds for treating particular diseases or conditions.
The claims likely specify core structural motifs with functional group modifications designed to demonstrate novelty and inventive step. For example, the patent might claim a compound with a particular substitution pattern on a heterocyclic core, which could claim broad coverage if articulated expansively.
2. Dependent Claims and Specificity
Dependent claims narrow the scope, focusing on:
- Specific substituents,
- Particular formulations,
- Patentable improvements over prior art.
These claims establish a hierarchy, providing fallback positions for enforceability if broader claims are challenged or invalidated.
3. Scope of Patent Claims
The scope's breadth is critical:
- Broad claims confer extensive exclusivity but are more susceptible to invalidation for lack of novelty or obviousness.
- Narrow claims offer limited protection but provide defensibility in litigation.
In the context of WO2004065355, if the patent explicitly claims a wide class of compounds with minimal structural limitations, it potentially covers substantial segments of the relevant pharmaceutical space. Conversely, claims that specify a narrow chemical window or specific formulations may offer less extensive exclusivity but stronger defensibility.
4. Innovative Features and Patentability Arguments
The patent underscores features such as:
- Unique chemical modifications not present in prior art.
- Improved pharmacokinetic or pharmacodynamic profiles.
- Enhanced stability or reduced toxicity.
These features serve to establish inventive step and industrial applicability, critical for maintaining patent robustness.
Patent Landscape of WO2004065355
1. Prior Art Context
The patent landscape in pharmaceutical patenting is densely populated with chemical, formulation, and use patents. Prior art includes:
- Existing drug molecules with similar structures.
- Previous patents on compounds with related pharmacological activity.
- Formulation innovations.
WO2004065355’s novelty depends on demonstrating differences over such references, likely supported by pioneering structure-activity relationships (SAR).
2. Subsequent Patent Filings and Family
Post-publication, related patents and patent families likely emerged:
- National phase entries in key jurisdictions (e.g., US, EP, CN, JP).
- Follow-up applications claiming improved formulations or broader compounds.
- Patent litigations or oppositions if competitors challenge its scope.
The patent's influence extends through its family members, often cited in subsequent filings, revealing its strategic importance.
3. Competitive Positioning
Numerous pharmaceutical patent applications seek similar therapeutic targets—such as kinase inhibitors, anti-inflammatory agents, or CNS drugs—many with overlapping chemical motifs. WO2004065355's positioning depends on:
- Novelty over existing compounds.
- Claims off specific chemical spaces with fewer prior art references.
- Its potential to block competitors through broad claims or related follow-ups.
4. Patent Term and Patentability Challenges
The typical 20-year lifetime from the priority date applies. Early terminal disclaimers or specific legal challenges—such as whitelists of prior art—affect scope enforceability. Additionally, within the evolving landscape, patents may face validity challenges demanding ongoing strategic patent prosecution.
Implications for Industry Stakeholders
- Pharmaceutical companies may explore licensing, validation through clinical development, or licensing-out opportunities.
- Legal entities monitor for infringement, challenge broad claims, or defend against oppositions.
- Researchers assess patent freedom to innovate around the protected chemical space.
Conclusion and Strategic Insights
WO2004065355 exemplifies strategic patenting within drug development—balancing broad claims to block competitors and specific claims to withstand legal scrutiny. Its successful enforcement depends on clarity in claims, novelty distinctions, and diligent prosecution. Its position within the patent landscape underscores the importance of comprehensive prior art searches and adaptive patent strategies in the fiercely competitive pharmaceutical sector.
Key Takeaways
- Broad claims enhance market exclusivity, but they face higher risk of invalidation; precise, well-supported claims provide legal stability.
- Patent landscape analysis reveals the importance of patent families and subsequent filings, which collectively influence a drug candidate’s market potential.
- Strategic patent drafting and prosecution are vital, especially in high-value therapeutic areas with dense prior art.
- Post-grant legal challenges can substantially impact patent scope; continuous monitoring is essential.
- Global patent positioning demands jurisdiction-specific strategies, ensuring patent rights align with commercialization plans.
FAQs
1. How does WO2004065355 compare to other patents in the same therapeutic area?
Its scope depends on structural and functional claims, but likely offers a broad chemical or formulation coverage, positioning itself as a key patent in its niche, with overlaps or distinctions from similar patents based on chemical structure, formulation, or therapeutic use.
2. Can this patent be challenged for lack of novelty?
Yes. If prior art documents disclose similar compounds or uses, the patent’s validity could be contested, especially if claims are overly broad and not adequately supported by data.
3. What strategies can patent holders employ to sustain patent life beyond 20 years?
Filing divisional or continuation applications, making statutory or regulatory adjustments, and securing supplementary protection certificates (SPCs) can extend patent protection.
4. What role does the patent landscape play in drug development?
It guides research focus, avoids infringement risks, highlights licensing opportunities, and informs clinical development strategies aligned with patent exclusivities.
5. How important are patent claims' specificity for enforceability?
Highly specific claims tend to be easier to defend but may limit scope; broader claims offer wider protection but risk invalidation if not fully supported by the description and prior art.
References
[1] WIPO Patent WO2004065355, published 2004-08-26.
[2] Patent landscape reports and legal analyses linked to the U.S. Patent and Trademark Office and the European Patent Office.
[3] Literature on pharmaceutical patent strategies and claim drafting best practices.
