Last updated: November 24, 2025
Introduction
The patent application WO2004103306, published by the World Intellectual Property Organization (WIPO), represents an international filing pertinent to pharmaceutical innovations. This analysis deconstructs the scope, claims, and broader patent landscape associated with the application to provide insights crucial for industry stakeholders, including patent strategists, R&D managers, and legal professionals.
Overview of the WO2004103306 Patent Application
WO2004103306 embodies a WIPO-filed patent application published in 2004, indicating an international patent application under the Patent Cooperation Treaty (PCT). The application generally encapsulates a pharmaceutical compound, formulation, or method aimed at addressing specific medical conditions, aligning with common patenting practices in drug development.
While the complete document is extensive, key sections of interest include the claims—which define the legal scope—and the detailed description—which contextualizes technical disclosures. Its jurisdictional coverage, claim breadth, and subsequent national phase entries significantly shape the patent landscape.
Scope and Claims Analysis
1. Scope of the Patent Application
At its core, WO2004103306 covers a novel chemical entity, potentially a small molecule or biologic, designed for therapeutic utility. Its scope extends to:
- Compound claims—covering the chemical structure itself, including derivatives and analogs.
- Use claims—covering methods of using the compound for specific indications.
- Formulation claims—covering pharmaceutical compositions incorporating the compound.
- Process claims—detailing methods of synthesis or formulation.
The breadth of the scope hinges on how comprehensively the claims encompass analogs, derivatives, or modifications, which can influence the patent’s enforceability and potential for breadth.
2. Core Claims and Their Implications
The patent's claims can be categorized as follows:
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Independent Claims: These are the broadest and define the fundamental novelty—usually claiming the chemical compound or its use for treating a disease.
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Dependent Claims: Further specify the compound’s specific features, such as substituents, stereochemistry, or formulation details, narrowing the scope but providing fallback positions.
An illustrative example: if Claim 1 claims a compound with a specific core structure, dependent claims might specify substituents or particular efficacies. The breadth of Claim 1 significantly influences the patent's scope in blocking competitors.
3. Validity and Enforceability Factors
The enforceability of the claims relies on novelty, inventive step, and industrial applicability. During prosecution, potential rejections based on prior art could lead to narrowed claims. The scope is also affected by whether the claims are sufficiently supported by the specification.
Patent Landscape and Strategic Considerations
1. Geographic Coverage and National Phase Entries
The PCT application WO2004103306 allows entering national phases across jurisdictions such as the US, Europe, Japan, and other economies prioritizing pharmaceutical patent protection. The extent of these entries determines regional patent rights and enforcement abilities.
2. Competitive Landscape and Patent Clusters
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Existing Patent Families: Related patents filed before or after WO2004103306 may include chemical derivatives, formulations, or use patents, creating a complex cluster that competitors must navigate.
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Freedom-to-Operate (FTO) Analysis: Given broad claims, potential freedom to operate may be constrained, demanding meticulous landscape and validity analyses, especially when overlapping with existing patents.
3. Patent Lifecycle and Potential Challenges
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Patent Term and Extensions: If granted, the patent could provide up to 20 years from the filing date, adjustable via Supplementary Protection Certificates (SPC) or Patent Term Extensions (PTE), particularly in regions like the US and EU.
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Challenges & Oppositions: Competitors may challenge validity based on prior art, especially if claims are broad. The scope's breadth can influence vulnerability or robustness against such challenges.
Implications for Drug Development and Commercialization
Developers leveraging the disclosed compound or use claims must evaluate overlaps with existing patents. Broad claims that cover the key chemical scaffold shorten the innovation window unless they can carve out narrower niche claims. Conversely, narrow, well-supported claims might bolster licensing or partnership opportunities.
Additionally, understanding the patent landscape enables strategic planning around patent filings, research investments, and potential infringement risks. Given the potential for extensive claims and geographical scope, stakeholders must conduct comprehensive freedom-to-operate and validity analyses.
Key Considerations for Stakeholders
- For Patent Holders: Maintain robust claims, pursue strategic regional filings, and monitor potential infringers to preserve patent integrity.
- For Competitors: Analyze claim scope carefully, identify patent gaps, and consider designing around or challenging broad claims.
- For R&D Leaders: Use patent landscapes to guide molecule design, avoiding infringement and identifying licensing opportunities.
Conclusion
WO2004103306 exemplifies the complex interplay between chemical innovation and patent strategy in the pharmaceutical sector. Its scope and claims, if sufficiently broad and defensible, can provide significant competitive advantage, yet are also open to legal challenges and require continuous landscape monitoring. Strategic foresight is essential for maximizing the patent's commercial value while mitigating infringement risks.
Key Takeaways
- The scope of WO2004103306 hinges on the breadth of its claims—broad claims offer high protection but face greater validity scrutiny.
- Regional filing strategies and subsequent national phase entries shape the patent’s global enforceability.
- Exceptionally broad claims must be balanced against potential prior art and validity challenges.
- The surrounding patent landscape influences innovation opportunities, licensing, and infringement risk management.
- Ongoing patent landscape analysis is vital in pharmaceutical R&D, fostering informed decision-making in drug development and commercialization.
FAQs
1. What is the significance of WO2004103306 in the pharmaceutical patent landscape?
It potentially covers a novel chemical compound or therapeutic method, offering patent protection critical for commercial exclusivity, especially if claims are broad and strategically drafted.
2. How does the scope of claims affect patent enforceability?
Broader claims provide wider protection but are more susceptible to validity challenges. Narrow claims are easier to defend but limit exclusivity.
3. Can WO2004103306 be challenged for validity?
Yes, through prior art searches, opposition procedures, or legal proceedings, especially if prior disclosures undermine novelty or inventive step.
4. Why is geographical coverage documentation important?
It determines where patent rights are enforceable; extensive regional filings can secure global market protection but also increase costs and complexity.
5. How do patent landscape analyses influence drug development?
They help identify potential infringement risks, licensing opportunities, and patent gaps, guiding strategic R&D and intellectual property management.
References
[1] WIPO Patent WO2004103306 (Publication Year: 2004).
[2] World Intellectual Property Organization (WIPO). "International Patent Application Publications."
[3] Patent Landscape Reports on Pharmaceutical Compounds, Industry Reports.
