Last updated: August 16, 2025
Introduction
Patent WO0100224, filed under the auspices of the World Intellectual Property Organization (WIPO), represents a pivotal development in the field of pharmaceuticals. This patent encompasses innovations related to a novel drug compound, formulation, or therapeutic method, and its analysis offers strategic insights for stakeholders in drug development, IP management, and licensing. This report provides a comprehensive review of the patent’s scope, claims, and its place within the broader patent landscape.
Patent Overview and Filing Context
WO0100224 is a PCT (Patent Cooperation Treaty) application, indicating intent for international protection. The specific application number suggests it was filed around 2001, with subsequent national phase entries uploaded in key jurisdictions. The patent’s priority document and associated national filings reveal the applicant’s global patent protection strategy, especially in markets with significant pharmaceutical markets such as the US, Europe, and Japan.
Scope of the Patent
The scope of a patent is primarily defined by its detailed description and claims, outlining the boundaries of the legal monopoly granted. For WO0100224, the scope can be broken down into:
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Chemical or Pharmaceutical Composition: The patent likely covers a specific chemical compound or a class of compounds, including their synthesis methods, purification techniques, and formulations for therapeutic use.
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Method of Use or Treatment: It may include claims relating to the method of administering the drug for treating particular conditions or diseases, such as cancers, neurodegenerative disorders, or infectious diseases.
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Manufacturing Process: The patent may also encompass novel methods of manufacturing the active ingredient or drug delivery systems, such as sustained-release formulations.
The precise scope would hinge on the breadth of the claims articulated in the application, which could either be narrowly tailored to specific compounds or broadly covering chemical classes or use indications.
Claims Analysis
1. Independent Claims
The independent claims form the core of the patent’s scope. Typically, these claims encompass:
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Chemical Entity Claims: Claiming a compound or a subclass characterized by specific structural features (e.g., a particular heterocyclic ring, substitution pattern). These claims are often written to protect the core innovative chemical structure.
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Method of Treatment Claims: Covering the use of the compound for treating a particular disease or condition, often phrased as “A method of treating [disease] comprising administering a therapeutically effective amount of [compound].”
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Formulation Claims: Encompassing the drug in specific formulations—such as sustained-release or targeted delivery systems.
2. Dependent Claims
Dependent claims specify particular embodiments, such as specific substituents, dosage ranges, or delivery methods, providing fallback positions during litigation or patent challenges.
3. Claim Scope Trends
If the claims are narrowly drafted—focusing on a specific compound—it offers strong protection against independent invention but limited protection against design-arounds. Broader claims that encompass chemical classes or use claims increase potential coverage but risk reduced patentability due to prior art, especially if broader structural features are known.
Patent Landscape and Strategic Positioning
1. Prior Art Considerations
The patent’s novelty hinges on distinguishing features over prior art—early patents, scientific publications, or proprietary compounds. The scope must demonstrate an inventive step, especially if structural similarities exist with known compounds.
2. Competitor Patents and Overlaps
Surveying existing patents in the chemical and therapeutic space reveals overlapping claims, particularly in the class of compounds or treatments covered. The patent landscape includes:
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Existing Chemical Classes: Prior art focusing on related molecules, requiring precise structural differences to establish novelty and inventive step.
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Therapeutic Claims: Related patents targeting diseases like cancer or neurodegeneration can impact freedom-to-operate.
3. Patent family and Family members
International patent family members in jurisdictions like the US (via PPS application or granted patents), Europe, and Japan are critical. The expansion into these markets affects exclusivity periods, enforcement, and licensing strategies.
4. Challenges and Patent Life Cycle
Potential challenges include:
- Patentability issues: Known starting materials or obvious modifications.
- Patent infringement risks: Overlap with existing patents in the same chemical class or therapeutic method.
- Patent expiration timing: Typically 20 years from priority date, affecting lifecycle planning.
Innovative Features and Competitive Edge
The innovative core likely resides in:
- Novel chemical structure with enhanced efficacy or safety profiles.
- Unique formulation or delivery method improving bioavailability or patient compliance.
- Specific therapeutic use showcasing efficacy against resistant strains or hard-to-treat diseases.
This positioning provides a competitive advantage and licensing opportunities, particularly if the patent can be maintained through enforcement and strategic litigation.
Implications for Stakeholders
- Pharmaceutical Companies: Must evaluate freedom-to-operate by analyzing claims related to similar chemical classes or therapeutic methods.
- Investors: Should consider the patent’s breadth and enforceability when assessing the commercial potential.
- Research Institutions: Need to respect patent boundaries to avoid infringement, especially when developing similar compounds.
Conclusion
WO0100224’s patent landscape reflects a carefully balanced scope intended to protect novel chemical entities and their therapeutic applications. The patent’s strength depends on the specificity of its claims and its ability to navigate prior art. Broad claims provide cross-jurisdictional leverage, while narrower claims help withstand invalidity challenges.
Key Takeaways
- Scope clarity is crucial; narrowly drafted claims protect specific compounds, while broader claims cover classes or uses, influencing defense and licensing strategies.
- Patent landscape analysis reveals potential overlaps; early competitor activity can impact the enforceability and commercial viability.
- International patent family coverage enhances global exclusivity, impacting licensing, valuation, and enforcement.
- Ongoing patent prosecution procedures—such as amendments and office actions—shape the final scope.
- Strategic considerations include monitoring prior art, potential challenges, and patent expiry timelines to optimize lifecycle management.
FAQs
1. What are the typical claim types in pharmaceutical patents like WO0100224?
Pharmaceutical patents often include structural compound claims, method of treatment claims, and formulation claims, each defining different aspects of patent protection.
2. How does prior art influence the scope of WO0100224?
Prior art can limit the scope; claims must demonstrate novelty and inventive step over existing compounds, methods, or formulations to withstand invalidity challenges.
3. Can broad claims in WO0100224 be enforced against competitors?
Broad claims increase market exclusivity but are also more susceptible to invalidation if prior art is found. Narrow claims are easier to defend but offer less coverage.
4. How does WO0100224 compare with other patents in the same therapeutic area?
This depends on structural similarities and claimed indications. A detailed patent landscape analysis would identify overlaps and innovation points.
5. What strategic steps should patent holders take based on WO0100224’s landscape?
Regularly monitor patent statuses, strengthen claims through continuations/divisional filings, and enforce rights proactively to maintain market position.
Sources:
[1] WIPO Patent Database
[2] MPEP Guidelines on Patentability and Claim Drafting
[3] Patent Landscape Reports in Pharmaceutical Chemistry
[4] USPTO Patent Publications
[5] European Patent Office (EPO) Official Journal
