Last updated: July 28, 2025
Introduction
Patent WO2010009197, authored by the World Intellectual Property Organization (WIPO), represents a significant contribution within the pharmaceutical patent landscape. This document, published on January 14, 2010, pertains to a novel drug invention, underscoring innovation in therapeutic agents. Analyzing its scope, claims, and positional landscape provides invaluable insights for stakeholders—bioscience companies, patent attorneys, and R&D strategists—aiming to navigate the complex realm of drug patenting effectively.
Overview of Patent WO2010009197
WIPO Patent WO2010009197, titled "Pharmaceutical Formulations", encompasses an innovative composition comprising a specific class of active pharmaceutical ingredients (APIs). The patent aims to protect compositions characterized by enhanced bioavailability, stability, and targeted delivery, focusing primarily on small-molecule therapeutics. It invokes improvements over prior formulations by potentially mitigating issues like bioinefficacy or adverse effects.
Publication Classifications:
The patent falls under the Cooperative Patent Classification (CPC) codes A61K (Preparations for medical, dental, or cosmetic purposes), A61P (Therapeutic activity of chemical compounds or medicinal preparations), and C07D (Heterocyclic compounds).
Priority and Related Filings:
- Priority date: August 14, 2008, based on a provisional application.
- International publication: WO2010009197, within the WIPO PCT system, facilitating broad territorial patent protections.
Scope of the Patent
Subject Matter and Technical Focus
The patent claims innovations in pharmaceutical compositions containing specific heterocyclic compounds designed to enhance pharmacokinetic properties. The core scope involves:
- Novel heterocyclic compounds: The patent delineates specific chemical structures, including substituted pyridines and pyrazoles, which act as active agents or co-formulants.
- Formulation techniques: Embedding these compounds into formulations like capsules, tablets, or injectable solutions with excipients that improve stability or bioavailability.
- Targeted delivery mechanisms: Use of carriers or delivery systems that direct compounds to specific tissues or cell types, reducing off-target effects.
Claim Set Breakdown
The patent claims can be generally categorized into:
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Chemical Composition Claims:
Covering chemical structures and their pharmaceutically acceptable derivatives. These claims specify substituents, stereochemistry, and salts, applying broad language to prevent easy circumvention.
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Formulation Claims:
Detailing specific formulations comprising the compounds and carrier excipients, including methods of preparing sustained-release or targeted formulations.
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Method of Use Claims:
Claiming therapeutic applications of the compounds in treating specific diseases, such as cancer, neurological disorders, or inflammatory conditions.
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Delivery System Claims:
Protecting formulations that incorporate nanocarriers, liposomes, or other advanced delivery mechanisms to enhance drug targeting.
Legal and Strategic Considerations
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The claims are characterized by a high degree of structural specificity, making them potentially strong against infringers, but they also exhibit broad coverage through generic language in composition claims.
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The presence of multiple dependent claims increases the scope of protection, covering various chemical derivatives and formulation variants.
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The patent emphasizes both composition and method claims, aligning with best practices for robust patent protection.
Patent Landscape and Contextual Positioning
Global Patent Coverage
Given its publication under the PCT system, WO2010009197 offers applicant protection in over 150 countries, including major markets like the US, Europe, Japan, and emerging economies.
- Priority countries: The initial filing in 2008 suggests potential patent applications in jurisdictions such as the US (via national phase), European Patent Office, and Japan, often within 30-31 months of priority [1].
- Continuation strategies: Entities may pursue divisional or continuation applications to broaden scope or address specific jurisdictions' patentability criteria.
Competitor and Patent Infringement Risks
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Several patent families exist claiming heterocyclic compounds for therapeutic purposes, notably by companies like Novartis, Pfizer, and Merck, which have extensive portfolios in small molecules.
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Patent landscapes reveal a high density of overlapping claims, especially in chemical compound patenting, emphasizing the need for thorough freedom-to-operate analysis.
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Given the broad chemical and formulation claims, potential third-party competitors may only design around specific structural features or delivery methods.
Freedom-to-Operate and Litigation Trends
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The recent trends in pharma patent litigation suggest that primary composition claims face challenges based on prior art disclosures, especially if similar chemical scaffolds exist.
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However, the method claims related to specific delivery techniques or unexpected therapeutic effects can provide stronger defensibility.
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The patent's lifespan extends until 2030+, assuming patent term adjustment and maintenance fees are paid, offering long-term market exclusivity.
Strategy for Patent Portfolios
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Complementing this patent with additional filings, such as process patents and metabolite-specific claims, can enhance overall protection.
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Monitoring patent expirations of related compounds is critical for future strategic planning.
Implications for Stakeholders
For Innovators and Pharma Developers
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The scope demonstrates an emphasis on formulating heterocyclic compounds with optimized pharmacological profiles, aligning with trends toward targeted therapies.
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The detailed chemical and formulation claims suggest that similar compounds or delivery mechanisms may infringe unless carefully designed.
For Patent Managers and Counsel
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The broad chemical scope necessitates ongoing prior art searches to ensure freedom-to-operate.
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The integration of method and formulation claims enhances patent resilience but also demands meticulous prosecution to avoid potential invalidations.
For Competitive Intelligence
- Identifying overlapping patent claims in the same class can aid in positioning new drug candidates and formulating licensing or acquisition strategies.
Conclusion
Patent WO2010009197 exemplifies a comprehensive approach to securing protection around chemical entities, formulations, and therapeutic methods, aligning with modern pharmac patent strategies. Its broad chemical coverage, coupled with claims on formulations and delivery methods, provides robust protection but requires vigilant landscape monitoring. Success in commercialization hinges on clear differentiation, respecting existing patent boundaries, and strategic portfolio management.
Key Takeaways
- The patent covers heterocyclic compounds with enhanced pharmacokinetic properties, along with innovative formulations and targeted delivery methods.
- Its broad chemical and method claims afford significant strategic protection, making it a valuable asset in the therapeutic area it targets.
- The patent landscape in this domain is densely populated; detailed prior art and freedom-to-operate analyses are essential before clinical development.
- Jurisdictional planning should leverage the PCT publication’s international coverage, with tailored filings in strategic markets.
- Continuous monitoring of related patents and potential challenges will be vital to sustain market exclusivity.
FAQs
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What types of compounds are claimed in WO2010009197?
The patent targets heterocyclic compounds, specifically substituted pyridines and pyrazoles, designed for therapeutic activity.
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How broad are the claims in this patent?
The claims encompass a range of chemical derivatives, formulations, and methods of use, providing extensive protection within the specified classes.
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Can this patent be enforced against generic competitors?
Enforcement depends on the specific formulations and compounds used. Its broad chemical claims can be both an advantage and a challenge, given overlapping prior art.
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What strategies can enhance freedom-to-operate around this patent?
Designing novel derivatives outside the scope of existing claims, developing alternative delivery systems, or licensing rights can mitigate infringement risks.
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How does this patent fit within the global patent landscape for small-molecule drugs?
It adds to a dense network of chemical and formulation patents, underscoring the importance of strategic patent drafting and clearance analyses in pharmaceutical innovation.
Sources
[1] World Intellectual Property Organization. WO2010009197 - Pharmaceutical Formulations. Published January 14, 2010.
