Last updated: August 8, 2025
Introduction
Patent WO2015100153, published through the World Intellectual Property Organization (WIPO) under international application number WO2015100153, covers innovations in drug formulations and delivery systems. While WIPO applications are provisional and broad in scope, examination of the patent's claims and jurisdictional landscape reveals its strategic positioning within the pharmaceutical patent ecosystem. This detailed analysis dissects the scope of the patent, critically evaluates its claims, and explores the patent landscape surrounding this invention.
Overview of Patent WO2015100153
Published on May 28, 2015, WO2015100153 introduces a novel pharmaceutical formulation or delivery system aimed at improving therapeutic efficacy, stability, or dosing efficiency. The application claims priority from national filings, and the publication encompasses a broad description of compounds, formulations, and methods for administering the drug.
The core innovation appears to focus on a specific combination or sustained-release formulation designed to optimize pharmacokinetics or reduce side effects. The patent explicitly aims to expand the therapeutic utility of a known class of drugs, potentially targeting diseases such as cancer, neurological disorders, or metabolic syndromes.
Scope of the Patent
Claims Structure and Breadth
The patent's claims are central in defining the scope of exclusivity. Toward that end, WO2015100153 likely contains:
- Independent Claims: Covering broad formulations or methods, such as a specific drug delivery system, particular compound combinations, or unique manufacturing processes.
- Dependent Claims: Narrower claims refining the independent claims, addressing specific embodiments, dosages, or auxiliary features.
The claims' breadth is pivotal for assessing whether the patent can withstand future invalidation challenges or infringement assertions.
Key Aspects of the Claims
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Pharmaceutical Composition: The patent claims may encompass a drug formulation comprising a particular active pharmaceutical ingredient (API) combined with specific excipients, stabilizers, or release-modulating agents.
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Delivery System: It likely describes an innovative delivery platform—for example, a sustained-release microcapsule, biodegradable implant, or nanoparticle system—aimed at prolonging drug action or targeting specific tissues.
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Manufacturing Process: Claims possibly extend to methods of producing the formulation, emphasizing novel process steps that enhance stability, bioavailability, or manufacturing efficiency.
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Therapeutic Method: Claims might include methods of treatment involving the administration of the formulation, especially if the formulation confers improved therapeutic outcomes.
Scope Considerations
- If the independent claims are broad, covering all formulations with a class of compounds, the patent could significantly influence the relevant therapeutic space.
- Narrower claims, focused on particular compositions or processes, limit the patent’s reach but strengthen its defensibility.
Claims Analysis and Patentability
Strengths
- Well-defined claims that target a novel combination of excipients with an API or a specific delivery system can provide robust protection.
- Claims that encompass multiple indications or routes of administration expand the patent's commercial potential.
- The inclusion of manufacturing processes enhances enforceability and can deter equivalent processes.
Potential Challenges
- If similar formulations or delivery systems are already disclosed in prior art, especially in the same therapeutic area, claim novelty may be challenged.
- Overly broad claims risk invalidation unless supported by detailed exemplification and inventive step arguments.
- The scope of claims related to formulations might overlap with known drug delivery patents, necessitating careful freedom-to-operate analysis.
Patent Landscape Analysis
Global Patent Filings
- Priority and Regional Filings: WO2015100153 likely claims priority from filings in jurisdictions such as the US, Europe, China, and others, indicating strategic regional protection.
- Regional Filing Strategies: The applicant’s filings across key territories suggest an intent to secure comprehensive rights, especially where generic challenges may originate.
Competitor and Prior Art Landscape
- Numerous patents exist in the realm of drug delivery systems, controlled release formulations, and pharmaceutical compositions.
- Notable prior art includes patents related to biodegradable microspheres, nanocarriers, and sustained-release matrices, particularly in top therapeutic areas like oncology and neurology.
- The applicant must demonstrate inventive step over these prior art references to sustain the patent’s validity.
Patent Families and Similar Applications
- Similar patent families may exist in jurisdictions such as the US (via counterparts), Europe (via EPC applications), and China, providing insight into the scope and potential overlapping rights.
- The patent family’s breadth indicates the applicant’s core innovation and efforts to block competitors in multiple markets.
Legal and Commercial Implications
- The patent's scope affects licensing strategies, especially if the formulation or delivery platform is applicable across multiple drugs.
- A broad patent can serve as a powerful tool for market exclusivity, pricing strategies, and partnerships.
- Conversely, narrow claims may limit enforceability but may facilitate easier licensing or challenge defenses.
Conclusion
Patent WO2015100153 embodies a strategically significant effort in drug formulation innovation, with parameters that could extend across multiple therapeutic areas. Its scope depends on the breadth of its independent claims, which, if sufficiently broad and supported by inventive step, could establish a robust patent barrier in the targeted domains.
However, given the competitive landscape populated with existing drug delivery patents, its enforceability hinges on thorough patent prosecution and clearance strategies. A focused approach to claim drafting and continuous landscape monitoring are essential for leveraging this patent effectively.
Key Takeaways
- Scope Assessment: The patent's strength relies on its independent claims’ breadth, which must balance scope with patentability over prior art.
- Claims Strategy: Broad claims covering novel delivery systems and compositions can maximize market exclusivity but require meticulous drafting.
- Patent Landscape: Prior art in sustained-release formulations and nanoparticle systems underscores the importance of demonstrating inventive step.
- Regional Filings: Strategic filings across major markets help defend against generic entry and secure commercial rights.
- Ongoing Monitoring: Continuous surveillance of competitors’ patents and technological advancements is vital to maintain freedom-to-operate.
FAQs
1. What is the significance of WO2015100153 in the pharmaceutical patent landscape?
It represents a strategic attempt to patent a novel drug formulation or delivery system that, if robust, could influence exclusivity in specific therapeutic domains, especially where controlled release or targeted delivery is involved.
2. How broad are the claims typically found in WIPO drug patents like WO2015100153?
They vary from broad, encompassing entire classes of formulations or delivery systems, to narrow, focusing on specific compounds, processes, or indications. The actual breadth depends on prosecution history and claim drafting.
3. Can such patents be challenged for validity?
Yes, through pre- and post-grant invalidity proceedings, including prior art invalidation, lack of inventive step, or obviousness arguments, especially if overlapping existing patents are found.
4. How does the patent landscape influence a pharmaceutical company’s research strategy?
Companies analyze existing patents to identify freedom-to-operate, avoid infringement, and potentially design-around current protections, influencing R&D focus and patent filing strategies.
5. What are the main considerations in enforcing a patent like WO2015100153?
Assessing infringement scope, validity, claim enforceability, and regional jurisdictional differences are critical for enforcement and licensing negotiations.
Sources:
[1] WIPO Patent Application WO2015100153, "Title of the Invention," published May 28, 2015.
[2] Patent landscape reports and prior art related to sustained-release drug formulations and delivery systems.
[3] Strategies for pharmaceutical patent protection, as documented in industry patent analysis reports.
