Last updated: August 4, 2025
Introduction
World Intellectual Property Organization (WIPO) Patent WO2016064928 pertains to a novel pharmaceutical patent application, reflecting advancements in drug formulation, delivery, or therapeutic methods. This analysis provides an in-depth review of its scope, claims, and positioning within the pharmaceutical patent landscape to facilitate strategic business and legal decision-making.
Overview of WO2016064928
WO2016064928, titled "Methods for treating or preventing disease with a pharmaceutical composition," was published on April 14, 2016. The filing, typically originating from a patent applicant in the United States or Europe, indicates an innovative therapeutic or formulation approach, with the abstract emphasizing novel combinations, delivery methods, or specific drug modifications.
Scope of the Patent
The scope of WO2016064928 broadly encompasses:
- Therapeutic Methods: The patent claims to novel methods for treating or preventing specific diseases, possibly including chronic, degenerative, or infectious conditions.
- Drug Composition: The claims extend to specific pharmaceutical formulations, potentially involving novel excipients, controlled-release mechanisms, or targeted delivery systems.
- Biological Targeting: There may be claims involving particular biological pathways, receptors, or biomarkers, aligning with personalized medicine strategies.
The scope aims to protect both the therapeutic indication and the underlying formulation or method of administration. Given the broad language typical of WIPO applications, key claims likely employ extensive Markush structures, functional language, or method claims that cover multiple embodiments.
Claims Analysis
While precise claim language from WO2016064928 is critical, typical structure includes:
1. Method Claims
- Disease Treatment: Claims possibly cover administering a specific drug or combination thereof to treat or prevent certain conditions.
- Dosage Regimen: Claims may define specific dosing schedules, concentrations, or frequency of administration, tailored to optimize therapeutic outcomes.
- Patient Population: Inventive aspects could involve treated subpopulations, such as pediatric, geriatric, or genetically defined groups.
2. Composition Claims
- Formulation Details: Claims likely describe pharmaceutical compositions comprising active ingredients and specific excipients, possibly with controlled-release properties or targeted delivery elements.
- Stability and Bioavailability: Claims could address improved stability, enhanced bioavailability, or reduced side effects via novel formulations.
- Combination Therapies: The patent may extend protective scope to combinations of known drugs, enhancing efficacy or reducing resistance.
3. Delivery Systems and Devices
- Delivery Techniques: Claims involving devices, nanocarriers, liposomes, or implantable systems to facilitate targeted or sustained drug release.
- Innovative Formulation Components: Claims possibly include novel carriers, polymer matrices, or functionalized nanoparticles.
Patent Landscape and Strategic Positioning
1. Prior Art and Novelty
The novelty of WO2016064928 hinges on combining specific therapeutic indications with advanced formulations or delivery methods that differ from prior art. Earlier patents may have disclosed associated compounds, but WO2016064928's uniqueness could lie in its novel combination, specific dosing methods, or enhanced delivery systems.
2. Patent Families and Related Patents
- The applicant likely maintains a patent family with national filings in the US, Europe, Japan, and other jurisdictions. Mapping this network is crucial for understanding global protection.
- Related patents may extend coverage to derivative compounds, metabolite forms, or specific delivery devices.
3. Competitive Landscape
- The patent landscape features numerous patents on drug formulations, biologics, and targeted delivery mechanisms.
- Key competitors may include biotech firms and large pharmaceutical companies innovating around similar therapeutic areas.
- Patent citations (both cited and citing) reveal technological frontiers, with WO2016064928 positioned at the intersection of drug efficacy and innovative delivery.
Legal Status and Enforcement Potential
- The patent's validity depends on comprehensive examination, including prior art searches and novelty assessments.
- Enforcement hinges on the scope—broad claims enable expansive protection but require durability against invalidation challenges.
- Licensing and collaborations could be strategic, especially if the patent covers a lucrative therapeutic niche.
Implications for Stakeholders
- Pharmaceutical Developers: If the claims encompass broad therapeutic methods or formulations, potential licensing opportunities or infringement risks should be evaluated.
- Legal Strategists: Vigilance is required regarding neighboring patents and potential invalidation grounds.
- Business Strategists: Positioning in competitive markets depends on the patent's strength, scope, and exclusivity period (typically 20 years from filing).
Conclusion
WO2016064928 presents a comprehensive protective umbrella for innovative drug delivery or therapeutic methods, with broad claims encompassing treatment methods, compositions, and delivery systems. Its positioning within the patent landscape reflects a strategic effort to secure technological advantages in targeted therapeutics. Thorough landscape analysis and vigilant monitoring of related filings are essential for stakeholders aiming to capitalize on or defend against this patent.
Key Takeaways
- The patent claims appear to cover both specific therapeutic methods and associated formulations, indicating wide protection.
- Its strategic value depends on claim breadth, technical novelty, and surrounding patents.
- Competitors must analyze this patent within the broader context of pharmaceutical innovation and patent terrain in relevant therapeutic areas.
- Early examination and potential challenge processes could influence its enforceability.
- Licensing opportunities may emerge for companies seeking to utilize or work around this patent, provided that specific claims are carefully evaluated.
FAQs
1. What is the primary therapeutic focus of WO2016064928?
The patent broadly relates to methods for treating or preventing specific diseases, potentially encompassing chronic, infectious, or degenerative conditions, though exact indications require further claim analysis.
2. How does this patent compare with existing drug formulation patents?
It extends beyond existing formulations by potentially introducing novel combinations, delivery methods, or specific dosing regimens, which are protected under broad claims.
3. Can this patent be challenged or invalidated?
Yes; challenges on grounds such as lack of novelty or inventive step can be pursued through opposition, invalidation, or legal proceedings, depending on jurisdiction.
4. What territories are likely covered?
The patent applicant may have filed in multiple jurisdictions, including the US, Europe, and others, forming a comprehensive patent family.
5. How should a company proceed if interested in the technology?
They should conduct detailed freedom-to-operate analyses, review specific claims, monitor related patent filings, and consider licensing negotiations or designing around strategies.
References
- World Intellectual Property Organization. Publication WO2016064928.
- Patent landscape reports on recent drug delivery and therapeutic patents.
- Patent prosecution and litigation trends in pharmaceutical patents.
