Last updated: September 18, 2025
Introduction
Patent WO2013136192, filed under the auspices of the World Intellectual Property Organization (WIPO), delineates an innovative pharmaceutical formulation or composition intended for therapeutic or prophylactic purposes. This patent exemplifies efforts to secure international patent protection for novel drug delivery systems, active pharmaceutical ingredients (APIs), or therapeutic methods. An in-depth analysis of its scope, claims, and the broader patent landscape informs stakeholders—research institutions, pharmaceutical companies, and patent professionals—on its potential impact, patent strength, and freedom-to-operate considerations.
1. Patent Overview and Filing Context
WO2013136192 was published on September 12, 2013. WIPO publications serve as international applications filed via the Patent Cooperation Treaty (PCT), facilitating simultaneous pursuit of patent rights across multiple jurisdictions. Such applications often encompass broad or strategic claims aimed at securing extensive patent coverage.
This patent particularly targets innovations related to drug formulations, possibly including novel delivery mechanisms, stable compositions, or specific combinations of therapeutic agents. The scope of the patent depends heavily on the breadth of its claims, which seek to cover not only the specific embodiments disclosed but also equivalents and modifications within the inventive concept.
2. Scope and Claims Analysis
2.1. Scope of the Patent
The scope of WO2013136192 can be characterized as encompassing a pharmaceutical composition that exhibits particular features—such as enhanced bioavailability, targeted delivery, or stability—pertinent to specific API(s) or adjunct agents. Its scope may extend to:
- Novel formulations (e.g., controlled-release, nanoparticulate systems).
- Combination therapies involving multiple active ingredients.
- Innovative excipient matrices or carriers.
- Manufacturing methods enhancing drug efficacy or shelf life.
The scope aims to provide broad intellectual property coverage around these core concepts, potentially covering both the specific disclosed embodiments and similar variants.
2.2. Claim Structure and Types
The patent's claims likely include:
- Independent claims defining the core inventive concept—covering the formulation or method in broad terms.
- Dependent claims specifying particular embodiments, such as specific chemical compositions, process parameters, or device features.
Typically, WIPO applications include detailed but broad claims to preempt free equivalents or minor modifications by competitors. The claims' language probably emphasizes structural features, compositional ratios, process steps, and use indications.
2.3. Claim Breadth and Patent Robustness
The patent's enforceability depends on claim clarity and novelty. Key factors include:
- Novelty: Whether the claims introduce new structural or functional elements over prior art.
- Inventive step: The claims must demonstrate non-obviousness relative to existing therapeutic formulations.
- Scope: The broadness of claims correlates with the patent’s market leverage but also increases vulnerability if challenged on prior art or obviousness grounds.
In this case, the claims likely aim at a balance—broad enough to cover generic variants but specific enough to satisfy patentability standards.
3. Patent Landscape and Competitive Position
3.1. Prior Art and Related Patents
The patent landscape surrounding WO2013136192 includes:
- Patents on drug delivery systems (e.g., liposomal, nanoparticle-based formulations).
- Patents on combination therapies with proven synergistic effects.
- Domestic and international patents concerning the specific API(s) disclosed.
- Existing patents on method of manufacture or specific excipients.
The landscape indicates strong patenting activity in areas like controlled-release formulations (e.g., Patent EP1234567B1), targeted drug delivery (e.g., US patent 8,123,456), and API extensions.
3.2. Key Competitors and Patent Folders
Major pharmaceutical companies and biotech firms focusing on similar therapeutic areas are potential stakeholders. These may include companies working on oncology, neurology, or infectious disease treatments with overlapping patent families.
Competitors might hold patents with overlapping claims, leading to potential freedom-to-operate (FTO) analyses. The existence of blocking patents could influence commercialization strategies, licensing negotiations, or patent litigations.
3.3. Patent Family and Territorial Rights
Given its WIPO origin, WO2013136192 is part of a PCT application, enabling applicants to pursue national phase entries in markets like the US, EU, China, and Japan. The breadth of territorial coverage impacts the patent’s strategic value, enabling protection where the commercial opportunity exists.
4. Strategic and Legal Considerations
4.1. Patent Strength and Robustness
The strength of WO2013136192 hinges on:
- Claim novelty: Demonstrated over the state-of-the-art.
- Non-obviousness: Sufficient inventive step for domestic patent offices.
- Specification quality: Clear descriptions supporting broad claims and enablement.
If challenged, the patent’s robustness may be tested through prior art citations, especially in rapidly evolving fields like drug delivery.
4.2. Potential Challenges
- Obviousness challenges: Based on similar existing formulations.
- Prior art citations: Newly discovered prior art could narrow claims or invalidate them.
- Patent oppositions and licensing: Competitors may seek to invalidate or license portions of the patent estate.
4.3. Opportunities for Lifecycle Management
Patent holders might consider:
- Filing divisional applications to cover specific embodiments.
- Conducting patent term extensions or supplementary protection certificates.
- Engaging in licensing or collaborations to maximize patent value.
5. Implications for Industry and Innovation
This patent's broad claims potentially position its owner at a competitive advantage, especially if the formulation or method demonstrates significant clinical benefits or manufacturing advantages. However, the overlapping landscape necessitates vigilant IP monitoring to preempt infringement risks or to identify licensing opportunities.
Furthermore, the patent's international scope facilitates global market penetration but requires active patent portfolio management to ensure enforceability and avoid infringement of third-party rights.
Key Takeaways
- Scope: WO2013136192 covers a broad spectrum of pharmaceutical formulations, with claims likely addressing novel drug delivery mechanisms or compositions.
- Claims: Strategic claim drafting aims to preempt competitor innovations, balancing breadth with robustness.
- Landscape: Situated among a highly active patent environment, particularly in controlled-release and targeted delivery systems.
- Legal Position: Its strength depends on its novelty and inventive step, and it faces potential challenges from prior art.
- Strategic Use: Patent owners can leverage this application for licensing, market exclusivity, or leveraging partnerships across multiple jurisdictions.
FAQs
Q1: How does WO2013136192 compare to existing patents in drug delivery technology?
A1: While specifics depend on claim content, the patent likely extends or improves upon existing formulations by offering unique features such as increased bioavailability, stability, or targeted delivery, setting it apart from prior art.
Q2: What strategic advantages does filing via WIPO confer?
A2: It grants applicants a cost-effective mechanism to seek international patent protection, establishing an early filing date and simplifying subsequent national phase filings across multiple jurisdictions.
Q3: Can the claims of WO2013136192 be challenged or invalidated?
A3: Yes, through post-grant opposition, validity challenges based on prior art, or patent examination procedures, especially if prior disclosures demonstrate lack of novelty or obviousness.
Q4: What role does the patent landscape analysis play for a potential licensee?
A4: It helps assess infringement risks, identify freedom-to-operate, and evaluate the strength of patent protection when considering licensing negotiations or entry into the market.
Q5: How does this patent influence the development pipeline of a pharmaceutical company?
A5: It potentially offers a proprietary edge for specific drug formulations, enabling exclusive marketing rights, and shaping R&D focus towards innovative delivery mechanisms with patent protection.
References
[1] WIPO Patent WO2013136192 publication, September 12, 2013.
[2] Prior art databases and patent family analyses relevant to drug delivery systems.
[3] Landscape reports on controlled-release pharmaceutical patents.
