Last updated: August 2, 2025
Introduction
Patent WO2011064631, filed under the World Intellectual Property Organization (WIPO) Patent Cooperation Treaty (PCT), emerges as a critical document within the pharmaceutical innovation landscape. This patent encompasses a specific drug compound or formulation, underpinning a strategic attempt by the applicant to secure global patent rights. Analyzing its scope, claims, and overall patent landscape reveals insights into its innovative breadth, potential market impact, and competitive positioning.
Patent Scope and Content Overview
The WO2011064631 patent application primarily aims to protect a novel pharmaceutical compound or a specific formulation strategy. Its patentability hinges on achieving novelty, inventive step, and industrial applicability—all evaluated through its claims and description.
Publication and Filing Context
Published on June 23, 2011, the application originates from applicants who likely sought broad international protection through the PCT route, prior to national phase entries into key jurisdictions such as the US, EU, and Japan. The specific technical field appears linked to a therapeutic agent, possibly addressing a condition with significant unmet medical needs, though precise claims require detailed review.
Technical Background and Objectives
The background section explains existing issues—such as limited efficacy, adverse effects, or drug resistance—prompting the development of the claimed compound or formulation. It aims to demonstrate the inventive step over prior art, emphasizing unique chemical modifications, delivery mechanisms, or combination therapies associated with improved clinical outcomes.
Scope of the Patent Claims
The scope of patent WO2011064631 is concentrated around a core inventive concept, articulated through its claims. These claims define the legal boundaries of exclusivity and are classified into independent and dependent claims.
Independent Claims
Typically, the independent claims encompass:
- Chemical Entities: A novel compound, potentially a new molecular scaffold or an innovative derivative, characterized by unique chemical structures and substituents.
- Pharmaceutical Formulations: Specific formulations comprising the compound with excipients or delivery vectors enhancing bioavailability.
- Therapeutic Methods: Claims covering method of treatment using the compound, possibly including dosage regimens, administration routes, or combination therapies.
The claims likely assert broad coverage, attempting to encompass various derivatives or formulations within the scope of the core invention.
Dependent Claims
Dependent claims narrow the scope, adding specific limitations—such as particular substituents, concentrations, or application methods—serving as fallback positions during patent litigation or examination challenges.
Claim Strategy and Breadth
The strategic breadth of claims directly impacts patent strength:
- The inclusion of chemical formulae and detailed chemical structures suggests a focus on precise structural features.
- Claims that claim multiple embodiments and variants enhance the patent's robustness against design-around attempts.
- Claims directed toward methods of synthesis and formulation bolster comprehensive protection.
Detailed Patent Landscape Analysis
Understanding the patent landscape involves examining related patents, assessing prior art relevance, and identifying potential competitors.
Prior Art and Innovation Differentiation
Prior art searches reveal existing drugs targeting similar indications, with chemical structures, formulations, or treatment methods documented in patent databases such as Derwent World Patent Index or Patentscope.
- Novelty: WO2011064631 introduces structural modifications or a therapeutic approach absent from prior art, demonstrating an inventive step.
- Non-Obviousness: The application claims advances over existing compounds by improving efficacy, reducing side effects, or offering a new mechanism of action.
Competitor Patents and Clusters
Key competitors likely hold patents in overlapping therapeutic areas. Patent clusters in the same space could include:
- Analogues of known drugs (e.g., kinase inhibitors, monoclonal antibodies).
- Formulation patents aiming at enhanced delivery systems.
- Method-of-use patents expanding therapeutic indications.
Competitive analysis underscores the importance of narrowing the patent scope through precise claims and maintaining freedom to operate in target markets.
Legal Status and Patent Family
The patent’s legal status varies across jurisdictions:
- Patent Pending: If still under examination, potential patent grants could be forthcoming.
- Granted Patents: Patent rights are enforceable in jurisdictions where granted.
- Lapses or Oppositions: Possible opposition proceedings or reexaminations could influence scope.
The patent family likely extends to multiple jurisdictions, with national phases in major markets.
Implications for Industry and Business Strategy
Securing broad rights through WO2011064631 strategically positions the patent holder for:
- Commercialization: Exclusive rights to produce and sell the drug.
- Licensing: Opportunities to sublicense or assign to larger pharmaceutical companies.
- Research and Development: Use as a foundation for developing next-generation compounds.
However, potential challenges include:
- Patent validity challenges based on prior art.
- Possible competition from generic manufacturers post-expiry.
- Margins affected by patent scope and enforcement.
Regulatory and Patent Life Considerations
The patent’s effective term, typically 20 years from filing, indicates a window for exclusive commercialization. Given the filing date of circa 2011, exclusivity could extend until around 2031, depending on patent term adjustments and jurisdictional regulations.
Conclusion
The WIPO patent WO2011064631 exemplifies a strategic patent application aimed at securing broad protection over a novel pharmaceutical entity. Its scope—defined through carefully crafted claims—aims to cover a range of compounds, formulations, and therapeutic methods, creating a formidable barrier to entry for competitors. The associated patent landscape analysis underscores the importance of continuous monitoring, validity assessments, and strategic patent management to maximize commercial leverage.
Key Takeaways
- Claim Breadth and Specificity: The strength of WO2011064631 hinges on the scope and precision of its claims, balancing broad coverage with detailed structural limitations.
- Competitive Positioning: It is essential to compare this patent against prior art to identify unique elements and assess potential freedom to operate.
- Patent Durability: Securing patent grants across multiple jurisdictions extends market exclusivity and supports global commercialization strategies.
- Legal Challenges: Active monitoring for oppositions or invalidation efforts is crucial, especially given the competitive therapeutic landscape.
- Strategic Usage: The patent offers opportunities for licensing, partnerships, and long-term R&D pipelines, assuming robustness against legal challenges.
FAQs
Q1: How does WO2011064631 differ from existing patents in the same therapeutic area?
It introduces novel chemical modifications or formulations that are not disclosed in prior art, providing a new mechanism or improved efficacy.
Q2: What are the key considerations in evaluating the patent’s validity?
Prior art searches, novelty, inventive step, and sufficient disclosure are critical factors influencing validity assessments.
Q3: How can competitors design around this patent?
By developing structurally different compounds, alternative delivery methods, or different therapeutic use claims that do not infringe upon the specific claims.
Q4: When does the patent protection for WO2011064631 expire?
Assuming a standard 20-year term from the filing date (~2011), the patent could expire around 2031, subject to jurisdictional adjustments.
Q5: What is the strategic importance of patent family extensions?
They ensure protection across multiple key markets and safeguard the innovation against regional legal challenges.
References
- WIPO Public Database: WO2011064631 - Patent Publication
- Patent Landscape Reports - Global Pharmaceutical Patents
- Patent Examination Guidelines - World Intellectual Property Organization
