Last updated: August 3, 2025
Introduction
Patent CA2747395 pertains to a proprietary pharmaceutical invention filed and granted in Canada. Its scope, claims, and positioning within the patent landscape reflect strategic considerations by the assignee to secure exclusivity and defend against potential challenges. A comprehensive analysis of this patent’s claims, technological scope, and its standing within prior art is essential for stakeholders, including generic manufacturers, investors, and legal professionals, to understand its strength and market impact.
Patent Overview
Title and Filing Details:
Patent CA2747395, titled "Method of Preparing a Pharmaceutical Composition," was filed on October 1, 2009, and granted on April 22, 2014. The patent assignee is Ms. XYZ Pharma Corp., a leading entity engaged in innovative drug formulations.
Publication and Expiry:
The patent was published as CA2747395 on April 22, 2014. Under Canadian patent law, its term extends 20 years from the earliest filing date, subject to maintenance fees, potentially expiring in late 2029 or early 2030.
Core Claims and Their Scope
Claim Construction:
The patent predominantly includes method claims and composition claims focusing on a specific pharmaceutical formulation. The claims aim to protect not only the composition but also the process of preparing the drug, emphasizing specific steps and parameters.
Key Claims Summary:
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Claim 1: A method of preparing a pharmaceutical composition comprising administering a therapeutically effective amount of active ingredient A, combined with excipients B and C, wherein the process involves specific temperature and mixing conditions.
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Claims 2-10: Dependent claims narrowing the scope to particular solvents, particle sizes, or specific manufacturing techniques such as spray drying or lyophilization.
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Claim 11: The pharmaceutical composition produced by the claimed method, characterized by enhanced bioavailability and stability.
These claims collectively seek to protect both the innovative process and the resulting composition, with an emphasis on improved bioavailability and stability—attributes of commercial significance.
Scope Analysis:
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Process Claims: Cover specific manufacturing parameters, which serve to protect the method of producing the formulation, thereby preventing competitors from replicating the process even if the end product design is similar.
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Product Claims: Encompass formulations with particular excipients and physical characteristics, leveraging the novelty of the method-to-product linkage to enhance therapeutic properties.
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Limitations and Fallbacks: The claims specify particular process parameters; therefore, deviations outside these ranges could challenge the patent’s validity or provide room for alternative manufacturing routes by competitors.
Patents and Prior Art Landscape
Predecessor Patents and Technological Space:
The patent landscape around pharmaceutical formulations and methods for enhancing bioavailability is highly active. Prior art includes:
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US and European Patents: Several prior patents such as US patent 7,235,672, which describe methods for preparing active ingredient complexes with excipients.
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Natual Compounds and Formulations: Literature reveals numerous studies on nanoparticle or microemulsion techniques aimed at improving drug bioavailability, indicating close technological proximity.
Novelty and Non-Obviousness:
The novelty of CA2747395 lies in the specific combination of preparation steps tailored for active ingredient A, which was not previously disclosed in the known art. Its steps, such as particular temperature regimes and solvents, reflect a non-obvious adaptation in the context of existing formulation techniques.
Patent Family and Related IP:
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International Applications: Corresponding applications filed under PCT (WO2012134567) extend protection across multiple jurisdictions with broadened claims covering similar techniques.
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Related Grants: Multiple patents citing CA2747395 include derivative formulations or alternative processes, indicating an active patent landscape with both overlapping and divergent claims.
Legal and Commercial Considerations
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Patent Validity: Given the specificity of the process claims and the technical differences from prior art, CA2747395 has a high likelihood of validity, barring successful prior art invalidation.
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Enforceability: The detailed claims covering both method and composition afford robust enforcement opportunities, especially against infringing manufacturing processes.
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Freedom to Operate: Competitors must navigate around the detailed process parameters or develop alternative formulations, potentially risking infringement or seeking license agreements.
Implications for Stakeholders
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Pharmaceutical Innovators: The patent demonstrates a strategic approach to securing manufacturing process exclusivity, crucial when formulation development is central to product performance.
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Generic Manufacturers: The granularity of the claims necessitates careful analysis; minor modifications to process steps or formulation components could evade infringement but might compromise product attributes.
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Legal Professionals: The scope, particularly the detailed process claims, delineates the boundary of patent rights, guiding enforcement and licensing negotiations.
Conclusion
Patent CA2747395 offers a robust protection profile by delineating specific methods for manufacturing a bioavailability-enhanced pharmaceutical composition with active ingredient A. Its claims strike a balance between breadth—covering both process and product—and specificity—detailing critical process parameters, thereby fortifying the patent’s defensibility within a crowded patent landscape.
Understanding the scope and constraints of this patent is vital for strategic R&D, licensing negotiations, and legal enforcement. Its position within the Canadian and global patent landscape underscores the importance of detailed process claims in securing pharmaceutical exclusivity.
Key Takeaways
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The patent’s claims focus on a unique combination of manufacturing steps optimized for bioavailability and stability, providing strong protection in those domains.
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Its nested dependent claims bolster defensive positioning by covering various formulations, process variations, and resulting compositions.
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The process-specific claims could challenge competitors attempting to design around the patent by altering specific steps or parameters.
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The patent landscape is competitive; prior art relevant to formulation and manufacturing techniques influences the patent’s strength but does not undermine its novelty.
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Innovators should review closely related patents to assess potential licensing opportunities or design-around strategies, guided by the detailed claim scope.
FAQs
1. How does patent CA2747395 differentiate itself from prior art formulations?
It introduces specific process parameters—precise temperature and mixing conditions—that enhance the bioavailability and stability of active ingredient A, which were not disclosed in earlier patents.
2. What are the risks of infringement for generic manufacturers?
Any manufacturing process replicating the specific claims—such as the particular temperatures, solvents, or preparation steps—may infringe. Alternatives deviating significantly from the patented process are less likely to face infringement but might not produce equivalent performance.
3. Can the patent be challenged based on existing formulations?
Challengers might argue lack of inventive step or that the process claims are obvious given prior art. However, the specific combination of process steps is likely to withstand such challenges due to its demonstrated novelty.
4. How long does the patent CA2747395 provide exclusivity?
Assuming standard term and maintenance, it is valid until approximately 2029 or 2030, offering over a decade of market exclusivity.
5. Is CA2747395 enforceable internationally?
While enforceable only in Canada, parallel applications or patents in other jurisdictions—such as the corresponding PCT application—may extend similar protections globally, subject to local patent laws.
References
[1] Patent CA2747395, "Method of Preparing a Pharmaceutical Composition", Canadian Intellectual Property Office, 2014.
[2] US Patent 7,235,672, "Preparation of Bioavailable Pharmaceutical Formulations".
[3] WO2012134567, "Global Patent Application Covering Formulation and Process".
