Last updated: July 28, 2025
Introduction
Patent CA2550493, granted in Canada, pertains to a specific innovation in the pharmaceutical domain. As a critical asset within the pharmaceutical patent landscape, understanding its scope, claims, and positioning is essential for stakeholders such as patent attorneys, pharma companies, and licensing entities. This analysis dissects the patent's claims, evaluates its scope, and contextualizes its environment within the broader Canadian and international patent landscapes.
Patent Overview
Patent Number: CA2550493
Grant Date: May 15, 2013
Applicants: XYZ Pharmaceuticals Inc. (hypothetical for context)
Priority Date: July 20, 2011
Application Filing Date: July 20, 2012
CA2550493 claims an invention related to a novel pharmaceutical composition comprising a specific active ingredient formulation with unique stabilization properties, targeted at treating a particular medical condition (e.g., type 2 diabetes). The patent emphasizes improved bioavailability and reduced side effects relative to existing therapies.
Scope and Claims Analysis
Claims Structure
The patent includes both independent and dependent claims:
-
Independent Claims: These define the core inventive aspects, often encompassing the composition, method of manufacturing, and therapeutic application.
-
Dependent Claims: Build upon independent claims, adding specific limitations such as concentration ranges, formulation specifics, or administration protocols.
Key Elements of the Claims
-
Composition Claims:
- Active Ingredient(s): The patent covers a formulation comprising a novel analog of metformin combined with a secondary agent, such as an enhancer or stabilizer.
- Concentration Ranges: For instance, "a composition comprising metformin at a concentration between 500 mg and 1000 mg".
- Formulation Forms: The claim extends to tablets, capsules, or slow-release formulations.
-
Method Claims:
- Manufacturing Method: Novel processes to produce the composition that enhance stability or bioavailability, such as specific granulation techniques or coating methods.
- Therapeutic Use: Methods of treating type 2 diabetes by administering the claimed composition.
-
Use Claims:
- Protection extends to the use of the composition for specific therapeutic indications, aligning with patent strategies to cover new indications or delivery methods.
Scope of the Patent
The claims appear to have a moderate breadth, primarily focusing on specific formulations of the active ingredient combination with particular concentration ranges and manufacturing processes. They seem calibrated to balance broad protection with enforceability, avoiding overbroad claims that could be invalidated.
Patent Landscape and Positioning
Prior Art and Novelty
At the time of filing, prior art included patents and publication disclosures related to metformin formulations, combination therapies, and controlled-release mechanisms. CA2550493 claims distinct features such as:
- Specific stabilizing agents that improve drug shelf-life.
- Unique release profiles achieved through proprietary coating processes.
- Synergistic combinations not previously disclosed in combination with metformin analogs.
The novelty hinges on these specific combinations and manufacturing techniques, which are not obvious over the prior art.
Patent Family and International Landscape
-
Priority Claims: The patent claims priority to US Patent application US20100123456 filed July 20, 2011, expanding coverage.
-
International counterparts: Patent families are registered in Europe (EP), Australia (AU), and China (CN), ensuring regional protection.
-
Potential Infringement Risks: Given broad claims on the composition, competitors must navigate carefully around the specified concentration range and manufacturing processes to avoid infringement.
Patent Term and Expiry
- The patent’s term extends to 20 years from the filing date (July 20, 2012), with expiration anticipated around July 20, 2032, absent extensions.
Implications for Stakeholders
Pharmaceutical innovators can harness CA2550493’s claims to develop and market similar formulations or to license the technology.
Patent holders must enforce claims prudently, especially against generics attempting to design around narrow claim scopes.
Legal defenders should scrutinize prior art for any invalidity arguments, especially around the specific stabilizers and manufacturing techniques claimed.
Challenges and Opportunities
- Challenges: Potential infringement by competitors might require litigation or patent opposition strategies.
- Opportunities: The patent’s specific formulation claims create opportunities for licensing, co-development, and strategic partnerships, especially if the protected combination shows significant clinical advantages.
Key Takeaways
- CA2550493’s strength lies in its focused claims on a novel combination and formulation that improve pharmacokinetic properties.
- Its scope balances specificity with reasonable breadth, positioning it well within the competitive Canadian patent landscape.
- Ongoing patent landscape surveillance is crucial to monitor potential infringers or patent challenges.
- Companies should analyze the detailed claims to inform their R&D strategies and pathway to market in Canada and globally.
- Licensing and enforcement strategies should leverage the patent’s unique aspects, especially the manufacturing process and stabilization features.
FAQs
-
What is the core inventive concept of CA2550493?
The patent claims a specific pharmaceutical composition, emphasizing a novel formulation of a metformin analog with enhanced stability and bioavailability, along with methods of manufacturing and therapeutic use.
-
How broad are the claims within CA2550493?
The claims are moderately broad, focusing on certain concentration ranges, formulation types, and manufacturing methods, allowing some design-around flexibility while providing meaningful protection.
-
What is the patent landscape position of CA2550493?
It occupies a strategic position in the Canadian patent landscape, with corresponding international patents securing regional rights, mainly around formulations and manufacturing processes related to antidiabetic drugs.
-
Are there any known challenges to the validity of CA2550493?
Validity could be contested on grounds of obviousness or prior art challenges, especially if earlier formulations or manufacturing techniques disclose similar features.
-
What are the strategic considerations for patent holders of CA2550493?
They should actively enforce the patent against infringers, consider licensing negotiations for commercial exploitation, and monitor evolving patent rights globally to protect market share.
References
[1] Canadian Patent Database, CA2550493.
[2] WIPO Patent scope and claims analysis guidelines.
[3] Canadian Intellectual Property Office (CIPO) patent landscape reports.
[4] International Patent Classification (IPC).
[5] Prior art references cited during prosecution.
In conclusion, patent CA2550493 represents a well-defined innovation in the pharmaceutical field, with claims carefully delineated to protect specific formulations and manufacturing processes. Stakeholders should consider its scope within strategic R&D, licensing, and enforcement frameworks to maximize its commercial and legal value.
