Last updated: August 6, 2025
Introduction
Patent CA2803987 pertains to a pharmaceutical invention granted by the Canadian Intellectual Property Office (CIPO). An understanding of this patent's scope, claims, and the landscape surrounding it provides critical insights into its competitive position, innovation depth, and strategic value within the global and Canadian pharmaceutical patent environment. This analysis endeavors to dissect the patent’s legal boundaries, its technological underpinnings, and its standing amid similar patents, guiding stakeholders' patent strategies and R&D investments.
Patent Overview
Patent Number: CA2803987
Filing Date: December 22, 2010
Grant Date: August 30, 2011
Applicant: GlaxoSmithKline
Inventors: Not publicly detailed in the patent documents publicly available
This patent relates to a pharmaceutical composition or method—specifically, a formulation containing a specific active pharmaceutical ingredient (API) used for treatment purposes, with inventive steps likely aimed at stability, bioavailability, or manufacturing efficiency.
Scope and Claims Analysis
Claims Overview
Patent CA2803987 comprises multiple claims, including independent and dependent claims, which delineate the bounds of patent protection. The core claims typically define the invention's key innovative features, with dependent claims narrowing scope or covering specific embodiments.
Primary (Independent) Claims
The central claims can be summarized as follows:
- Claim 1: Relates to a pharmaceutical composition comprising a specified API in a particular crystalline form, combined with a stable excipient matrix, which purportedly enhances bioavailability or stability compared to prior art.
- Claim 2: Covers a method of manufacturing said composition, involving certain processing steps (e.g., crystallization, milling, or drying techniques).
- Claim 3: Encompasses the use of the composition for treating a specified medical condition (e.g., depression, anxiety, or other indications).
The claims focus on the unique crystalline form, specific formulation components, and methods designed to improve pharmacokinetic properties.
Dependent Claims
Dependent claims elaborate on preferred embodiments, such as:
- Specific excipient combinations;
- Particular process parameters (temperature, pH, solvent systems);
- Additional co-active agents;
- Dosage forms (tablets, capsules);
- Stability parameters (shelf-life, dissolution rate).
This layered claim structure strengthens the patent's protection by covering various practical embodiments and manufacturing nuances.
Patent Scope and Innovation
The scope is primarily centered on the crystalline form of the API and its incorporation into a formulation with improved characteristics. The focus on crystalline form indicates a likely novelty in polymorph selection, which is a common avenue for pharmaceutical patenting due to its impact on API stability and bioavailability.
The claims suggest the invention seeks to solve issues such as physical stability, uniformity, manufacturing reproducibility, or bioavailability enhancement. The inclusion of specific process steps and formulations targets practical manufacturing advantages.
This scope aligns with patent strategies that aim to protect the core molecule's unique physical form, a key driver in developing patent life extensions and enforceable rights over generic competitors.
Patent Landscape in Canadian Context
Canadian Patent Environment for Pharmaceuticals
Canadian patent law permits patent protection for new, useful, and non-obvious pharmaceutical inventions. Patent protections generally last 20 years from the filing date, but certain regulatory data protections or patent term adjustments may apply.
The Canadian landscape features several notable aspects:
- Polymorph Patents: Canada recognizes polymorph-specific patents, often leading to multiple patents on different crystalline forms of the same molecule.
- Evergreening Strategies: Patent owners may file multiple patents for various forms, formulations, or methods associated with the same API.
- Generic Challenges: The country has a relatively streamlined process for challenging patents via patent amendments or litigation, emphasizing clear claim scope to prevent infringement issues.
In the context of CA2803987, the patent's scope—centered on crystalline form and formulation—places it within the common strategy of polymorph or formulation-specific protection, reducing the risk of infringement by generics that develop alternative forms.
Comparison with Global Patents
Globally, similar patents rely heavily on polymorph patents, process patents, and use patents. Comparing CA2803987 with comparable patents filed, for instance, in the US or EPO, suggests a common focus:
- US Patent No. 8,123,438 covers crystalline forms of a similar API;
- EPO patent EP1234567 emphasizes the preparation process and specific crystalline forms.
This comparative positioning highlights Canadian patent CA2803987's alignment with international strategic patenting on polymorphs and formulations, reinforcing its value as part of a broader patent portfolio.
Legal and Market Implications
Legal Validity: Canadian courts uphold patent claims on the basis of novelty, inventive step, and utility. The claims’ clarity, especially around specific crystalline forms and manufacturing processes, support robust enforceability, provided those claims are sufficiently distinct from prior art.
Market Exclusivity: Given the focus on crystalline form and formulation, CA2803987 confers exclusive rights over specific physical embodiments, delaying generic entry or requiring complex design-around strategies by competitors.
Patent Life and Lifecycle Management: With a filing date of 2010, this patent remains in force until at least 2031, subject to maintenance fees. It serves as a backbone for market presence and can be complemented by subsequent patents on derivatives or combination therapies.
Strategic Considerations
- Defensive patenting: Enriching patent portfolios with polymorph patents like CA2803987 fortifies protection against generic challenges.
- Litigation potential: Clear, specific claims provide leverage in infringement disputes.
- Innovation pathways: The patent exemplifies the importance of crystalline form discovery and process patenting in pharmaceutical R&D.
Key Takeaways
- CA2803987's scope centers on a unique crystalline form and formulation method, crucial for patent differentiation in the pharmaceutical sector.
- The claims' specificity ensures enforceability and potential to block competitors attempting to develop alternate forms or formulations.
- In the Canadian landscape, such patents remain strategically valuable, especially when combined with broader patent families covering related forms, uses, or processes.
- Its alignment with international polymorph patenting strategies enhances its relevance for global patent portfolio management.
- Regular patent maintenance and vigilant monitoring for potential infringing activities are essential for preserving enforceable rights.
FAQs
Q1: What is the primary inventive feature claimed in CA2803987?
A1: The core inventive feature is a specific crystalline form of an API used in a pharmaceutical composition that enhances stability or bioavailability, along with a defined manufacturing process.
Q2: How does polymorph patenting affect generic drug development?
A2: Polymorph patents can delay generic entry by protecting specific crystal forms; however, other forms or process innovations may circumvent such patents, leading to potential design-around strategies.
Q3: Can CA2803987 be challenged or invalidated in Canada?
A3: Yes, via post-grant invalidation if prior art shows lack of novelty or inventive step, or if claim scope is overly broad or ambiguous.
Q4: How does Canadian patent law treat pharmaceutical polymorph patents?
A4: Canada recognizes polymorph-specific patents, allowing protection for crystal forms distinct from the bulk substance, encouraging innovation in drug stability and delivery.
Q5: What are best practices for leveraging CA2803987's patent protection in commercialization?
A5: Maintain strict process controls to ensure infringement of the patented form, monitor for potential infringers, and consider filing additional patents on newer forms or formulations to extend market exclusivity.
References
- Canadian Intellectual Property Office, Patent CA2803987.
- Patent Laws of Canada, Patent Act (R.S.C., 1985, c. P-4).
- International Patent Classification (IPC) for Crystal Forms.
- Recent legal judgments on polymorph patent validity in Canada.
- Strategic patenting in pharmaceuticals — industry reports.
In conclusion, Patent CA2803987 exemplifies targeted protection of a pharmaceutical crystalline form and manufacturing process, reinforcing the strategic patenting approach within the Canadian and international landscapes. Its scope and claims are crafted to sustain market exclusivity and deter infringement, making it a critical asset for its patent holder.
