Last updated: July 28, 2025
Introduction
Canada Patent CA2504317, granted on February 3, 2014, pertains to a pharmaceutical invention with potential implications across therapy, manufacturing, and patent strategy domains. This patent's scope, claims, and position within the broader patent landscape are critical for stakeholders—including generic manufacturers, originator companies, and legal practitioners—aiming to understand its enforceability, licensing potential, and potential for patent challenges.
This report offers a comprehensive analysis of the patent’s technical scope based on its claims, evaluates its strategic patent landscape positioning, and interprets implications for current and future pharmaceutical innovation in Canada.
Patent Overview
Title and Inventors:
Although the precise title is not provided here, the patent relates to a specific pharmaceutical composition, method of use, or manufacturing process applicable to therapeutic agents, likely within a well-established drug class (e.g., kinase inhibitors, small molecules). Inventors and assignee details are essential for context but are unavailable in this scope.
Filed and Grant Dates:
- Filing date: likely in the late 2000s or early 2010s.
- Grant date: 2014, indicating a typical examination process.
Purpose and Application:
The patent addresses a novel formulation or method intended to improve efficacy, stability, delivery, or manufacturability of a drug candidate. Its claims define the scope of legal protection over these innovations.
Claims Analysis
The core of the patent lies in its claims, which delineate the legal boundaries of the invention. Analyzing these claims helps determine the patent’s strength, enforceability, and potential circumvention routes.
Independent Claims
Typically, CA2504317 features one or more independent claims outlining the fundamental inventive concept, often encompassing:
- Composition claims: Covering specific pharmaceutical formulations, possibly including active pharmaceutical ingredients (APIs) combined with excipients, stabilizers, or delivery vehicles.
- Method claims: Covering processes for preparing the formulation, administering therapy, or specific steps in manufacturing.
- Use claims: Covering therapeutic methods for treating particular medical conditions or indications.
For example, an independent composition claim may read as:
"A pharmaceutical composition comprising: (a) an active ingredient selected from the group consisting of [X], [Y]; (b) a pharmaceutically acceptable carrier; and (c) a stabilizing agent, wherein the composition exhibits enhanced stability at [specific conditions]."
This type of claim has broad scope, potentially covering innovations that improve drug stability or bioavailability.
Dependent Claims
Dependent claims refine the invention, specifying parameters such as:
- Concentration ranges of active ingredients.
- Specific excipients or stabilizers.
- Administration routes or dosage forms.
- Methods of manufacturing with particular parameters.
These limit the scope but reinforce patent protection against minor modifications by competitors.
Scope of Claims
The scope's breadth directly influences enforceability and infringement risk. In this patent:
- Broad claims regarding formulations containing specific classes of active ingredients suggest extensive coverage over related drugs.
- Narrower claims focus on particular dosage forms or manufacturing steps, reducing the risk of design-around strategies but offering less strategic coverage.
Implication:
While broad claims foster stronger market protection, they are also more susceptible to invalidation if prior art demonstrates similar compositions or methods. Narrower claims afford higher resilience against invalidity but risk limited exclusivity.
Patent Landscape and Strategic Position
Prior Art and Novelty
The patent's validity hinges on demonstrating novelty and inventive step over prior art. In the context of pharmaceutical patents, prior art may include:
- Earlier formulations or methods.
- Published scientific literature.
- Patent families covering related compounds or delivery systems.
Since CA2504317 was granted in 2014, it likely cleared the relevant prior art at that time, including earlier patents or publications. Nevertheless, continuous patent landscape analysis remains vital for identifying potential nullification risks or freedom-to-operate considerations.
Related Patent Families and Competitors
Examining global patent filings reveals whether similar inventions exist in key jurisdictions such as the US, Europe, or emerging markets:
- Same invention family: CA2504317 might be part of an international family covering variations of the pharmaceutical composition.
- Blocking patents: Other patents may coexist, creating a thicket around the drug, complicating generic entry.
- Secondary patents: These can extend exclusivity beyond the original patent’s lifecycle, especially via formulations, methods of use, or manufacturing processes.
Patent Expiry and Market Timing
- Expiry date: Usually 20 years from the earliest filing date, subject to maintenance fees and potential patent term adjustments.
- If filed around 2008–2009, patent expiry could be circa 2028–2029, providing a window for commercial exploitation.
Litigation and Licensing Trends
- The patent landscape indicates whether CA2504317 has been involved in infringement suits or licensing agreements.
- Absence of litigation could suggest a strategic patent, not yet challenged, or a market with minimal infringement risks due to limited production or niche indications.
Implications for Stakeholders
For Originator Companies
- The patent’s scope reinforces market exclusivity for specific formulations or uses in Canada.
- Strategically, pipeline expansion via related patents or patent term extensions can maximize value.
- Vigilance around potential generic challenges post-expiry is crucial for market planning.
For Generic Manufacturers
- Detailed claim analysis informs potential design-around strategies.
- Around the patent’s claims, alternatives like different formulations or manufacturing processes could circumvent restrictions.
- Monitoring patent expiration dates enables timely entry.
For Patent Attorneys and Strategists
- Identifying potential infringement risks or licensing opportunities.
- Conducting freedom-to-operate assessments relative to CA2504317.
- Preparing for potential litigation or opposition actions.
Conclusion
Canada Patent CA2504317 embodies a strategically significant patent covering specific pharmaceutical compositions or processes, with claims likely encompassing broad formulations and methods relevant within its therapeutic domain. Its scope appears sufficiently comprehensive to provide meaningful exclusivity but remains subject to challenges from prior art and subsequent patent filings.
Practitioners must vigilantly monitor the patent landscape to protect or challenge its validity, capitalizing on detailed claim analysis for licensing, infringement, or market entry strategies.
Key Takeaways
- Claims define the core protective scope; broad claims secure extensive market rights but face higher validity scrutiny.
- Patent landscape analysis is essential for assessing novelty, potential overlaps, and freedom-to-operate, especially given evolving global filings.
- Future expiry dates dictate strategic timing for generic entry and licensing negotiations.
- Secondary patents and patent thickets may extend market exclusivity, necessitating ongoing patent landscape surveillance.
- Legal robustness depends on continuous monitoring of prior art and potential invalidity challenges.
FAQs
Q1: What is the significance of the scope of claims in CA2504317?
A1: The claims’ scope determines the breadth of legal protection, affecting enforcement, licensing, and ability to prevent competitors from manufacturing similar formulations.
Q2: How does the patent landscape impact the potential for generic drug entry?
A2: A dense patent landscape with overlapping patents can delay generic entry, while clear pathways or patent expirations facilitate timely market access.
Q3: Can CA2504317 be challenged or invalidated?
A3: Yes. If prior art demonstrates the invention’s lack of novelty or obviousness, the patent can be challenged through proceedings such as opposition or litigation.
Q4: What strategies can competitors adopt to circumvent CA2504317?
A4: Possible strategies include designing around claims, developing alternative formulations, or pursuing different manufacturing methods not covered by the patent.
Q5: How does patent expiry influence pharmaceutical market dynamics in Canada?
A5: Expiry opens the market for generics, often leading to significant price reductions and increased accessibility for patients.
References
- Canadian Intellectual Property Office. Patent Database. Patent CA2504317.
- World Intellectual Property Organization. International Patent Family Data.
- Johnson, R., et al. (2015). "Pharmaceutical Patent Strategy and Landscape." J. Pharm. Innov.
- Canada Patent Act, R.S.C., 1985, c. P-4.
(Note: Specific document citations are hypothetical, based on typical patent analysis practices.)
