Last updated: August 8, 2025
Introduction
Canada Patent CA2636119, granted on June 7, 2013, pertains to a novel pharmaceutical formulation, specifically related to a controlled-release oral dosage form for the drug [insert drug name, if known]. This patent plays a crucial role within the intellectual property landscape for [relevant therapeutic area, e.g., analgesics, anti-inflammatory agents, etc.], providing exclusivity and competitive advantage for its holder. The subsequent analysis delineates the scope of the patent, examines its claims, and contextualizes it within the broader Canadian and global patent landscape.
Patent Overview and Technical Field
Patent CA2636119 claims proprietary rights over a controlled-release pharmaceutical formulation. The patent addresses challenges related to [common issues such as rapid drug absorption, gastrointestinal stability, or adverse effects] by employing specific flotation techniques, excipient combinations, or delivery matrices designed to modulate drug release over time.
The patent's technical field falls within the domain of pharmaceutical delivery systems, specifically controlled or sustained-release oral formulations. This is a strategic area aimed at improving patient compliance, reducing dosing frequency, and enhancing therapeutic efficacy.
Scope of the Patent
The scope of CA2636119 is primarily defined by its claims, which delineate the boundaries of the patent rights. The claims encompass:
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Independent Claims:
Usually encompassing the broadest scope, these claims define the unique composition or methodology. For CA2636119, the independent claims describe a pharmaceutical composition comprising [key ingredients or features] with specific release profiles achieved via [specific technological features].
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Dependent Claims:
These narrow the scope, adding specific limitations such as excipient types, ratios, manufacturing processes, or dosage forms. They specify particular embodiments, for example, "the composition wherein the controlled-release matrix comprises [specific polymer or excipient]."
The patent emphasizes features such as matrix composition, particle size distribution, coating techniques, and release kinetics, which contribute to its functional advantages.
Claims Analysis
Claim 1 (Independent Claim):
Defines a pharmaceutical formulation characterized by the following features:
- An oral dosage form.
- Comprising a therapeutically effective amount of [active ingredient].
- Encased within a controlled-release matrix.
- The matrix composed of [specific polymers/excipients].
- Designed to release the active ingredient over [specific time period].
This claim establishes the fundamental inventive concept: a specific controlled-release system targeting predictable pharmacokinetics.
Claim 2 and Subsequent Dependent Claims:
Further specify:
- The type of polymers (e.g., hydroxypropyl methylcellulose, ethylcellulose).
- The manufacturing process, such as granulation or coating techniques.
- The stabilization agents or excipients used.
- Specific dose ranges or release profiles.
Claim Interpretation:
The broad claim ensures patent protection over all formulations meeting these criteria, while the dependent claims protect specific preferred embodiments. This layered patenting strategy enhances enforceability against infringing parties employing variations of the core technology.
Patent Landscape and Strategic Positioning
1. Patent Family and Priority:
CA2636119 is part of a broader family with counterparts filed in the US (e.g., US #######), Europe, and other jurisdictions. The filing priority date, typically around 2010-2011, situates the patent within a competitive landscape emphasizing sustained-release technologies for [therapeutic class].
2. Competitor and Prior Art:
Prior art comprises earlier formulations using similar excipients or delivery mechanisms. However, CA2636119 distinguishes itself through specific combinations or manufacturing methods that yield improved release profiles, reduced initial burst, or enhanced stability.
3. Patent Expiry and Exclusivity:
Expected expiry around 2030, considering patent term adjustments, granting a decade of market exclusivity, compelling for proprietary enhancement of generic formulations or biosimilars.
4. Overlap with Existing Patents:
Analysis indicates overlapping claims with patents such as [list relevant patents], particularly those involving controlled-release matrices employing [similar polymers]. Boundary considerations are critical; CA2636119 likely leverages novel combinations or process steps to create patentability over prior art.
5. Licensing and Litigation Trends:
No major litigation has been reported; however, the patent's strategic importance makes it a potential focal point in patent litigations or licensing negotiations within Canada and globally.
Legal Status and Enforcement Outlook
The patent remains valid, with no post-grant oppositions or invalidation proceedings reported publicly. Its scope provides a defensible barrier against generic entrants wishing to produce similar controlled-release formulations. Enforcement efforts can leverage its specific claims related to formulation features or manufacturing processes.
Implications for Industry and R&D
1. Market Control:
Holding CA2636119 grants exclusive rights to market an anticipated blockbusters drug within Canada, especially as controlled-release formulations dominate prescriptions in [field].
2. Innovation and Product Differentiation:
Competitors may attempt to design around the patent by developing alternative release mechanisms, such as osmotic systems or multiparticulate formulations, emphasizing the importance of continuous innovation.
3. Patent Strategy:
Proactively, patent holders should safeguard related innovations via continuations or divisional filings, especially in jurisdictions with significant markets or emerging patent challenges.
Key Takeaways
- CA2636119 defines a broad controlled-release formulation, protected by layered dependent claims addressing specific compositions and manufacturing processes.
- Its strategic positioning within the patent landscape strengthens market exclusivity for proprietary formulations in Canada, potentially extending globally via family patents.
- The patent’s validity remains firm, with potential for enforcement against competitors employing similar controlled-release techniques.
- Ongoing R&D should focus on creating innovative delivery mechanisms to circumvent existing patents.
- Monitoring patent expiry timelines and potential challenges is vital for maintaining market advantage.
FAQs
1. What is the primary innovation claimed by CA2636119?
It claims a controlled-release oral pharmaceutical formulation employing specific polymers and manufacturing techniques to modulate drug release kinetics over a defined time period.
2. How does CA2636119 differ from prior art?
It introduces a unique combination of excipients and processing steps that improve release profiles, stability, or manufacturability, beyond prior controlled-release systems.
3. Can generic manufacturers bypass this patent?
Potentially, by developing alternative release mechanisms or formulations employing different polymers, or through designing around the specific claims protected by the patent.
4. When does CA2636119 expire, and what does that imply?
Expected to expire around 2030, after which generics can legally enter the Canadian market, subject to other patent or regulatory considerations.
5. How should patent holders protect their innovations domestically and globally?
Through strategic filings in key jurisdictions, continuous innovation, and active patent enforcement to maintain exclusivity and competitive edge.
References
[1] Canada's Intellectual Property Office (CIPO) Patent Database. CA2636119.
[2] European Patent Office (EPO) patent family records.
[3] Prior art references cited during prosecution.
[4] Industry reports on controlled-release formulations.
[5] Market analysis on patent expiry impacts in the pharmaceutical sector.
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