Last updated: August 7, 2025
Introduction
Canada Patent No. CA2619426, granted to Teva Canada Innovations in 2018, pertains to a pharmaceutical composition designed for ocular administration. This patent forms a substantial part of Teva's portfolio in ophthalmic drug delivery, offering potential market exclusivity for specific formulations used to treat ocular conditions such as glaucoma and intraocular hypertension. This analysis provides an in-depth review of the patent’s scope, claims, and the broader patent landscape, informing stakeholders on its strategic significance and competitive positioning.
Scope of Patent CA2619426
CA2619426 primarily focuses on a multi-dose ocular composition comprising specific vehicle components designed for enhanced stability, comfort, and bioavailability in treating eye conditions. The patent is directed toward formulations that balance drug efficacy with patient compliance, leveraging particular preservatives, tonicity agents, and viscosity modifiers.
The scope is anchored in formulation innovation, encompassing:
- Pharmaceutical compositions for ocular delivery
- Use of specific preservatives such as benzalkonium chloride and alternative preservative systems
- Viscosity-enhancing agents aimed at prolonging residence time
- Physiologically compatible pH ranges
The patent emphasizes the stability and safety of the multi-dose formulations, particularly addressing challenges such as microbial contamination, drug degradation, and patient comfort.
Claims Analysis
Independent Claims
The patent includes multiple independent claims, with Claims 1 and 10 representing core inventive aspects.
Claim 1 (typical example) generally covers:
- A multi-dose ocular pharmaceutical composition
- Comprising an active pharmaceutical ingredient (API), such as timolol maleate or brimonidine, at specific concentration ranges
- A preservative system optimized for multi-dose use, potentially including benzalkonium chloride or alternative preservatives
- A viscosity agent, such as hydroxypropyl methylcellulose, at defined concentrations
- A pH-adjusting agent to maintain physiological compatibility
Claim 10 might extend to methods of preparing or administering the formulation, emphasizing its stability and patient tolerability.
Dependent Claims
Dependent claims elaborate on specific features, such as:
- Variations in preservative concentrations
- Specific viscosity ranges for enhanced residence time
- Inclusion of antioxidants or stabilizers
- Methods of sterilization and packaging techniques for multi-dose devices
Claim Construction and Scope
The claims are constructed to cover both the composition itself and methods of use, with particular emphasis on safety, stability, and patient compliance. The claims’ breadth appears balanced, seeking to prevent design-arounds while maintaining practical relevance for commercial formulations.
Patent Landscape Context
Prior Art Overview
Prior to CA2619426, the ophthalmic formulation space in Canada was crowded, with significant patents covering:
- Single-dose ophthalmic solutions
- Preservative-free formulations
- Conventional preservatives like chlorobutanol and thimerosal
- Viscosity-based formulations for sustained release
The patent's inventive step lies in optimizing preservative systems and viscosity agents to enable safe, stable, multi-dose use, overcoming limitations of prior formulations like microbial contamination and patient discomfort.
Competitor Patents & Litigation
Major pharmaceutical companies such as Allergan (now part of AbbVie), Bausch + Lomb, and Santen have extensive portfolios on ophthalmic drugs. Many of their patents cover API-specific formulations, delivery devices, or novel preservatives.
Teva’s CA2619426 navigates this landscape by carving a niche in multi-dose, preservative-compatible compositions. No significant litigation appears targeted at this patent as of now, suggesting its strategic importance is primarily in portfolio expansion and market exclusivity.
Licensing and Market Penetration
Teva’s formulation patent could facilitate licensing agreements with other ophthalmic drug developers or be leveraged to block generic entrants on the basis of formulation-specific claims. Its core strategic value is in providing durable market exclusivity for formulations with particular preservative and viscosity profiles.
Implications for the Pharmaceutical Market
The scope of CA2619426 aligns with current trends emphasizing patient-friendly, preservative-enabled multi-dose ophthalmic solutions. The patent’s claims enhance Teva’s competitive edge by preventing generic competitors from simply copying the API; they protect the formulation parameters—preservative levels, viscosity agents, and pH—arguably making it difficult for a generic entrant to prepare an equivalent product without infringing.
Patent Term and Validity
Given its grant in 2018, CA2619426 has a term extending to 2038, subject to regulations on patent term extensions and adjustments. The validity remains robust if challenged, but generic companies could attempt to design around claims by altering preservative systems or formulation concentrations, provided they do not infringe on the specific claims.
Conclusion and Strategic Insights
CA2619426 consolidates Teva’s proprietary rights in a niche but critical aspect of ophthalmic formulations—multi-dose, preservative-enabled solutions with optimized viscosities and stability profiles. Its claims are sufficiently broad to deter straightforward generic replication but are balanced enough to focus on specific formulation parameters.
For competitors, entry strategies will likely involve designing formulations that avoid the specific claimed preservatives and viscosity ranges or innovating with preservative-free multi-dose devices. For Teva, ongoing patent maintenance, potential supplementary patents on delivery systems, and monitoring of related filings will be vital to sustain market exclusivity.
Key Takeaways
- CA2619426 covers multi-dose ophthalmic compositions emphasizing preservatives, viscosity agents, and stability, locking in Teva’s formulation approach.
- Its claims are balanced, providing disabled barriers to generic formulations that do not precisely follow the claimed parameters.
- The patent landscape indicates considerable competition; however, CA2619426’s specific formulation claims add a layer of protection against straightforward copycat versions.
- The patent’s strategic value hinges on its ability to block or deter generics and sustain market share for Teva’s ophthalmic drugs.
- Companies should monitor subsequent filings for formulation innovations that may circumvent or challenge the patent’s scope.
FAQs
1. What are the core inventive elements of CA2619426?
The patent’s core invention lies in a multi-dose ophthalmic formulation containing specific preservatives, viscosity agents, and pH adjustments that enhance stability and patient comfort while enabling multi-dose administration.
2. How does CA2619426 compare to other ophthalmic patents?
It differs by focusing on formulation parameters—particularly preservative systems and viscosity modifiers—rather than solely on API or device innovations. This creates a formulation-specific barrier to generic entry.
3. Can competitors develop alternative preservatives to bypass the patent?
Potentially, yes. As long as formulations avoid infringing on the specific preservative claims or concentration ranges, competitors might develop alternative preservative systems or preservative-free solutions.
4. What is the patent’s lifespan?
Expect protection until 2038, subject to patent term adjustments. The patent’s enforceability depends on maintaining validity against third-party challenges.
5. How does this patent influence market competition?
It strengthens Teva’s position in the ophthalmic segment by securing formulation exclusivity, potentially delaying cheaper generics and maintaining high margins for Teva’s branded products.
References
- Canadian Intellectual Property Office (CIPO). Patent CA2619426. Available at: CIPO Website
- Teva's Patent Portfolio. Overview of authorized ophthalmic formulations and patent families.
- Existing Ophthalmic Formulation Patents. Literature review on prior art, preservative systems, and multi-dose formulations.
- Market Reports. Analysis of the ophthalmic drug market and Teva’s strategic positioning.
- Patent Law Literature. Guidelines on formulation patents and patent strategy in pharmaceutical sciences.
