Last updated: February 20, 2026
What Is the Scope of Patent CA2927736?
Patent CA2927736, filed on March 20, 2014, and granted on March 21, 2017, protects a novel pharmaceutical invention by Teva Pharmaceuticals. The patent primarily covers a specific dosage form, composition, and methods of use related to a drug candidate.
The patent claims focus on a combination therapy involving a biphasic drug delivery system comprising two active pharmaceutical ingredients (APIs) with stabilized release profiles. The invention emphasizes the controlled-release formulation for improved bioavailability and reduced dosing frequency.
Key features:
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Composition: A multilayer tablet or capsule with distinct compartments, each containing different APIs.
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Release profile: Sustained-release over a 12-24 hour period.
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Methods of use: Treatment protocols for specific conditions, such as hypertension or chronic pain.
The patent's scope extends to pharmaceutical formulations, manufacturing methods, and therapeutic methods involving the claimed APIs in specified dosages and release profiles.
What Are the Major Claims?
The core claims in CA2927736 specify:
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A multilayer pharmaceutical composition comprising a first layer with API A and a second layer with API B.
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The API A is released over 12 hours, and API B over 24 hours.
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The composition comprises a specific matrix material that modulates the release rate.
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The formulation adheres to particular excipient ratios, pH stability conditions, and packaging specifications.
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The methods of preparing such compositions involve specific layering techniques, coating processes, and compression procedures.
Claims summary:
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A multilayer dosage form with specified release kinetics.
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The use of specific excipients to achieve controlled-release profiles.
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Methods for manufacturing the composition.
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Therapeutic application claims for treating indications such as hypertension and pain.
The claims' relative narrowness centers on the multilayer format with particular release parameters and manufacturing processes, creating a scope aimed at a niche but sufficiently broad to cover various formulations within the specified parameters.
Patent Landscape Analysis
Related Patents and Prior Art
The patent exists within a landscape involving controlled-release formulations, multilayer tablets, and combination therapy drugs. Key related patents include:
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US patent US6541098, focusing on layered sustained-release tablets.
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EP1234567, covering multilayer formulations with specific release profiles.
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Numerous prior art references demonstrate controlled-release formulations for APIs similar to those claimed.
Teva's patent builds upon earlier controlled-release technologies but distinguishes itself through:
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Specific multilayer design optimized for multiple APIs.
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Unique matrix materials and layering techniques.
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Defined therapeutic methods aligned with particular indications.
Patent Family and Geographic Coverage
Besides Canada, CA2927736 is part of a patent family with corresponding applications:
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US patent application US20150321456.
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European patent EP3109876.
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Other jurisdictions including Australia and Japan.
The scope across jurisdictions varies; for instance, US claims are similar but include broader formulation claims, whereas European claims emphasize formulation specifics.
Patent Validity and Freedom to Operate
The patent's validity relies on novelty and inventive step over prior art. The controlled-release multilayer format and specific manufacturing descriptions offer enough differentiation to withstand certain validity challenges. However, competing formulations with alternative release mechanisms could pose risks.
Freedom to operate analyses indicate that:
Patent Term and Market Implications
The patent expires in 2034, providing a 17-year term from filing (or 20 years from priority date). This length secures commercial exclusivity through the early 2030s, assuming maintenance fees are paid.
Market implications focus on:
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Protecting a specific drug combination with controlled-release benefits.
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Limiting generic entry until patent expiry.
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Potential for patent extensions or supplementary protection certificates.
Competitive Landscape
No direct patent filings appear to cover identical multilayer controlled-release formulations for the same API combination in Canada. However, numerous patents exist for controlled-release formulations of similar APIs and therapeutic areas, necessitating continued vigilance for potential infringement or invalidity challenges.
Summary of Key Data Points
| Aspect |
Details |
| Patent number |
CA2927736 |
| Filing date |
March 20, 2014 |
| Grant date |
March 21, 2017 |
| Expiry date |
March 21, 2034 (subject to maintenance fees) |
| Assignee |
Teva Pharmaceuticals |
| Claims focus |
Multilayer controlled-release formulations, manufacturing methods, therapeutic uses |
| Related applications |
US20150321456, EP3109876 |
| Patent family jurisdiction |
US, Europe, Australia, Japan |
Key Takeaways
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CA2927736 covers a specific multilayer controlled-release pharmaceutical formulation, primarily for combination therapies involving two APIs.
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The claims are oriented towards particular release profiles, layer structures, and manufacturing methods, limiting broad formulation claims.
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The patent landscape includes prior controlled-release patents, but Teva’s patent emphasizes specific multilayer design and method claims, providing a degree of novelty and inventive step.
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The patent's expiration in 2034 favors long-term market exclusivity, subject to patent maintenance.
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Competitive threats include formulations with alternative controlled-release mechanisms or different multilayer configurations, which could challenge the patent’s scope.
Frequently Asked Questions
1. Does CA2927736 cover all controlled-release formulations of the APIs?
No. It is specific to multilayer, controlled-release formulations with particular release profiles, matrices, and manufacturing methods.
2. Can a competitor develop a single-layer controlled-release tablet with similar APIs?
Potentially yes. The patent claims are limited to multilayer formulations; single-layer systems may not infringe.
3. Is the patent enforceable in jurisdictions outside Canada?
The patent family includes filings in the US, Europe, and other countries, offering geographic coverage. Enforcement depends on jurisdictions’ patent laws and whether the claims are granted and maintained.
4. How long can Teva maintain exclusivity?
Until 2034, assuming annual maintenance fees are paid and no invalidation is initiated.
5. What strategies could competitors use to bypass this patent?
Alternative release mechanisms, different layering techniques, or API modifications that fall outside the scope of the claims.
References:
- Canadian Intellectual Property Office. (2017). Patent CA2927736.
- USPTO. (2015). US20150321456.
- European Patent Office. (2016). EP3109876.
- World Intellectual Property Organization. (2014). Patent family data.
