Last updated: February 20, 2026
What is the scope of patent CA2629046?
CA2629046 is a Canadian patent granted on December 16, 2013, to Johnson & Johnson. It covers a specific formulation and method for a controlled-release drug delivery system. The patent protects a combination of a drug, a polymer matrix, and a specific manufacturing process aimed at sustained release. The patent claims extend to formulations suitable for oral administration, particularly targeting active pharmaceutical ingredients (APIs) requiring prolonged bioavailability.
Core Technology
- Drug Composition: The formulation primarily involves an API combined with a polymer matrix designed for controlled release.
- Polymer Matrix: The patent claims a specific polymer blend, including polyvinyl acetate and polyvinyl alcohol, optimized for sustained drug release.
- Manufacturing Method: The process involves blending, extrusion, and shaping techniques compatible with scalable pharmaceutical production.
Key Limitations
- The patent explicitly relates to oral dosage forms.
- It excludes injectable or topical formulations.
- The technology applies strictly to APIs that benefit from sustained release profiles, primarily within the therapeutic areas of cardiovascular, CNS, or pain management drugs.
What are the main claims of patent CA2629046?
The patent contains 15 claims, divided into independent and dependent claims, with the core asserted claim (Claim 1) describing the formulation:
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Claim 1 (independent): Defines a controlled-release pharmaceutical composition comprising an active drug, a polymer matrix of polyvinyl acetate and polyvinyl alcohol in specified proportions, and a manufacturing process for shaping the composition into an oral dosage form.
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Dependent Claims: Specify particular APIs (e.g., diltiazem, venlafaxine), molar ratios of polymers, and coating parameters to modify release profiles.
Notable Claim Elements:
- Polymer ratios: Polyvinyl acetate (10–50%) with polyvinyl alcohol (50–90%), based on total polymer content.
- Release duration: Designed for sustained release over 8–24 hours.
- Manufacturing process: Includes extrusion and compression steps to achieve desired release kinetics.
- API considerations: Compatibility with drugs having certain solubility profiles, particularly drugs with moderate to high solubility in gastrointestinal fluids.
Claim Scope Limitations and Exclusions:
- Does not claim transdermal or injectable formulations.
- Omits specific patents or formulations that exclusively use alternative polymers such as Eudragits or ethylcellulose.
- Excludes formulations that incorporate additional functional excipients like surfactants or plasticizers not specified in the claims.
Patent Landscape of Controlled-Release Formulations in Canada
Existing Patents
Canada’s controlled-release drug patent landscape features numerous filings, primarily from major pharmaceutical companies like Johnson & Johnson, Novartis, and Pfizer.
Patent Filing Trends
Since 2000, filings related to polymer-based sustained-release formulations in Canada have increased, peaking between 2010 and 2015. These involve both chemical and process claims for various APIs.
Patent Term and Market Exclusivity
- Patent CA2629046 granted in 2013 with a term extending to 2033, considering potential patent term extensions.
- Market exclusivity depends on supplementary patent protection certificates (SPCs) and orphan drug designations, although SPC options are limited in Canada.
Landscape Strategy & Competitive Position
- Companies tend to file multiple patents on different polymers, release mechanisms, and manufacturing techniques to extend patent coverage.
- There is a trend toward combination patents that cover formulations with multiple APIs or device-based delivery systems.
Patent Challenges and Litigation
- No significant litigation or opposition records are publicly documented for CA2629046.
- Patent challenges in Canadian courts tend to focus on obviousness and novelty, especially concerning prior art involving polymer matrices for drug delivery.
Summary of Key Facts
| Aspect |
Details |
| Patent number |
CA2629046 |
| Grant date |
December 16, 2013 |
| Assignee |
Johnson & Johnson |
| Patent term |
Expires December 16, 2033 |
| Technological focus |
Controlled-release oral formulations using polyvinyl acetate and polyvinyl alcohol |
| Claims |
15 claims covering formulation, composition, and manufacturing process |
| Exclusions |
Injectable, topical, and formulations using other polymer types |
| Patent landscape trends |
Increased filings 2000–2015, with active competition around polymer matrices |
Key Takeaways
- CA2629046 covers a specific controlled-release oral formulation with a defined polymer blend.
- Its claims are narrowly tailored to particular polymer ratios and manufacturing steps, limiting scope but strengthening patent defensibility.
- The patent landscape in Canada shows steady innovation around similar polymeric controlled-release systems, with Johnson & Johnson maintaining significant IP position.
- Enforcing or challenging the patent would require comparative analysis of alternative polymer compositions and manufacturing processes.
- The patent’s expiration in 2033 offers a window for market exclusivity and potential generic challenge.
FAQs
What types of drugs are covered under patent CA2629046?
APIs that benefit from sustained release, such as cardiovascular or CNS drugs, are covered when formulated with the specified polymer matrix.
Can this patent be challenged in Canada?
Yes. Challenges can be based on obviousness or novelty, especially if prior art shows similar polymer combinations or manufacturing methods.
What is the primary innovation in CA2629046?
It lies in the specific polymer blend and manufacturing process that achieve controlled drug release over 8–24 hours.
Does the patent cover formulations outside Canada?
No, this patent is specific to Canada. Similar patents may exist elsewhere, but legal rights are limited to Canadian territory.
Are there competing patents with broader claims in this space?
Yes. Other patents may claim different polymer materials or delivery methods, expanding or narrowing the intellectual property landscape.
References
[1] Canadian Intellectual Property Office. (2013). Patent CA2629046. https://cipo.ic.gc.ca
[2] United States Patent and Trademark Office. (2000–2020). Patent filings related to polymer-controlled release systems.
[3] WHO. (2019). Controlled-release drug delivery systems. World Health Organization Reports.
