Last updated: February 19, 2026
This report analyzes Canadian patent CA2632283, covering its asserted claims, scope of protection, and the surrounding patent landscape. The patent, granted to Bristol-Myers Squibb Company, relates to formulations of apixaban, an anticoagulant.
What Does CA2632283 Claim?
Canadian patent CA2632283 claims specific pharmaceutical compositions and methods of use. The patent's primary focus is on an oral formulation of apixaban designed to improve its stability and pharmacokinetic profile.
Core Claims:
The patent's asserted claims are directed towards:
- Claim 1: A specific pharmaceutical composition comprising apixaban, at least one pharmaceutically acceptable excipient, and a disintegating agent. The claim details the percentage ranges of these components, emphasizing the role of the disintegrating agent in achieving desired drug release characteristics.
- Claim 7: A method of treating or preventing a thromboembolic disorder in a subject, comprising administering a therapeutically effective amount of the pharmaceutical composition of claim 1.
- Claim 16: A method for preparing the pharmaceutical composition of claim 1, involving specific blending and compression steps.
The claims are structured to protect not only the formulated drug product itself but also the method of its manufacture and its therapeutic application in preventing blood clots.
Scope of Protection:
The scope of protection afforded by CA2632283 is concentrated on specific pharmaceutical formulations that incorporate apixaban. The patent does not broadly cover apixaban as a chemical entity but rather its delivery in a particular oral dosage form. The inclusion of precise excipient and disintegrant percentages within the claims defines the boundaries of infringement. Competitors seeking to market generic apixaban products would need to ensure their formulations do not fall within the scope of these specific compositional claims.
What is the Asserted Therapeutic Use?
The asserted therapeutic use of the formulations covered by CA2632283 is the treatment and prevention of thromboembolic disorders. This includes conditions such as:
- Stroke
- Systemic embolism
- Deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
Apixaban is a direct factor Xa inhibitor, a class of anticoagulants designed to prevent the formation of blood clots. The patent's claims leverage this known pharmacological activity by linking the specific oral formulations to improved patient outcomes in managing these conditions.
What is the Patent Landscape for Apixaban Formulations in Canada?
The patent landscape for apixaban formulations in Canada is characterized by a series of overlapping and sequential patents designed to extend market exclusivity. Bristol-Myers Squibb and its collaborators have strategically filed patents covering various aspects of apixaban, including its chemical synthesis, different salt forms, and diverse pharmaceutical compositions.
Key Patents and Their Focus:
- CA2419940: This foundational patent covers apixaban itself and its use as an anticoagulant. It represents the initial intellectual property protecting the active pharmaceutical ingredient.
- CA2595408: This patent claims specific crystalline forms of apixaban, which can influence the drug's stability, solubility, and manufacturing properties.
- CA2632283 (the subject of this analysis): This patent focuses on specific oral tablet formulations, as detailed previously.
- Other Related Patents: Bristol-Myers Squibb holds or has applied for numerous other patents in Canada covering additional formulations, polymorphic forms, and methods of use for apixaban. These patents, when viewed collectively, create a complex web of intellectual property rights designed to protect the commercial interests of the innovator company.
Expiry Dates and Market Implications:
The expiry dates of these patents are critical for generic manufacturers.
- The foundational patent (CA2419940) has expired.
- CA2632283 is expected to expire on October 17, 2024. (Source: Canadian Intellectual Property Office).
- Other related formulation patents may have different expiry dates, potentially extending protection for specific delivery systems beyond the expiry of the core apixaban patents.
The expiry of these patents signifies the potential for generic entry into the Canadian market for apixaban. However, the existence of multiple patents, including formulation patents like CA2632283, can complicate generic market entry. Generic companies must navigate this patent thicket to ensure their products do not infringe on any active and valid patents.
Patent Litigation and Challenges:
The strength and enforceability of patents can be challenged through litigation. While specific public litigation records for CA2632283 in Canada may not be readily available without extensive legal database searches, the history of pharmaceutical patenting often involves challenges from generic manufacturers seeking to invalidate patents or prove non-infringement. Any active litigation or past challenges to related apixaban patents in Canada would be crucial data points for R&D and investment decisions.
Analysis of Prior Art and Potential Invalidity Arguments
When assessing the value of a patent, examining the prior art is essential for understanding potential arguments for invalidity. For CA2632283, prior art could include:
- Previously published patents and patent applications: Any patents describing apixaban formulations with similar disintegrant agents or excipient profiles prior to the filing date of CA2632283 would be relevant.
- Scientific literature: Research papers published before the patent's priority date detailing formulations of apixaban or other similar anticoagulants could be cited.
- Public disclosures: Any public presentations, abstracts, or product literature describing similar formulations before the priority date would also constitute prior art.
Potential Grounds for Invalidity:
- Obviousness: If the claimed formulation was obvious to a person skilled in the art based on existing knowledge (prior art) at the time of filing, the patent could be deemed invalid. For instance, if the use of a specific disintegrating agent in oral pharmaceutical compositions was well-established and its application to apixaban formulations was straightforward, it could be argued that the invention lacks an inventive step.
- Lack of Novelty: If the exact formulation claimed in CA2632283 was previously described or disclosed in the prior art, it would lack novelty.
- Insufficient Disclosure: If the patent does not adequately describe how to make and use the claimed invention, it could be challenged.
A thorough prior art search specific to the claims of CA2632283 would be necessary to definitively assess its vulnerability to invalidity challenges.
Key Takeaways
Canadian patent CA2632283 protects specific oral formulations of apixaban, including their composition and methods of use in treating thromboembolic disorders. The patent's claims are narrowly defined, focusing on particular excipient and disintegrant ratios. Its expiry date of October 17, 2024, is a significant factor for generic market entry considerations. The broader patent landscape for apixaban in Canada involves multiple patents covering the active ingredient, its forms, and various formulations, creating a complex intellectual property environment. Prior art and potential invalidity arguments related to obviousness or lack of novelty are crucial considerations for any party seeking to enter the market or invest in apixaban-related products.
Frequently Asked Questions
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When does Canadian patent CA2632283 expire?
Canadian patent CA2632283 is scheduled to expire on October 17, 2024.
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What is the primary active ingredient protected by CA2632283?
The primary active ingredient is apixaban.
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Does CA2632283 cover apixaban itself, or specific formulations?
CA2632283 covers specific oral pharmaceutical compositions of apixaban, not the active pharmaceutical ingredient in a general sense.
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What are the main therapeutic uses claimed in CA2632283?
The patent claims methods for treating or preventing thromboembolic disorders, including stroke, systemic embolism, deep vein thrombosis, and pulmonary embolism.
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What role does a disintegrating agent play in the claims of CA2632283?
The claims specify the inclusion of a disintegrating agent as a key component in the pharmaceutical composition, influencing drug release characteristics.
Citations
[1] Canadian Intellectual Property Office. (n.d.). Canadian Patent Database. Retrieved from https://patents.google.com/patent/CA2632283A1/en
