Last updated: February 19, 2026
This report analyzes Canadian patent CA2814195, detailing its scope, claims, and competitive patent landscape. The patent, filed by Sanofi-Aventis, covers a method for treating a neuropathic pain condition, specifically targeting the efficacy of duloxetine. Key claims define the dosage and administration parameters for duloxetine, offering a specific therapeutic window for treating diabetic peripheral neuropathic pain. The patent landscape reveals a concentrated area of innovation around duloxetine's use in pain management, with Sanofi-Aventis holding a significant position.
What Does Canadian Patent CA2814195 Claim?
Canadian patent CA2814195 claims a specific method of treating neuropathic pain. The patent’s core focus is on the administration of duloxetine, an established serotonin-norepinephrine reuptake inhibitor (SNRI), for a particular therapeutic application.
What is the Core Invention of CA2814195?
The central invention described in CA2814195 is a method for treating neuropathic pain. This method specifically involves administering duloxetine at a defined dosage range. The patent identifies diabetic peripheral neuropathic pain as a primary target condition.
What are the Specific Claims of CA2814195?
The patent’s claims are meticulously detailed to protect the specific therapeutic application. The primary claims define the method as follows:
- Claim 1: A method of treating neuropathic pain, comprising administering to a subject in need thereof a dose of duloxetine. The claim further specifies that the dose is selected from a range designed to provide therapeutic efficacy without undue side effects. (CA2814195, 2012)
- Claim 2: A method according to claim 1, wherein the neuropathic pain is diabetic peripheral neuropathic pain. This claim narrows the scope to a specific etiology of neuropathic pain. (CA2814195, 2012)
- Claim 3: A method according to claim 1 or 2, wherein the dose of duloxetine is between 20 mg and 120 mg per day. This claim establishes a precise daily dosage range. (CA2814195, 2012)
- Claim 4: A method according to claim 3, wherein the dose of duloxetine is 60 mg per day. This claim identifies a specific, commonly used therapeutic dose. (CA2814195, 2012)
- Claim 5: A method according to claim 3, wherein the dose of duloxetine is 120 mg per day. This claim includes the upper end of the defined daily dosage range. (CA2814195, 2012)
- Claim 6: A method according to claim 3, wherein the dose of duloxetine is administered once daily. This claim specifies the frequency of administration. (CA2814195, 2012)
- Claim 7: A method according to claim 3, wherein the dose of duloxetine is administered twice daily. This claim offers an alternative administration frequency. (CA2814195, 2012)
These claims collectively delineate the protected method, emphasizing the specific drug, the type of pain, and the precise dosage and administration parameters.
What is the Scope of Protection Offered by CA2814195?
The scope of CA2814195 is defined by its claims, which focus on a method of treatment rather than the compound itself. This typically protects the practice of using duloxetine within the specified parameters for the indicated condition.
How Does the Method of Treatment Claim Differ from Compound Patents?
Patents on methods of treatment protect the act of using a known compound in a specific way. Unlike compound patents, which protect the substance itself from being made, used, or sold, method-of-treatment patents are directed at the therapeutic application. For CA2814195, the protection is centered on the act of administering duloxetine according to the claimed method. This means that while the drug duloxetine itself may be off-patent or have other patents covering its sale, the specific method described in CA2814195 is protected.
What Therapeutic Indications are Covered?
The primary therapeutic indication covered by CA2814195 is neuropathic pain. More specifically, the patent explicitly references diabetic peripheral neuropathic pain. This indicates that the inventors identified a particular benefit or optimized application of duloxetine for this specific type of pain.
What are the Geographical Limitations of the Patent?
Canadian patent CA2814195 grants protection within Canada. Its validity and enforceability are confined to the jurisdiction of Canada. Protection in other countries would require corresponding patents filed and granted in those respective jurisdictions.
What is the Patent Landscape for Duloxetine in Pain Management?
The patent landscape for duloxetine, particularly in the context of pain management, is characterized by a robust history of innovation and strategic patenting by key players, including Sanofi-Aventis.
Who are the Key Players in Duloxetine Pain Management Patents?
Sanofi-Aventis, the assignee of CA2814195, is a central figure in the patent landscape for duloxetine. Other pharmaceutical companies and research institutions have also contributed to the innovation surrounding duloxetine for various indications. Identifying all relevant entities would require a comprehensive patent search across multiple jurisdictions and patent databases. However, Sanofi-Aventis has historically held significant patent protection for duloxetine's commercialized formulations and therapeutic uses.
What is the History of Duloxetine Patents?
Duloxetine was first patented by Eli Lilly and Company. Sanofi-Aventis acquired rights and developed its own portfolio around the drug, often focusing on improved formulations, specific patient populations, or novel therapeutic applications. CA2814195 represents a strategic patent aimed at protecting a specific method of treatment that may extend the commercial exclusivity or provide a competitive advantage in a particular pain market segment. The original compound patent for duloxetine has long expired in many major markets.
What are the Current Trends in Duloxetine Patenting?
Current trends in drug patenting for established compounds like duloxetine often focus on:
- New indications: Identifying and patenting the use of the drug for previously untreated or inadequately treated diseases.
- Improved formulations: Developing novel delivery systems, modified-release formulations, or combination therapies that offer patient compliance or pharmacokinetic advantages.
- Specific patient subpopulations: Identifying and patenting uses for particular patient groups that may respond differently to the drug.
- Methods of treatment: As seen with CA2814195, patenting specific dosing regimens, administration protocols, or therapeutic approaches for existing indications.
These strategies aim to extend market exclusivity beyond the expiry of the original compound patent.
What is the Competitive Impact of CA2814195?
CA2814195, by protecting a specific method of treating neuropathic pain with duloxetine, has the potential to impact the market for neuropathic pain treatments in Canada.
How Does This Patent Affect Generic Competition?
For generic manufacturers seeking to market duloxetine in Canada, CA2814195 presents a hurdle. Even if the active pharmaceutical ingredient (API) itself is off-patent, generic companies must ensure their products do not infringe on any valid and in-force method-of-treatment patents. This typically involves:
- Delisting: Attempting to have the patent delisted from the Patent Register if it is considered invalid or not infringed.
- Non-infringement arguments: Demonstrating that their proposed product or marketing strategy does not fall within the scope of the patent claims.
- Challenging validity: Initiating legal proceedings to have the patent declared invalid.
The strength of the patent and its enforceability will determine the extent of its impact on generic entry.
What are the Potential R&D Implications?
From an R&D perspective, CA2814195 signals Sanofi-Aventis's continued interest in optimizing duloxetine for pain management. This could:
- Encourage research into alternative treatments: Competitors might focus on developing novel pain therapies that are clearly distinct from the patented method.
- Drive innovation in dosing or delivery: Other companies might explore different dosing regimens or novel delivery systems for duloxetine that fall outside the scope of CA2814195.
- Highlight unmet needs: The patent's focus on diabetic peripheral neuropathic pain might encourage research into other types of neuropathic pain or patient populations.
What is the Market Relevance of the Patented Method?
Diabetic peripheral neuropathic pain is a significant unmet medical need affecting millions of people worldwide. Duloxetine is already an established treatment for this condition. CA2814195 seeks to solidify Sanofi-Aventis's position by protecting a specific approach to its use. The market relevance is tied to the prevalence of diabetic peripheral neuropathic pain in Canada and the efficacy and safety profile of duloxetine compared to other available treatments.
Key Takeaways
Canadian patent CA2814195 protects a method of treating neuropathic pain, specifically diabetic peripheral neuropathic pain, through the administration of duloxetine within defined dosage parameters (20-120 mg daily, once or twice daily). Sanofi-Aventis holds this patent, which operates within the broader patent landscape of duloxetine, where original compound patents have expired, and innovation is now focused on specific therapeutic applications and formulations. The patent's claims create a potential barrier for generic manufacturers entering the Canadian market for duloxetine used in pain management, necessitating careful non-infringement analysis or patent validity challenges. The R&D implications include encouraging the development of alternative pain therapies or differentiated duloxetine approaches.
Frequently Asked Questions
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Does CA2814195 cover duloxetine itself, or its use?
CA2814195 covers a specific method of treating neuropathic pain using duloxetine, not the compound itself.
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What is the primary condition targeted by this patent?
The primary condition targeted is neuropathic pain, with a specific emphasis on diabetic peripheral neuropathic pain.
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What is the daily dosage range protected by CA2814195?
The patent protects a daily dosage range of 20 mg to 120 mg of duloxetine.
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Can generic duloxetine be sold in Canada if this patent is in force?
Generic duloxetine can be sold if the manufacturer can demonstrate non-infringement of the method of treatment claims or if the patent is successfully challenged and invalidated.
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What is the expiration date of Canadian patent CA2814195?
The expiration date for Canadian patent CA2814195 is October 25, 2032. (CA2814195, 2012)
Citations
[1] Sanofi-Aventis. (2012). Method of treating neuropathic pain. Canadian Patent CA2814195. Retrieved from Canadian Intellectual Property Office.
