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Ontario’s Working for Workers Five Act receives royal assent
On October 28, Bill 190, Working for Workers Five Act, 2024 received royal assent.
Canada | Publication | June 6, 2024
In recent years, the incredible promise of gene therapy has become a reality as multiple gene therapy products have come to market. Here we provide an overview of how commercial gene therapy products are regulated and protected in Canada. We also identify emerging issues affecting these products.
In Canada, 10 gene therapy products have been approved for marketing (see Table 1 below). These products can be divided into two groups: (i) six CAR-T therapies for treating blood cancers; and (ii) four AAV-based therapies for restoring gene function. In brief:
Canada does not have a distinct legislative framework for gene therapy products. These products are subject to the same regulatory provisions as other drug products under the Food and Drugs Act and Food and Drug Regulations. To sell a gene therapy product in Canada, the sponsor must file a new drug submission with Health Canada. If approved, the sponsor will receive a drug identification number and a notice of compliance (NOC).
Health Canada classifies gene therapy products as biologic drugs under Schedule D of the Food and Drug Regulations. They are reviewed by Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate under guidelines for biologic drugs.
Gene therapy products are often evaluated in small patient populations and without traditional phase 3 clinical trials. As such, they are often candidates for Health Canada’s Notice of Compliance with Conditions (NOC/c) pathway, in which drugs showing promising evidence of effectiveness for serious, life-threatening, or severely debilitating diseases can be approved subject to the drug’s sponsor agreeing to conduct further clinical trials.1 The NOC/c pathway is also expedited relative to the traditional review process. Most of the gene therapy products approved in Canada to date have been with an NOC/c.
Gene therapy products may also be subject to other areas of Canadian regulation, including under the Assisted Human Reproduction Act and the New Substances Notification Regulations (Organisms).2
Data protection: Gene therapy products are generally eligible for eight years of data protection market exclusivity under section C.08.004.1 of the Food and Drug Regulations. A new drug is eligible for data protection if it is an “innovative drug,” meaning it contains a medicinal ingredient not previously approved in Canada. While a new drug is under data protection, a generic or biosimilar drug manufacturer cannot rely upon the innovator’s data (e.g., clinical trial results) to obtain an NOC.
Patent protection: Gene therapy products are patentable in Canada and subject to the same legislation as other patented products. Of note:
Patent litigation: Canada’s first litigation concerning a gene therapy patent started in October 2022. The litigation concerns the validity of certain claims in Canadian Patent No. 2,737,094 (titled “Factor IX Polypeptide Mutant, its Uses and a Method for its Production”). The plaintiffs are represented by Norton Rose Fulbright Canada LLP.
Issues to keep an eye on in gene therapy in Canada include:
For more information on these and other legal and regulatory developments in Canadian pharma and biotech, please contact the authors and subscribe to our Pharma in Brief newsletter.
Product | Company | Gene | Indication(s) | Approval |
---|---|---|---|---|
CAR-T therapies | ||||
ABECMA® (idecabtagene vicleucel) |
Celgene Inc. | BCMA- CAR | Multiple myeloma | 2021-05-26 |
CARVYKTI® (ciltacabtagene autoleucel) |
Janssen Inc. | BCMA- CAR | Multiple myeloma | 2023-02-09 |
BREYANZI® (lisocabtagene maraleucel) |
Bristol-Myers Squibb Canada | CD19- CAR | Large B-cell lymphoma | 2022-05-06 |
KYMRIAH® (tisagenlecleucel) |
Novartis Pharmaceuticals Canada Inc. | CD19- CAR | B-cell acute lymphoblastic leukemia; Large B-cell lymphoma; Follicular lymphoma | 2018-09-05 |
TECARTUS® (brexucabtagene autoleucel) |
Gilead Sciences Canada Inc. | CD19- CAR | Mantle cell lymphoma; B-cell precursor acute lymphoblastic leukemia | 2021-06-08 |
YESCARTA® (axicabtagene ciloleucel) |
Gilead Sciences Canada Inc. | CD19- CAR | Large B-cell lymphoma; Follicular lymphoma | 2019-02-13 |
Product | Company | Gene | Indication(s) | Approval |
---|---|---|---|---|
AAV-based therapies | ||||
BEQVEZ® (fidanacogene elaparvovec) |
Pfizer Canada ULC | FIX-R338L | Hemophilia B | 2023-12-27 |
HEMGENIX® (etranacogene dezaparvovec) |
CSL Behring Canada Inc. | FIX-R338L | Hemophilia B | 2023-10-23 |
LUXTURNA® (voretigene neparvovec) |
Novartis Pharmaceuticals Canada Inc. | RPE65 | Retinal dystrophy | 2020-10-13 |
ZOLGENSMA® (onasemnogene abeparvovec) |
Novartis Pharmaceuticals Canada Inc. | SMN1 | Spinal muscular atrophy | 2020-12-15 |
For instance, the Assisted Human Reproduction Act prohibits knowingly modifying the human genome in a manner that can be passed on to future generations. In addition, the New Substances Notification Regulations (Organisms) requires an environmental assessment of new microorganisms, including new viruses. See Guidelines for the Notification and Testing of New Substances: Organisms (link).
Publication
On October 28, Bill 190, Working for Workers Five Act, 2024 received royal assent.
Publication
The Federal Court of Appeal’s 2023 decision in Canada (Attorney General) v Benjamin Moore & Co [Benjamin Moore FCA] overturned the Federal Court’s decision in Benjamin Moore & Co. v. Canada (Attorney General) [Benjamin Moore FC] that had previously established a new test for patentable subject matter in computer-implemented inventions.
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