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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Identifying Drug Protection in Canada
IQVIA Patent Intelligence
Jul 08, 2021
The pharmaceutical industry is one of the most regulated sectors of the healthcare system that facilitates the discovery, development, production, and commercialization of medicinal drugs. In order to ensure the health and safety of people, every country imposes an imperative regulatory system on the ever-growing pharmaceutical industry. There are dedicated federal departments or agencies to assure the safety, quality, and efficacy of drugs available in the market, such as the Food and Drug Administration in the United States, the European Medicines Agency in the European Union, and Health Canada in Canada.
For an innovator drug to be marketed in Canada, information gathered from preclinical studies and clinical trials must be submitted to Health Canada in a New Drug Submission (NDS). This NDS is then thoroughly reviewed and evaluated on the parameters of safety, efficacy, and quality of the drug(1,2). If the review concludes that the benefits of the drug outweigh the risks and the risks can be mitigated, a Notice of Compliance (NOC) and Drug Identification Number (DIN) are issued to the innovator. The NOC and DIN indicate that the drug is officially approved and can be marketed in Canada(3) (Figure 1). For the approval of generic drugs, companies can file an Abbreviated New Drug Submission (ANDS) by referring to and proving the “bioequivalence” to a Canadian Reference Product, the first version of the drug sold by an innovator manufacturer(4).
Regulatory Data Protection in Canada
While applying for regulatory approval, the applicant must submit the complete clinical and non-clinical data as part of the NDS. Health Canada rewards the innovator drug manufacturer with regulatory data protection and market exclusivity period for the long and complex drug development process. Under Food and Drug Regulations, data protection provisions provide an innovator drug six-years of New Chemical Entity (NCE) exclusivity and an additional two-years of market exclusivity (ME). A “no-file” limit imposed by Canada’s data protection regime prevents a generic drug manufacturer from filing an ANDS in the first six years when the NCE exclusivity is still active. The innovator drug can also qualify for additional six-months of pediatric extension (PED) if the manufacturer provides clinical trial data on the use of the drug in relevant pediatric populations(5).
In addition to the regulatory data protection in Canada, the innovator could also benefit from 20 years of patent protection which could be extended by two years of Certificates of Supplementary Protection (CSP). The CSP aims to compensate for the time spent in the development and approval phases, and it further impedes the generic competitors to enter the market. This form of protection can only be availed for a drug product that is market authorized with a NOC by Health Canada(6).
Using Ark Patent Intelligence to Identify Exclusivities
Using the Data Exclusivity module of Ark Patent Intelligence, it is possible to find various non-patent exclusivities such as NCEs, MEs and PEDs approved in Canada, along with their expiry dates.
There are 29 drugs that have their MEs expiring in 2026, which is the highest amongst the next five years, possibly indicating that in 2026 there are good opportunities for generics to enter the market (Figure 2). Although non-patent exclusivities are a constraint for the generics to enter the market, the generic manufacturer should also consider the patent protection and ongoing litigation to predict how soon they can enter the pharmaceutical market without any risk of infringement.
Information related to various drug approvals in Canada can also be found using a combination of the Market Authorizations and Data Exclusivity modules of Ark Patent Intelligence.
Conclusion
Health Canada ensures research and development momentum by implementing data protection laws in Canada. Innovator drug manufacturers can take benefit from data protection and exclusivities and can recoup their invested resources in the drug development process. The first six years of NCE protection prevent generic manufacturers from comparing to innovator drug and thus block the establishment of bioequivalence. Pediatric extensions and CSP can further extend the protection period of an innovator drug and thus qualifies as critical factors to be considered by a generic manufacturer who is looking to launch their product in the Canadian market.
References
1) https://www.canada.ca/en/health-canada/services/clinical-trials.html
Ark Patent Intelligence is produced by IQVIA, a global provider of intelligence for the pharmaceutical sector, and provides solutions to pharmaceutical firms in every continent. To find out more, please visit Ark Patent Intelligence