Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through government programs and/or private insurance. Further, Health Canada, the regulatory body for drug approvals, is well-respected globally, and approval in Canada may be recognized favourably in other jurisdictions. Below are ten patent and regulatory topics that in-house counsel need to know before bringing an innovative product to Canada.
- Regulatory pathways: generics, biosimilars, submissions based on literature and market experience, drugs for rare diseases
- Eight-year data exclusivity for new biologic and pharmaceutical drugs
- Certificates of supplementary protection
- Listing patents on Patent Register
- Price controls over patented medicines
- Transparency: submission filings and clinical trial data
- Special Access Program (SAP)
- How to calculate Loss of Exclusivity (LOE) date
- Marketing the drug
Canada mirrors the regulatory/patent regimes in other jurisdictions in many respects but has key differences. Pre-planning by coordinating between regulatory and patent groups before bringing any drug to Canada is critical to ensure all necessary decisions are taken well in advance of critical deadlines.
This abbreviated article has been reproduced with permission from the original publisher Association of Corporate Counsel (ACC). If you would like to learn more, the full article is available to view online in the ACC Resource Library.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.