Find And Stay In The Safe Harbour To Avoid Patent Infringement

The Canadian and US governments have created safe harbours (exemptions to patent infringement) to encourage product development. Canada’s patent laws have a “safe harbour” exemption from patent infringement (s. 55.2(1) of the Canadian Patent Act)¹. The safe harbour applies to activities reasonably related to generation of information for a regulatory agency, such as Health Canada or the U.S. FDA. The Canadian safe harbour is based on a similar provision in U.S. law, but the Canadian law’s wording is broader. The US law is limited to drug approval as the regulatory purpose. The Canadian law is not so limited, and applies to other types of regulatory approvals. For example, the Canadian safe harbor was litigated in the context of helicopter landing gear, and the Court found that the safe harbor was applicable in that context². Most of the safe harbor court decisions in Canada are in the pharmaceutical industry.