For Canadian Companies Entering the U.S.
For many Canadian device companies, the United States is the first export market and sometimes the main one. The closeness of the two systems makes it easy to overlook the timing and inventorship differences that shape a sound U.S. portfolio.
Canada's medical technology industry employs more than 35,000 people in roughly 1,500 facilities, and its national association, Medtech Canada, represents companies ranging from Canadian-owned firms to multinationals. Health Canada classifies devices in four risk classes, and a manufacturer needs a medical device licence to import or sell its own Class II, III, or IV device. Those manufacturers must also hold a certificate issued under the Medical Device Single Audit Program, even if they sell only in Canada. Because Canada and the United States are both participating MDSAP authorities, one quality-system audit can serve both markets; the patent picture, however, has to be built separately.
The Canadian Intellectual Property Office (CIPO) examines patent applications, and Canada is a PCT contracting state. Section 28.2 of the Patent Act provides a one-year grace period for disclosures by the applicant or by someone who obtained the information from the applicant. The Canadian year is counted back from the Canadian filing date, or the PCT filing date, not from an earlier priority date. U.S. law measures its one-year exception from the effective filing date, which can include a priority claim. A disclosure that is safely inside the U.S. window can therefore fall outside the Canadian one if the Canadian filing comes late in the priority year. Canada does not impose a general foreign filing license on privately developed inventions, with a narrow exception for government employees, so a Canadian company can usually file first in the United States if that suits its strategy.
Cross-border development is where care is needed. When part of an invention is made in the United States, as happens with U.S.-based engineers, contract developers, or clinical collaborators, U.S. law generally requires a foreign filing license before an application is filed outside the United States, including in Canada, unless a U.S. application has been on file for six months. Classification also changes: FDA applies its own three-class scheme and its 510(k), De Novo, and premarket approval routes, and only PMA-route devices can support patent term extension under 35 U.S.C. 156.
U.S. rights remain territorial. A Canadian application can anchor U.S. filings only within the 12-month Paris Convention priority period, and PCT applications must enter the U.S. national stage within 30 months of priority. Before launch, a freedom-to-operate review of U.S. patents is prudent; importing an infringing device from a Canadian plant is itself infringement, and the International Trade Commission can exclude infringing imports. We work with Canadian patent agents and counsel on CIPO matters and focus on the U.S. portfolio.
Home-country organizations active in this sector include Medtech Canada. Knechtel Law Group is not affiliated with them.
Patent Strategy Considerations
Because Canada counts its grace period from the Canadian or PCT filing date, investor pitches, conference abstracts, and early publications should be timed so that both countries' windows are satisfied, not just the U.S. one.
Record inventor locations at the time of conception and development. If any contribution was made in the United States, obtain or confirm a U.S. foreign filing license before filing in Canada or under the PCT outside the USPTO.
Devices built in Canada and shipped south are exposed to U.S. patents at the border as well as in the market. Clearance should cover the product as imported, its components, and methods of use promoted in U.S. labeling.
How Engagements Work
Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of Canadian or European law are for your home-country counsel; the work here is coordinated with them so priority claims, filings and deadlines line up. Consultations are scheduled across time zones.
Request a Confidential ConsultationCommon Questions
Generally yes. Canada does not impose a general foreign filing license on privately developed inventions, apart from a narrow rule for government employees. If any part of the invention was made in the United States, however, U.S. foreign filing license rules may affect where you can file first.
The MDSAP audit can support quality-system requirements in both countries, but FDA makes its own classification and premarket decisions, and patent rights must be secured separately in each country.
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