코로나-19 공중보건비상사태에서의 캐나다 강제실시 제도의 변화

Abstract

On March 25, 2020, Canada enacted the 'COVID-19 Emergency Response Act' to protect its people and economy from the effects of the COVID-19 pandemic, and newly established compulsory licenses under public health emergencies in the Patent Act. Among other things, part 12 of Canada's‘COVID-19 Emergency Response Act’amends the Patent Act to provide that the Commissioner must, on the application of the Minister of Health, authorize the Government of Canada and any person specified in the application to make, construct, use and sell a patented invention to the extent necessary to respond to a public health emergency that is a matter of national concern. Under ordinary circumstances, under section 19 of the Patent Act, the Government of Canada or a provincial government may apply for a government compulsory license of a patent for its own use if it is not able to enter into a commercial contract with the patent owner. However, situations like COVID-19 are far from normal. In response, the Canadian government has created a new compulsory license as part of its fight against COVID-19. Article 19.4 of the Patent Act has been added to the Patent Act to strengthen Government of Canada's ability to provide the drugs and medical devices needed across the country to fight this pandemic. Where the federal Minister of Health believes there is a public health emergency, the Commissioner of Patents may authorize the government and others to make, construct, use and sell a patented invention during that public health emergency without fear of infringement. This new amendment aligns with other similar compulsory license provisions that already exist under the Patent Act. However, new article 19.4 of the Patent Act goes further by expressly allowing non-governmental entities to obtain compulsory patent licenses even in circumstances where the patent owner is capable of making, constructing, using and selling his patented invention. This new provision, however, is time-limited and it will only be in effect until September 30, 2020. The debate is not resolved concerning the usefulness of the compulsory license in terms of promoting public health. While the granting of compulsory licenses is still unfamiliar and rare in practice in Korea, the case of Canada illustrates how compulsory licenses can work in public health emergencies.