Pangaea Express: Bill C-13 Amendments to Patent Act and Food and Drugs Act
On March 25, Bill C-13, the COVID-19 Emergency Response Act, received Royal Assent that includes amendments to both the Patent Act and the Food and Drugs Act to ensure the availability of drugs and medical devices.(1)
The Patent Act has been amended to allow for compulsory licensing by adding a new section, 19.4. The Minister of Health, through an application to the Government of Canada, will be allowed to make, construct, use and sell a patented invention to the extent necessary to respond to the public health emergency described in the application. The use or sale of such an invention would not be any infringement of the patent.(2) As explained by Norton Rose Fulbright, Section 19.3 of the Patent Act does already authorize the government’s use of a patent invention, “however, under these pre-existing provisions, the government is first required to negotiate use with the patentee, except in cases of “national emergency or extreme urgency”. This newly enacted Section 19.4 does not require any negotiation, only that the patent holders will be notified.(3) The patentee will be remunerated according to what the Commissioner considers to be adequate in the circumstances, taking into account the economic value of the patented invention.(2)
As this is only for the purposes of the COVID-19 pandemic, authorization will only be granted until September 30, 2020. As well, all authorizations that were granted will expire the earlier of: one year after the day in which it was granted or when the Minister of Health considers the authorization to no longer be necessary to respond to the health emergency.
This Emergency Response Act also includes amendments to the Food and Drug Act to prevent shortages or to alleviate any shortages of therapeutic products in order to protect human health. Bill C-13 will allow the Minister to require persons to provide information in respect of food, drugs, cosmetics or devices.(2)
In addition to the amendments to the Patent Act and Food and Drugs Act, on March 18, the Minister of Health issued an interim order to enable the expedited review of health product submissions to address the diagnosis, treatment, mitigation or prevention of COVID-19. The federal agency made it known that Canada’s Special Access Program continues to be available to practitioners or other healthcare professionals to allow for the importation of drugs and medical devices that may provide supportive treatments to the infection, or to identify COVID-19 in patients.(4)
For more information, please contact Suzanne Solman.