On March 25, 2020, the Canadian Government passed into law Bill C-13, An Act respecting certain measures in response to COVID-19, following emergency sittings of Parliament and the Senate. Bill C-13 amends both the Patent Act and the Food and Drugs Act and may have implications for the pharmaceutical industry.
Patent Act – Limited government use of patented inventions for public health emergencies (s. 19.4)
A new stand-alone provision has been added to the Patent Act: section 19.4. This section allows the Minister of Health to apply for government authorization to make, construct, use, and sell a patented invention for a public health emergency. Section 19.4 comes into force immediately.
Section 19.4 will have limited use. The Minister of Health can only apply for government authorization under section 19.4 until September 30, 2020. Further, any authorizations will expire either a year after grant or when the Minister of Health deems it no longer necessary, whichever comes earlier.
The Patent Act already included provisions that authorized the government's use of a patented invention under sections 19–19.3. 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 is not required under newly enacted section 19.4. The patentee will, however, be notified of any such authorization.
Under section 19.4, the patentee will be compensated in an "amount that the [Patent] Commissioner considers to be adequate remuneration in the circumstances, taking into account the economic value of the authorization and the extent to which they make, construct, use and sell the patented invention."
Food and Drugs Act – Additional regulatory powers
Bill C-13 also amends the Food and Drugs Act to allow the Minister of Health to make regulations "for the purpose of preventing shortages of therapeutic products in Canada or alleviating those shortages or their effects, in order to protect human health". The Minister may also request information not otherwise required by the Food and Drugs Act in respect of these products. Additional regulations have not been posted at this time. These temporary provisions are set to be automatically repealed on October 1, 2020.
Government funding for coronavirus research
The Canadian Government has also pledged $275 million to coronavirus research and medical countermeasures. This funding will go to research projects underway at universities and private entities, and will also be used to ensure a domestic supply of potential vaccines.
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