Apr 27, 2020
Nathaniel Lipkus, a partner in Osler’s Intellectual Property Group, spoke with Sam Tarantino, host of the Pharma Podcast, on an episode that aired April 27, 2020.
They discussed coronavirus treatments and related IP issues, including what Canada needs to be doing over the next year or so to ensure the country is positioned to benefit from any potential emerging COVID-19 treatments.
The conversation started off by going through Canada’s regulatory framework and the details of the COVID-19 Emergency Response Act (the Act), which was passed in March 2020. Nathaniel says that the legislation focuses on major financial relief measures, but the only section that didn’t focus on financial measures detailed patents.
“It’s one of the only sections of the Act that is not directed to financial relief,” Nathaniel says. “And what the Act provides for is the ability to override patents on medical products required to treat COVID-19. It’s actually framed as a public health emergency provision. But it’s quite clear that it is directed to the current pandemic,” Nathaniel says.
They talked about how the Act modifies the Patent Act to allow for compulsory licences (sec. 19.4), which allows the government to compel licences. But this COVID-19 legislation allows for the government to license to a third party if there is a public health emergency, it is time limited and there is a requirement to pay the patent owner. The expiry of this provision is currently September 30, 2020.
Nathaniel discusses another provision of note in the modifications to the Patent Act as part of this emergency legislation: the government created a pathway for the importation and sale of drugs on a list published by the government, for shortages that arise due to issues stemming from COVID-19.
Nathaniel also explains how entrance into the World Trade Organization (WTO) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has impacted countries. Nathaniel spoke about how in the early 1990s, when Canada entered into international trade agreements, the country largely abandoned its compulsory licensing regime. Although initially provisions under TRIPS limited countries’ flexibility to grant compulsory licences, Nathaniel explains, TRIPS did allow for compulsory licences in public health emergencies. Currently, many countries do have an escape valve for compulsory licences, Nathaniel says.
Nathaniel also points out that there are a lot of unknowns right now. Depending on how the crisis unfolds, or if and when a treatment is found, the government may extend the date to issue compulsory licences. It also remains to be seen whether these provisions will be useful. Currently, he says, it is unclear if patents will actually pose a barrier to treatment or if other obstacles such as manufacturing capacity or availability of non-patent intellectual property will emerge.
They spoke about how companies are really taking action and ramping up manufacturing. They talked about how policy makers, in response, need to establish a critical path for companies to be able to manufacture and receive approval for COVID-19 medicines. Currently, Canada doesn’t have sufficient capacity to manufacture biological molecules for vaccine development to the standard that Health Canada requires and Canadians will demand, and that is a serious issue, Nathaniel says.
Key recommendations for policy makers that Nathaniel highlights are as follows:
- We need to be evidence based to best predict what’s likely to be effective in treatment, so that we can determine what obstacles to access are likely to be faced.
- We need to be modelling what the distribution of treatment across Canada will look like for likely solutions.
- We need to have a predictable pricing model for industry, including a one-stop shop for pricing and entry to our market.
- We need to ensure relevant manufacturers are ready and, if needed, provide resources to them get up to regulatory standards.
- We need investment in domestic biomanufacturing to ensure long-term access to vaccines, as needed.
For more of Nathaniel’s insight, listen to the full podcast, “COVID-19 Special Edition – Canadian Access to Future Coronovirus Treatment – Canadian Regulatory Framework,” on the Pharma Podcast’s website.