On March 11th 2021, Biolyse Pharma (“Biolyse”) issued a statement publicly indicating their capacity to manufacture a COVID-19 vaccine and their intent to apply for a compulsory license in Canada. Biolyse is a Canadian manufacturer of cancer drugs based out of St. Catharines, Ontario, with the potential to manufacture two million doses a month. To help meet growing COVID-19 vaccine demand, Biolyse can contribute to the global scale-up of vaccine manufacturing capacity.
Biolyse wants to manufacture and export a generic version of the Johnson & Johnson (“J&J”) adenovirus vaccine to developing countries. Biolyse had sought a license from J&J that was rejected. Since then, Biolyse has submitted a new request that also raises the issue of requesting a compulsory license if a voluntary license is not available.
Biolyse will be trying to obtain the compulsory license through the Canadian Access to Medicines Regime (CAMR). The Canadian Commissioner of Patents can provide a compulsory license to manufacture and export the adenovirus vaccine, but the process has several requirements. As a first step, Biolyse has to demonstrate it has sought a voluntary license from J&J, and this was done in a March 5, 2021 letter.
The compulsory license application process under CAMR largely entails two substantive parts.
The first is fulfilling a number of prescribed forms, the requirements of which are set out in Section 21.04 of the Patent Act. The information needed in the application includes the name of the pharmaceutical product, quantity to be manufactured, patents which protect the products, the name of the importing country and the identity of the purchaser. Additionally, the applicant must provide a copy of the notification that the importing country provided to the WTO or the Government of Canada. However, while the informational requirements are manageable, the process is rife with unanswered questions and dead ends. For example, on the CAMR contact website, they provide two phone numbers. The first number provided is invalid and out of service and when calling and leaving a message for the second number, there was no response. Additionally, the compulsory license application forms are not readily available. Applicants are directed to call the Canadian Intellectual Property Office (CIPO) to gain access to the forms. Yet the only contact numbers provided are general CIPO phone numbers, there is no specific compulsory license contact number, enquiry form, or CIPO webpage.
The second requirement is amending Schedule 1 of the Patent Act. An authorisation for a compulsory license under CAMR can only be granted if the pharmaceutical product in question is included on the list of approved pharmaceutical products for export. Schedule 1 may be amended by Order-in-Council with the recommendation of the Minister of Industry and the Minister of Health. However, the process to set in motion an order to amend Schedule 1 is not transparent. It states on the CAMR website that “[a]s of April 2006, an advisory committee was being established and a website will be created”. The purpose of this advisory committee is to advise the Ministry of Health and Ministry of Industry on their recommendations to the Governor in Council with respect to amending Schedule 1. Additionally, in the Report on the Statutory Review of Section 21.01 to 21.19 of the Patent Act – Canada’s Access to Medicines Regime, published in 2007, it specifies that in order for amendments to take place in an “informed and transparent manner, CAMR calls upon the Ministers of industry and Health to establish an expert committee by May of 2008, to advice them on what drugs should be eligible for export under the regime”. Thirteen years later, there is still no website and no existing advisory committee to ensure that amendments to Schedule 1 are made in an informed and transparent manner.
These requirements and Biolyse’s attempts have shown that the compulsory license application process under CAMR is complicated and challenging. Biolyse’s effort to obtain a compulsory license will test the actual intentions of the Canadian Government to scale-up production of COVID-19 vaccines and to permit export of pharmaceutical products under a compulsory license to developing or least-developed countries to address unmet needs.