Winter is coming, and while this chilly season should feel like a jolly period filled with holiday fun, such feelings are not as apparent for 2020, with COVID-19 lurking among us. Paired with decreasing temperatures of the Canadian climate, the number of cases for the novel COVID-19 virus across Canada has risen at a pace exponentially faster than ever before. Such a rise in case numbers has resulted in the re-implementation of public health restrictions and increased demand for the availability of a vaccine. However, the implications of COVID-19 vaccine manufacturing may not be as simple as many believe, given that patent protection and enforcement serve as prime objectives for biotech manufacturers.
Legislative Encouragement for Small Entities
The Federal government has recognized the ongoing legal clash between new innovators and smaller generic manufacturers. It has since passed legislation such as the Patent Act and its corresponding Patented Medicines (Notice of Compliance) Regulations to assist judicial decision-making on patent infringement cases. While applications for patents for COVID-19 vaccinations would undoubtedly have to be in accordance with federal legislation, it seems that the federal government and the Canadian Intellectual Property Office (CIPO) is encouraging the submission of applications from small entities.
This summer, the CIPO launched a pilot program seeking to accelerate examining Canadian patent applications related to COVID-19 relief from small entities, i.e. a university or business employing 50 or fewer employees. With that said, the accelerated examinations of smaller entities' applications results in the risk of having a more significant number of submissions that infringe upon the patents of monopoly biotech manufacturers.
War or Co-operation?
Given the multitude of COVID-19 vaccine candidates, from both large and small entities, the question of whether leading biotech companies will enforce their patents and intellectual property rights persists. Beyond a vaccine produced by large biotech manufacturers, there may be separate COVID-19 vaccines in development that utilize large companies' patented technologies.
Nonetheless, it seems that at least some companies may be leaning towards a more passive enforcement strategy. For example, in October, one of America's leading messenger RNA vaccine (mRNA) developers named Moderna, provided a statement claiming that it would not enforce its COVID-19 related vaccine patents against other 'competitors' making vaccines intended to combat the pandemic. The company also claimed that they would be willing to license its intellectual property for COVID-19 vaccines to others after the pandemic as well. Although the statement also contains a blunt disclaimer stating that Moderna does not guarantee these promises, it is interesting to see more co-operative efforts being put forward in the realm of IP.
Criticism and Room for Future Collaboration
Moderna has since been the only biotech company manufacturing a vaccine to pledge to share its COVID-19 patents openly with others, and critics believe that such a model is one that others should follow. However, a great deal of competition lies in the world of IP. While collaboration may seem the most feasible option to tackle a pandemic, sharing information can impede market share and company profitability and create tension among invested shareholders. As a result, we may not see many collaborative efforts to tackle COVID-19 like that of Pfizer and BioNTech in April 2020. That collective effort sought to advance multiple COVID-19 vaccine candidates through BioNTech's proprietary mRNA vaccine platforms paired with Pfizer's vaccine research expertise.
Still, one can envision that the rising number of cases paired with the onset of cold temperatures will serve as an incentive for future collaboration with both limits on patent enforcement and patent sharing.
Khristoff Browning is an IPilogue Editor and a JD candidate enrolled in his first year at Osgoode Hall Law School.