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| Nik Khakhar |
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| Alyssia Sanchez |
One of the ways that this can be achieved is through compulsory licensing, despite its complexities. Presently, the Ontario-based pharmaceuticals company, Biolyse Pharma, is seeking approval from Canada to manufacture and export already approved vaccines to Bolivia under compulsory licensing. With a population of 11.67 million and staggeringly low vaccination rates, Bolivia is desperate to acquire vaccines in any capacity. Once equipped, Biolyse has the potential to roll out an estimated 50 million vaccine doses a year. Far from restricting their abilities, this case illustrates the potential that patent rights have to further encourage development in vulnerable nations.
From a resource perspective, patent waivers may in fact do more harm than good. Many trade groups, including the International Federation of Pharmaceutical Manufacturers and Associations, are strongly opposed to any decision to explicitly waive patent rights, since the waiver would worsen the existing strain on raw materials and ingredients required to manufacture the vaccine. The waiver would also be unable to provide an immediate solution to pandemic relief, as it would require at least several months to share technology and establish trained personnel and manufacturing capacities.
Retaining patent protections while encouraging free market collaborations ensures that supplies are not extinguished rapidly, and resources are shared across the world. Notably, there have already been efforts by current vaccine producers to increase their manufacturing capacities, such as Moderna’s speculated partnering with local generic drug companies in India such as the Tata Group. Rather than waiving patent rights, countries could remake government policies that may restrict the exportation of vaccines and related medical products and encourage partnerships among other companies to produce vaccines.
Reaching new licensing deals, however, has notable obstacles as well, including a lack of manufacturing personnel available to transfer to new partners. Acquiring skilled manufacturing personnel is paramount due to the relatively novel nature of the technology, such as the newer gene-based mRNA technology.
With that being said, it is necessary to acknowledge the need for ethics in vaccine-related collaborations. Vaccines are typically produced using raw materials from biological processes, such as yeast extract, enzymes and materials from animal origins. Inevitably, this will require pharmaceutical manufacturers to utilize resources from developing countries in order to produce vaccines that will combat life-threatening viruses such as COVID-19. It seems fitting to place a positive obligation on rights-holders to extend patent privileges to everyone involved in the development of vaccines, including developing countries where production has been outsourced. This ensures that contributing parties are rewarded for their role in vaccine development, which promotes subsequent vaccine development.
While critics of patent rights argue that vaccine-related patents may lead to the monopolization of life-saving technologies, patents could also encourage the environment of innovation necessary to combat this changing pandemic. Article 27.1 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement states that patentable inventions are novel, non-obvious and industrially applicable. The criterion of novelty provides a springboard for progress, as it only requires that the invention is different in some way from prior art. While Pfizer and Moderna have placed patents on their two-dose vaccine, companies such as Johnson & Johnson have introduced novelty by developing a one-dose solution. In the future, novelty could be sustained through the development of needle-free methods — one that could be consumed through a pill or syrup. The encouragement of novelty renders the ostensibly restrictive nature of patents to be, in fact, a push for further development of innovative technologies based on changing needs and new information related to COVID-19.
Vaccine producers are attempting to expand their manufacturing scales, likely in response to the patent waiver campaign. On May 3, Moderna announced that it would supply up to 500 million vaccine doses to COVID-19 Vaccines Global Access (COVAX ). Shortly afterwards, Pfizer and partner BioNTech SE followed suit claiming they would provide up to two billion vaccine doses within the following 18 months. This demonstrates that intellectual property drives fair and equitably driven competition rather than unjustly monopolizing industries.
In the face of the COVID-19 pandemic, numerous examples highlight the value of socially responsible corporate practices, including the sharing of patents, independent of a formal waiver. In 2020, a biotechnology company, Medtronic, created a ventilator to help manage severe respiratory illness caused by COVID-19. Medtronic publicly disclosed all design specifications via its website, which allowed other well-equipped companies, such as Baylis Medical, to immediately step up and aid in expediting the manufacturing of these lifesaving ventilators. This was done through partnership with Ventilators for Canadians, which is a consortium of Canadian companies that are manufacturing ventilators for hospitals across Canada. While this instance does not involve vaccines, it reveals that industries are pushing to unify efforts in battling the pandemic.
Perhaps the most fundamental principle of patent law is its mandate concerning the advancement of human epistemology and the encouragement of knowledge-sharing. While patent waivers run the risk of undermining these important goals, the proposal developed by the coalition of countries and the World Health Organization reflects the need to reconceptualize our understanding of patent law. Rather than engendering absolute control, patent rights should be interpreted in a manner that includes corresponding obligations to ensure equitable access and development of vaccines. For example, encouraging existing patent-holders to provide financial support to developers around the world could allow the WTO to achieve its goals of international co-operation, in tandem with organizations such as COVAX. Moreover, ensuring that all countries that have a stake in vaccine development are appropriately compensated through accessible supply will play a role in minimizing the global impacts of COVID-19. Such measures balance the risk of excessive control, by ensuring that the push towards vaccines is not a race, but rather, a marketplace.
This is part two of a two-part series. Part one: On the morals of giants: Patent rights, waivers during COVID-19
Nik Khakhar is currently a summer legal intern at Baylis Medical, a Canadian medical device company. He will be entering his second year at the University of Toronto, Faculty of Law. His graduate research in sociolegal studies and undergraduate background in ethics, society and law inform his analysis on the ethical, societal and global implications of vaccine patent law. Alyssia Sanchez currently works as a junior intellectual property associate at Baylis Medical, as part of her co-op as a biomedical engineering student at the University of Guelph where she has recently completed her fourth year. Her research in biomedical technology informs her technical perspective when examining the nuances, challenges and potential of current industrial trends in the global vaccine trade.
Photo credit / Pict Rider ISTOCKPHOTO.COM
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