One year ago, the Wake Forest Journal of Business & Intellectual Property Law addressed the prospect of compulsory licensing under the Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement“). The TRIPS Agreement is an international treaty that came into effect in 1995 and sets out minimum standards of intellectual property (“IP”) protection each signatory country must uphold. Later that same year, on Oct. 2, 2020, India and South Africa proposed a waiver of the TRIPS Agreement (amended in May 2021). Since then, murmurings of IP waivers for vaccines have sparked a national debate whether the United States should continue to protect IP relating to the medical industry if the IP could be used to treat or prevent COVID-19, as Carli Berasi (JD ’23) discussed in her recent blog.
Contrary to the popular slogan of “people before patents,” the current proposal applies to patents, as well as copyright, industrial designs, and undisclosed information protections (such as trade secrets). In essence, all IP protections would be waived, allowing signatory countries to legally steal the IP of all health products and technologies to aid in the fight against COVID-19. This IP includes inventions relating to diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture.
The alleged reasoning for the TRIPS waiver is to decrease barriers to the access of the tools necessary to fight the COVID-19 pandemic. While this is an important and necessary goal, the current proposal is the equivalent of using a sledgehammer to try to push in a thumbtack. The waiver will not significantly decrease the number of COVID-19 cases, but instead will ravage the IP protections of the next generation of pharmaceuticals. Scientists did not pull a COVID-19 vaccine from a hat—the foundations of the technology behind mRNA vaccines have been underway since 2005 at the University of Pennsylvania and resulted in the touchstone Patent, US8278036, directed towards a “method of inducing a mammalian to produce a protein of interest.”
Another key to the development of mRNA vaccines was the lipid nano-particle delivery system jointly developed by the University of British Columbia and Protiva Biotherapeutics. In 2004, the joint venture filed U.S. Patent 7,901,708—a process for producing lipid vesicles encapsulating a nucleic acid. This and similar patents were later assigned in a venture between Arbutus Biopharma and the University of British Columbia to develop vaccines for hepatitis B and other RNA viruses. Another critical aspect to RNA vaccinations is the nano-particle delivery system used, such as the one described in the 2014 U.S. Patent 10,751,410, for the polymer encapsulation of SARS-CoV spike protein. However, mRNA and lipid nano-particle delivery has been explored to vaccinate against far more than coronaviruses. Applications of this technology extend to vaccines for the Ebola virus, HIV, Zika, and rabies.
It might be an understatement to say that the development of mRNA vaccines over the past two decades may prove to be some of the greatest scientific achievements in the field since Jenner created the smallpox vaccine in 1796. If the TRIPS agreement is waived, not only will the patents concerning COVID-19 mRNA vaccines be vulnerable, but the future development of these other life-saving vaccines concerning other diseases will be compromised since the same touchstone patents govern all vaccines. This would essentially allow any country to steal not just the COVID-19 vaccine but also the entire arsenal of mRNA vaccines.
In essence, when United States Trade Reprehensive Katherine Tai stated the government’s support of the “waiver of [ . . . ] protections for COVID-19 vaccines,” she was explaining that the scope of the wavier is far broader than just COVID-19 vaccines since the actual technology behind it applies to so many different applications. Additionally, the wavier proposals ignore a critical problem—simply having the rights to IP does not put one in a better position to fix immediate demand. Instead, it would only exasperate the situation. Even if a new pharmaceutical company in a signatory country were to use the mRNA vaccine technology without obtaining a license of the patent owner, many months of clinical trials would be required before the vaccine would be approved (depending on regulatory laws of the signatory country). Recall that in the United States, scientists at Moderna had developed and had begun clinical testing of a COVID-19 mRNA vaccine in March of 2020, only days after a state of emergency was declared under the Stafford Act. And one year assumes that the infrastructure is already there to produce mRNA vaccines like there were in the United States. In all likelihood, additional time would be needed to actually build new facilities, which are different than traditional vaccine production plants.
However, even if these counties were somehow able to access facilities immediately, forgo clinical trials, and were able to start production as soon as possible, the net effect would still be fewer available vaccines. This is because the greatest bottleneck to creating COVID mRNA vaccines is not the throughput of the reactors but rather the plastic bags and filters used in the process. Additionally, there is a shortage of qualified and skilled personnel who have the technical training to actually run the microcarrier bioreactors or the like used in the production process. If the goal is to provide vaccines at the fastest rate possible, countries should focus on supporting the production of the consumables such as the filters and plastic bags used in vaccine production.
The need for a waiver of all IP is even more ridiculous when one considers that under Article 31 of the TRIPS agreement, there is already a provision for compulsory licensing to allow a signatory country like India or South Africa to produce vaccines for their county without infringing on IP. Additionally, India has already licensed AstraZenica’s vaccine and manufactures it under the brand “Covidshield.” Furthermore, both India and South Africa are paying $8 and $5.25 per dose, respectively, which is far lower than the annual flu shot in the United States ($14). Moreover, the United States has already delivered over 110 million COVID-19 vaccine doses to 65 countries that need aid and has acquired over 500 million more doses to be delivered this fall. The notion that economically challenged nations will not be able to fight against COVID-19 without a complete IP waiver is entirely baseless.
However, the continued pressure for a waiver of all IP makes more sense if viewed from the perspective that the primary purpose of the TRIPS IP waiver is not about fighting COVID-19, but rather is a battle against IP rights for the medical and pharmaceutical industries. Ron Klain, President Biden’s chief of staff, candidly said in an interview, “[i]ntellectual property rights is [sic] part of the problem” in the fight against COVID-19.
While there are no advantages to India’s and South Africa’s proposal, the European Union’s proposal to strike down export barriers is quite sensible and would get vaccines to more people. Efforts to strip IP rights away will not protect people, but will instead defund the only industries that can create the life-saving cures. Whatever the solution, the ultimate test should be: what approach will actually help people? Quite frankly, the current proposal does not satisfy that test.
Benjamin Suslavich is a second-year law student at Wake Forest University School of Law. He is a certified Chemical Engineer EIT and holds a Masters of Science in Metallurgical and Process Engineering.