The Intellectual Property Framework of the COVID-19 Vaccine Race

Ana Santos Rutschman, Saint Louis University

 

The COVID-19 pandemic drew renewed attention to the importance of vaccines for pandemic preparedness. While undeniably ground-breaking on multiple levels, the quick development and authorization of new vaccines also constitutes a reminder that the global vaccine innovation ecosystem is often dependent on expedited collaborations between players with complementary, yet distinct, agendas. In my work studying vaccine races, I have been focusing on the role of intellectual property – especially patents – in research and development (R&D) of new vaccines needed to help prevent or curb the spread of emerging pathogens.

 

The first question with legal and policy salience relates to rights over emerging technologies – which in the case of vaccines are also technologies likely to be welfare-enhancing. In the context of the COVID-19 vaccine race, we have observed the commercialization of a new type of vaccines (mRNA vaccines, like the ones made by Pfizer/BioNTech and Moderna) alongside the development of vaccines based on approaches that have been in use for decades (like the vaccines made by Sinopharm and Novavax). Irrespective of the type of vaccine technology, there is almost certainly one or more layers of intellectual property rights giving patent holders significant control over the commercialization of these vaccines – and, indirectly, over the allocation of goods that for a significant part of the pandemic are likely to be scarce.

 

The intellectual property landscape in itself is bound to be opaque for the duration of the pandemic. Several patent offices across the world publish patent applications 18 months after the filing (or earliest priority date). During COVID-19, some patent offices shared information rather quickly – for instance, the Chinese patent office published the first known application for a COVID-19 vaccine-related patent in June 2020, and granted the patent the following August. But this is not the norm, and it causes players in this field to operate against a backdrop of legal uncertainty – not to mention the fact that it opens the door to potential litigation for years to come.

 

Vaccines developed through reliance on new technology raise additional intellectual property “flags.” In the case of the COVID-19 mRNA vaccines, this new technology is not only very likely to be of use for the future development of vaccines targeting other pathogens, but also for other types of biomedical products, such as treatments for autoimmune diseases. In this sense, mRNA techniques are widely expected to function as platform technologies, which enable diverse uses by follow-on researchers. Intellectual property decisions being made now are thus likely to affect research on – and ultimately the production and commercialization of – health goods well beyond the realm of vaccines.

 

This veil of uncertainty is important because it adds to other problems posed by the commodification of health goods like vaccines. Protecting the development of vaccine technology through intellectual property rights is one of the ultimate embodiments of this commodification ethos: it drives companies to invest in vaccine R&D according to calculations that are largely driven by risk- and revenue-related considerations, rather than public health preparedness imperatives. And while the public sector plays a considerable role in both funding and performing vaccine research, we have historically always needed private-sector players to conduct late-stage and manufacture vaccines. Balancing the need to keep these commercially driven players interested in vaccine R&D with extra-commercial considerations is tricky – but necessary.

 

I do not mean to suggest that there should be no patents over these vaccines, or components thereof. First, given the present articulation of international laws (TRIPS article 27) with domestic or regional legal regimes, carving out a patent-free space for vaccines – even if it were just for pandemic vaccines – violates international intellectual property and country-level laws. Changing the current legal regime would require a long and politically fraught quasi-global negotiating process – which is not to say that the international community should not reassess whether patents are really doing their utilitarian, innovation-enhancing job in this area; but we certainty should be able to move towards a more balanced legal and innovation regime through more timely interventions.

 

The COVID-19 pandemic has proved a fertile ground for considering what some of these interventions might be. First, Costa Rica and a few other countries prompted the World Health Organization to create a patent pool for the cross-licensure of patent-protected health technologies. In response, the COVID-19 Technology Pool was launched in May 2020. Second, a group of law professors and lawyers launched the Open COVID Pledge, a structure that allows patent owners to adopt binding licenses promising not to enforce their patents during the pandemic – thereby lessening both the fenced-in nature of patented technologies and the uncertainty as to the legal status of a particular technology. These developments highlight how it is possible to infuse proprietary frameworks – our patent-centric health innovation system – with less commercially driven motivations.

 

The drawbacks of both patent pools and pledges relate to the fact that they depend almost entirely on voluntary gestures of the patent holders. Additionally, most of the medical technologies made available under pool and pledge models during the COVID-19 pandemic were not related to vaccines. This once again points to how poorly vaccines fare under the current dynamics of vaccine R&D. We do not invest nearly enough in vaccine R&D targeting emerging pathogens before an outbreak occurs – but should one occur, we tend to subject vaccine development to the rules that apply to the development of other types of goods, even if these goods obey very different economic models or are of lesser importance from a public health perspective.

 

It is possible to build on the success of mechanisms that mitigate the siloed nature of intellectual property in areas other than vaccines during the COVID-19 pandemic – and hopefully to import some measure of that success to the field of vaccines. In the post-outbreak, as we reassess preparedness mechanisms, the intellectual property of vaccines should at a minimum be one of the topics of discussion. And perhaps policymakers should consider the formation of vaccine-specific patent pools before another large outbreak occurs. Likewise, they may wish to put proposals on the table to nudge companies to pledge or pre-license some of their vaccine technology – perhaps more established forms of technology – in advance of an outbreak, rather than engaging in these efforts during pandemics and epidemics. I proposed a similar vaccine-specific model in the aftermath of the Ebola and Zika outbreaks a few years ago. In the meantime, the COVID-19 vaccine race is poised to have a long intellectual property arm – one that should be discussed more often outside academia and activism arenas, as it has a substantial impact on the availability, types and costs of health goods we will need to prepare for, and respond to, future pandemics and epidemics.

 

Ana Santos Rutschman is an assisnt professor at the Center for Health Law Studies, Saint Louis University School of Law & Institute for Vaccine Science and Policy, Saint Louis University.

 

Suggested citation: Ana Santos Rutschman, ‘The Intellectual Property Framework of the COVID-19 Vaccine Race’ COVID-19 Law and Human Rights Observatory (23 March 2021) https://tcdlaw.blogspot.com/2021/03/the-intellectual-property-framework-of.html