By Lavinia Meliti*
The creation of the Covid-19 vaccine has been one of the key challenges in the battle against the pandemic. The urgency in responding to this global health crisis has called for extraordinary efforts worldwide to tackle the pandemic as quickly and possible.
In response to the pressing need for more global supply and given the huge surges in number of cases and deaths, the World Trade Organization has worked hard to ensure that the protection of intellectual property (e.g., patents) rights did not create barriers to the access of affordable medical products, including vaccines.
Nonetheless, the outbreak has led to a swift increase in global demand, and the proposal to suspend intellectual property rights on Covid-19 vaccines has been welcomed widely, but not without criticisms.[1]
Critics of the waiver proposal firmly believe that in the vaccines’ development, patents play a key role as means to enhance innovation.[2] Following this line of thought, patent rights are justifiable because without such patents new medicines would not be created, as there would be a lack of incentive to invest in their creation. Thus, while considering the patentability of the Covid-19 vaccine, it is crucial to determine whether the existence of such patent protection will incentivize its research and development or, rather, negatively impact the ability of developing states to procure the resources required for their population.
Many have expressed concerns about patenting the Covid-19 vaccine as patents may grant a temporary monopoly to the patent holder, thereby preventing generic market entry. In other words, that “[t]he immediate impact of intellectual property protection is to benefit financially those who have knowledge and inventive power, and to increase the costs of access to those without.”[3] The other side, however, believes that creating the optimal conditions for innovation in vaccines is one of the most important roles the law may undertake in this battle.
Patents provide a right in knowledge generated by way of an invention.[4] What a patent substantially does is to prevent knowledge from becoming a public good, since there is no control over its dissemination.[5] In other words, the patentee has the right to exclude others from utilizing the knowledge, for the life of the patent.[6]
In the pharmaceutical field, however, excluding the public from such knowledge may be controversial. As Kevin Outterson has noted on this point: “[t]he goal of IP laws should be to maximize nonrival access to pharmaceutical knowledge . . . [and] [s]ince pharmaceutical knowledge is non-rival, it should be disseminated in the widest possible fashion at the lowest possible cost for the greatest possible benefit to global public health.”[7]
The whole point of patenting an idea is protection against imitators. Some may claim that if imitators deprive the inventor of all his advantages by selling at a lower price, potential investors would not fund the development of innovator products, and it would not be possible to recoup the initial investment.[8] Thus, this would lead to stagnation in research and development, which would ultimately halt the progress of modern medicine.[9]
There is a very little risk, however, that imitators may “copy” the vaccine and sell it at a lower price in a world where price barriers and technological knowhow needed to utilize the knowledge are inaccessible. Even if a patent for the vaccine did not exist, it would be very difficult for imitators to produce it in absence of resources.[10] Thus, liberalizing patents does not guarantee that good quality vaccines get into the arms of those who need them.[11]
There is a huge need of global solidarity, before vaccine nationalism[12]; global sharing of technology, before competition. Hopefully, this will stop the pandemic in its tracks, and it will reverse the trend of its consequential global distress.
[1] Council for Trade-Related Aspects of Intellectual Prop. Rights, WTO Doc. IP/C/W/669 (Oct. 2, 2020).
[2] Qiwei C. Xue & Lisa L. Ouellette, Innovation Policy and The Market for Vaccines, J. Law & the Biosciences, Vol. 7, Issue 1 (Jan-Jun 2020).
[3] Comm’n on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy 7 (2002).
[4] Mark Eccleston-Turner, The Economic Theory of Patent Protection and Pandemic Influenza Vaccines: Do Patents Really Incentivize Innovation in The Field?, Am. Journal of Law & Medicine, 572, 576 (2016).
[5] Id.
[6] Id.
[7] Kevin Outterson, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets, 5 Yale J. Health Pol’y L. & Ethics 193, 217 (2005).
[8] Dominique Guellec & Bruno Van Pottelsberghe, The Economics of the European Patent System: IP Policy for Innovation and Competition, J. of Intell. Cap., 49, 50 (Apr. 2008).
[9] See supra note 4 at 578.
[10] See Simon D. Roger & Ashraf Mikhail, Biosimilars: Opportunity or Cause for Concern?, 10 J. Pharmacology & Pharmaceutical Sci. 405, 406 (2007).
[11] Gareth Iacobucci, Covid-19: How Will a Waiver on Vaccine Patents Affect Global Supply?, The Bmj (May 10, 2021), https://www.bmj.com/content/373/bmj.n1182 .
[12] Protecting Lower-Income Countries with Covid-19 Vaccines Require Global Solidarity, UN Chronicle, United Nations, https://www.un.org/en/un-chronicle/protecting%20lower-income%20countries%20with%20covid-19%20vaccines%20requires%20global%20solidarity .
*Lavinia Meliti is General Counsel and Corporate Development Officer at IPwe, Inc., a tech start-up disrupting the field of Intellectual Property through the escalating integration of AI and Blockchain technology. She oversees all legal matters including IP, M&A, and Compliance, while helping in streamlining business development and strategic partnerships.
Fluent in English, Italian, and Spanish, Lavinia holds a double Juris Doctor degree from Nova Southeastern University, an