By: Heather Chang*
The healthcare industry, like others, relies on patent and trade secret law to protect sensitive and profitable information. More broadly, the industry is a prime example of the harm and inequity that can be caused by broad intellectual property (IP) protections. These protections negatively impact public welfare (in the United States and globally), as monopolies held by pharmaceutical companies “delayed entry of lower-cost generic drugs”1 and the “[c]ommodification of essential medicines, such as vaccines, pushes poorer countries into extreme debt and reproduces national inequalities that discriminate against marginalized groups.”2 In the context of COVID-19, where vaccines and COVID-related inventions qualify for patent protection, pharmaceutical companies may hold a 20-year, protected monopoly for their work,3 and where information constitutes a trade secret,4 this monopoly may theoretically last indefinitely.5 As a result of these IP protections, other companies and countries must bargain for and pay licensing fees for this information.
Recognizing the deeply inequitable and dangerous consequences of vast IP protections for COVID-19 vaccines on lower-income countries, in May of 2021 the Biden administration announced it would support waiving IP protections related to COVID-19 vaccines under the World Trade Organization’s Agreement on Trade-Related Intellectual Property Rights.6 While many of the details of the waiver are still in process, the current proposal allows for the use of “‘patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic.’”7 It further waives IP rights for “ingredients and processes necessary for COVID-19 vaccine manufacture, a move aimed at granting critical know-how to many countries lacking expertise, especially for advanced mRNA-type vaccines.”8
Opponents of emergency reform argue that it runs antithetical to patent and trade secret law and that reform will harm the overall public welfare. They argue that if IP rights are waived, researchers and “pharmaceutical companies will otherwise be disincentivized to innovate and invest in vaccine research and development.”9 That changing the system, which is designed to incentivize innovation by offering inventors exclusive IP rights in exchange for disclosure of their work, will result in a slowing or halting of healthcare innovation.
Proponents of emergency reform, however, argue that without government-mandated reform, vulnerable populations are thus forced to rely on corporations’ sense of philanthropy in order to gain equitable access to healthcare.10 Arguments in favor of reform parallel that of the AIDS epidemic––in Africa, hundreds of thousands of people died of AIDS “long after antiretroviral drugs were widely available in wealthy nations, because the patented medications were being sold at a price far too high for governments in the worst-affected countries to purchase.”11 Although the COVID-19 pandemic has improved within United States “most of the world isn’t so lucky. The virus is currently raging in India and throughout South America, overwhelming health care systems and inflicting suffering and loss on a horrific scale.”12 As of May 2021, long after COVID-19 vaccines were available in the U.S.,13 “[f]ewer than 1% of people in low-income countries received COVID-19 vaccines.”14
In the context of the COVID-19 pandemic, and from an equity and ethics perspective, it is unjust to deny equitable access to vaccines and healthcare research when facing a global health crisis, while allowing large pharmaceutical companies, who hold all of the bargaining power, to profit. This is especially true when considering the U.S.’s (and other Western Powers’) long history of exploiting lower-income countries, as related to healthcare research and drug trials.15
IP reform, however, must be tailored to balance equity concerns and inventors’ rights. Where reform is overly expansive, it may disincentivize innovation; but without it, corporations are entitled to exploit vulnerable populations for profit, even in emergency situations. An emergency suspension of IP rights, like the proposed COVID-19 waiver, appears to best balance these competing needs: although the waiver is unprecedented (and broadly waives IP rights), it is limited in scope (to the COVID-19 pandemic) and actively considers the dangers and inequities in allowing for expansive IP rights during a global health crisis. While the COVID-19 emergency policy would only be the first step in working towards future emergency IP reform, it would remove a major barrier to equitable access to healthcare and act as a basis for other forward-looking IP policies.
* J.D., University of Minnesota Law School Class of 2022, JLI Vol. 40 Editor-In-Chief
- Youn Jung & Soonman Kwon, The Effects of Intellectual Property Rights on Access to Medicines and Catastrophic Expenditure, 45 Int’l J Health Serv. 507, 507 (2015). ↵
- Sharifah Sekalala et al., Decolonising Human Rights: How Intellectual Property Laws Result in Unequal Access to the COVID-19 Vaccine, 6 BMJ Global Health (2021), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8277484/. ↵
- Patent Basics, LawShelf Educ. Media, https://lawshelf.com/videocoursesmoduleview/patent-basics-module-1-of-5 (last visited Mar. 12, 2022). ↵
- See 18 U.S.C. §§1831–1839. ↵
- Elizabeth A. Rowe & Sharon K. Sandeen, Trade Secret Law Cases and Materials 2 (3rd ed., 2020). ↵
- See Andrew Shalal & Emma Farge, U.S., EU, India, S. Africa Reach Compromise on COVID Vaccine IP Waiver Text, Reuters (Mar. 16, 2022), https://www.reuters.com/business/healthcare-pharmaceuticals/us-eu-india-s-africa-reach-tentative-pact-covid-vaccine-ip-waiver-sources-2022-03-15/. ↵
- Id. ↵
- Id. ↵
- Harvey Rubin & Nicholas Saidel, Innovation Beyond Patent Waivers: Achieving Global Vaccination Goals Through Public-Private Partnerships, Brookings (Aug. 31, 2021), https://www.brookings.edu/blog/up-front/2021/08/31/innovation-beyond-patent-waivers-achieving-global-vaccination-goals-through-public-private-partnerships/. ↵
- Moderna claims it will not enforce COVID-19 vaccine IP rights in several low-income countries. Krista Mahr, Moderna Says It Will ‘Never’ Enforce Covid-19 Vaccine Patents in Dozens of Low- and Middle-Income Countries, Politico (May 7, 2022), https://www.politico.com/news/2022/03/07/moderna-never-enforce-covid-vaccine-patents-low-income-countries-00014874. ↵
- Brink Lindsey, Why Intellectual Property and Pandemics Don’t Mix, Brookings (June 3, 2021), https://www.brookings.edu/blog/up-front/2021/06/03/why-intellectual-property-and-pandemics-dont-mix/. ↵
- Id. ↵
- FDA Approves First Covid-19 Vaccine, U.S. FDA, (Aug. 23, 2021), https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine. ↵
- Amy Maxmen, In Shock Move, US Backs Waiving Patents on COVID Vaccines, Nature (May 6, 2021), https://www.nature.com/articles/d41586-021-01224-3. ↵
- Susan Donaldson James, Syphilis Experiments Shock, but So Do Third World Drug Trials, ABC News (Aug. 30, 2011), https://abcnews.go.com/Health/guatemala-syphilis-experiments-shock-us-drug-trials-exploit/story?id=14414902; see Katrin Weigmann, The Ethics of Global Clinical Trials, 16 EMBO Reports 566, 566 (2015), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4428044/ (“In developing countries, participation in clinical trials is sometimes the only way to access medical treatment.”). ↵