Intellectual Property and COVID-19 

By Dr. Kevin E. Noonan, McDonnell Boehnen Hulbert & Berghoff LLP

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The current SARS-CoV-2 and the COVID pandemic is the greatest global health threat caused by a virus since the influenza pandemic of 1918 (and, before that, innumerable smallpox outbreaks throughout history). So far, the number of infections and deaths has not reached levels seen during the “Spanish flu” pandemic. However, modern travel and global trade (and new factors such as social media, whether for good or ill) have increased risks, and awareness of those risks, throughout the world.

The potential for intellectual property issues or disputes to inhibit development or distribution of COVID-19 vaccines or treatment have been voiced in certain quarters. A number of critics believe that IP issues or disputes could inhibit development or distribution of COVID vaccines or treatments.[1] Some have called for individuals or organizations that develop COVID-19 treatments, tests, vaccines, or technology to voluntarily (or under duress) refrain from asserting IP rights. For example, in spring 2020, several universities and companies in the high-tech sector proposed the “Open COVID Pledge,” to “make our intellectual property available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.”[2]

This pledge and other efforts to prevent IP protection for COVID technology failed to gain traction and the need for them and purported effectiveness were rebutted by several pharmaceutical industry executives, government leaders, and politicians who understand the cost and challenge entailed by drug development.[3] Indeed, those in favour of IP protection for COVID-19 vaccines, treatments, tests and technologies argued that IP protection laws should be strengthened to provide incentives for innovation and investment in products such as vaccines which are, by definition, unpredictable, risky, and expensive to develop. For example, Jan Fischer, former Prime Minister of the Czech Republic stated that, if a COVID-19 vaccine is produced, “robust IP laws” should be given some credit.[4]

More recently, the rationale has changed to be directed to access to current vaccines and COVID treatments. Most significantly, India and South Africa have proposed that the World Trade Organization (WTO) suspend the IP enforcement provisions of the GATT/TRIPS treaty for any IP related to COVID, including vaccines and treatments.[5] This proposal is not limited to patents but includes copyright and trade secrets. The impact of this proposal, if adopted, is much more threatening to development of effective vaccines and treatments. This is because, unlike patents which are published and which disclosed technologies are dedicated to the public when their term has expired, relaxing other IP protections will destroy the intellectual property rather than share it. The available evidence supports the conclusion that, even if there might be circumstances under which intellectual property negatively affects vaccine availability, suspending patent protection is not an effective answer because the rate-limiting step for COVID vaccine production (at least for the mRNA-based vaccines) involves proprietary machines and methods for making the vaccine that are, more than likely, not covered by patents and never will be.[6] And that raises the spectre of an even more dangerous attack on intellectual property. Because the technological circumstances involve trade secrets regarding formulation of vaccines are what can be the bottleneck in the process. But trade secrets are the type of property the rights to which cannot be suspended; disclosure destroys the secret and thus the property.

This “moveable feast” of policy rationales illustrates the political fact that the aim and goal of this and other proposals by India, South Africa, and other countries is to escape the TRIPS requirement for recognizing and enforcing IP protections, imposed as part of the requirements for WTO membership. When these facts are considered, the call by these governments (and others) should be understood for what it is: an attempt to use the pandemic to achieve a goal of status quo ante (prior to the establishment of the GATT/TRIPS/WTO global trade and patent regime), which was imposed upon these and other countries a generation ago. The COVID pandemic provides the humanitarian excuse for a solution that isn’t a solution but that resonates with uninformed (albeit generally well-meaning) politicians, humanitarians, and religious and non-governmental organizations. Recently the WTO announced general agreement for a version of the proposal that solves none of these concerns.[7]

Potential real solutions for the manufacturing, financing and distribution challenges

Much bigger barriers to widespread (if not universal) vaccination are the manufacturing, distribution, financing, and infrastructure required to support these efforts.[8] [9] But there are ways to achieve these valid goals without challenging IP that got us to the vaccines we now need to produce and distribute. More productive routes to achieving these solutions would be better focused on 1) open and resilient global supply chains; 2) further cooperation between industry players to ramp up production; 3) strengthened financing and sharing of vaccines for middle- and low-income countries; 4) continued regulatory approval of new vaccines; 5) improving the strength of healthcare systems in lower-middle- and low-income countries; 6) tackle the issue of vaccine hesitancy.

The motivations for such efforts need not rely exclusively on altruism. As has become evident, recently the virus has the capacity to mutate in ways that variants of unknown resistance to current vaccines can arise.  Vaccines may be less effective against these variants[10] and thus it is in everyone’s interest to extend vaccination globally (regardless of how daunting that challenge may be) to reduce the probability of such variants arising.

The efforts being applied globally to develop vaccines, treatments, and better tests and technology in response to COVID-19 have been impressive. We can hope that, ultimately, these efforts will prove to be successful. Intellectual property protection has a role to play in these efforts. Past experience and recent developments suggest that protecting IP for vaccines, therapies, and technologies to fight COVID-19 will have a positive impact, and advance the cause of eradicating, or at least treating, and preventing this disease. IP is part of the solution, not part of the problem.

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We invite you to join the discussion on social media using #IPinEUFTAs and bookmarking our Trade and IP Project webpage to capture all future updates.

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[1]      Koons, C. (2020) “The Vaccine Scramble is Also a Scramble for Patents: Intellectual property disputes throughout the drug supply chain could hold back a Covid-19 shot,” Bloomberg Business Week, August 12, 2020.

[2]     See https://opencovidpledge.org

[3]      For example, Pfizer CEO Albert Bourla called the pledge and similar proposals “nonsense” and “dangerous,” tantamount to saying “If you have a discovery, we are going to take your [intellectual property].” E. Silverman, “Pharma Leaders Shoot Down WHO Voluntary Pool for Patent Rights on Covid-19 Products,” statnews.com, May 28, 2020; Francis Gurry, former director general of the World Intellectual Property Organization (WIPO) stated that the main barriers to a vaccine were scientific and technical, that no vaccine has been identified, and that there was no evidence that IP protection was a barrier to vaccine development. F. Gurry, “Intellectual Property, Innovation, Access and COVID-19,” www.wipo.int/wipo_magazine, June 2020.

[4]      Fischer, J. (2020) “When Researchers Discover A COVID-19 Cure, Credit Should Go To Robust IP Laws, Says Former Czech PM,” International Business Times, Aug. 15, 2020.; leaders from the International Chamber of Commerce (ICC) also voiced support for strong IP protection, which, they noted, already protects the public from counterfeit and adulterated drugs and from stockpiling medicines in developing countries. ICC, “How Intellectual Property Can Strengthen Our Response to Climate Change and COVID-19,” Press Release, April 24, 2020.

[5]      Communication IP/C/W/669, “Waiver from certain provisions of the TRIPS agreement for the prevention, containment and treatment of COVID-19, 2 October 2020. URL: https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True

[6]      Lowe, D. (2021) “Myths of Vaccine Manufacturing,” Science Translational Medicine, February 2021. URL: https://blogs.sciencemag.org/pipeline/archives/2021/02/02/myths-of-vaccine-manufacturing

[7]    See, Noonan, K. (2021) The Proposed WTO IP Waiver: Just What Good Can It Do – An Analysis, Patent Docs weblog, March 25, 2022. URL: https://www.patentdocs.org/2022/03/the-proposed-wto-ip-waiver-just-what-good-can-it-do-an-analysis.html.

[8]      Callaway, E. (2020) “The unequal scramble for coronavirus vaccines – by the numbers,” Nature 584, 506-507 (2020).

[9]    Evenett, S. (2021) “Export Controls on COVID-19 Vaccines: Has the EU Opened Pandora’s Box?”, 31 January 2021.

[10]    Noonan, K. (2021) Do mRNA-based COVID Vaccines Have an Achilles Heel?, Patent Docs weblog, January 26, 2021. URL:  https://www.patentdocs.org/2021/01/do-mrna-based-covid-vaccines-have-an-achilles-heel.html