The debate over Covid-19 vaccine patent waivers and licensing

According to the World Health Organization (WHO), all the world’s countries must reach a vaccination rate of at least 70% by mid-2022 in order to achieve an effective response to the coronavirus pandemic. With a number of countries calling for Covid-19 patent waivers, Marion Toanen, subject matter expert at Questel, explains what that means in practice. 

Although many countries have rolled out successful Covid-19 vaccine programs, the reality is that three quarters of vaccine doses are concentrated in rich countries, with a vaccination rate of just 13% for those in low income countries as of March 2022 (see graph below).  

Source: https://ourworldindata.org/coronavirus 

In order to remedy this situation, India and South Africa called on the World Trade Organization (WTO) for a patent waiver on coronavirus vaccines on October 15, 2020. This proposal was supported by a majority of WTO members, including the public support of US President Joe Biden (as of May 5, 2021). However, the rule of consensus prevails, with some countries remaining opposed to the project. What is clear is that the coronavirus pandemic has highlighted a discrepancy between the global public interest and current legal and financial incentives to produce and distribute vaccines equitably.  

What is a Covid-19 vaccine patent waiver – and will it help? 

A patent is a title which confers an exclusionary right on its holder, preventing anyone else from exploiting the invention, while being limited in time and space. At its expiry, the invention falls into the public domain and can be used freely. 

By definition, the patent is only valid for the national territory for which it has been approved. Thus, a patent granted by the French IP office (INPI), for example, will only have effect on French territory, whereas a European patent can be validated to have effect in the territory of the 38 member states of the European Patent Office (plus extension and validation countries).  

As each patent title is legally protected in the country where it applies, an infringement action, for example, will only apply in the state that granted the title. The waiver of patents would therefore similarly be subject to the spatial limits of the patent holder’s rights, with the consequence that it would be considered on a state-by-state basis according to the application of national law.  

Furthermore, the description contained in the Covid-19 vaccine patent application is intended to disclose the invention and to interpret the claims. Although the description details the technique for manufacturing the vaccine, it does not contain all the knowledge associated with the technique. This knowledge is characteristic of the skilled person in the art and could not be conferred by a patent waiver.  

In practice, therefore, a patent waiver could not attain global vaccine equity due to patents’ territorial nature and the sometimes inadequate description of the invention contained therein.  

More than a single Covid-19 vaccine patent 

The vaccines produced by AstraZeneca and Janssen are based on a non-replicating viral vector. This technique uses a safe virus as a vector, onto which a protein of the virus, against which immunity is sought, is grafted. This well-known technique is covered by patents that have, for the most part, fallen into the public domain.  

By contrast, the vaccines produced by Pfizer/BioNTech and Moderna use messenger RNA technology. This technique involves injecting laboratory-made messenger ribonucleic acid (mRNA) molecules. This RNA, encapsulated in lipid particles, instructs the cells to make a virus-specific protein, causing the immune system to react and produce antibodies. The RNA is then eliminated by the body within a few days. The mRNA technique is new and only mastered by certain laboratories. Unlike more traditional vaccine techniques, it remains subject to patent and is therefore directly targeted by the Covid-19 vaccine patent waiver movement.  

In this particular case, however, merely waiving the patent would be insufficient to enable the manufacture of mRNA vaccines. The use of this technology is dependent on numerous patents, not all of which are owned by the laboratory manufacturing the vaccine. In order to waive these patents, it is necessary to identify the different patents needed for vaccine development and to act on each of them. The sheer number of patents involved would make it excessively complex and burdensome. Moreover, as considered above, the description is not know-how, so a patent waiver would not necessarily equip third parties with the facilities and expertise to manufacture products of the same quality and efficacy as the patent holders’ vaccines.  

Business intelligence databases, such as Orbit Intelligence, can provide insight into existing patent data and scientific literature. 

What about Covid-19 vaccine patent licensing? 

Patent licensing can enable the circulation of innovations and inventions. A license allows a patent owner to lease it to a third party and that third party may then exploit the patent against payment of a royalty. The owner of a patent has the freedom to engage in licensing negotiations and to determine licensees. However, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) specifies certain exceptions.  

In short, TRIPS is an international legal agreement between all WTO member nations which sets minimum standards for the regulation of various forms of intellectual property (IP), to be applied to nationals of other WTO member nations. The TRIPS Agreement allows for compulsory licensing and government use of a patent without the authorization of the patent holder. All WTO members can grant such licenses and government use orders for health technologies, such as medicines, vaccines and diagnoses, as well as for any other product or technology needed to combat Covid-19.   

However, the use of these licenses is subject to numerous conditions. The duration and scope of the license must be limited and the remuneration of the owner must be negotiated on an equitable basis. In addition, the use of this type of license would require that the countries using it have sufficient production capacity and appropriately  qualified people, which is not always the case. Practically speaking, such licenses may be useful only in limited circumstances and would not necessarily ensure a domestic supply of high-quality vaccines within low income countries.  

The ethical debate for Covid-19 patent vaccines: Is there another solution? 

Among the various options for facilitating access to vaccines, the question of IP rights remains at the heart of the debate. Bringing a new therapeutic molecule to market requires a development period of about 10 years, at a very high cost. Consequently, it is licensing fees or commercial exploitation of a patent which make it possible to amortize investments and finance future innovations. The proceeds from any such exploitation constitutes an integral part of future-proofing laboratories’ missions. Looking beyond the present context of the coronavirus pandemic, waiving patents now may be a simplistic response to a complex problem.  

In response to the urgency and complexity of the situation, Covid-19 Vaccines Global Access (COVAX) has been set up, based on the principle of international solidarity. Through its financing mechanism, it allows low- and middle-income countries to access vaccines free of charge (see graph below). Another way to contribute to the COVAX system is to redistribute doses which have already been purchased, as France did on 23 April 2021 by allocating 105,600 doses of the AstraZeneca vaccine to Mauritania.  

Another solution, initiated by the company Moderna, has allowed the WHO’s African Vaccine Center to replicate its vaccine without risking prosecution. This has allowed the country to develop expertise and greater independence in the field of vaccination, with clinical trials against Covid-19 scheduled for November 2022.  

Two years into the pandemic, complex – yet fundamental– issues such as patent clearance and licensing remain unresolved. For now, the international community has found solutions based on international aid to support countries in need.  

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