Vaccine patent rights - a scapegoat for inequality?

The uneven distribution of vaccines has emerged as a vital problem hindering the treatment of covid-19 worldwide. While some developed countries have been able to provide citizens with multiple dosages, many less developed or developing countries are struggling to provide even initial doses. According to Our World in Data, 59.2% of the world’s population has received at least one dose of a covid-19 vaccine, but as of 11 January 2022, this is the case for only 8.9% of people in low-income countries.

While the reasons behind this undesirable situation remain a subject of hot debate, how far IP rights have contributed to the situation has become a big talking point.

Removing barriers

With their communications to the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPs) of the World Trade Organisation (WTO) (submitted on 2 October 2020), India and South Africa proposed that members of the WTO should “work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19”.

India and South Africa’s proposal, which did not initially receive much support, has since gained a great deal of traction – particularly with the changing position of the Biden Administration. US trade representative Katherine Tai announced in an official statement on 5 May 2021 that the administration supports waiving IP protections for covid-19 vaccines.

TRIPs aims to reduce barriers and irregularities in international trade and to ensure that the procedures and measures regarding the implementation of IP rights do not constitute an obstacle, while determining the minimum standards to be followed by the member states. In this context, signatories undertake to respect and protect IP rights, including patent rights, among other obligations.

If a TRIPs member state does not protect IP rights in its own country and, for example, uses or makes use of patented technologies without the consent of the rightful owner, it may be accused of breaching its obligations. In the event of such a temporary waiver being decided, members will not be able to subsequently claim violations of the TRIPs obligations by other countries that temporarily waive IP rights.

Procedural challenges

On 9 June 2021, the WTO TRIPs Council agreed to begin text-based negotiations for a patent waiver on covid-19 vaccines and treatments, which is considered by some to be a milestone in enhancing global access to affordable vaccines. However, whether this alleged solution addresses the vaccine inequity problem remains highly controversial.

First and foremost, the virus continues to mutate very rapidly and it is unknown how much long-term protection vaccines provide, or will provide, against each mutation. Although scientists have taken a big step in developing vaccines, the need for innovation continues. Intellectual and industrial property rights holders should not be discouraged without making sure that the IP right waiver is indeed the ultimate solution to vaccine inequity.

It is a known fact that vaccine production is a complex process involving know-how, trade secrets and technical training. A major cause of vaccine shortage and inequity is the lack of raw materials, production capacity constraints and the extremely complex nature of the production of drugs. A typical vaccine manufacturing plant uses approximately 9,000 different materials sourced from 300 suppliers across 30 different countries, according to figures from the International Federation of Pharmaceutical Manufacturers and Associations. Besides raw material shortage, export prohibition and restrictions are still big issues. Arguably, therefore, rights waivers will not yield more supplies of vaccines as constraints are physical, rather than legal.

The scope of the waiver is also highly controversial from the perspective of patent rights. Although covid-19-related patent applications have been filed they have not yet been published, since publication takes place only after 18 months. As for current patents, the scope of a potential waiver still seems problematic and will not be limited to covid-19-related rights. The mRNA technology used in the BioNTech/Pfizer vaccine is protected by patents that have already been granted, and these technologies also have useful applications in in, for example, the treatment of cancer. If patents on vaccines are suspended, the knock-on effect could be devastating.

Another point raised is the number of patent rights in a single product. If a product has more than one patent right, this raises the crucial question of and which of them should be waived.

Further, the probability of a patent owner refraining from granting a licence seems to be quite low. The legal instruments to overcome this hurdle are included in both national law and Articles 30, 31 and 31bis of TRIPs.

While Article 30 regulates the general exemption provision to the patent right, Article 31 regulates the exemption foreseeing use of the invention by a third party or government without the consent of the patent owner. Article 31bis, on the other hand, paves the way for the compulsory licence application pertaining to the internal market that needs to be issued, to send to the necessary countries.

Looking ahead

All in all, patent protection is not the main obstacle to vaccine access. If all patents were abolished, would injustice be eliminated? The answer is hardly a clear-cut ‘yes’. It would be far more effective for patent owners to cooperate and provide each other with the necessary licences within the framework of contractual relations. In particular, international alliances such as COVAX should be supported, the rapid transfer of existing vaccine stocks should be facilitated and new international agreements should be concluded, if necessary.