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The “Patent Waiver” story on Covid-19 vaccines

The “Patent Waiver” story on Covid-19 vaccines

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17 June 2021

At the beginning of June this year (2021), the European Parliament (EP) voted in favor- with a single vote margin - of negotiating with the World Trade Organisation (WTO) regarding a temporary waiver of rights afforded by COVID-19 vaccine patents. The idea is to make way for worldwide upscaling of vaccine production and access by avoiding the need to assess patent rights.

The decision was broadly announced in the international press as a victory for its supporters. However, if we read the resolution as finally adopted by the EP (Text adopted - Thursday, 10 June 2021), said resolution does not say much more about the waiver than the following: [the EP] “…calls for support for proactive, constructive and text-based negotiations for a temporary waiver of the WTO TRIPS Agreement, aiming to enhance global access to affordable COVID-19-related medical products and to address global production constraints and supply shortages."

In addition, the resolution goes on to state that [the EP] “...stresses that intellectual property protection is a key incentive for innovation and research across the globe; notes that such protection is the basis for voluntary licensing agreements and know-how transfer and is therefore an enabler of rather than a barrier to vaccine availability; cautions that under a paradigm of unenforceability for patents, companies would have to resort to secrecy or exclusivity to protect their innovations; underlines the threat that an indefinite TRIPS Agreement waiver would pose to research finance, in particular for researchers, investors, developers and clinical trials; emphasises that the protection of property rights, including intellectual property rights, is a constitutional obligation of the European Union and its Member States."

In contrast to the EP, the European Commission (EC) presented a more nuanced position, which identified the actual bottlenecks to the accessibility of Covid-19 vaccines, and stressed the importance of intellectual property and voluntary technology transfer for increasing vaccine availability (EU communication to the WTO general council), by stating the following: “Intellectual property is not and should not be an obstacle to equitable access to COVID-19 vaccines and therapeutics during the pandemic”. The EC further stresses that "Compulsory licences are a perfectly legitimate tool that governments may wish to use in the context of a pandemic if voluntary solutions are not available."

In other words, putting the blame on IP rights from “big pharma” for the insufficiently fast production and worldwide distribution of COVID-19 vaccines may sound politically appealing but it far from addresses the real causes.

In Belgium, two proposals of resolution were submitted to the Chambre (Kamer van Volksvertegenwoordigers) with similar content: “to guarantee the availability of and access to COVID-19 vaccine by waiving the patent rights on the vaccine” and  “to make the COVID-19 vaccine worldwide public property”. The outcome of these proposals remains unclear for now. The Federal Council for Intellectual Property (Raad Intellectuele Eigendom) as well as the Belgian group of AIPPI has advised strongly against these two proposals. 

In this respect, we would like to point your attention to a very interesting publication in Nature Biotechnology of May this year (A network analysis of COVID-19 mRNA vaccine patents | Nature Biotechnology), wherein the authors Mario Gaviria & Burcu Kilic analysed the network of IP rights on mRNA-based vaccines such as the ones from Pfizer/BioNtec and Moderna. They based their analysis amongst others on data of the US Securities and Exchange Commission (SEC) to map the web of license and collaboration agreements in connection with the mRNA vaccine technology. It is interesting to see how complex the IP situation is (cf. Figure 1 in the article). Even more interesting is that, unlike what many politicians may think, many of these IP rights are not owned by the “Big Pharma” but are owned by smaller Biotech companies and Research Institutes, often funded by public money. I wonder if they would be so happy to lose the contracts they have in place with “Big Pharma” which would be an inevitable (collateral) result of waiving the patent rights on COVID-19 vaccines.

As can also be read in the letter from the EC, limited manufacturing capacity, access to raw materials and other inputs are the main bottlenecks as regards the production of COVID-19 vaccines. India for example is one of the largest producers of vaccines but is limited in capacity because of shortages in supplies of raw materials due to import/export restrictions.

Considering that the WTO members may have very divergent views on the desired strength of the international IP regime, focusing on such less contentious and potentially more impactful solutions could be a more successful way forward.

At De Clercq & partners, we evidently believe in the importance of society-wide knowledge and appreciate the key role of intellectual property rights in supporting the continued viability and success of the innovation-based European economy, which benefits all citizens of Europe and beyond. Accordingly, while all avenues to defeat the Covid-19 pandemic across the world need to be discussed, we would caution against politically popular but likely ineffective solutions, such as a patent waiver, and indeed encourage the stakeholders to focus on solutions with real promise to deal with the bottlenecks to the vaccine availability as identified by the EC.

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