The case for a suspension of intellectual property rights

Pfizer-BioNTech is a two-shot mRNA vaccine to be given 21 days apart. (File photo)
Pfizer-BioNTech is a two-shot mRNA vaccine to be given 21 days apart. (File photo)


Covid vaccine production qualifies for an emergency provision granted by WTO rules

Last week Bill Gates got himself into a bit of a soup with a controversial comment. When asked, in an interview on Sky News, whether global intellectual property laws should be amended to allow the recipe for covid vaccines to be more widely distributed, he replied with a categorical “no". The bottleneck, according to him, was not intellectual property law, but manufacturing capabilities. “There are only so many vaccine factories in the world" he said, “and people are very serious about the safety of vaccines."

I admire Gates for many things—his success as a pioneer of the information technology industry, and the breadth and vision of his philanthropy. But I simply cannot wrap my head around his refusal to endorse the waiver of intellectual property rights that we need in order to increase the global production of covid vaccines.

Let us break down the facts.

Our global vaccine production capacity is about 3.5 billion doses a year. In order to cover even 70% of the global population, we need to increase that to 10 billion doses (most vaccines require 2 doses per person to be effective). There is no way to reach that number unless we radically expand our current manufacturing capacity.

Gates is against the sharing of intellectual property because covid vaccines (particularly the new mRNA ones) are particularly difficult to manufacture. Factories in developing countries, he argues, will not be able to produce the kind of pharmaceuticals that we need to safely inoculate the global population against the disease.

A recent Foreign Policy article, on the other hand, suggests that there are facilities in low- and middle-income countries that can easily be re-tooled to make mRNA vaccines. This view was echoed by a former director of chemistry at Moderna who went so far as to say that all that was needed was the blueprint and some technical assistance, and any modern factory would be able to get vaccine production going in three to four months. It appears that concerns about production capabilities are misplaced.

Which brings us back to intellectual property. All countries of the world that are members of the World Trade Organization (WTO) are bound by the Agreement on the Trade Related aspects of Intellectual Properties (TRIPs), and have to comply with its stipulations with regard to patents, copyrights and other intellectual property laws. The manufacture of covid vaccines are, for the most part, protected under patent law, with various ancillary but essential technologies protected under copyright, trade secret and industrial design regulations. Thanks to their obligations under the TRIPs agreement, nations that have the capabilities and are willing to invest in funding the re-tooling of existing factories are unable to contribute to the global demand for vaccine production because they need to first secure the right to manufacture vaccines from holders of the intellectual property rights over these recipes.

The TRIPs Agreement does permit countries to exercise special powers under extraordinary circumstances. All member countries have the right to opt for the compulsory licensing of intellectual property if they feel this is required in order to deal with a public health emergency. As useful as this option might seem, in the current circumstance, it will be of no practical benefit, considering that the production of mRNA vaccines also requires access to over 100 key components that are themselves manufactured across over a dozen countries. In addition, we will need access to various other non-chemical intellectual properties—such as algorithms, software and training materials —without which the vaccines cannot be usefully deployed.

Compulsorily licensing recipes from developers, therefore, would solve just one part of the problem. For this to be useful, we will need to negotiate arrangements with a multitude of entities which have collectively established a thicket of patents around all the information that would be required.

All this is further complicated by WTO restrictions on production-for-export. While countries can invoke compulsory licensing provisions for the manufacture of covid vaccines, they will need to source essential ingredients and supplies required from other countries where they are manufactured. Even if those countries, in turn, compulsorily license the technology for their manufacture to increase production, they cannot export those supplies because of the WTO rules on production-for-export.

What all this boils down to is this: Unless we can put in place a broad TRIPs waiver that will allow a swathe of countries to temporarily suspend the intellectual property restrictions that currently restrict the ramping up of vaccine manufacture, we will simply not be able to increase vaccine production to the levels that we need.

Last October, India and South Africa proposed exactly this to the Council of TRIPs at the WTO. Over 100 other countries joined in, expressing their support. However, due in large part to the strong opposition of the US and other European nations that are home to big pharmaceutical companies, nothing has come of the proposal so far.

As a technology lawyer who has been practising in the field for over a quarter of a century now, I understand, better than most, the importance of intellectual property for innovation. Yet, once in a while, there comes a time when we have to set aside commercial imperatives in the larger interests of all mankind. This is one such moment.

Rahul Matthan is a partner at Trilegal and also has a podcast by the name Ex Machina. His Twitter handle is @matthan

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