Delays in the deliveries of the Astra Zeneca vaccine doses are raising doubts among the public (and among politicians) about whether vaccination plans laid out by governments can be met.

For these reasons, alternative solutions are being considered from many quarters, and recently in Italy the debate seems to have shifted to patents that protect vaccines, which are considered by many to be an obstacle to public health.

Indeed, patents – like other intellectual property rights – are nothing more than monopoly rights granted to their holder for a period of twenty years during which they may be exploited commercially.

As is well known, the scope of these ‘exclusive rights’ lies in the increased welfare of the community: by rewarding inventors for a limited period of time, the community achieves the dissemination of knowledge, which otherwise would be kept hidden as much as possible.

However, the global health emergency calls for reflection on whether exclusive patent rights can be circumvented by the need to obtain patent-protected vaccines very quickly.

In other words, we should ask ourselves whether, in this situation of absolute necessity – where the health of citizens is at stake – it is reasonable to persist in looking exclusively after the interests of the patent holder rather than those of the community.

Take, for example, the case of the well-known Astra Zeneca vaccine, for which the owner company was unable to secure production on time and in the quantities that were originally planned.

For such reasons, in Italy it has been suggested that companies equipped for this purpose could be granted the extraordinary right to produce this vaccine even if they do not hold the patents, obviously upon payment of a royalty in return.

This solution would allow for avoidance of possible failures by pharmaceutical companies, which would in any case receive financial compensation for their research and inventive activity.

More generally, the proposals made and discussed were as follows:

  1. require large multinational patent-holding companies to grant ‘compulsory licences‘ to companies that can produce vaccines of similar quality;
  2. suspend the efficacy of the patent, so that anyone can use the knowledge protected by it to produce vaccines until the health emergency continues;
  3. expropriate the holders of patents on vaccines by transforming them into state property, against payment of fair compensation.

Such proposals are supported by several legal bases, first of all the international treaty known as the “TRIPS Agreement”[1], which provides for the possibility for the adhering states to impose compulsory licenses for the manufacture and export of medicines to countries that do not have a sufficient production capacity of their own.

The difficulty in using this instrument lies in the fact that it was designed to provide support to developing countries that do not have the domestic resources to buy expensive foreign drugs (the case of the HIV drug in Africa is well known).

Its application appears more difficult in countries such as Italy, which is developing its own vaccine and has the resources to buy vaccines produced abroad.

On this point, mention should also be made of article 141 of the Italian Industrial Property Code[2], which provides for the power of the Italian State to expropriate or otherwise use patents or patent applications for reasons of public utility. The term ‘public utility’ indeed seems to include the current pandemic crisis.

If the hypothesis of expropriation of the patent seems disproportionate or in any case an excessive compression of the rights of the patent holder, the hypothesis of compulsory licenses granted in favour of third companies seems to us a reasonable and viable way to compensate for the various complications described above.

However, the practical – and therefore technical – aspect of producing vaccines against Covid 19 must also be taken into account. Indeed, there are different vaccine production methods and processes, which correspond to different measures of efficacy (for example, among the vaccines already approved by the competent authorities, Pfizer and Moderna guarantee 94-95 % efficacy, while Astra Zeneca guarantees 82.4 %)[3], as well as different abilities for providing coverage against Covid variants.

At the same time, vaccines are not the subject of a single patent, but of several interlinked patents that often belong to different parties. As a result, third-party companies would have to obtain compulsory licenses from a large number of owners, which would lead to greater organisational difficulties.

In addition, it is clear that the patents in question are based on complex, confidential know-how, which would have to be transferred and disclosed by the owners to the licensee companies as soon as possible so that the vaccine could be produced; this would, however, lead to longer production times and additional organisational difficulties.

In light of the above, the suggested and discussed route of compulsory licensing certainly seems feasible to solve the shortage and related delays in the delivery of vaccines but, in our opinion, there is a need for collaborative conduct between the owner companies and the licensees, rather than open conflict between them, all in order to safeguard the public health priority.

Moreover, the hypothesis being discussed would be immediately operational without the need for new legislative intervention, which often requires the convergence of political forces (often not easy to implement). This circumstance is certainly an incentive to be exploited in order to achieve a desirable result for the whole community within a short span of time.

[1] Articles 31 and 31bis of said Agreement, in its wording updated to the Protocol of 6 December 2005, which was enacted on 23 January 2017.
[2] Legislative Decree No 30 of 2005, as amended.