Studio Legale Stefanelli & Stefanelli

European Union July 27 2022

Technological progress leads to the development of the so-called “economy of knowledge”, based on the use of information to generate value. In recent years, we are in fact witnessing an increase in cultural and scientific products circulating within the national and EU market.

In this context, the relationship between the world of Open Science and the world of intellectual property comes into play.

The European Commission has been promoting a policy based on Open Science since 2015, defining it as “an approach to the scientific process that focuses on disseminating knowledge as soon as it becomes available, using digital and collaborative technology”. 

From a reading of this definition, it is clear how the field of open science contrasts with the field of intellectual property, where the aim is to provide means of protection exclusively to the author/inventor of the work.

We are thus faced with two different interests:

  • on one hand, that of the scientific community, to share research results as early and widely as possible;
  • on the other hand, that of industry, to control the dissemination of an invention, establishing how it is marketed in order to obtain protection and profit.

It is clear, therefore, the paradox that arises in the European and national scenario: the opposition to the right of access to knowledge, and the right to the protection of the moral and economic interests of the creator.

From an operational point of view, it frequently happens that publicly funded research carried out within research institutes or universities leads to the realization of an invention that will subsequently be patented and transferred to commercial enterprises that will economically exploit the “invention”.

This is especially the case in pharmaceuticals and medical devices where the exercise of Intellectual Property Rights (IPR) enables faster knowledge transfer and reduces delays in the re-use of scientific research results, thus facilitating a faster path from research to innovation.

The European Commission, in its Report of Study entitled Open Science and Intellectual Property Rights” published in April 2022, examined the important core principle of “as open as possible, as closed as necessary” concerning IPR.

In the view of the scientific community, scientific results should be as open as possible and only restricted, if necessary, also pointing out that “open science offers the necessary protection for sensitive data, information, sources and study subjects. Proportionate restrictions on access are justifiable on the basis of national security, confidentiality, privacy and respect for study subjects”.

Therefore, open science understood as public and accessible science, presupposes a compression of intellectual property rights, which will be undermined by damaging the commercial interests of entrepreneurs in the market.

But how is this perspective reconciled with the fundamental rights to health and safety?

The Italian panorama

The spread of the Covid-19 pandemic has accentuated the debate on the relationship between Open Science and intellectual property, especially concerning the commercialisation of vaccines and medical devices.

While it was feared that the existence of IPRs on vaccines would prevent public access to medicines, large pharmaceutical companies saw the presence of patents on vaccines as necessary incentives to invest in innovation.

What has happened in practice is that research institutes have been willing to patent vaccine types and subsequently sell their IPRs to pharmaceutical companies for commercialisation purposes, thus minimising the role of public funding on scientific research.

However, it is the Italian Ministry of Universities and Research (MUR) itself that, through the publication of the PNRR System Initiatives Guidelines, under Mission 4 “Education and Research” encourages universities and research institutes to practice technology transfer to companies through intellectual property.

Some considerations

Although points of the distance between open science and intellectual property seem to prevail, the European Commission in its Report of Study of 2022 pointed out that there are no incompatibilities between these two areas, assuming a role in promoting open science and its balance with IPR.

This, therefore, leads to the view that legislative intervention is needed in this regard, taking into account the relationship between public research and the market, by reviewing the system for evaluating and incentivising patents by public researchers. 

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