Project title: The Implications of Industry 4.0 in Patent Law: a Case Study on Pharma

Researcher: Francesca Mazzi

Francesca Mazzi (Assisi 04-10-1990) completed her master degree in law in 2014 at Luiss Guido Carli University of Rome with a thesis in Private Comparative Law about Round Trip Investments in China. During her studies, she had traineeship experiences in law firms based in London and Beijing. After graduation, she volunteered in India and she worked for a private firm in the field of fashion and international business.

In 2016 she attended an LLM in Computer and Communications Law at Queen Mary University of London, specializing in Data Protection, Information Security, E-commerce law and Intellectual Property and the creative industries, with a final dissertation about the lack of copyright protection for non-human generated works in the US.

Francesca speaks Italian, English and Spanish.


Host Institution: Queen Mary University of London; Degree Partner: Maastricht University


The 4th industrial revolution is bringing radical change with the automation of tasks not only physical but also intellectual, previously only performable by human beings. The increasing automation of tasks involves, amongst others, inventive activities. Indeed, 4th industrial revolution technologies already have, and will increasingly have, a determinant role in those activities that can lead to inventions.
The patent system has proven to be adaptable to technological advancement in the past. Nonetheless, the revolutionary scope of automation, the rapidity of technological growth and the unpredictability of its result are likely to challenge practically and theoretically fundamentals of patent law.
Therefore, the present thesis seeks to investigate the crucial disharmonies between the patent system and the engagement of 4th industrial revolution technologies for the production of potentially patentable outcomes ( “4th ir generated inventions”). For this purpose, the pharma sector will be evaluated as case study due to the significance of the sector, the ever-growing role in inventive activities therein and the peculiar market competition in relation to R&D investments.
The research will investigate whether 4th ir generated inventions are theoretically compatible with the rationale of the patent system. Specifically, the research will consider certain identified essential requirements that are likely to be challenged, namely inventorship, inventive step, ownership, novelty.

The research questions will be answered with a doctrinal methodology, via analysis of statutory provisions and line of cases, through arguments by analogy, analysis of wording and legal history as a means of understanding, criticizing and assessing the state of the law. Additionally, comparative analysis (with a specific focus on US, UK and the EPO) and empirical research methods will be engaged.
The secondments at Hovione and EFPIA allow the researcher to engage in empirical qualitative research, having access to data and contacts that will contribute to the robustness of the findings of the thesis.

Expected Results:

The aim of the thesis is to evaluate the efficiency of the role that IP rights play in the pharmaceutical sector, as a means to incentivise the creation, the introduction and the dissemination of new products in the relevant markets; and to make recommendations to policy makers regarding the eventual need of adaptation of the regulatory framework in order to meet current challenges, specifically the challenges posed by the 4th industrial revolution.

Hence, ESR6 is aimed at evaluating whether the patent system is equipped to continue promoting quality and innovation in the pharmaceutical sector in light of the technological advancement. Therefore, the identified research questions will provide not only an overview of the challenges posed to the patent system by the engagement of 4th industrial revolution technologies In inventive activities from a legal perspective, but also recommendations in terms of potential measures to implement from a policy perspective.

Planned secondment(s): EFPIA, and Hovione


Prof.Dr. Meir Pugatch

Prof.Dr. Meir Pugatch