The impact of the reform of the Industrial Property Code on innovation in healthcare

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The reform of the Industrial Property Code is law.

On 24 July, the reform project was approved by Law No. 102/2023 published in the Official Gazette No. 184 of 8 August 2023; the measure will be in force since 23 August 2023.

The reform was envisaged in Mission 1 of the National Recovery and Resilience Plan.

Component 2 of Mission 1 (M1C2) is aimed at pursuing the digitisation, innovation and competitiveness of the production system. Two measures relating to industrial property are included in this policy area:

the reform of the industrial property system with the aim of
strengthen the industrial property protection system;
encourage the use and dissemination of industrial property, particularly by small and medium-sized companies;
facilitate access to and sharing of intangible assets, while ensuring a fair return on investment;
ensure stricter respect for industrial property;
strengthen Italy's role in European and international councils on industrial property
investment in industrial property in order to support the industrial property system and accompany its reform.

Some relevant aspects of the reform for innovation

Overturning the 'Professor's Privilege' mechanism

Article 3 amends Art. 65 of the Industrial Property Code (CPI) by providing that the rights arising from an industrial invention made in the performance or fulfilment of a contract, employment or employment relationship, even if for a fixed term, with a university, a public research organisation or a hospital and care institute of a scientific character (IRCCS), as well as within the framework of an agreement between the same subjects, belong to the structure to which the inventor belongs, unless the same structure has no interest, without prejudice to the right of the researcher to be recognised as the author. If the invention is achieved by more than one person, the rights arising from the invention belong to all the organisations involved in equal parts, unless otherwise agreed.

On the contrary, the previous text of Art. 65 of the CPI provided instead that when the employment relationship was with a university or a public administration whose institutional purposes include research, the researcher was the exclusive owner of the rights deriving from the patentable invention of which he was the author.

In procedural terms, the inventor must promptly notify the organisation to which he belongs of the subject matter of the invention, with the duty on both parties to safeguard its novelty. The organisation shall file the patent application or notify the inventor of the lack of interest in proceeding with it, within six months of receiving the communication.

Universities, public research institutes and IRCCSs, within the scope of their autonomy, must regulate their relations with inventors and the bonus associated with inventive activity, as well as their relations with the financiers of the research that produced the patentable inventions. It will therefore be a matter of drawing up clear internal regulations to protect the intellectual property rights of the organisation and the researchers/inventors and equally detailed agreements with possible funders, in order to establish from the outset, for example, who will own the economic exploitation rights or who will be responsible for applying for patent rights.

The objective pursued by the reform is to foster technology transfer processes from research to business.

Technology Transfer Offices

Article 4 of the reform law introduces into the ICC the discipline of Technology Transfer Offices, with the function of promoting the valorisation of industrial property titles, also through the promotion of collaborations with companies.

The new Art. 65-bis allows universities and institutions of higher artistic, musical and coreutical education, public research bodies or IRCCSs to set up, within the resources available under current legislation, also in associative form, a Technology Transfer Office with the scope of promoting the valorisation of industrial property rights, also through the promotion of collaborations with companies. The personnel in charge of this office must have appropriate professional qualifications for the performance of industrial property promotion activities.

The Technology Transfer Guidelines

The provisions of the CPI reform are coordinated with the Guidelines for System Initiatives of Mission 4: 'Education and Research', Component 2: 'From Research to Enterprise' of the PNRR, which concern precisely research and technology transfer in general - Guidelines for Initiatives of Mission 4: Education and Research Component 2: From Research to Enterprise issued by the MUR - and, in particular, innovation in the healthcare system - Guidelines for Initiatives of the Plan complementary to the National Recovery and Resilience Plan (Decree-Law no. 59/2021 issued by the MUR and the Ministry of Health.Law no. 59/2021) issued by the MUR and the Ministry of Health.

The guidelines on innovation in the healthcare system aim precisely at

to fund research programmes for the enhancement of enabling technologies in healthcare to improve diagnosis, monitoring, treatment including rehabilitation.
to create an 'Innovative Health Ecosystem' in order to set up clinical-transnational networks of excellence to strengthen national biomedical research, also creating a network of technology transfer centres.

The reform of IRCCSs

The ICC reform is also coordinated with the reform of the IRCCSs (Legislative Decree 200/2021), the core of which is precisely the issue of research, industrial property protection and technology transfer. The aim of the reform is to 'strengthen the role of the IRCCSs (...) in order to promote, as a priority, excellence in preclinical, clinical, translational and clinical-organisational research, as well as innovation and technology transfer...', establishing 'appropriate measures for the protection of industrial property and technology transfer'.", establishing "appropriate measures to guarantee the protection of the intellectual property of IRCCSs, also with regard to the technological transfer of research results, regulating the regime of incompatibilitỳ of civil servants with the technology transfer, spin-off and start-up phases, as well as the relationship with companies in the research sponsorship phase and in the choice of scientific and industrial partners for the development of patents held by the IRCCS to which they belong".

With the final approval of the reform of the Industrial Property Code, the framework designed by the legislator to foster innovation in healthcare is finally outlined.