Technology transfer, that is, activities aimed at transferring knowledge from scientific research to productive and industrial sectors, is an essential element of innovation exploitation processes.
Technology transfer, namely activities aimed at transferring knowledge from scientific research to productive and industrial sectors, is an essential element of innovation exploitation processes. The presence of a proper research incentive system enables a more significant commercial utilization of research and development results.
A virtuous example is represented by the United States, where since the 1980s the so-called Bayh-Dole Act has been introduced, transferring control over the economic exploitation of inventions deriving from privately funded research to universities and research-financing companies. In the United States, therefore, it is possible to grant structured entities the rights to exploit innovations born in the university environment, thus facilitating osmosis between the research and productive worlds.
Thanks to the Bayh-Dole Act, the United States has created the most efficient technology transfer system in the world: it is estimated that the contribution of technology transfer to the U.S. gross domestic product in the 1997-2017 period was nearly $900 billion, generating over 6 million jobs. Focusing on the Life Sciences sector, during the same period, numerous vaccines and new drugs have been created in the United States thanks to technology transfer and partnership systems between the public and private sectors.
In Italy (and in other European countries), the situation is not equally rosy.
Italy is a country with an excellent system of basic research in many sectors, especially in the Life Sciences field. For instance, Italy ranks among the top countries for the number of high-quality scientific publications, ranking seventh in the lists (eighth for the most cited articles), according to the report “Dynamics of scientific production in the world” published by Hcéres, the French high authority for the evaluation of research and higher education. Similarly, Italy confirms itself as an industrial-oriented country with a strong propensity for technological innovation, ranking eleventh in the world for patent filings in 2023.
If we consider only the Life Sciences sector, over 600 new startups were born between 2021 and 2023, with over 2 billion euros in investments. The area of greatest growth is that of biotechnology, followed by Med Tech, Digital Health, and services in the Life Sciences field. Moreover, this is a sector destined to intercept a significant portion of Italy’s resources from the National Recovery and Resilience Plan (PNNR), with the possibility of attracting additional resources from Mission 4 of the PNRR, dedicated to technology transfer, which has a budget of 2.4 billion euros. Today, more than ever before, financial resources are available to transform the national heritage of scientific and technical knowledge into economic value for the entire country, and technology transfer is an effective tool for doing so.
And yet, as of today, the “Italian” numbers in technology transfer are limited. According to data published in a recent study, around 150 spin-off companies were established in 2018 from universities and research centers, employing approximately 400 staff in their Technology Transfer Offices (“TTO”). In short, we are light-years away from the United States.
Part of the explanation is linked to the rules on the ownership of rights derived from research activities in the university setting. Until recently, Italy applied the so-called “professor privilege,” which granted university researchers the rights to industrial property related to patentable inventions obtained within research activities. According to a widely shared assessment, this regulatory framework has hindered the development of virtuous models of technology transfer in our country, penalizing sectors such as life sciences, which would have significantly benefited from an ecosystem favoring technology transfer. There have been numerous calls for reform of this legislation.
Well, perhaps today we are there.
With Law No. 102/2023, significant changes have indeed been introduced to the Industrial Property Code (“c.p.i.”), revolutionizing the ownership regime of inventions obtained in the context of university research, also thanks to the abolition of the “professor’s privilege.”
The current formulation of Article 65 of the Industrial Property Code (IPC) recognizes universities and research institutions as the holders of rights relating to inventions devised by researchers, provided that the findings have been made within the scope of an employment relationship, including temporary employment, with the university. The structures covered by this provision include universities, even non-state ones, legally recognized research institutions, scientific research and care institutes (“IRCCS”), and organizations conducting research and promoting technical-scientific activities without profit or under agreement among the same subjects. Article 65 IPC has therefore been aligned with what is established – for the private sector – by Article 64 IPC, which, under certain conditions, grants the employer rights regarding inventions made by employees within the scope of employment.
Article 65 IPC also introduced a specific mechanism to follow for the filing of patent applications for inventions obtained by researchers, who are required to promptly communicate the invention to the university or research institution. Within 6 months of the communication, the institution must proceed with the filing of the patent application or inform the inventor that it does not intend to proceed. The researcher’s ability to file the patent application in their own name has thus become a residual option. In any case, the researcher is entitled to all moral rights relating to the invention, including the right to be recognized as the inventor.
Regarding the remuneration due to the researcher, Article 65 IPC assigns to universities, public research institutions, and IRCCS the task of regulating relationships with inventors and the incentives granted for inventive activity, as well as relationships with research funders from which patentable inventions arise. The internal regulations of universities and research institutions must also regulate any other aspect related to the valorization of inventions, as well as relationships with other subjects in research activities, such as students, and with any research funders.
The reform of Article 65 IPC is expected to eliminate the difficulties encountered in exploiting inventions related to the previous regulatory framework. In many cases, indeed, the researcher holding the rights to the discovery did not have the opportunity to protect and make the best use of the inventions resulting from research activity. The new rules should make the transfer of new technologies to the production system more efficient and faster. As rights holders, universities and research institutions will be able to approach markets on par with private companies and invest in innovations promising significant results.
Specific regulations have been provided for research funded by private entities. In particular, according to Article 65 IPC, the rights to inventions derived from research activities funded, wholly or partially, by third parties will be governed by contracts to be drawn up based on guidelines prepared by the Ministry of Enterprises and “Made in Italy” with the Ministry of University and Research (the “Guidelines”), adopted by Interministerial Decree of September 26, 2023.
The Guidelines have established general principles and guidelines aimed at directing entities and funding entities, focusing primarily on the ownership of rights to findings generated by research and the exploitation of results, while also emphasizing the importance of defining the regime of confidentiality to which information derived from research must be subject. In particular, the Guidelines have identified three types of contracts that can intervene in the relationship between research institutions and funders, namely service contracts, development activity contracts, and contracts for innovative research.
In the context of collaboration between funders and universities, agreements included in the latter category are of primary relevance, characterized by a strong inclination toward innovation. The results of activities provided for in these agreements should be patentable, and the allocation of ownership of the respective rights must be adequately regulated by the contract. The Guidelines lean towards recognizing the original ownership of rights to the research institution, with the provision for the transfer of exploitation rights to the funding entity to best leverage the results.
Finally, according to the new article 65-bis of the Industrial Property Code, universities and institutions of higher artistic, musical, and dance education, public research institutions, and IRCCS can establish, within their autonomy, a technology transfer office aimed at promoting the valorization of industrial property rights. These offices must be staffed with personnel possessing professional qualifications suitable for the valorization of innovation and must interact with representatives of the industrial system to efficiently convey knowledge and findings obtained through research to businesses.
The reform of the ownership regime of researchers’ inventions aims to promote closer collaboration between the public and private sectors to enhance the development and exploitation of new technologies, also thanks to technology transfer. It is hoped that this will be an opportunity for renewed interest in research conducted at universities and the objectives to be achieved through such activities: universities and research facilities will have greater interest in determining projects aimed at practical purposes and obtaining innovative results. If adequately protected, such results can be effectively implemented and utilized in industrial contexts.
By improving the flow of rights from research institutions to entrepreneurial sectors through technology transfer and consequently enhancing the exploitation of inventions, organizations should thus derive a significant economic return, which should contribute to increasing research funding. On the other hand, businesses interested in innovation will be incentivized to invest in research, as they will ensure the opportunity to economically exploit the findings of activities they have financed through agreements contained in contracts with research institutions.
Article written by Roberto Valenti and Chiara D’Onofrio
Article translated from Sanità33
https://www.sanita33.it/digital/2681/la-riforma-del-codice-della-proprieta-industriale-nuove-opportunita-per-il-technology-transfer-in-ambito-life-sciences.html