The inauguration was entrusted to Giorgio Racagni, Full Professor of Pharmacology at the University of Milan and Scientific Director of ITTBIOMED, who opened the proceedings by introducing a series of high-profile interventions. Among the speakers from DLA Piper were Gualtiero Dragotti and Roberto Valenti, both Partners, Chiara D’Onofrio, Trainee Lawyer, Massimo D’Andrea, Senior Lawyer, and Lauren Murdza, Technology and Corporate Transactional Partner. The event also saw the participation of Sergio Abrignani, Full Professor Department of Clinical and Community Sciences, University of Milan; Paola Bagnoli, Head of Technology Transfer Office, Galeazzi Hospital; Fabrizio Grillo, President of Federated Innovation @MIND; Onofrio Mastandrea, General Manager, Incyte; Francesco Mazza, Legal, Tax, Compliance, and Regional Regulation Director, Farmindustria; Tiziana Mele, Managing Director, Lundbeck Italy; Marica Nobile, Director of Federchimica Assobiotec; Pierluigi Paracchi, Chief Executive Officer, Genenta; Riccardo Pietrabissa, Rector of the University Institute of Higher Studies of Pavia, and Diego Valazza, Business Development Director, Lendlease.

In the first intervention, Gualtiero Dragotti explored the evolution of rights related to inventions in Italy, highlighting the “transition from rights originally assigned to the inventor to the new regulations that attribute them to the research entity”, particularly for university inventions. “The regulatory revision of 2023 introduced significant changes, such as the requirement for researchers to notify the inventions to the entity for an evaluation of their protection and emphasis on the confidentiality of pre-patent research. Additionally, the legislation modernizes technology transfer, adapting it to market needs and establishing guidelines to balance scientific publication and confidentiality”.

On the other hand, Roberto Valenti focused on the importance of “protection of trade secrets in the life sciences sector”, highlighting that in some sectors “protection of trade secrets is crucial”. In particular, “Italy stands out in Europe for its advanced legislation on the matter, dating back to 2004, which considers trade secrets as an industrial property right. Despite the recognized importance of this protection, Valenti points out that companies do not always adopt the necessary measures to adequately protect commercial information. For example, in the pharmaceutical sector, where there is tension between the need to keep information confidential and the need to publish data to obtain authorization for the commercialization of drugs. The speaker also emphasized that, given the crucial importance of trade secrets for corporate protection, the adoption of effective protection tools is always advisable”.

Chiara D’Onofrio delved into the topic of technology transfer, describing it as “the set of activities aimed at developing, protecting, and commercializing technologies originated from universities and research institutions towards the private sector”. The goal is to “encourage public research and simultaneously improve the supply of goods and services in the private sector, with the two main contractual forms used for this purpose being research and development contracts and licensing agreements”. To promote intellectual property, she highlighted two possible main strategies: “open dissemination of knowledge and its valorization through the protection of intellectual property rights, often through licenses or the creation of spin-offs”. D’Onofrio emphasized the importance of “clearly defining agreements in research and development contracts and carefully managing the negotiation of tech transfer contracts, including due diligence to ensure ownership and protection of intellectual property. The complexity of licensing agreements, determination of fees, and the importance of warranty, indemnity, and non-contestability clauses for proper enforcement of rights were also discussed in depth”.

Massimo D’Andrea, on the other hand, examined the link between antitrust law and technology transfer agreements, emphasizing that the latter, “despite their positive potential on competition and efficiency, may sometimes contain clauses that restrict competition.” He highlighted the importance of evaluating these clauses through the antitrust lens, referring to European Commission Regulation No. 316/2014, which provides an exception to competition restrictions for certain agreements, under specific conditions related to market shares and absence of severe restrictions. He also discussed research and development agreements, “also subject to antitrust evaluation, citing a specific regulation that governs their exemption from antitrust rules, emphasizing the need for detailed analysis to ensure compliance with competition laws, also in light of additional regulations relevant to the competitive relationship between the involved parties”.

Lauren Murdza wanted to examine the Bayh-Dole Act, a US federal law from the 1980s aimed at creating a uniform patent policy for research funded by federal agencies. “Before this law, there was no uniformity in terms of intellectual property ownership for government-funded research, which retained ownership of any resulting IP. The Bayh-Dole Act introduced significant changes, aiming to create uniformity and reliability in the management of intellectual property and federal research funding.” Murdza emphasized the “crucial role of this law in increasing university technology transfer, with a significant increase in federally funded patents from 1980 to 2020. The law allowed universities to take an active role in technology licensing, accelerating the commercialization process of federally funded research.”

She highlighted how, thanks to Bayh-Dole, universities “have become more agile and competent commercial partners compared to the federal government. Key provisions of the Bayh-Dole Act include the retention by the university of ownership of any invention resulting from federal funding, an obligation to disclose to the federal government, and a mandate for diligence in implementing the development and commercialization of inventions. The law also guarantees the federal government a non-exclusive license with the right to sublicense and emphasizes the priority of granting licenses to small businesses, although in practice this does not preclude agreements with large pharmaceutical companies”.
Finally, Murdza addressed the controversies and implications of the so-called “march-in rights,” rights that have sparked debates, especially regarding drug prices and the Biden administration’s proposal to use these rights to influence prices. The speaker then concluded by highlighting the obligation of universities to allocate excess revenues from licenses to research and education and to share a portion of royalties with inventors, underscoring the importance of the Bayh-Dole Act in the landscape of technology transfer and intellectual property in the United States.