Effective management of intellectual property in universities requires a nuanced understanding of the various laws governing patents and copyright, as well as a careful strategy for balancing the interests of researchers, institutions and public funders. In the U.S. innovation and academic research landscape, the Bayh-Dole Government License or Bayh-Dole Act (Patent and Trademark Law Amendments Act) of 1980 emerges as a crucial turning point, as it redefined the relationship between federally funded research and commercialization of inventions in the United States.
Importantly, this legislation is specific to the U.S. context and has had a significant impact on the way government-funded research is managed and commercialized in the U.S. However, its impact and implications have extended far beyond the borders of the United States, influencing innovation and technology transfer policies in many other countries. The Bayh-Dole Act is named after Senators Birch Bayh and Bob Dole and has had a significant impact on technology transfer from universities to industry, stimulating innovation and commercialization of academic research.
The idea was born in a time (the 1970s) and in a context in which brilliant ideas born in U.S. university laboratories could easily be transformed into products to improve everyone’s lives, and this is exactly what the Bayh-Dole Government License makes possible today. Birch Bayh, a Democratic senator from Indiana, was known for his commitment to legislative reform, and had previously worked on issues such as civil rights and gender equality; Bob Dole, a Republican from Kansas, was a World War II veteran known for his pragmatism and expertise in economic issues.
Despite their political differences, Bayh and Dole shared a common vision: they saw untapped potential in federally funded university research and wanted to allow universities to patent and commercialize inventions that could result. Their collaboration demonstrated that, on certain issues, it was possible to overcome partisan divisions to pursue common goals in research and innovation. Thanks to this law, universities and small entrepreneurs have the power to protect their inventions with patents and then share them with the outside world, as if they had received special permission to turn ideas into reality. Universities can gain from their discoveries, reinvesting profits in new research; companies, especially smaller and innovative ones, can gain access to cutting-edge technologies.
The federal government’s “VIP pass”
It’s not all sunshine and roses, however: the federal government, which funds this research, maintains a kind of “VIP pass” to use these inventions when needed, in a delicate balance between private innovation and public benefit. The Bayh-Dole License functions as a bridge between academia and industry and is a demonstration of how collaboration between academia and industry can foster innovation in labs, classrooms and startups across the country, allowing universities, small businesses or nonprofits to own and commercialize government-funded inventions. Strengths include accelerating technology transfer, stimulating the local economy and strengthening university-industry collaboration. Balancing public and private interests, the law requires disclosure of inventions and retains some government rights. It has created a dynamic ecosystem that accelerates technological progress, reducing the time between research and market, and promoting research that is more focused on industrial needs. Questo nuovo paradigma continua a influenzare positivamente l’economia e la ricerca statunitense, tuttavia emergono questioni etiche, specialmente in ambito biomedico. Inoltre, essendo specifica degli Usa, questo tipo di regolamentazione può a volte complicare le collaborazioni di ricerca internazionali in un contesto sempre più globalizzato. Vi sono inoltre numerosi altri punti di debolezza o criticità, ad esempio nel rischio di privilegiare la ricerca commercializzabile a scapito di quella di base, potenzialmente limitando l’accesso a tecnologie cruciali e creando monopoli, oppure di favorire progetti più redditizi, trascurando aree socialmente rilevanti ma meno lucrative. La gestione dei brevetti richiede inoltre risorse significative, favorendo le grandi istituzioni e ampliando le disparità, generando i pericoli di controversie sulla proprietà intellettuale e di sottoutilizzo delle tecnologie.
A complex topic
The complexity of the topic underscores the need for universities to balance protecting their interests with maintaining an environment conducive to research and innovation. In this regard Stanford v. Roche case, argued in 2011 in the U.S. Supreme Court, is emblematic. The issue involved patent rights to a method for quantifying human immunodeficiency virus (HIV) in blood, developed by a researcher affiliated with both Stanford University and the company Cetus. The Supreme Court ruled that, under the Bayh-Dole Act, patent rights initially belong to the inventor and not the institution even in the case of federally funded research, highlighting the need for explicit agreements between universities and researchers and highlighting the importance of the language used in contract clauses. As a result, many American universities later had to revise their intellectual property policies and contracts with researchers in order to effectively secure rights to inventions developed within their institutions.
The situation in Europe, however, is different, where there is apparently a supposed contradiction between scientific excellence and the difficulty of transforming this knowledge into commercial innovations: the so-called “European Paradox,” a concept that emerged in the 1990s in the debate on science and technology policy in the European Union. In 2006, Lissoni and Montobbio’s analysis had shown that European academic patenting activity is more significant than is often acknowledged, emphasizing the absence of a trade-off between publications and patents at the individual level among researchers. The authors highlighted significant differences between the U.S. and European university patenting systems, questioning the effectiveness of adopting Bayh-Dole Act-like legislation in Europe and suggesting that the success of the U.S. university system stemmed more from available resources and institutional autonomy than from specific patent legislation.
This critical analysis, which was also useful for the purposes of amending Italian Industrial Property Code 30/2005, provided an important basis for rethinking innovation strategies in Europe, highlighting the need for solutions suited to the specific European context rather than the uncritical adoption of American models. For this purpose we refer to the Clarivate 2024 report that highlights the growing role of European universities in promoting global innovation, focusing on the social impact of research. The global knowledge flow between academic research and industrial innovations is interesting, showing how the relationships between universities and leading innovators are shaping the global innovation landscape and how Italy is not yet launched.
The Italian situation
As for Italy, Law No. 102 of July 24, 2023, introduces important changes to the Code, with particular relevance to the academic and public research sector. The law includes measures to strengthen universities’ technology transfer offices, providing resources and expertise for more effective management of intellectual property. The reform specifically addresses the issue of university patents, seeks to balance the interests of academic inventors, research institutions and the private sector. While sharing some general objectives with the Bayh-Dole Act, the reform is not a replication of the American model but rather an approach adapted to the needs and characteristics of the Italian research and innovation system. A key aspect of the new legislation concerns the ownership of inventions made in universities where a more flexible approach is introduced, changing the previous regime, which aims to incentivize both the inventive activity of researchers and technology transfer. In particular, the principle that in the past gave ownership of inventions to researchers themselves instead of to universities, the much-discussed rule on university inventions under the Tremonti package, is revised. From this point of view, today the Code provides for a system of co-ownership between the inventor and the research institution, with mechanisms for sharing the proceeds from the commercialization of inventions, aiming to balance the recognition of the individual contribution of the researcher and the university’s interest in enhancing the results of research conducted with public resources. The reform also introduces measures to promote closer collaboration between universities and industry, encouraging the creation of research and development partnerships. The law also addresses the issue of intellectual property management in international collaborations, an increasingly relevant aspect in the era of globalized research, clarifying rights and responsibilities with the aim of facilitating the participation of Italian universities. Another novelty concerns support for the patenting and commercialization of academic inventions.
The reform also introduces measures to promote closer collaboration between universities and industry, encouraging the creation of research and development partnerships. The law also addresses the issue of intellectual property management in international collaborations, an increasingly relevant aspect in the era of globalized research, clarifying rights and responsibilities with the aim of facilitating the participation of Italian universities. Another novelty concerns support for the patenting and commercialization of academic inventions.
Law 102/2023 while addressing some of the complexities highlighted by the European Paradox, is more a step toward overcoming it than a definitive solution. This is because although it introduces significant measures to foster technology transfer and stimulate university-industry collaboration, the Italian and European context requires further development. Indeed, the law risks generating distortions if not accompanied by continuous monitoring and appropriate refinements. In particular, the management of co-ownership and intellectual property in international collaborations could present application difficulties or conflicts among the actors involved, which need continuous adaptation.
In this regard, contractual clauses are a crucial aspect and can have a significant impact on the effectiveness of the law. If not well defined, they could cause conflict or uncertainty, undermining the goals of technology transfer and exploitation of inventions. In addition, lack of standardization or clear provisions could lead to divergent interpretations, slowing the commercialization of patents or creating imbalances among stakeholders. Training of administrative practitioners and clearer and more consistent handling of contractual clauses will therefore be key to ensuring that the law not only promotes innovation, but does so in a balanced way and without risking distorting or disincentive effects.
The interaction between the academic system and the private sector must also be overseen, avoiding the risks of research being influenced more by economic than scientific logic. The process of adapting the Italian research and innovation system to global dynamics is set to continue, and will need to be constantly monitored to avoid the emergence of new distortions or risks.
Read Antonella De Robbio‘s article in full and in Italian on: https://ilbolive.unipd.it/it/news/societa/brevetti-universitari-innovazione-usa-ue-italia
