TECHNOLOGY TRANSFER FROM ACADEMIA AND PATENTS IN THE BIOTECH ENVIRONMENT - COMPARATIVE STUDY OF THE AMERICAN AND THE EUROPEAN LEGAL FRAMEWORK

Without a doubt, it is a long way to the market. An invention made during university research, may face difficulty in entering the market or worse, it may never manage to be commercialized. Without industry’s intervention, the latter would certainly have been the case due to university’s normal lack of means regarding the access to the marketplace and of course because of university research having a different goal. This cooperation between academia and industry has been considered useful in different fields of research and has led to achievements in technology unachievable by independent institutions. In the particular field of biotechnology, this mechanism of cooperation has been characterized not only as producing results but as absolutely necessary for the evolution of the biotech science.

It is the nature of the biotech science itself and the multi-leveled practice of its actors that make this cooperation between university and industry unavoidable. First of all, it should be taken into consideration that research in this field starting from the basic research and lasting until a commercial application is a long-term procedure, whose duration may continue even for decades without results. For instance, there are cases where biotech companies have not managed to produce a good or a service that could be commercialized or to achieve the expected results because, for example, of a drug’s lack of market qualities such as its manufacturing cost or its price elasticity.

Secondly, the cooperation between academia and industry seems even more necessary from the capital investing point of view. The long duration of the pre-clinical and clinical trials maximizes the manufacturing cost usually unbearable for the academia’s potential. The industry’s intervention may assure - up to a certain degree - funds that the academia, sponsored by governmental funds, is unable to provide.

The American legal framework dealing with the cooperation academia-industry has been established almost thirty years before. It is the so-called Bayh-Dole Act launched on December 12, 1980 by the US Congress, codified in 35 U.S.C. § 200-212. This Act is considered as possibly the most inspired piece of legislation to be enacted in America in the last half-century .

The objective of this study is to compare the American legal framework with the European one, which is under development following the Lisbon Strategy, regarding the cooperation between academia and industry applied in the biotech field. Moreover, the results of this comparison and the American experience could serve as basis for further development of such cooperation in the European field.