Table of Contents

Biotechnological Inventions and Patentability of Life

Biotechnological Inventions and Patentability of Life

The US and European Experience

New Directions in Patent Law series

Andrea Stazi

In today’s technological world, biotechnology is one of the most innovative and highly invested-in industries for research, in the field of science. This book analyses the forms and limitations of patent protection recognition for biotechnological inventions, with particular regard to patentability of life.

PART V: Conclusions: Biotechnological inventions and the patentability of living beings in the United States and European models between legal issues and bioethical profiles – The utility of the comparative method, the perspective of the legal process and relations with other sciences and humanistic disciplines (in particular bioethics)

Andrea Stazi

Subjects: law - academic, biotechnology and pharmaceutical law, intellectual property law


In the western legal tradition, both in the United States and European models, patent law finds its justifying rationale mainly in the provision of incentives for innovation, in exchange for the so-called disclosure of the technology on which the invention is based to the public. Directly, this is functional also for the development of subsequent innovations, as well as for the pursuit of pro-competitive aims. This is in virtue of some ‘competitive antibodies’ which characterize the patent discipline, in particular: (a) the evaluation regarding the fulfillment of patent requirements; (b) the so-called numerus clausus of exclusive rights; and (c) the provision of specific limits to ownership. Through the patent system, then, the ‘differential price’ of the innovation is paid only by the first generation of those who actually make use of the innovation itself: which shall then circulate, and be used, in the system of free competition – and at the basically subsequent level of price and variety/quality of production. In particular, with regard to the aforementioned internal corrective measures to the patent system itself, the evaluation of the requirements for patentability, at least according to the traditional setting of the patent system, is aimed at the identification of findings which are actually worthy of exclusive rights, in that they are the expression of a ‘flash of genius’ which gives rise to a substantial innovation with respect to the previous technical state.

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