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 II: Interventions on human genetic material: Legal and bioethical issues

Andrea Stazi

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


The development of biotechnology and the progress of genetic science, with the technical opportunities they create, have increased the power of human beings over themselves and over nature immensely. In this sense, problems arising from the application of new genetic techniques on man are particularly significant. The threat that may arise from an uncontrolled and destructive use of the increased technical power with regard to man and life provokes fundamental questions of an ethical nature. With respect to technical-mechanical errors, which allow for the reversibility of the effects, technical-genetic errors are unsettling, given that they are irreversible. All of these reasons have contributed to the rise of bioethics, through which it is possible to continue the analysis of biotechnological applications which affect the fundamental value of man, life, or better, the entire biosphere where human life takes place, with important possibilities for progress, but also with the risk of tragic errors or abuses. Bioethics consists, according to the so-called classic definition, in the systematic study of moral dimensions – including the moral vision, decisions, conduct and policy – of life sciences and the protection of health, through the use of a variety of ethical methods according to an interdisciplinary setting. This is part of general ethics and is characterized as applied ethics. Bio-law, then, indicates the part of legal reflection which deals with distinguishing that which is just and unjust in the context of new possibilities of manipulation (even if it is not therapeutic) of human life.

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