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 III: The evolution of the discipline and problematic issues in the United States of America

Andrea Stazi

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


In developed countries like the United States of America, the biotechnology industry has gradually grown to occupy a prominent position on the national economic scene. The patent system has played a fundamental role in this growth. Public and private institutions have recognized the significance of biotechnology in everyday life today and in the innovation of business models, and have invested considerable amounts in the research and development of biotechnological inventions, in the face of the legal system’s clear preference for the encouragement of such innovations through the granting of exclusive patent rights. In the United States, further, a continuous increase of research on human genetic material has been seen in recent decades, with increasing success and a consequent large number of patents on genes, DNA, etc. What is more, with the decoding of the human genome, medical science has been revolutionized, and individualized treatment is expected for many genetic and hereditary diseases. As a consequence, an extremely large number of patent requests for various segments of the human genome have been filed with the United States Patent and Trademark Office. In general, the purpose of the American patent system is to promote scientific and technical progress, providing compensation to inventors as an incentive to reveal information which may benefit the public. Compensation is given as a concession by the federal government of the right to exclude third parties from the creation, use or marketing of the invention. At first sight, then, the American patent system appears similar to the European one.

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