The US and European Experience
New Directions in Patent Law series
PART I: Patent protection of biotechnological inventions and the limits of patentability
The concept of biotechnology refers to a wide range of techniques using living organisms. According to the accepted meaning, biotechnology can be defined as a group of techniques which use living organisms or their parts in order to create or modify products, to improve the characteristics of plants or animals, or to develop microorganisms or organisms destined for specific uses. In other words, biotechnology includes all techniques which use or cause organic changes in biological material, microorganisms or animals, or cause changes in inorganic material, using biological methods. A fundamental distinction within the subject exists between traditional biotechnology and so-called innovative or advanced biotechnology. The former consists in biological processes applied by man for centuries for the production of food and drink, cheese and wine, the cultivation of plants and the disposal of waste. Innovative or advanced biotechnology, first developed in the 1970s, is based on the combined use of new biological techniques – such as genetic engineering, the culture of cells in vitro, the production of monoclonal antibodies, etc. – applied to various production sectors but brought together with organic material or biological organisms being the final or intermediate products. Today’s biotechnology involves living organisms and their direct genetic modification. Until recently, the modification of living organisms could occur only through gradual selection. The genes which caused the modification of a particular organism could be chosen only from the full group of genes of the species to which the organism belonged.