Biotechnology covers a wide range of techniques that use living organisms; in particular, the Rio Declaration on Enviroment and Development of 5 June 1992 defines that:
“Biotechnology means any technological application that uses biological systems, living organisms, or derivates thereof, to make or modify products or processes for specific use”.
In other words, biotechnologies concern all those techniques that use or cause organic changes in a biological material, in microorganisms, plants or animals, or cause changes in inorganic materials, using biological means. At present the biotechnology and pharmaceutical industry represents a characterized area by large investments in research and science; in order to protect the results of these works, the legal order prepares a protection system based on patent rights, which grants the inventor an exclusive right to the biotechnological invention.
Specifically, the biological patent consists of a biological invention, concerning, for example, a specific composition of material or a precise process for obtaining a genetic sequence; in other words, we are not talking about a property right linked to a specific tangible asset, like a DNA sequence, but rather a monopolistic protection on the use of an invention related to a product or process. In light of above, one of the most complex debates on this topic concerns, in fact, the possibility of extending patent protection also to a natural biological substance in itself, regardless of any specific associated procedures.
From this point of view, a decisive legislative contribution comes from the United States of America, with the case of 1980 Diamond vs Chakrabarty, about the possible patentability of a microorganism that does not exist in nature and is produced through genetic engineering. In particular, the Court established that it was susceptible of patenting “anything under the sun made by man“, identifying human intervention as the key element to distinguish patentable inventions from the non-patentable “principles of nature and natural phenomena“. Since that decision, in the United States, during the following years, a lot of patents, relating to inventions based on materials or genetic information, were granted. In 2001, the US Patent and Trademark Office published the “Utility Examination Guidelines”, confirming the position according to which genome-based inventions are patentable on condition that human intervention is sufficient to meet the “made by man” standard dictated in the Chakrabarty decision.