Biotechnology Law and Legal Definition

Biotechnology is a procedure of transferring genes from one living entity such as a plant, animal, or microbe into another or into a synthetic compound using advanced recombinant DNA technology. It is any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. [United Nations Convention on Biological Diversity]

Biotechnology has been used to develop Bt crops, herbicide-tolerant crops, and quality enhanced crops, and currently is being investigated as a way to develop crops or animals containing pharmaceuticals for use in animals or humans.

In 1995, the U.S. government enacted the Biotechnology Patent Process Protection Act that made biotechnological processes per se patentable if either the process or the resulting material is novel and non obvious.

The following is an example of a federal regulation defining the term:

According to 7 CFR 3415.2, ‘biotechnology’ means any technique that uses living organisms (or parts of organisms) to make or modify products, to improve plants or animals, or to develop microorganisms for specific use. The development of materials that mimic molecular structures or functions of living systems is included.