Source: European Parliament
Legal protection of biotechnological inventions in the EU is governed by Directive 98/44/EC[1] ‘Biotech Directive’. According to the provisions of the directive, biological material which is isolated from its natural environment or produced by means of technical processes may be patentable if it also meets the general patentability requirements, such as novelty, inventive step, and industrial applicability.
However, the directive excludes animal varieties and animals produced solely by essentially biological processes from patentability. In this context, an ‘essentially biological process’ is defined as a process that consists entirely of natural phenomena such as crossing or selection (e.g. conventional breeding methods). Accordingly, animals and their offsprings resulting from conventional breeding methods, without the application of a technical process such as genetic modification, would generally not constitute a patentable invention within the meaning of the directive.
Patentable biotechnological inventions relating to animals include, for instance, modifications of animal genome aiming to tackle hereditary diseases or enabling animals to survive environmental changes. Where a patented invention (e.g. a modified gene) is incorporated into an animal, the protection extends to any material in which the patented genetic information is contained and continues to perform its function. This principle also applies to the offspring of such animals, provided that the patented invention remains present.
- [1] https://eur-lex.europa.eu/eli/dir/1998/44/oj/eng .