Gene-Edited crops and patentability
One of the fastest growing fields of research is that which focusses on gene-edited crops or organisms. These are crops or organisms that have had their genomes edited in order to make changes to the plant or organism at the DNA level. Such changes can include the addition, altering or removal of DNA from the plant or organism genome. The European Commission recently published proposals to change the legislation governing such changes. Currently, the rules regarding “new genomic techniques” or NGTs are rather restrictive. Under the new proposals, gene-edited crops which contain changes to existing DNA within the organism and which can be obtained via conventional breeding methods will be subject to much lighter regulation on the European level.
Such proposals do not however address the issues associated with the intellectual property in this technological field. Such regulatory changes, for now, do not require wholesale changes with regards to the EPO framework. The most relevant issue at hand is whether a technical invention present or not. If there is a technical invention, then the product is patentable, while something that is essentially biological and is therefore excluded from patentability. Thus, gene-edited crops and organisms that use a technology are patentable, while those which are either natural or selectively bred are not.
While certain technologies for NGTs such as Crisper-Cas technology is clearly patentable, there is a grey area where less sophisticated technical approaches are used. Under the new EU regulations such approaches will be allowed to be carried out but will not be patentable at the EPO. It may be in the future the EPO, in light of the new regulations, has to more clearly define what is meant by a technical invention and what is defined as essentially biological.