The European Patent Convention (EPC) excludes from patentability inventions consisting of plant or animal varieties or essentially biological processes for the production of plants or animals (this does not apply to microbiological processes or the products thereof). An “essentially biological process” is defined in the EPC as consisting entirely of natural phenomena such as crossing or selection.
In the context of plants, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) has previously decided that essentially biological processes are those which contain steps of sexually crossing whole genomes of plants and subsequently selecting plants. Therefore patent claims directed to such processes cannot be granted. However, if the claimed process involves an additional technical step (such as an artificial genome modification), then the process could be patentable.
There was some uncertainty over whether the products of such processes (rather than the processes themselves) could be patented even though the EBA has previously decided that the exclusion of essentially biological processes does not also exclude products obtained from using essentially biological processes, provided all other requirements for patentability are met. However, there was some concern that this position conflicted with the legal protection provided to plant varieties under EU plant variety legislation and in relation to access to genetic resources.
Taking account of a Notice from the European Commission in November 2016, the EPO has now taken the decision to amend the relevant Regulations in order to exclude from patentability plants and animals exclusively obtained by an essentially biological breeding process. The EPO notice can be found here.
The new provisions at the EPO applied with immediate effect from 1 July 2017. Examination and Opposition proceedings that have up until now been stayed pending the outcome of this process will now gradually resume in the light of the EPO’s decision.
It will be interesting to see how this will be applied in practice, since this seems to widen the area of excluded subject matter considerably and depart from the EBA decisions G2/12 (Tomatoes II) and G2/13 (Broccoli II). We will keep you informed with developments in this area as further details of the amendments emerge.
If you have any concerns or questions about these provisions, then please get in contact with Ross Cummings or your usual attorney at GJE.