The EPO's Enlarged Board of Appeal (EBoA) recently issued a combined decision in referrals G2/12 and G2/13, further clarifying the extent to which European patents may be granted in respect of the products of "essentially biological processes."

Article 53(b) of the European Patent Convention (EPC) states that European patents shall not be granted in respect of "plant or animal varieties or essentially biological processes for the production of plants or animals", with the proviso that the exclusion "shall not apply to microbiological processes or the products thereof". The European patent applications underlying decisions G2/12 and G2/13 related to the production of plants (tomatoes in one case and broccoli in the other) via traditional breeding combined with additional steps. The methods concerned had been deemed excluded from patentability in decisions G1/08 and G1/07 of the Enlarged Board in 2010, but those decisions did not address the patentability of the products of such methods.

The present decision the EBoA concludes that the products of essentially biological processes are not excluded from patentability. Patents may therefore be granted in respect of such products provided, of course, that all other patentability requirements are met.

For new applications, applicants should ensure that appropriate language is included at the application preparation stage for use before the EPO, even where the focus in other territories may be on the process itself. Product claims would be allowable in certain circumstances, but product-by-process claims, which were at issue in the broccoli case, may be particularly useful where the end product cannot be easily defined. In both product or product by process claims, care must be taken to ensure that the resulting product claim is not directed to a single plant variety, since these claims would be excluded by the first part of Article 53(b) EPC ("European patents shall not be granted in respect of … plant or animal varieties …"; see also EBoA decision G1/98).

In the case of pending applications, converting potentially excluded process claims to product or product by process claims will be reliant on the availability of adequate basis for the relevant product claim in the application as originally filed.

When it comes to later enforcing such patents, many clients are aware that proving infringement of a product claim can be seen as a more straightforward task than proving infringing use of a patented process. However, it should be remembered that where the direct product of a patented process is concerned, it is sometimes possible to reverse the burden of proof onto the defendant.

This long awaited, but straight forward decision does bring clarity to what had previously been a grey area for applicants in this technological field.