On 14 May 2020, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) provided their long-awaited opinion on the controversial G3/19 case relevant to the patent eligibility of traditionally bred plants and animals.
This decision likely brings to a close a long running legal saga on this issue.
Summary of the opinion and its application
In short, plant or animal products that are exclusively obtained by means of an essentially biological process are no longer patent eligible subject matter at the EPO.
This exclusion only applies to patent applications filed on or after 1 July 2017. It does not apply to patents granted before this date, or to pending applications filed before this date.
Under longstanding Article 53(b) EPC, "essentially biological processes for the production of plants or animals" are excluded from patentability. However, this Article does not explicitly exclude the plants or animal obtained by the processes. Thus, claims to the plants and animals have been granted.
This apparent anomaly has been the subject of a protracted series of legal disputes with two previous decisions of the EBA ("Broccoli" - G2/12 and "Tomatoes II" - G2/12) finding that the exclusion should not be applied to the plants and animals produced.
Following lobbying from the European Union, Rule 28(2) EPC was then introduced by the Administrative Council on 1 July 2017. This rule explicitly states that under Article 53(b) EPC European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.
However, because this apparently contradicted the earlier EBA decisions G2/12 and G2/13, and because articles are supposed to trump rules, an EPO Technical Board of Appeal ("Pepper" - T1063/18) then ruled that Rule 28(2) EPC should be ignored.
With a view to resolving this ongoing conflict, and under pressure from various lobbyists, the President of the EPO made a referral of the issue to the EBA. Present G3/19 represents the EBA's opinion on the issue.
G3/19 decision and reasoning
The EBA has now controversially reversed its own earlier decisions in G2/12 and G2/13.
Specifically, the EBA has adopted a "dynamic interpretation" of the exception to patentability under Article 53(b) EPC and held that the non-patentability of essentially biological processes for the production of plants or animals also extends to plant or animal products that are exclusively obtained by means of an essentially biological process.
The EBA has apparently justified reversal of its previous decisions in G2/12 and G2/13 on the basis that they were made before Rule 28(2) EPC was introduced. In making the new decision the EBA has reportedly taken into account the preparatory work on Rule 28(2) EPC and the circumstances of its adoption, as well as legislative developments in the EPC contracting states.
The EBA's current decision in G3/19 cannot be appealed, and although it may not be popular with patent applicants, it does at least provide some certainty on the issue of patent eligibility for applicants in the agricultural sciences.
Pending applications for which prosecution was stayed while awaiting the present decision, should now also re-enter examination.
How can plants and animals now be protected in Europe?
Patent protection is still available at the EPO for plants and animals that are not exclusively obtained by means of an essentially biological process such as those produced by biotechnological methods including genetic modification (transformation), gene-editing and artificially induced (as opposed to spontaneous) mutation. However, patent applications destined for the EPO should be carefully drafted in order to provide basis for claims that will not be interpreted as falling foul of the new exclusion.
Plant variety rights
It, of course, also remains possible to protect traditionally bred plants via plant variety rights in Europe at the Community Plant Variety Office (CPVO). Although the protection afforded is narrower than what was once available via European patents, there are some advantages to plant variety rights over patents, and this mechanism should not be underestimated or overlooked.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.