Products of Essentially Biological Processes Patent-Eligible Again?

5 December 2018

We understand that, at an oral hearing held on 5 December 2018 in relation to case T1063/18 concerning an application entitled “New pepper plants and fruits with improved nutritional value”, EPO Technical Board of Appeal 3.3.04 held that Rule 28(2) EPC introduced in July 2017 is in conflict with Article 53(b) EPC. Once confirmed, this will have important implications for EPO practice regarding inventions in the field of plant (and animal) breeding as in principle the Rule can no longer stand or be used to reject patent applications if it does not conform to the Article it is supposed to implement.

Article 53(b) EPC renders patent-ineligible plant and animal varieties and essentially biological processes for the production of plants and animals. The scope and impact of this prohibition have been controversial for over 20 years and resulted in several decisions of the EPO’s Enlarged Board of Appeal that have clarified the position somewhat over the years. The latest of these are the so-called “Broccoli and Tomatoes II” decisions (G2/13 and G2/12) from 2015, which indicated that although essentially biological processes for the production of plants are patent-ineligible according to Article 53(b), the products of such processes are not ineligible just because the process used to make them could not be patented. This meant that, if other patentability conditions such as novelty and non-obviousness were complied with, a plant or animal obtained by “classical” breeding as opposed to biotechnological means could in principle be patented. Such patents were hard to obtain in practice but nevertheless these decisions were highly unpopular with plant breeders and some European national governments influenced by them. Breeders concerned about access to plant germplasm for breeding purposes thus lobbied the European Union for change. In 2016, the European Commission issued a notice on this topic that (even though the EPO is not an EU body) was followed by the EPO’s Administrative Council via implementation of Rule 28(2) EPC, to the effect that “European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process”. The EPO reinforced this by amending its Guidelines for Examination and internal practices accordingly. Although generally not impacting plants obtained by biotechnological means, including so-called new breeding techniques (NBTs) such as the well-known CRISPR/Cas technology, this has made it almost impossible to obtain a patent to a plant obtained by breeding, no matter how inventive it might be.

There was however always a possible problem with this in that Rule 28(2) EPC was in conflict with the Enlarged Board of Appeal decisions interpreting Article 53(b) EPC in the opposite way. This situation is governed by Article 164(2) EPC, which indicates that if an Article and a Rule are in conflict, the Article prevails. Since July 2017, therefore, it has been open to the EPO’s Boards of Appeal to hold Rule 28(2) to be ineffective because the Enlarged Board case law represents the correct interpretation of Article 53(b) EPC. This could have been done either by a Technical Board taking a decision or referring a question to the Enlarged Board on the issue. It appears that the Technical Board of Appeal has now taken the former step. On the face of it, this sweeps away Rule 28(2) EPC and the EPO’s practice based on it and reinstates the situation under the Broccoli/Tomatoes II decisions, whereby plants obtained by breeding could be patentable under the right circumstances.

However, it is too early to say what the effects will be. In the short term, the EPO may react to this by suspending examination of applications whose outcome turns on Rule 28(2) EPC, pending issuance of the Board’s written decision and any reaction from the EPO’s Administrative Council, to give it time to decide how and when affected cases should be examined. Also, plant breeders and other lobby groups may try to obtain contrasting decisions in order to provoke a referral to the Enlarged Board. The situation will therefore remain uncertain but nevertheless this is positive news for patent applicants in the agricultural sector. We will look out for further developments and consider their effects on pending cases for which we are responsible.

For more information, please feel free to contact Andrew Bentham or your usual J A Kemp contact.

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