There is a large uncertainty regarding patenting of plants and animals exclusively obtained by means of essentially biological processes in Europe.
Amended Rule 28(2) EPC, which entered into force in July 2017, stipulates that no patents may be granted for plants or animals exclusively obtained by means of an essentially biological process. Also, amended Rules 27 and 28 EPC were considered as clarifying the interpretation of Article 53(b) EPC, which excludes essentially biological processes from patentability, but which does not provide for an exclusion for the products thereof.
However, amended Rule 28 has now been challenged in an appeal filed against the decision rejecting the European patent application, EP 2753168, entitled “New pepper plants and fruits with improved nutritional value” filed by Syngenta Participations AG. This application was rejected by the Examining Division in view of amended Rules 27 and 28 EPC. Syngenta disputed this interpretation and their view was supported by several third parties. The Board of Appeal handling this case was extended by two additional members, likely due to the legal complexity of the case. Oral proceedings in the case were held on 5 December 2018 and the outcome is yet to be confirmed but seems to be remarkable.
The scope of the prohibition according to Article 53(b) has been subject to debate for a long time. After extensive study of the legislative history and interpretation standards of the EPC, the Enlarged Board of Appeals provided the interpretations of Article 53(b), most recently in the so-called “Broccoli and Tomatoes II” cases (G2/13, G2/12) from 2015. “Broccoli and Tomatoes II” indicated that the products of essentially biological processes are not patent-ineligible just because the process used to make them could not be patented according to Article 53(b).
Interestingly, the European Commission issued a notice on the interpretation of the Biotech Directive 98/44/EC in 2016 stating that such products are not considered patentable, and this notice was followed by the Administrative Council of EPO even though the EPO is not an EU institution. Therefore, the Administrative Council amended Rule 28(2) to exclude plants and animals exclusively obtained by means of essentially biological processes from patentability.
In the case at hand, the Board of Appeal decided that amended Rules 27 and 28 are indeed in conflict with Article 53(b) EPC and therefore the EPOs practice based on these Rules appears not valid, since according to the Article 164(2) EPC, when Articles and Rules are in conflict, the Articles prevail. Hence, it appears as that plants and animals obtained by essentially biological processes may again be patentable provided they fulfill all other patentability criteria, in line with the Broccoli and Tomatoes II decisions.
The outcome of this case, T 1063/18, is important for determining strategies for current and future European patent applications within the field of essentially biological processes and plants and animals exclusively obtained by means of such processes. We will continue to follow the development of legislation within this field.