On 3 July, the EPO lifted its stays of proceedings on cases that had been held in abeyance pending new rules on the patent-eligibility of plant-related subject matter. Following an intervention by the European Commission in November 2016, as of December 2016 the EPO had stayed the prosecution of a number of plant-related applications pending a possible rule change. The EPO’s Administrative Council then decided at the end of June 2017 to enact some new EPC Rules in this area. These became effective almost immediately, as of 1 July 2017 and are applicable to both existing and newly filed applications.
The main change is the addition of new Rule 28(2) EPC, which reads as follows
Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.
Article 53(b) EPC provides that patents cannot be granted for plant or animal varieties or essentially biological processes for the production of plants or animals. The interpretation of these provisions has been controversial for some two decades. The latest area of dispute has been around whether, in light of the exclusion of essentially biological processes, it is nevertheless possible to patent the products of those processes, eg to patent “classically” bred plants even though not the breeding processes by which they are created. Some European countries’ national laws already contain provisions to the effect that the products of essentially biological processes are not patentable, even though the EPC refers only to the processes themselves. In its so-called Broccoli/Tomatoes I decisions in 2010, the EPO’s Enlarged Board of Appeal held that, in essence, any process claim containing one or more breeding steps was patent-ineligible under Article 53(b) but then in further decisions known as Broccoli/Tomatoes II it held in 2015 that the products of such processes could be patented. In fact, prosecution of such applications tended to be very difficult for other reasons so few such patents were granted but improvements in technology, especially growth in the availability of molecular marker data, that gave applicants more information about their plants and allowed better definition of traits contained in them have recently been beginning to render such filings more realistic. In the meantime, however, political pressure from breeders’ groups, non-governmental organisations and continental European governments opposed to such patents led the EU to lobby the EPO and the EPO to change its Rules.
New Rule 28(2) is prima facie in conflict with the Broccoli/Tomatoes II decision so it remains to be seen how this will be play out when the EPO begins to apply it. In principle, Article 23 EPC means that the EPO’s Boards of Appeal have to follow only the EPC itself, not its Rules, so if the Boards feel that the Rules are not in line with the EPC, they can ignore them. However, day to day examination will of course be conducted in line with the Rules so it seems likely that applications will be refused and test cases filed with the Boards of Appeal, leading ultimately to a further Enlarged Board of Appeal decision on the topic in the next few years. If the Enlarged Board ultimately re-confirms its existing case law, this will create a conflict in that the EPO will be forced to grant patents that may be unenforceable in litigation in many EPC member states, i.e. all those that are members of the European Union. This situation however exists to an extent already because of the national laws that are drafted differently than the EPC. The position of non-EU states that are members of the EPC is interesting in this regard, as those countries will more easily be able to reach their own decisions and may be more swayed by EPO case law than EU opinion. It is for example possible that UK practice on this issue could diverge when the UK leaves the EU. However, it is equally possible that the UK could enact a rule change similar to the one that introduced Rule 28(2) EPC.
All of this is however for the future. In the meantime, examination of the stayed cases will now resume and the new rules will also be applied to newly filed cases. Exactly how they will be applied will only become clear with time and experience but, from guidance published by the EPO before the changes were made, it appears that practice will remain similar in some ways and toughen in others. The use of the word “exclusively” in new Rule 28(2) suggests that plants and animals that are obtained partly by breeding and partly by technical means such as transformation and mutagenesis (including gene-editing techniques such as CRISPR/Cas) should still be patent-eligible as long as the claims are not confined to individual plant varieties, which are excluded by the other limb of Art 53(b) EPC. Claims to transgenic and mutant plants are thus unlikely to be affected, and new Rule 28(2) also does not change the position on claims in process format, on which the main authority remains Broccoli/Tomatoes I.
However, the rule change is likely problematic for so-called “native trait” claims in which the invention lies in the identification and definition of a beneficial characteristic and its transfer into other genetic backgrounds by breeding because, even when such traits are well-understood and defined in terms of sequences or marker positions, the plants themselves are still obtained by breeding processes. The EPO has in particular opined that claims to plants produced by marker-aided selection processes, in which breeding is accelerated by reliance on molecular markers but still fundamentally composed of crossing and selection steps, should not be patent-eligible under new Rule 28(2) EPC. Such subject matter could already not be claimed in process format because of the Broccoli/Tomatoes I decisions but this is a significant step away from the position in the Broccoli II decision, where the Enlarged Board of Appeal specifically approved claims relating to subject matter of this type in product-by-process format. The growing introduction into national infringement laws (including that relating to the forthcoming EU unitary patent) of so-called breeder’s exemptions, which have somewhat differing scopes but in general provide that it is not an infringement to breed a new variety from a patented plant, further tends to weaken patentees’ positions in this regard.
Patent applicants in this field therefore continue to face uncertainty but in general may need to recognise that some options previously available to them have been closed down and other strategies will have to be developed for protection of their inventions in Europe. For more information, please feel free to contact Andrew Bentham or your usual J A Kemp contact.