Plants and animals produced by essentially biological processes: not patentable at EPO (again)

Introduction

Most interested in patenting are by now well aware that a new Enlarged Board of Appeal (EBoA) decision has been published, G3/19.

Although the technical area affected by G3/19 is relatively narrow (plants or animals that are exclusively obtained by essentially biological processes), there has generally been much debate around the topic, driven by NGO’s advocating the “no patents on life” slogan and, not least, the EU itself. No less than 41 amicus curiae briefs show part of the engagement. Moreover, decision G3/19 is interesting because of the legal discussion behind it. A brief explanation follows below.

Background

In decisions G2/12 (tomatoes II) and G2/13 (broccoli II), the EBoA found that the EPC does not prohibit the patenting of plants or animals exclusively obtained by essentially biological processes. G2/12 and G2/13 gave a narrow interpretation of the exception to patentability as laid down in Art. 53(b) EPC: although essentially biological processes are exempt from patenting, their direct products are not.

This interpretation created dissatisfaction within the EU because it differs from the European Commission’s interpretation of the EU biotech directive 98/44/EC (see Art. 4(1)(b)) which considers that both plants and animals which are exclusively obtained by essentially biological processes should also be exempt from patenting (see the Commission Notice of 2016, in response to G2/12 and G2/13 ). Nevertheless, it is worth noting that the Court of Justice of the EU has not interpreted Art. 4(1)(b) of 98/44/EC yet; there is thus no case law from the EU’s highest court in this area.

The Administrative Council of the EPO and the EPO President were clearly of the opinion that the European Commission’s interpretation should be followed in practice at the EPO. Afterall, Rules 26 to 29 EPC were inserted in the EPC1973 as a direct implementation of directive 98/44/EC. Accordingly, an amended Rule 28(2) EPC was introduced (OJ 2017 A56, A62), explicitly prohibiting the patenting of plants and animals exclusively obtained by essentially biological processes. Thus, decisions G2/12 and G2/13 were «overruled». Or not?

The amendment of R. 28(2) EPC was, in fact, not the last word in the discussion: in a subsequent BoA decision, T1063/18, a technical BoA with five judges found that the interpretation in amended R. 28(2) EPC was contrary to Art. 53(b) EPC, as interpreted in G2/12 and G3/13. Because Art. 164(2) EPC states that Articles always precede Rules in the event of conflict, amended R. 28(2) EPC was declared invalid. Apart from legal fireworks, T1063/18 thus led to a lack of legal certainty for those applying for a patent in this technical field.

Decision G3/19

Of course, there was a reaction from the EPO President to this situation, in the form of a referral to the EBoA under Art. 112(1)(b) EPC, which has now become decision G3/19. The questions posed in the referral were 1. “can Art. 53 EPC be interpreted in a Rule without this interpretation being a priori limited by an earlier interpretation in an (E)BoA decision?” and 2. «If the answer to 1. is yes, is amended R. 28(2) EPC in accordance with Art. 53(b) EPC? ».

Contrary to expectations by many, G3/19 accepts the interpretation provided by amended R. 28(2) EPC. Contrary to expectations, because (i) there was much discussion around this referral being legal or not (this was argued in some amicus curiae briefs. Indeed, the EBoA ended up reformulating questions 1 and 2, see reasoning II.5 and further) and (ii) it is not often that the EBoA contradicts its own previous interpretation of the Convention. In fact, this has only happened once before; when G1/84 was overturned in G9/93 (self-opposition; now no longer relevant after the introduction of Art. 105b EPC under EPC2000).

With G3/19, the EBoA has managed to tackle the problem by using a «dynamic interpretation» of the law (see r. XVIII and onwards). The reasoning is really interesting: although the EBoA (see r. XXVI.3) believes that Art. 31 and 32 of the Vienna Convention do not lead to an unambiguous interpretation that is in line with amended R. 28(2) EPC, it is pointed out that the intention and objectives of the EPC member states have changed. Consequently, the basis for the interpretation as forwarded in G2/12 and G2/13 is not the same anymore, thereby allowing a dynamic interpretation of Art. 53(b) EPC, in accordance with amended R. 28(2) EPC.

Interesting for Norwegian readers is that the EBoA also refers to Norwegian practice (see r. XV.3.1): Norway is one of only ten EPC states that explicitly prohibit the patenting of plants and animals obtained by essentially biological processes, see the Norwegian guidelines for examination C-IV, 2a.3.2, although it is also pointed out in G3/19 that the Norwegian Patent Act does not mention anything explicit on this matter.

Final word?

So has the final word on the exception to patentability of plants and animals exclusively obtained by essentially biological processes now been said with decision G3/19?

G3/19 (see r. XXVIII) does seem to end the debate in that “product claims or product-by-process claims directed to plants, plant materials or animals” where the product is exclusively obtained by essentially biological processes are excluded from patentability. Inclusion of the term “plant material”, which does not appear in amended R. 28(2) EPC, is relevant, as it covers parts of plants, such as fruits. On the other hand, it will be interesting to see where future decisions draw the lines for “exclusively obtained” regarding mixed processes.

Finally, it must be mentioned that the decision does not apply to European patents from before 1 July 2017 (when amended R. 28(2) EPC came into effect) or to European applications filed before that date. Here, the decision deviates from R. 28(2) EPC, which, upon entry into force, was to be applied with retroactive effect to all European patent applications and patents pending on 1 July 2017.