Of Molecules & Medicine: Peppers, Politics, and Patentability

By Isobel Finnie, Partner and Joanna Rowley, Patent Attorney

Can a new referral to the Enlarged Board of Appeal finally settle whether plants and animals exclusively obtained by means of an essentially biological process are patentable at the EPO?

Background

The EU Biotech Directive and Article 53(b) EPC clearly state that essentially biological processes for the production of plants or animals are not patentable, but are silent with regard to the patentability of plant and animal products exclusively obtained by means of such essentially biological processes. In 2015 the Enlarged Board of Appeal ruled that such products are patentable (G2/12 and G2/13, often referred to as “Broccoli/Tomatoes II”). This was seen as a positive step by agrochemical companies using the patents system and many commentators thought the issue was settled.

However, shortly afterwards in 2016 the European Commission issued a Notice (2016/C 411/03) stating that the EU Biotech Directive was intended to exclude products obtained by essentially biological processes from patentability, even though it didn’t explicitly say so. Although this Notice was not legally binding it added to the existing pressure on the EPO from certain member states and political groups. The Administrative Council of the EPO responded by adding Rule 28 part (2) EPC, which states “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.”

This amendment came as a surprise to many in the field because it created a conflict between Rule 28(2) EPC and Article 53(b) EPC as interpreted by Broccoli/ Tomatoes II. Soon enough a case came before the Boards of Appeal (T 1063/18) in which a patent application had been refused by an Examining Division for the sole reason that the invention was deemed to be a plant product exclusively obtained by essentially biological processes. In brief, the invention related to a “cultivated blocky fruit type pepper plant” and the only method described in the application for obtaining the pepper plant was an essentially biological process, namely crossing two previously known peppers followed by selfing and conventional pedigree selection to create stable fixed inbred lines. The Board in T 1063/18 held that the Articles of the EPC as interpreted by the Enlarged Board of Appeal must prevail over the Rules (in accordance with Article 164(2) EPC) and hence, Rule 28(2) EPC must be considered void. The Board of Appeal considered the law on this issue to be clear and hence a referral to the Enlarged Board of Appeal was not justified.

The Referral (G3/19 aka “Peppers”)

The new President of the EPO, Antonio Campinos, has sought clarity on the issue by referring the following two questions to the Enlarged Board of Appeal:

Q1 – Having regard to Article 164(2) EPC, can the meaning and scope of Article 53 EPC be clarified in the Implementing Regulations to the EPC without this clarification being a priori limited by the interpretation of said Article given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal?

Q2 – If the answer to question 1 is yes, is the exclusion from patentability of plants and animals exclusively obtained by means of an essentially biological process pursuant to Rule 28(2) EPC in conformity with Article 53(b) EPC which neither explicitly excludes nor explicitly allows said subject-matter?

As a result of the referral, the EPO has stayed all proceedings before the examining and opposition divisions in which the decision depends entirely on the Enlarged Board of Appeal’s decision. Frustratingly for Applicants in the field, this is the third time that the EPO has stayed proceedings relating to products obtained by essentially biological processes [1].

Throwing yet another spanner in the works, many commentators have suggested that the referral may in fact be inadmissible. According to literal interpretation of the EPC, the President can only refer a question to the Enlarged Board of Appeal where two Boards of Appeal have issued conflicting decisions on the same issue. On the legal point of patentability of plant or animal products exclusively obtained by essentially biological processes, there are currently no such conflicting decisions.

Even if the Enlarged Board of Appeal deems the appeal admissible following the President of the EPO’s rationale and if it rules that products obtained exclusively by essentially biological processes are patentable, it would not necessarily be the end of the road for this controversial issue. Theoretically, plant and animals products obtained exclusively by essentially biological processes could still be excluded from patentability at the EPO. However, this would likely require an interpretation by the CJEU of existing EU law or an amendment of EU law governing the patentability of plants, followed by an amendment of Article 53(b) EPC to bring it in line with the EU law.

[1] The first was whilst the outcome of Broccoli/Tomatoes II was pending and the second was in response to the European Commission’s Notice, whilst Rule 28 EPC was being amended.