The patentability of the plant products of essentially biological processes (again…).

The Enlarged Board of Appeal (EBA), the highest instance of the European Patent Office (EPO), is tasked with ensuring the uniform application of the law under the EPC and to settle matters of fundamental legal importance. 

We previously reported on the “Broccoli I” (G2/07) and “Tomato I” (G1/08) cases in which the EBA decided on the scope of the exclusion from patentability of plant breeding methods in view of Article 53(b) of the European Patent Convention (EPC), which excludes from patentability “essentially biological processes” for the production of plants and animals.  What was not decided in Broccoli I / Tomato I was the patentability of products resulting from processes excluded as being essentially biological under Article 53(b) EPC.  To seek clarification on the patentability of such products, there was a second referral to the EBA in Broccoli II (G2/13) and Tomato II (G2/12). In Broccoli II and Tomatoes II, the EBA confirmed that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC is a process exclusion which does not extend to products obtained by the excluded process, meaning that plants and plant materials resulting from an essentially biological process are considered patentable subject matter.  However, that was not quite the end of the matter.

The EU Directive on the legal protection of biotechnological inventions (Directive 98/44/EC), the “Biotech Directive”, aims to harmonise national law on the patentability of inventions relating to biological material and has been incorporated into the EPC.  The exclusion to patentability, both in the Biotech Directive and in Article 53(b) EPC, expressly excludes from patentability essentially biological processes for the production of plants and animals, but neither mentions the patentability or otherwise of the products derived from such processes.  Subsequent to the Broccoli II / Tomatoes II EBA decision, the European Parliament asked the EU Commission to consider the abovementioned patentability exclusions and whether the finding of the EBA would also have been reached in the EU context.  The EU Commission however concluded the opposite to the EBA in Broccoli II / Tomatoes II in stating “that the EU legislator’s intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes” (see Commission Notice 2016/C 411/03).

Although the Commission Notice was not legally binding on the EPO and was mentioned as “intended to assist in the application of the [Biotech] Directive” and confirmed that “only the Court of Justice of the European Union [CJEU] is competent to interpret Union law”, the EPO’s Administrative Council (AC) nevertheless controversially amended Rules 27 and 28 EPC to specifically exclude from patentability plants (and animals) exclusively obtained by means of an essentially biological process.

Amended Rule 28(2) EPC, which entered into force on 1 July 2017, 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 states:

“European patents shall not be granted in respect of:  

(b) plant or animal varieties or essentially biological processes for the production of plants or animals; … ;”.

The EPO’s reasoning for introducing the Rule amendments was to safeguard uniformity and given the Biotech Directive’s incorporation into the EPC.  This however resulted in the EU Commission’s position being in direct conflict with the EBA in Broccoli II / Tomatoes II, but being in line with the patent laws of a few member states, currently Austria, Germany, France, The Netherlands and Portugal, who have specific provisions in their national law excluding from patentability plants and plant parts obtained by an essentially biological process. 

The amendment to Rule 28(2) EPC was tested in appeal case, T1063/18, against a decision by the Examining Division to refuse European patent application number 12 756 468.0, relating to “extreme dark green, blocky peppers”, for the sole reason that it considered the claimed subject-matter to be plants exclusively obtained by means of an essentially biological process which fell within the exception to patentability according to Article 53(b) and Rule 28(2) EPC.  The Technical Board of Appeal in T1063/18, in an enlarged composition consisting of three technically and two legally qualified members, decided that Rule 28(2) EPC was in conflict with Article 53(b) EPC as interpreted by the EBA in decisions G 2/12 and G 2/13 (Broccoli II and Tomatoes II).  Article 164(2) EPC states that in case of conflict between the Articles and Rules of the EPC, the Articles shall prevail.  The Technical Board saw no reason to deviate from the interpretation of the EBA.

Following the Technical Board of Appeal’s written decision in T1063/18, issued on 5 February 2019, the EPO issued a statement particularly supporting measures to obtain an opinion from the EBA on this matter. 

The President of the EPO may under Article 112(1)(b) EPC refer a point of law to the EBA where two Boards of Appeal have given different decisions on that question.  There have been no such contradicting Board of Appeal decisions and questions were therefore raised by different parties, including CIPA (The Chartered Institute of Patent Attorneys) as to whether any such referral by the President would be admissible. 

Nevertheless, on 5 April 2019, the President of the EPO submitted questions to the EBA to clarify the applicable legal framework in reaction to concerns expressed by the Contracting States, the user community and representatives of civil society worried about legal uncertainty resulting from decision T 1063/18.  The President of the EPO stated that the referral to the EBA was an important step on the way to restore legal certainty in the interest of the users of the European patent system and the general public.

Various commentators however argued that the legal situation was made clear by the EBA in Broccoli II and Tomatoes II in deciding that plants produced by essentially biological processes were patentable and that it was the AC who introduced legal uncertainty by introducing amended Rule 28(2) EPC in direct contradiction the EBA’s decision.  The President, by now referring questions to the EBA, was criticised by some for adding to the uncertainty in asking the EBA to consider a question they have already considered. 

The questions referred to the EBA by the President of the EPO were as follows:

1)      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?

2)      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?

It remains to be seen whether the referral will be admissible and, if so, whether the EBA will simply reiterate its previous position that plants produced by essentially biological processes are patentable under Article 53(c) EPC.

In the meantime, The President of the EPO has issued a Notice confirming that proceedings before the EPO examining and opposition divisions in which the decision depends entirely on the outcome of the EBA’s decision in G3/19 will be stayed until the EBA issues its decision.  This should not affect the majority of plant-related cases since the decision pending before the EBA concerns only plants produced by breeding.  If proceedings are stayed, the responsible examining or opposition division concerned will inform the party or parties concerned.