New Rule 28(2) EPC – Products of essentially biological processes before the EPO

In an attempt to harmonise European law relating to the patentability of products obtained from essentially biological processes, the EPO introduced an amendment to Rule 28 EPC that came into force on 1 July 2017[1].  New Rule 28(2) EPC states:

“Under Article 53(b) EPC, European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.”

Whilst at first glance this Rule update appears to resolve ambiguity, unanswered questions still remain. Unfortunately, this means that the patentability of the products of essentially biological processes is likely to remain uncertain for some time.

Background

Article 53(b) EPC states that European patents shall not be granted in respect of:

“plant or animal varieties or essentially biological processes for the production of plants or animals [other than microbiological processes or the products thereof]”

The EPO’s Enlarged Board of Appeal (EBoA) has considered the patentability of plants, and essentially biological processes for their production, on two separate occasions.

In December 2010 the EBoA decided two cases (known as Broccoli and Tomatoes)[2] concerning the patentability of essentially biological processes for the production of plants.  However, those decisions were silent on the patentability of the products of such processes.

A second referral was then made to the EBoA (known as Tomatoes II and Broccoli II)[3], which concerned the patentability of products of essentially biological processes.  In March 2015 the EBoA held that:

“the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to plants or plant material”.

Thus, following these EBoA decisions, the products of essentially biological processes could be patented.

The EBoA’s ruling was vocally opposed by many plant breeders, and at the European Parliament.  In November 2016 the European Commission issued a Notice[4] in which it gave its opinion 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.”

The Commission Notice directly contradicted the EBoA’s conclusions in Broccoli II and Tomatoes II.

In the Notice, the Commission indicated that one reason for the variance between its opinion and the EBoA’s decisions was that the EBoA had not considered the legislative intent behind the Biotech Directive.  However, the legislator’s intent had been considered by the EBoA in Broccoli II and Tomatoes II[5].

The Commission Notice is entirely non-binding.  Indeed, the Notice explicitly states that a decision of the Court of Justice of the European Union (CJEU) is required to interpret the Biotech Directive.  Notwithstanding the non-binding nature of the Notice, the President of the EPO then stayed all proceedings before Examining and Opposition Divisions in which the patentability of a plant or animal obtained by an essentially biological process was the sole outstanding issue[6].

In June 2017 the EPO Administrative Council (whose members represent governments of EU member states) adopted changes to the Implementing Regulations, and new Rule 28(2) EPC was introduced:

“Under Article 53(b) EPC, European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.”

New Rule 28(2) EPC came into force on 1 July 2017 and the stay of proceedings was lifted the same day.

What next?

Now that the stay of proceedings has been lifted, prosecution of any affected cases should resume.  However, a number of issues remain following the change to Rule 28 EPC.

First, the legality of the change to Rule 28 EPC is questionable[7].  The amendment to Rule 28 EPC was drafted with the intention of excluding from patentability subject matter that the EBoA had already held to be patentable in Broccoli II and Tomatoes II.

The EBoA is responsible for deciding points of law referred to it by Boards of Appeal, and its decisions are binding on the Boards of Appeal[8].  The Administrative Council have amended Rule 28 EPC according to their competency under Article 33 EPC[9].  Article 164(2) EPC states that:

“In the case of conflict between the provisions of this Convention and those of the Implementing Regulations, the provisions of this Convention shall prevail.”

Thus, a decision of the EBoA in relation to an Article of the EPC is binding, and can only be overturned by amendment to the EPC itself, not the Implementing Regulations, which are secondary to the Articles.

In terms of the Biotech Directive, only the CJEU is competent to rule on the interpretation of EU law.

Therefore, a referral to the CJEU as to the true intention of the Biotech Directive may ultimately be required to give a final answer on the patentability of the products of essentially biological processes.  However, such a referral could take many years, if it occurs at all.

There is no mechanism for the EPO to refer cases to the CJEU.  Instead, referrals must come from national courts of EU member states.  If, following the introduction of new Rule 28(2) EPC no European patents are granted with claims to essentially biological products, then there will be no national validations which can give rise to actions in the national courts and hence there would be no opportunity for a corresponding referral to the CJEU.  Nevertheless, it is possible that there are existing granted European patents with relevant claims that could be litigated nationally and give rise to a referral.

Aside from the question of legality, there is also a question as to whether new Rule 28(2) EPC is enforceable.  Even if Examining and Opposition Divisions were to apply new Rule 28(2) EPC, it is likely that their decisions would be appealed.  The Boards of Appeal would find themselves bound by the EBoA’s decisions in Broccoli II and Tomatoes II, and would have to find claims to products of essentially biological processes allowable under Article 53(b) EPC.

Strategy

Applicants with pending applications and Patentees in ongoing opposition proceedings may wish to proactively submit arguments to the EPO regarding the validity and enforceability of new Rule 28(2) EPC.  For other pending applications, Applicants may wish to delay prosecution until the issue of patentability of the products of essentially biological processes is finally resolved, although this may take some years yet.

For Applicants preparing new patent applications, consideration should be given as to whether it is possible to draft claims in such a way to fall outside the exclusion of new Rule 28(2) EPC.  In particular, new Rule 28(2) EPC only excludes products “exclusively obtained” by an essentially biological process.  Therefore, potentially claims could be drafted to make clear that other non-essentially biological processes are used in the production of a product, thereby taking it outside the exclusion.  No further guidance is presently available regarding what is meant by the term “exclusively obtained”, although we are hopeful that guidance will be forthcoming as the case law develops.   In addition, it may be that, on investigation, a product is not made by an essentially biological product according to the definitions set out in the first Broccoli and Tomatoes decisions.

If you have any questions about this article please contact our Agritech team.