By Agnes Jung - Trainee Patent Attorney - Life Sciences
FOR THE LATEST UPDATE, SEE OUR ARTICLE HERE: https://wynne-jones.com/news-events/2018/12/epo-board-of-appeal-finds-that-plants-stararestar-patentable-at-the-epo-rule-28-2-epc-is-unenforceable/
Last July we reported1 on the introduction of new Rule 28(2) EPC regarding the patentability of plants and animals obtained by “an essentially biological process”.
Following this, a case2 is now going to appeal at the EPO to contest the interpretation and validity of this new Rule. Significantly this will be the first case to go to the Boards of Appeal since Rule 28(2) EPC was implemented. Oral proceedings are scheduled to take place on 5th December 2018.3
The outcome of these proceedings will therefore be important for determining strategies for current and future patent applications.
In this article, we look at the background of Rule 28(2) EPC, details of the appeal case, possible outcomes at the oral proceedings (including the next case to watch if the appeal is refused), and strategies for patent applications at different stages.
- In November 2016, the European Commission issued a notice6 stating that its interpretation of the Biotech Directive 98/44/EC is that plants obtained by essentially biological processes are not considered patentable.
- Following this, the Administrative Council of the EPO introduced new Rule 28(2) EPC, which came into force on 1 July 2017, and states that:
“(2) 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.”
- As we previously reported1: (i) the EPO is not a European Union institution and is therefore not bound by the Biotech Directive; (ii) the Commission Notice has no legislative or judicial effect; and (iii) the new Rule 28(2) should be unenforceable as it directly conflicts with Article 53(b) EPC as interpreted by the Enlarged Board of Appeal (EBA) in its decisions G2/124 and G2/135
Syngenta’s appeal case
In its March 2018 decision to reject the claims, the Examining Division reasoned that the claimed subject matter would fall into the exclusion of patentability as set out in Article 53(b) EPC and the newly added Rule 28(2) EPC.
This decision led to Syngenta filing an appeal against the decision of the Examining Division. Soon after the appeal was filed, three sets of third party observations were submitted by two parties (detailed below), all supporting Syngenta's case and disputing the validity of Rule 28(2) EPC.
In the first set, Solynta, a potato breeding company based in the Netherlands, has asked the EPO to review the legitimacy of the Rule 28(2) EPC. Having had its own patent application EP26996847 stayed following the Commission Notice, Solynta has requested a stay of proceedings for its own European patent applications in view of the present appeal proceedings.
In the second set of observations, a patent attorney firm presents arguments on the same basis as our July 2017 article1.
In the third set of observations, the same patent attorney firm argued that Rule 28(2) EPC is incompatible with the European Convention on Human Rights.
Expansion of the Board of Appeal
The Board of Appeal handling this case was recently expanded to include two additional members, including one legally qualified member. It would therefore appear that the Board of Appeal foresees complex legal arguments being made at the oral proceedings.
Opinion of the Board of Appeal and further communication
In early October, the Board of Appeal issued a communication indicating a lack of clarity (Article 84 EPC) and inventive step (Article 56 EPC) regarding claims 1, 2 and 3.
In a response dated 26th October, Syngenta has submitted arguments in response to the clarity and inventive step objections, and has made several requests, including referral to the Enlarged Board of Appeal.
What will happen at the Oral Proceedings?
Three basic outcomes are possible at the Oral Proceedings:
- The Board of Appeal allows the appeal. Reasons for grant will be provided at a later date, but it will be evident that the decision was made on the basis of the EBA’s binding interpretation of Rule 53(b) EPC in G2/12 and G2/13. This case could then be used as guidance by Examining Divisions for future applications affected by Rule 28(2) EPC.
- The appeal is refused. Basic reasons will be provided on the day. If they were not overcome in the amendments, the refusal will be based on lack of clarity / inventive step. In this case, it will be necessary to wait for the next case to go to appeal to clarify the Board of Appeal’s interpretation of Rule 28(2) EPC (further details below).
- There may be a referral to the Enlarged Board of Appeal. In this case, although the decision by EBA may be delayed due to logistical reasons (rather than uncertainty), the patent will most likely be granted in due course, and be used as binding case law for future applications.
Strategy for patent applications
In its Statement of Grounds of Appeal, Syngenta has noted that there are multiple pending cases in examination, opposition or appeal that are affected by the Rule 28(2) EPC. The next appeal case that we are aware of where Rule 28(2) EPC is at issue is EP28250248, relating to a tomato plant. Thus, should the December hearings not conclude on the validity of Rule 28(2) EPC, this will be the next case to follow.
Another case to note that is scheduled for oral proceedings is an opposition against EP21668339, relating to a seedless pepper plant and for which inter partes oral proceedings are due to take place in February 2019 (opposition proceedings do not result with a binding decision).
For patent applications that were recently refused on the grounds of Rule 28(2) EPC, it may be worth filing an appeal.
For applications that are later in the EPO patenting process, it may be beneficial to delay proceedings where possible, and when making any submissions include observations/comments regarding this appeal case and the forthcoming February opposition case.
For earlier stage patent applications, it may be worth delaying prosecution where possible whilst we wait for a final decision on the validity of Rule 28(2) EPC.
The EPO has revoked patent EP159796510 relating to a broccoli plant. The patent was granted in 2013 to Monsanto (acquired by Bayer), which was followed by a number of oppositions in 2014. According to No Patents on Seeds (an alliance of organisations including Greenpeace), this ruling is the first time Rule 28(2) EPC has led to the revocation of a patent. 11 However, the interpretation of Rule 28(2) EPC still requires clarification, as recently in October 2018, the EPO rejected oppositions against patents held by Carlsberg and Heineken relating to a strain of barley (EP238411012 and EP237315413).
EPO BOARD OF APPEAL FINDS THAT PLANTS *ARE* PATENTABLE AT THE EPO - RULE 28(2) EPC IS UNENFORCEABLE, read the full article here.
- IS NEW RULE 28(2) EPC UNENFORCEABLE? - PLANT PATENTS AT THE EPO AND EXCLUSIONS FROM PATENTABILITY
- EPO appeal case T1063/18 (EP2753168)
- Oral proceedings in case T1063/18 on 5 December 2018
- G2/12: http://www.epo.org/law-practice/case-law-appeals/recent/g120002ex1.html
- G2/13: http://www.epo.org/law-practice/case-law-appeals/recent/g130002ex1.html
- Commission Notice 2016/C 411/03
- Solynta’s previously stayed application (EP2699684)
- Next case to go to appeal (EP2825024)
- Oral proceedings in oppositions case (EP2166833) on 13 February 2019
- Revoked broccoli patent EP1597965
- No Patents on Seeds
- Barley patent EP2384110
- Barley patent EP2373154