BREAKING: TBA decides that Rule 28(2) EPC, excluding plant products produced by essentially biological processes from patentability, is void

IPKat has received breaking news that the Technical Board of Appeal (TBA) yesterday decided that recently amended Rule 28(2) EPC is in conflict with Art. 53(b) EPC as interpreted by the Enlarged Board of Appeal in G 2/12 (Broccoli/Tomato II). Further, according to the Art. 164(2) EPC the Articles prevail, thus rending the R. 28 amendment void. 

The case is yet another development in the on-going legal confusion on the issue of whether plant products produced by essential biological processes are patentable. Article 53(c) EPC excludes from patentablity processes for producing plants and animals by essentially natural processes. Rule 28(2) was recently added to extend this exclusion to plant products produced by essentially biological processes. The TBA yesterday ruled that new Rule 28(2) is incompatible with Article 53(b) as previously interpreted by the Enlarged Board of Appeal, and therefore void. 

The decision was issued in oral proceedings yesterday for T 1063/18, an appeal from the Examination Division against an objection under Rule 28(2). Rule 28(2) was amended in a 2017 decision of the Administrative Council (OJ EPO 2017, A56) to exclude plant products produced by essentially biological processes (e.g. natural breeding methods) from patentability. Rule 28(2) relates to Article 53(b), which excludes essentially biological processes for the production of plants or animals from patentability. 


Protecting his tomatoes
Following a long-running legal saga, the Enlarged Board of Appeal (EBoA) decided in Broccoli/Tomatoes I (G 2/07 and G 1/08, IPKat post here), that Article 53(b) EPC excludes from patentability claims directed to an essentially biological process for the production of plants. The follow-up EBoA decisions Broccoli/Tomatoes II (G2/12 and G2/13, IPKat post here) found that the Article 53(b) exclusion should be interpreted narrowly. Particularly, Article 53(b) should not prevent claims directed to plants or plant products produced by essentially biological processes. 

In wake of the Broccoli/Tomatoes II, the European Commission (EC) was asked by the European Parliament to review the Biotech Directive (Directive 98/44/EC). Article 4 of the Biotech Directive mirrors the wording of Article 53(b) EPC, and excludes from patentability essentially biological processes for producing plants and animals, but does not explicitly exclude products produced by such processes. The EC concluded that the intention of the Biotech Directive was to exclude products produced by essentially biological processes from patentability, not just the processes themselves. The EC position was thus at odds with the view of the Enlarged Boards of Appeal in Broccoli/Tomatoes II, but in line with the patent laws in some member states, including France, Germany, Italy and the Netherlands. 

The Administrative Council of the EPO subsequently decided to amend the EPC regulations to reflect the EC's position (IPKat post here). Particularly, Rule 28 of the Implementing Regulations was amended to include the following paragraph:

(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.

The Administrative Council decision was considered a blow for the EU agritech industry, already hampered by arguably the world's most stringent GMO regulations, in the form of the GMO directive (recently ruled by the CJEU also to include gene-edited products, IPKat post here). 

The appeal case decided yesterday, T 1063/18, related to Syngenta's EP patent application EP2753168. The application seeks protection for a pepper plant. The application was rejected by the Examining Division in view of the Rule 28 amendment. Syngenta filed a notice of appeal and statement of grounds in April 2018. The TBA agreed to expedite proceedings in view of the many pending applications to which the issue of new Rule 28 is relevant. Oral Proceedings were held yesterday, 5 December 2018. In view of the nature of the appeal, the EPO also decided to enlarge the number of members on the Board to include 3 technical members and 2 legal members.  Third party observations were filed by  the European See Agency (ESA), urging the board to maintain the rejection in view of Rule 28. Third party observations were also filed in support of Syngenta, for example by Solynta (a potato seed breeding company).

The EPO has not yet issued a statement regarding the decision, and IPKat is therefore indebted to our source and Katfriend Bart van Wezenbeek for information on the outcome of proceedings yesterday at the Board of Appeal, HaarAccording to Bart, the Board found the matter so crystal clear that they did not see the need to refer the question to the Enlarged Board. Particularly, the Board found that Article164(2) EPC stipulates that the Articles have precedence over the rules, and the amendment to Rule 28 is therefore void. The Broccoli/Tomatoes II decisions therefore stand. The case has now be remitted back to the Examining Division, for examination on clarity and inventive step.

Yesterday's decision is an exciting turn of events for the European agritech industry. It seems that the legal uncertainty regarding plant and plant product inventions will continue for some time to come. 

IPKat will, of course, bring you detailed analysis of the published decision once this has been issued.  

by Rose Hughes