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EPO – recent developments and background re plant products produced by essentially biological processes

11 Dec 2018

Exceptions to patentability – Plant products produced by essentially biological processes, Technical Board of Appeal 3.3.04, decision of 5 December 2018 in case T 1063/18, reported by Dr. Rudolf Teschemacher, Bardehle Pagenberg

The reported decision sets the refusal of an application for new pepper plants and fruits with nutritional value aside. The ground for refusal was that the claimed subject-matter was excluded from patent protection under Article 53 (b) and Rule 28 (2) EPC. Pursuant to Rule 28 (2) EPC, European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process. The Board’s decision was pronounced in oral proceedings on December 5, 2018. Only the result was made public by participants in the oral proceedings, whereas one has to wait for the reasons until the written decision will be issued in due course. However, already now it seems appropriate to put the decision in the proper context of the development of European patent law for the protection of plants.

According to Article 53 (b) EPC, European patents shall not be granted for plant or animal varieties or essentially biological processes for the production of plants or animals. The Enlarged Board of Appeal (EBA) was faced with the interpretation of this provision several times.

In G 1/98, OJ EPO 2000, 111 – Transgenic plants/NOVARTIS, the EBA decided that a claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Article 53 (b) EPC, even though it may embrace plant varieties. In parallel cases Broccoli I and Tomatoes I, G 2/07 and G 1/08, OJ EPO 2012, 130 and 206, the EBA stated that a biological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of Article 53 (b) EPC. Finally, the Board held in Tomatoes II and Broccoli II, G 2/12 and G 2/13, OJ EPO 2016, A27 and A28, 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 such as a fruit.

By the time the Novartis case was pending before the Enlarged Board of Appeal, the European legislator was active in the area of the patentability of biotechnological inventions. The Biotech Directive (98/44/EC) was adopted in 1998. As the EPC, it excludes plant and animal varieties as well as essentially biological processes for the production of plants or animals from patent protection. It stipulates that plants or animals are patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. The Administrative Council of the EPO incorporated the provisions of the Biotech Directive into the Implementing Regulations to the EPC as far as they were not already present in Article 53 (b) EPC.

The ethical, social and economic aspects of patent protection on biological inventions are highly controversial with different prevailing opinions in different countries. Contrary to the aim of the European patent system to harmonize the patentability criteria in Europe, some countries amended their national law in order to cope with public criticism. The Netherlands were the first to introduce into their Patent Act the explicit exclusion from patentability of plants and animals which are exclusively obtained by essentially biological processes. In the following France, Germany and Italy enacted similar provisions, whereas most other EPC member states kept their patentability provisions harmonized with the EPC.

In 2015, the European Parliament adopted a resolution asking the EU Commission inter alia to look into the patentability of products derived from essentially biological processes. In its Notice published in November 2016, the Commission took the view that the EU legislator’s intention when adopting the Biotech Directive was to exclude from patentability plants and plant parts obtained by essentially biological processes.

In Broccoli I and Tomatoes I, the EBA studied the long legislative history of the Biotech Directive which was full of changes and turns in the somewhat broader context of interpreting the term “essentially biological processes”. Its poor result is in remarkable contrast to the clear conclusion in the EU Commission’s Notice. The EBA noted:
“As a result, the legislative history of the Biotech Directive does not assist in determining what the legislator intended to say by the wording which was eventually adopted for Article 2 (2) Biotech Directive. On the contrary, it must be concluded that the contradiction between the terms of the provision cannot be further clarified.”

In Broccoli II and Tomatoes II, the EBA concluded:
“Thus the Biotech Directive, to which Rule 26 (1) EPC refers as a supplementary means for interpreting the EPC in relation to biotechnological inventions, does not provide a basis for extending the process exclusion under Article 4 (1) Biotech Directive and Article 53 (b) EPC to products of such processes.”

Thus, the EBA concluded that the patentability of a plant product is to be assessed independently from the process by which it is produced whereas the Notice of the EU Commission extends the exclusion for essentially biological processes to products obtained by such processes.

The Notice of the EU-Commission of November 2016 prompted the President of the EPO to stay immediately all first instance proceedings in which the question of the patentability of plants obtained by essentially biological processes was the decisive question and to propose an amendment to Rule 28 EPC by adding a new paragraph 2, according to which European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process (Doc. CA/56/17). The amendment was discussed in the Patent Law Committee in spring 2017 and adopted by the Administrative Council in June 2017.

Decision T 1063/18 is the logical consequence of two provisions: Article 164 (2) EPC stipulates that in cases of conflict between the EPC and its Implementing Regulations, the provisions of the EPC prevail. Article 21 of the Rules of Procedure of the Boards of Appeal gives the decisions of the EBA a binding force not only for the answers to the questions referred to it but also for the interpretation of the Convention contained in its decisions. Should a Board of Appeal consider it necessary to deviate therefrom, a question has to be referred to the EBA again. So far, it has happened only once that a Board decided to make a referral on this basis in G 9/93, OJ EPO 1994, 891 – Opposition by patent proprietor/PEUGEOT AND CITROEN.

The case was remitted to the Opposition Division because properties of a plant disclosed in the document considered by the Board as the closest prior art were still contested. Thus, the proprietor’s second auxiliary request to refer a question to the Enlarged Board of Appeal was not discussed in the oral proceedings. Whereas a Board of Appeal may make a referral in a future case, the President of the EPO can make a referral only if a divergence in the case law of the Boards of Appeal exists, which is at present not the case.

What does all this mean for legal certainty and harmonization aimed at by the EU Notice? In the absence of a new referral, the EPO practice will follow Broccoli II and Tomatoes II. In validity proceedings in the EPC member states, national courts will have to apply and interpret Article 53 (b) EPC. In this exercise, also national courts are bound by the prevailing force of the Convention via Article 138 (1) in conjunction with Article 164 (2) EPC. This will result in diverging decisions, depending whether the courts find the interpretation of Article 53 (b) EPC by the EBA persuasive or whether they follow the Summary of the proposal for amending Rule 28 EPC stating that the amendment “is proposed to clarify the interpretation of Article 53 (b) EPC”.

In some cases, national courts taking the EU Commission’s approach may save a patent by applying the very narrow definition of an “essentially biological process” in Rule 26 (5) EPC, corresponding to Article 2 (2) of the Biotech Directive, instead of the broader interpretation by the EBA in Broccoli I and Tomatoes I.

The Notice of the EU Commission can be read here.
The proposal to amend Rules 27 (b) and 28 EPC can be read here.
The Minutes of the oral proceedings, issued on December 14, 2018, can be read from the electronic file here.

Reported by: Dr. Rudolf Teschemacher, updated on December 17, 2018