Munich, Germany
9 December 2010
The European Patent Office's Enlarged Board of Appeal has now rendered its decisions in the so-called "broccoli" (G 2/07) and "tomato" (G 1/08) cases, bearing on the correct interpretation of the term "essentially biological processes for the production of plants (or animals)" used in the European Patent Convention (EPC) to exclude such processes from patentability.
The Enlarged Board of Appeal is the highest instance in the EPO's judiciary and, as all other Boards of Appeal of the EPO, acts in full independence of the Office in carrying out its duties. Its task is to ensure a uniform application of the patent law under the EPC.
In its decision the Board concludes that a process for the production of plants involving sexually crossing whole plant genomes, and the subsequent selection of plants is not patentable. The mere inclusion of a technical step which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants does not override this exclusion from patentability. While technical devices or means, such as genetic markers, may themselves be patentable inventions, their use does not make an essentially biological process patentable. The Board held finally that processes for producing plants by inserting or modifying a trait in the genome by using genetic engineering do not rely on sexual crossing of whole genomes and may therefore be patentable. However, in such a case sexual crossing and selection steps should not be in the claims, since adding further technical processing steps before or after the steps of sexual crossing and selection does not render such processes patentable either.
To reach their decision, the Board considered the arguments put forward by the respective patent owners and opponents in the cases underlying the referral decisions (T 83/05 - Broccoli and T 1242/06 - Tomatoes), the comments submitted by the President of the EPO and the vast number of submissions by the public, the so-called "amicus curiae" letters, which it had solicited in the course of procedure.
In its 70 pages long decision the Enlarged Board of the EPO also gave a very comprehensive overview of the historical development of the relevant legislation and case law referring to the question of the patentability of essentially biological processes in Europe, including the development of the so-called Biotech Directive (98/44/EC) of the European Parliament and Council.
While the present decisions have the objective of clarifying the legal meaning of the concept of "essentially biological processes" under the EPC, a first concrete application will be provided by the Technical Boards of Appeal, which had referred the questions to the Enlarged Board of Appeal and are now called to decide upon the individual cases in the light of the guidance provided by the Enlarged Board of Appeal.
Background to the decision
In Article 53(b) the EPC prohibits patents on "plant or animal varieties" and on "essentially biological processes for the production of plants or animals". On the basis of this formulation the European Patent Office (EPO) has hitherto held marker-assisted selection to be a technical process and therefore patentable because in addition to conventional breeding steps it also involves the use of marker genes to select particular characteristics.
On that basis, Plant Bioscience Ltd. was granted a patent (EP 1069819) in 2002 on a method for selectively increasing the level of a potentially anticarcinogenic substance in broccoli plants. The method involves locating the relevant genes on the broccoli genome and identifying them with genetic markers. Then broccoli lines containing the desired substance at a high concentration are selected by means of these markers and used in plant breeding.
The patent was initially granted even though the process also includes conventional breeding steps. In April 2003 a Swiss competitor, Syngenta Participations AG, filed notice of opposition, maintaining that the patented selection method was an "essentially biological process" and hence not patentable under the EPC. This opposition then went to appeal before one of the EPO's technical boards of appeal.
Patent EP 1211926 is a similar case: in 2000 the Israeli Ministry of Agriculture applied for a patent on a method for breeding tomatoes with reduced water content and on products of that method. In 2004 the Dutch company Unilever N.V. filed notice of opposition to the granted patent and called for it to be revoked on the same grounds as in the broccoli case. This case too then went to appeal before an EPO board.
The technical board responsible for both appeals deemed that the fundamental issue of how to construe the term "essentially biological processes for the production of plants or animals" had to be settled before it could rule on the patentability of the two applications. In 2007 it referred questions on the subject to the EPO's Enlarged Board of Appeal. As the two cases raised similar issues, the Enlarged Board considered them in consolidated proceedings.
A hearing on these proceedings was held in Munich on 20 and 21 July 2010. The Enlarged Board looked at whether marker-assisted selection was a biological breeding process or was a technical method and therefore patentable. The public too had an opportunity to comment on the issue in written statements.
The patentability of plants and animals is not affected by the decision and was not open to discussion at any time.
Patenting practice in the field of biotechnology is governed by the EU's 1998 Directive on the legal protection of biotechnological inventions, which among other things states that inventions concerning plants and animals are in principle patentable. At the behest of the European Patent Organisation's Administrative Council the Directive has been incorporated in the EPC; but it cannot regulate all cases in practice, and does not clearly define the boundaries between classical breeding, crossing and selection and modern methods of breeding by biotechnological means.
The EPO can only examine whether a patent application concerns a technical development which is new and industrially applicable and involves an inventive step. It is not authorised or able to assess its social, economic or ecological implications. That is a task for the legislator and for the competent European and national regulatory authorities.
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