Tag Archives: marker-assisted selection

The battle of the broccoli and tomatoes

I believe that the entire agricultural and biotechnology community is looking forward to learning about the outcomes of last week’s hearing at the European Patent Office (EPO) Enlarged Board on whether marker-assisted selection is a biological breeding process or a technical method and therefore patentable. 

At stake are two patents: Patent EP 1069819, which the EPO granted in 2002 to Plant Bioscience Ltd., on a method for selectively increasing the level of a potentially anti-carcinogenic substance in broccoli plants; and Patent EP 1211926 granted to the Israeli Ministry of Agriculture in 2004 on a method for breeding tomatoes with reduced water content. Both patents have been challenged respectively by Syngenta Participations AG and Unilever N.V. on grounds of invalidity: the selection method was essentially a biological and not a technological process and thus not patentable.

Both Syngenta and Unilever referred to the Board the following questions:

1.         Does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants fall under the exclusion of Article 53(b) of the European Patent Convention (EPC) only if these steps reflect and correspond to phenomena which could occur in nature without human intervention?

2.         If question 1 is answered in the negative, does a non-microbiological process for the production of plants consisting of steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as part of any of the steps of crossing and selection, an additional feature of a technical nature?

3.         If question 2 is answered in the negative, what are the relevant criteria for distinguishing non-microbiological plant production processes excluded from patent protection under Article 53(b) EPC from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?

In answering the above questions the Board will analyze and apply article 53(b), trying to establish:

“…. whether marker-assisted selection is a biological breeding process or is a technical method and therefore patentable”.

The problem comes from a tension created between article 53(b) of the 1973 EPC which excludes (or exempts) from patentability plant or animal varieties and essentially biological processes for the production of plants and animals and Directive 98/44 article 3(2) which states that:

 “biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature”.

Article 3(2) is controversial because, as Dr Van Owervalle points out:

“a distinction has to be made between the natural phenomenon discovered by the researcher and the invention resulting from the searcher’s work after the discovery of a natural phenomenon”.

To complicate the matter further, the broccoli and tomato patents do not protect only the method used to identify the anti-carcinogenic substance and water content, but also the plants selected and produced by this method.

So would the patents breach or contradict article 53(b) of the EPC?  Will the patents grant a monopoly (even if only for 20 years) over the plants themselves, with potentially negative consequences for independent farmers and consumers as DW-World states?  According to Christopher Then of Greenpeace, the only way this tension and complexity can be resolved is by simplifying the patent system and clarifying the bans on what can be patented.  The protests taking place in Germany are around the patentability of new varieties of plants which should not be allowed as “they belong to all humankind”. 

 In my opinion the key point is whether the patents do really extend to the plants themselves or are limited to the technical method used to identify certain elements in the plants.  If the applicability of such inventions is the use of the method for the production of the specific modified plant, then a ban should be imposed. What is clear is that if developing countries adapt or, even worse, translate our already confusing standard to their patent systems, nothing good will come out of it! Carlos Correa, Director of the Centre for Interdisciplinary Studies on Industrial Property and Economics Law, at the University of Buenos Aires, believes that this is perhaps a good opportunity to review the system and says that:

Changes are visible not only in Europe, but also in the US where healing has started and the patent system is being given a second look after years of ever-extending patenting”.

We will see….a decision is likely to be taken only towards the end of the year…

If you want to read more about this issue, please refer to the following documents: http://www.epo.org/about-us/press/backgrounders/history.html; http://www.droit-technologie.org/actuality-1175/the-directive-98-44-ec-for-the-legal-protection-of-biotechnological-in.html.

Post written by Francesca Re         Manning of CAS-IP