Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-05-09-Speech-3-201-000"
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"en.20120509.21.3-201-000"2
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"Mr President, the issue of the patentability of essentially biological processes is very sensitive, and the patenting of plant-related inventions is particularly sensitive for plant breeders.
A biotechnological patent is granted in order to promote innovation. Under the breeders’ exemption principle, it should, however, not keep breeders from innovating further by using protected material to create new plant varieties. The Biotech Directive does not explicitly address the question of a breeder’s exemption. In some Member States though – Germany and France for example – such an explicit provision exists in national patent legislation.
The Commission intends to take a closer look at questions concerning the breeders’ exemption, and also at the issue of essentially biological processes, in the coming months.
As already mentioned in our replies to written questions by honourable Members, the Commission will indeed publish a new report under Article 16(c) of the Biotech Directive covering breeders’ relevant issues, national developments and the relevant case-law.
In conclusion, let me assure you that the Commission is taking the concerns raised – especially those related to blend breeding – very seriously. We are already looking closely into the matter and will deal with all relevant topics in full transparency and openness. Commissioner Barnier will be happy to provide further information on this subject.
Biotechnological inventions relate to biological material, meaning any material which contains genetic information and which can either reproduce itself or be reproduced. Such inventions concern either a product consisting of, or containing, biological material, or a process by which biological material is used or produced.
Biotechnology is very diverse and covers agriculture, pharmaceutical, medical or industrial applications. Therefore, biotechnology offers a great potential to assist us all in our daily lives and in life-saving circumstances. It is a hallmark of the European capacity for innovation.
The number of patent applications relating to plants in Europe has been stable over the last decade, with an average of 800 applications per year. Since 1990, some 1 700 such patents have been granted, of which slightly less than 100 concerned non-genetically modified inventions. This may seem low compared to an overall number of 2 100 patents granted in 2011 in the sole field of biotechnology. However, because of rapid technical progress in breeding activities, the granting of plant-related patent rights creates potential tensions.
The directive on biotechnological inventions, or ‘Biotech Directive’ for short, sets limits on the patentability of biotechnological inventions. Similar provisions also exist in the European Patents Convention (EPC).
Let me be very clear here: elements occurring naturally cannot be patented. They are mere discoveries and not inventions. To be patentable, an invention must have a technical character, be new and inventive, and must not be exempted from patentability.
With regard to the third condition, the Biotech Directive and the EPC set strict exclusions. Essentially, biological processes for the production of plants may not be patented. Such essentially biological processes consist purely of crossing and selection.
Breeding techniques have, however, substantially evolved in the past years. Modern, so-called ‘smart’ techniques make breeding more efficient; they use markers which allow for the targeted selection of existing plant material genes for further breeding. In the so-called ‘broccoli’ and ‘tomato’ cases, the enlarged Board of Appeal of the European Patents Office clarified that conventional breeding methods are still excluded from patentability even if they make use of marker techniques.
However, some grey areas remain, in particular, as to whether a new plant which is a product of conventional breeding may itself be patentable. Of course, if this product is a plant variety – for example, Angel’s Dream, one of the 3 000 varieties of tulips – it cannot be patented. But the issue arises where the invention can be applied to different plant varieties. This question will soon be examined by the enlarged Board of Appeal. We therefore expect further guidance in the future."@en1
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