Today the European Patent Office’s Enlarged Board of Appeal will hear a highly contested and much anticipated case on on the patentability of biotechnological enhanced breeding methods (in this case for broccoli and tomatoes). The patentability of biotechnological inventions is equally controversial as whether software patents are eligible for patent protection. Critics argue that patenting biotechnological inventions is nothing less than patenting life itself, despicable as that would be. As with many other inventions that are by law not eligible it all boils down to definitions on how wide or narrow biotechnological inventions are being defined. Critics argue we are better off having no patent protection at all. Nonetheless, most worldwide patent systems already provide patents on biotechnological inventions and the EPC does so too if the common presuppositions of patentability are met, and the patent does not claim a plant, an animal or an essentially biological process.
Considering the exception of plants from patentability one could come up with an idea to go around it by applying for a patent claiming a biotechnological process from which the plant is made. This process would be patentable if it is not about an essentially biological process or if it is a microbiological process. And thus the hearing is not about the patentability of plants itself but to clarify under which circumstances the biotechnological process the tomato and broccoli stem from is patentable. Practitioners and anti patent lobbyists alike expect a fundamental decision about what is a biotechnological process, when such a process is an essentially biological process that could not be patented under EPC Art. 52(b) and what distinguishes it from a patentable microbiological process.
The two patents in question concerning breeding methods of tomatoes and broccoli. The cases are also known as the “Broccoli” and “Tomato” cases (for a slight history of the patents see here). The Broccoli Patent, EP 1069819, was granted in 2002, the Tomato Patent, EP 1211926, in 2000. Both patents have been attacked by competitors of the patentee through opposition. The method claimed in the broccoli case is about selectively increasing the level of a potentially anti carcinogenic substance in broccoli plants. Relevant genes on the broccoli genome were located by genetic markers. Broccoli lines containing the desired genes are selected by the means of this markers and used in (conventional) plant breeding. A similar method of breeding tomatoes with reduced water content has been applied for patent protection in the Tomato case. The EPO deemed both processes of marker-assisted selection as a technical process and therefore patentable.
Just as line selection is a very common means in conventional breeding, marker-assisted selection of genes is a very common means in biotechnology. Could the combination of these means, i.e. the integration of a biotechnological means into a common breeding process as one single step, really make the whole process patent worthy by coining it (bio-)technical as a whole? The answer will obviously be at the EPO’s Enlarged Board of Appeal, but let us try to give an impartial view as possible in this highly politically driven debate.
Biotechnology could be broadly defined as any technique that uses living organisms or parts of organisms to make or modify products to improve plants or animals or to develop micro-organisms for specific uses. It is not a single technique but a combination of different techniques used to manipulate living organisms in directed fashion. Biotechnology is multi-disciplinary in nature, a series of advanced technologies spanning biology, chemistry, biochemistry, microbiology, protein engineering and genetic engineering put together. In other words, biotechnology means the application of technology or scientific knowledge to biological processes. It involves human intervention to the natural biological process by way of technical contribution to arrive at desired results. Therefore biotechnology is an application of human-invented techniques to natural biological processes.
Coming from this definition, the EPO’s Enlarged Board of Appeal is likely to come to the result that the claimed process is actually a patentable biotechnological process. But another – in our opinion the most crucial – question remains: the question whether the common presuppositions of patentability are met, i.e. novelty and inventive step. Such as the patentability of computer programs should not be linked to an obscure term of technical nature (see the comment on the Siemens-application decision) the term “biotechnological” should not be used to decide whether a process is patentable or not. Instead the presuppositions of “novelty” and “inventive step” should decide about the patentability.
Just one note to that. On reflection, the claimed processes from the patents in questions are just line selection on specific attributes of the natural plants. It is similar to selecting the color of a rose to breed a special colored rose, or to use a microscope to find out about a special cell structure worth to breed further. No one would come to the idea to apply the use of a microscope for breeding purposes for patent protection. In other words, it is very questionable whether the mere application of any (bio-)technological process or means to find out what is already given in nature could meet the presuppositions of novelty and inventive step. In my opinion: regularly no. Finding natural attributes of plants is neither a new technique nor does it require an inventional step to approach. And also the process of adjusting the modality of breeding to natural attributes discovered in such way regularly lacks the presuppositions of patentability.
That does not mean that enterprises which have been investing in plant breeding should remain without legal protection. But their investments in breeding plants could be also protected by use of plant varieties protection. This way the legal protection of breeding results would be put back to where it justifiably belong to.
Stephan Dorn, (Human Technology Centre (HumTec), RWTH Aachen, Germany
 Raju/Sreenivasulu, Biotechnology and Patent Law, Bangalore 2008, pp. 2
For an overview of the history of this case, read more here