Biotechnology and patents

26 November 2012

Although biotechnology is important for the economy and society, patenting in this field sometimes faces opposition from the public, especially NGOs. The few cases concerned tend to attract a lot of attention, as did three patents recently granted by the EPO. They cover different kinds of processes for re-engineering genes to be used in medical research into cancer treatment. This technique could apply to various animals, including great apes, which has prompted criticisms from animal protection organisations.

At this stage, I will refrain from commenting on these specific cases, which are now pending before EPO opposition divisions. However, I would like to make a couple of general points about the role of patent offices, and the framework in which they operate. Firstly, despite what some people seem to think, it is not easy to get a patent. The EPO applies a very rigorous examination procedure (the grant rate was 47% in 2011). It is even more stringent in biotechnology, where only 27% of applications lead to granted patents – very few in the form originally requested by the applicant. We devote considerable resources to strengthening our procedures and continuously improving the quality of our products and services.

Secondly, we have integrated the EU biotech directive into our legal framework, and EPO practice carefully follows the case law of the EU Court of Justice. The EPO’s examination procedure is strictly confined to a legal assessment of the application. The main grounds for refusal are lack of novelty or inventive step. In biotechnology, exceptions to the general principle of patentability exist for plant and animal varieties, and for essentially biological plant- and animal-breeding processes. Moreover, inventions which are contrary to a common concept of morality are also excluded from patentability. And before a granted patent can be used, the owner often has to comply with other legislation or legal restrictions outside the EPO’s remit. New drugs, for example, must be approved by the relevant regulatory authorities prior to marketing.

Biotech patenting is at the forefront of technology but sometimes can also involve ethical and other considerations. These are open to differing interpretations, depending on each individual’s sensitivities, background and experience. While some reactions especially from the lay public are perfectly understandable, a strict ban could be highly detrimental to promising economic sectors. In this connection, as part of Horizon 2020 the European Commission has recently initiated a new strategy – “Innovating for Sustainable Growth: A Bioeconomy for Europe”. One of its many aims is to boost bioscience by improving research facilities to develop new technologies for the benefit of the bio-industries at large.

For its part, a patent office has to be neutral, and apply the rules as laid down by legislators and interpreted by the courts. It cannot allow itself to be influenced by the lobbying of different groups. The EPO will continue its rigorous application of the patentability criteria and all exclusions.

Benoît Battistelli

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Categories: Biotechnology, Patents

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