03 November 2011
In no other area are patentability issues so controversial as in biotechnology. That might appear surprising; after all, the R&D work done in this field can pave the way for new therapies with enormous medical and commercial potential, so encouraging it through patents might seem only logical.
But patents are also ownership rights, which some people consider inappropriate on ethical grounds where living organisms are concerned. Devising a balanced system responsive to these opposed standpoints is not an easy task. In Europe, after many years of debate, EU legislators drew a line between what is patentable and what is not, and their 1998 biotechnology directive was incorporated into the EPO’s legal framework back in 1999, far earlier than in many EU member states.
The EPO is now doing its best to implement this legislation in its daily work. It is well aware of the sensitivity of the issues involved, and although biotech accounted for under 5% of all European patent applications received in 2010 has set up a dedicated specialist taskforce and applies the rules very strictly (the grant rate in biotech is 28%, compared with 42% overall). Even so, every so often one of these cases becomes a cause célèbre.
The Court of Justice of the EU recently gave its opinion (in the Brüstle v Greenpeace case) on the limits to patentability for human embryonic stem cells, following a referral by the Federal Court of Justice of questions arising in connection with Mr Brüstle’s German patent. Parallel proceedings are pending on a similar European patent, albeit with a narrower scope of protection. Two other cases – the “tomato” and “broccoli” ones – are also currently pending before the EPO’s boards of appeal.
If the judges rule in favour of a restrictive interpretation of biotech patentability provisions, the EPO will immediately implement it. The European legislator may also decide that further changes to the law are needed. Whatever is decided, I welcome evidence-based debate and invite all interested parties, especially associations active on these issues, to discuss them with us on the basis of objective data. It should also be kept in mind that changes to our legal framework are likely to have economic consequences, including possible deterrent effects for the siting of research centres in Europe.
Tags: Biotechnology, biotechnology directive, EPO EPA Europäisches Patentamt European Patent Office, EPO president, Ethics, European Court of Justice, Patents on life, stem cells, stemcells