Europe's biotech trade group, EuropaBio, responded with dismay this week to news that the European Commission has no intention of taking action to further harmonize the way that different EU states implement a directive on patenting of human gene sequences or stem cells.
In a report released Monday, the commission discussed developments in the patent field that relate to the EU Biotechnology Patents Directive of 1998. Since 2000, all EU member states except Italy, Luxembourg, Latvia, and Lithuania have implemented the directive into national law.
However, while most countries have implemented the directive in a similar way, France and Germany–two countries with big biotech sectors–have interpreted the patent protection offered on gene sequences in a more restricted manner. Those two countries have limited the scope of patent protection for human gene sequences to the specific use disclosed in the patent application.
In the report, the commission acknowledges variations in the way the directive is implemented, and concludes that there are no objective grounds for restrictions on traditional patent protection for inventions. However, it adds that it "does not intend to take a position on the validity of member states' implementation on the basis of whether they have chosen a classical or a limited scope of protection for gene sequences."
Bo Hammer Jensen, chairman of EuropaBio's intellectual property working group, told
"We would have preferred that the commission had clearly stated that what Germany and France have done is not what the directive says," said Jensen. "What they do is not only a deviation from the words of the directive, but also its spirit," he added.
"The main objective of the directive was to harmonize the patent laws of the EU member states," he said. "We have to conclude that the actual result is a situation with more disharmony than ever."
When EU member states do not properly implement an EU directive, the commission can file suit at the European Court of Justice in Luxembourg. In 2003, it took such action against eight countries that had not implemented the directive. EuropaBio would like to see the commission take this action in the case of France and Germany, Jensen said.
However, the commission said that it would limit itself to monitoring events and seeing whether there are any consequences of divergence between member states' legislation.
On the subject of stem cell patents, it took a similar line. While totipotent stem cells–those capable of developing into a human being–are excluded from patentability on the grounds of human dignity, the commission has decided that it is premature to come to a definitive conclusion when it comes to pluripotent cells.
"The field of biotechnology research is rapidly developing," said EU Internal Market and Services Commissioner Charlie McCreevy in a statement. "It is important that the European Union continues to monitor developments in patent law in this complex and sensitive area."