Brussels 19 July 2005:
Uncertainty reigns as biotech patents remain unharmonised
The EU Commission has published its long awaited 2nd report (1) on the EU Biotechnology Patents Directive (Directive 98/44/EC ). The report deals with "Developments and implications of patent law in the field of biotechnology and genetic engineering", and specifically investigates the issues of (i) patenting of human DNA, and (ii) patenting of human stem cells. These issues have for a long time been at the centre of a debate as to whether inventions comprising human gene sequences or human stem cells can be patented. On both issues the Commission recommends to continue monitoring the developments, and has refrained from taking a position, judging it premature to do so at this stage.
Implementation of Directive 98/44
The Directive entered into force in July 2000, and 21 Member States of the EU have now implemented the Directive with Italy, Luxembourg, Lithuania and Latvia still remaining. Furthermore the EEA states Norway and Iceland have implemented the Directive, and the Candidate State of Croatia. It seems that the Commission is unaware that the Candidate States of Bulgaria, Romania and Turkey have all actually implemented the Directive. Finally, the Commission does not mention that the European Patent Organisation, including France and Germany implemented the Directive as early as 1999. Thus a total of States and one international patent organisation have implemented the Directive, while four EU Member States and Switzerland/Liechtenstein still are in the process.
On gene sequences
Two EU Member States, France and Germany, have in different ways limited the scope of patent protection for human gene sequences to the specific use disclosed in the patent application - generally known as "purpose bound protection". France has outrightly banned the patenting of human gene sequences.
The remaining countries provide absolute product protection for human gene sequences that gives a scope covering possible future uses of that sequence.
While the Commission considers that there are no objective grounds for limiting the protection relating to sequences or partial sequences of human genes, it has decided to withhold judgement on whether these Member States have correctly or incorrectly