This highly controversial issue covers the protection of biotechnology inventions and a potentially lucrative and large market, but also the ethical aspects of patenting.
These ethical concerns have been at the heart of a 10 year stand-off between EU governments and MEPs that was ended by the adoption of a Directive and a European Court of Justice ruling (explained below).
The new report from the Commission is issued at a time of intensive debate in the European Parliament over bioethics within the 7th Framework Programme and regarding the alleged sale of human eggs for fertility treatment.
Report on biotechnological inventions addressing gene patents and stem cells
The Biotechnology Directive (98/44/EC) obliged the Commission to report on the scope of patents on sequences of genes which have been isolated from the human body; and the patentability of human stem cells and cell lines obtained from them.
The Commission report states that:
With regard to patents on gene sequences, the Commission will continue to monitor the economic consequences of the differing legisative environments in Member States;
Totipotent stem cells (i.e; cells that are capable of developing into a human being) should not be patentable, on grounds of human dignity;
Because of the divergence of laws and laws among Member States, the patentability of pluripotent stem cells (ie cells that can develop into other types of cells but not into a human being) cannot be solved and the Commission report considers that it is premature to come to a definitive conclusion on this issue.
Background on the Biotechnology Directive
In 1998 the Council and the Parliament adopted a Directive to cover the legal protection of biotechnological inventions, the so-called Biotecthnology Directive 98/44/EC, which came into force in July 2000.
The Directive states that patent protection is necessary to encourage vital investment in the biotechnology industry. The law distinguishes between discoveries (i.e. materials that already exist and add to or extend scientific knowledge) which cannot be patented and inventions defined as covering gene sequences (ie the technical process to isolate or reproduce a natural element) which are patentable.
But the Directive does not permit patents on some processes for ethical reasons:
cloning human beings,
modifying the genetic identity of human beings,
use of human embryos for industrial and commercial purposes,
processes for modifying the genetic identity of animals and animals resulting from such applications.
Specifically the Directive states that DNA or the genetic code of human beings cannot be patended but industrial applications or products involving DNA can be patented if they meet the criteria for ’invention’ which include novelty, innovation and industrial applicability. This means that a particular gene is not patentable but the process leading to its dicovery and isolation can be.
A 2001 European Court of Justice (ECJ) ruling backs the Biotechnology Directive
After the Biotechnology Directive was adopted, the Dutch government, supported by Italy and Norway, challenged the legal basis of the Directive at the European Court of Justice.
The Netherlands argued that the Directive undermines the inalienable nature of human beings and as such, contradicts the fundamental right to human dignity and integrity.
In 2001, the ECJ ruled in favour of the Directive->ECJ), stating that the law has sufficient safeguards to protect human integrity and dignity because the human body as such (DNA or genes) cannot be patented.
The ECJ ruling underlined that all processes which may offend human dignity must be excluded from patentability.
