The European Commission is taking court action against eight of the 15 European Union (EU) member states for nonimplementation of legislation to allow the patenting of biotechnological inventions.

Austria, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, and Sweden have been referred to the European Court of Justice for failure to transpose Directive 98/44/EC into national law. The deadline for implementation was almost three years ago on July 30, 2000.

The commission designed the directive "to clarify certain principles of patent law applied to biotechnological inventions whilst ensuring that strict ethical rules are respected." But the legislation has proved controversial because it allows the patenting of processes involving DNA, genetically modified organisms, and materials derived from the human body. This has generated concern that such patenting may become too easy and be used without proper regard to ethical sensitivities. Each of the noncomplying member states has its own specific objections, but the general concern is that tighter controls are needed.

When Internal Market Commissioner Frits Bolkestein met representatives of member states to review the issue earlier this year, he warned them, "Unless the directive is properly implemented, Europe's biotech sector will be working with one hand tied behind its back and will fall further and further behind."

The directive has been through an unusually lengthy preparation and review process, with a 10-year debate prior to its adoption in 1998. The final text includes many safeguards designed to address the concerns expressed during that debate. It explicitly excludes from patentability discoveries that do not actually apply new knowledge for a new purpose. So it does not allow the patenting of DNA sequences with no clearly identified function. The directive also excludes processes for the cloning of human beings or modifying their genetic identity, the use of human embryos for industrial purposes, and processes for modifying the genetic identity of animals, which may cause them suffering without substantial medical benefits.

"There have been concerns from some of the member states about the patenting of DNA sequences," Sandy Thomas, director of the Nuffield Council on Bioethics told The Scientist. "Even though you can't patent raw DNA sequence, it is nevertheless possible to claim a DNA sequence if you can meet the criteria."

But, Thomas added, "A lot of the criticism that has been made should more justifiably be directed at the US Patent and Trademark Office, which has been generally more liberal in awarding patents in biotechnology."

Hugo Schepens, secretary general of EuropaBio, the European Association for Bioindustries, told The Scientist, "As representatives of the European biotech industrial community, we welcome this strong step taken by the commission." Schepens feels the commission has made every possible effort to try to meet the concerns of the directive's opponents.

If the Court of Justice finds in favor of the Commission, history suggests the member states will eventually comply. Court spokesperson Chris Fretwell told The Scientist, "If they fail to comply with the court's judgment… the commission may commence proceedings against those countries, requesting the court to fine them a certain amount per day."

In previous disputes of this kind, only one country has ever resisted to the point of being fined.