BRUSSELS, Belgium - New European Union rules on biotechnology patents, agreed to two years ago at the European level, are due to come into effect at national level on July 30, but not all member states are yet ready, and the rules already have come under attack.

The Netherlands has lodged a formal appeal at the European Court of Justice (ECJ). The European Commission is insisting, however, that since the court has not yet set a date for a hearing, all 15 member states must implement the directive by the deadline.

The EU directive on the legal protection of biotechnological inventions, which aims to provide a coherent legal framework across Europe for patent protection for biotechnology-derived products, was approved by a majority of member states and by the European Parliament in 1998, the commission pointed out in response to the challenges. In a statement last week, the commission stressed the importance of patents in the area of biotechnology as "essential to encourage the investment required to create jobs and maintain the European Union's competitiveness in this crucial field."

"EU rules provide that any member state may challenge EU legislation," the commission acknowledged. "However, until such time that the ECJ has ruled on the issue all member states are bound by the existing law."

The commission said it is working with the member states to help them implement the directive correctly and on time. It already has started to receive notifications of implementing regulations from them.

EU Clarifying Genome Patent Issues

In the wake of the recent progress on the human genome project, the commission has been trying to clarify some of the complexities surrounding EU intellectual property rights and the results of biotechnology research.

Neither DNA nor the human genome can be patented under the EU biotech patents directive (due to come into effect on July 30) because they are not inventions but discoveries.

"The mere sequencing of a genome," the directive says, "belongs to the area of discovery, and cannot be the subject of patent protection. The directive confirms that all biotechnological inventions which deal with human, vegetable, or animal genes involve materials which already occur in nature and can therefore under no circumstances be invented, but only discovered."

"Intellectual property protection for gene based inventions will, however, play an important role in stimulating investment into using this raw data on the human genome to develop important new products," the commission said in a briefing last week. The use of DNA during an industrial application does not of itself preclude patenting an industrial process or a product: "This would be a patent not on the DNA but on the industrial application or isolation process using it," the commission explained. Patents for inventions comprising, or based on, gene sequences or partial gene sequences should be allowed under the new EU rules. The reasoning is that the invention arises from the isolation of a particular gene from its natural surroundings by means of a technical process. But patents should be granted only when the application does not include specific reference to the industrial application of the gene sequence, the EU rules require.

All patent systems in Europe include exceptions so as to allow for research and experimentation on the subject matter covered by a patent, and other safeguards such as compulsory licenses prevent patent holders charging unreasonable fees for the use of their inventions, the commission pointed out.

It also sought to allay concerns that EU rules would allow cloning human beings to be patented. The directive clearly disallows patenting of certain inventions because their commercial exploitation would be contrary to the public order or morality, including processes for cloning human beings or modifying the germ line genetic identity of human beings, and uses of human embryos for industrial and commercial purposes. The commission said the patent on transgenic stem cells granted by the European Patent Office to the University of Edinburgh in December 1999 would have been illegal under the directive.

And it confirmed that EU law cannot override national law in this area.

The commission said it had no current plans for any further initiatives in the area of patents and biotechnology, but that it will monitor the directive to ensure that its scope of protection remains relevant to the technological developments and that it remains in line with public attitudes.

Friends Of Earth Want Destruction Of French Maize

Friends of the Earth is calling upon the French government to order the destruction of up to 5,000 hectares of maize that have been planted with seed contaminated with genetically modified (GM) varieties. The discovery of the contaminated maize was first made public during June, and a decision by French Prime Minister Lionel Jospin was promised in early July, but "so far nothing has happened," Friends of the Earth's Europe office in Brussels said.

The maize seed, distributed by the company Golden Harvest, was found to be contaminated by three GM varieties: Bt 176 (authorized for cultivation in the EU), Bt 11 (authorized for import, but not for cultivation), and a third variety that has not been identified by genetic testing.

"We urge the French government to take as firm a stand on the GM-contaminated maize as it did in the recent case of the GM-contaminated oilseed rape," said Gill Lacroix, biotechnology coordinator at Friends of the Earth Europe. "To do nothing would be a complete travesty of the EU's legislative procedure because two varieties involved in this latest contamination scandal are not approved for growing in the EU, and farmers once again have been the victims of GM pollution."

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