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No absolute protection for gene sequences in Europe?

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No absolute protection for gene sequences in Europe?

In the case C-428/08, the Advocate-General of the European Court of Justice recently issued his conclusion.

The case deals with questions of the Dutch Court of First Instance on the interpretation of the Biotech Directive in relation to the general patent law. Especially important was whether a claim directed to a gene sequence would have a scope of protection that was determined by the normal patent law and thus, an absolute scope of protection like any chemical compound, or whether the protection of a gene sequence would be solely limited to the protection as defined in the European Directive on the Protection of Biotechnological inventions (Directive 98/44/EG), i.e. a purpose-bound protection.

The specific case on which the Dutch court referred questions to the European Court of Justice was the case Monsanto vs. Cefetra, where Monsanto has a European patent on a gene that was used to make soybean plants resistant to glyphosate. The plants were grown in Argentina, where Monsanto had no patent protection, and the soy meal from these plants was imported into Europe. It was in confession between the parties that there still was intact DNA in the meal, in which the complete gene was available. The court held that this could be called infringement on the basis of the absolute protection for chemical compounds. On the other hand, there was the Biotech Directive. According to Article 9 of this directive, protection conferred by a patent for a product containing or consisting of genetic information is extended (or limited) to all material in which the product is incorporated and in which the genetic information is contained and performs its function. Thus, according to the directive, there is only protection if the genetic material performs its function. In the present case, however, the DNA in the meal did not exert its function at the moment of the alleged infringement.

The Advocate-General has studied the question in depth, also relying on the legislative history of the directive. Some of his arguments were:

1) The question that has to be answered is generally applicable in all cases where a product is imported in the European Union that is obtained by production (in a non-European country) of a genetically modified plant on which a European patent is vested.

2) For determination of patentability of a genetic sequence it is prescribed in the directive that a function of the sequence be given. This requirement is meant to distinguish between an invention and a discovery.

3) An absolute protection would mean that a gene sequence is protected for all its possible functions. This would (in view of 2 above) lead to the patenting of a discovery, i.e. grant of a patent for a function that is yet unknown at the moment of filing.

4) If a sequence were to be granted absolute protection, Article 9 of the directive would have no meaning (since it would not add any protection).

5) Function-limited protection (although with respect to human gene sequences) has been implemented in the German and French national patent laws on the basis of the directive.

6) A de minimis solution to resolve the dispute would be unwanted since there would always be uncertainty as to the metes and bounds of such a de minimis rule.

On the basis of these arguments, the Advocate-General concluded that, according to the system of the directive, the protection for a gene sequence should be limited to situations in which the genetic information exerts its function. This holds both for the protection of the sequence and for the material in which the sequence is incorporated.

The Advocate-General clarifies that the protection should not be limited to only those cases in which the gene is “turned on”. It is clear that for application of the directive, in particular Art. 9,  genetic information exerts its function if this genetic information a) is part of living material; b) is transferred to the progeny if the living material multiplies; and c) constantly, or any time in certain circumstances, exerts the function for which it is patented.

Although this is only the conclusion of the Advocate-General, it is very common that the European Court of Justice will follow the advice and will respond to the referred questions along the lines of the present conclusion.

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