NautaDutilh represents several soy meal importers in the Dutch chapter of the pan-European litigation brought by Monsanto in an effort to stop imports of soy meal from Argentina. In its 24 September 2008 decision, the District Court of The Hague (having heard the parties' observations in respect of the draft questions included in its 28 March Decision) refers several questions to the European Court of Justice. At stake is whether the Biotech Directive determines the scope of DNA patents, or whether there is room for a more absolute protection conferred by national patent laws.

Background

Monsanto is the proprietor of European patent EP 0 546 090 relating to glyphosate-tolerant 5-enolpyruvylshikimate-3 phosphate synthesis, an invention causing glyphosate (a herbicide) tolerance in soy plants. Argentina is one of the few places in the world where no IP protection for this invention exists, and farmers in Argentina have adopted this technology. Argentina is one of the largest exporters of soy products.

Monsanto's invention results in genetically modified plants and produces benefits at the crop growth stage of the production. A large part of the soy beans from these plants are used for the extraction of oil. After oil extraction, the residual parts of the soy beans are then further processed into soy meal, which is used as cattle feed. Monsanto argues that intact DNA molecules are residually present in soy meal imported into Europe and that its patent is therefore infringed under national patent laws in Europe.

The soy meal importers, on the other hand, argue - inter alia on the basis of Article 9 of the Biotech Directive - that the scope of protection of Monsanto's patent does not extend to situations where the DNA molecules, if present at all, are residually present and are incapable of performing any function whatever, least of all the function for which the patent was granted: creating glyphosate tolerance.

The Questions

The District Court decided that it cannot clearly ascertain whether "classic", absolute product protection would apply for DNA molecules on the basis of national patent laws and that their scope of protection is unrelated to any function or expression of characteristics within the meaning of the Biotech Directive. It will effectively ask the ECJ whether, under the present circumstances of the case, the scope of protection of DNA patents is governed exclusively by the Biotech Directive.

The questions referred to the ECJ are as follows:

  1. Should Article 9 of Directive 98/44/EG of the European Parliament and the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 0013-0021) be understood in such a way that the protection meant in this Article can also be relied upon in a situation such as in these proceedings, whereby the product (the DNA-sequence) is part of a material that is imported in the European Union (soymeal) and does not perform its function at the time of the stated breach, but has performed it (in the soyplant) or possibly, after it is isolated from the material and incorporated in the cell of an organism, might perform its function once again?
  2. Assuming the presence of the DNA sequence as described in claim 6 of the patent with number EP 0 546 090 in soy meal imported into the European Community by CEFETRA and ACTI and assuming that the DNA is incorporated in the soy meal as meant in Article 9 of the Directive 98/44/EG of the European Parliament and the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 0013-0021) and that it therein no longer performs its function: Does the protection of a patent for biological material provided for in the directive, especially article 9, stand in the way of the national patent legislation (In Article 53 ROW 95, in so far as relevant here is provided: A patent gives the patent holder (...) the exclusive right: a. to manufacture the patented product in or for his business, to use, bring into circulation or further sell, to rent out, to supply or otherwise trade, or to this end offer, import or have in stock). to (additionally) allow absolute protection for the product (the DNA) as such, whether or not the DNA performs its function, and must the protection provided by article 9 of the directive therefore be considered to be exhaustive, in the situation meant in that article that the product consists of genetic information or contains such information, which product is incorporated in material and in which material the genetic information is contained?
  3. Does it make any difference for the answer to the previous question that the patent with number EP 0 546 090 was applied for and granted (on 19 June 1996) before the Directive 98/44/EG of the European Parliament and the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 0013-0021) was adopted and that such an absolute product protection was offered by the national patent legislation before this directive was adopted?
  4. Can you, on answering the previous questions, take into consideration the TRIPs Treaty, specifically the Articles 27 and 30 thereof? NautaDutilh will refrain from commenting on this case as it is involved in this litigation, but will keep you informed of the progress in this case. It will be the first time that the ECJ reviews the important issue of the scope of protection in the context of DNA patents.