Advocate General opinion Round up and Ready

Today, Advocate General Mengozzi has rendered his opinion in the much debated Monsanto v. Cefetra case (C-428/08).

Background

Monsanto is the proprietor of European patent EP 0 546 090 relating to glyphosate-tolerant 5-enolpyruvylshikimate-3 phosphate synthesis. This patent protects one of the key biotech inventions that are part of Monsanto's Round-Up Ready technology. This particular invention results in genetically modified, herbicide resistant plants and creates benefits at the crop growth stage of soy production. Farmers in Argentina have widely adopted this technology and Argentina has become one of the largest exporters of soy products. Argentina however, is one of the few places in the world where Monsanto has no patent protection for the modified genes and DNA molecules. Monsanto has therefore targeted European imports of soy derivates (important cattle feedstuffs) from Argentina, relying on its European patents.

In Argentina, the soy plants are grown. After harvesting the soy beans, these are processed further into soy meal pellets. The oil is extracted, and the remains are crushed, dried, heated and pressed into the end product, before being shipped to Europe.

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. Monsanto argues that it enjoys absolute product protection. 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 at all.

Article 9 of the Biotech Directive provides as follows:

The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product is incorporated and in which the genetic information is contained and performs its function.

The case is pending before the District Court of The Hague, which has referred several questions to the Court of Justice of the European Union (ECJ). The main questions can be summarized as follows:

  • Should Article 9 of the Biotech Directive be understood in such a way that it confers protection when the genetic information present in the material does not perform any function but has performed a function in the past or when it is theoretically capable of performing a function in the future (ie. when the gene sequence is isolated and again introduced in plant cells)?
  • Should the protection offered by Article 9 of the Biotech Directive be considered to be exhaustive, or is there still room for absolute product protection under national laws?

Opinion of Advocate General Mengozzi

After examining the wording and aims of the directive on the legal protection of biotechnological inventions, Advocate General Mengozzi maintains that the patented DNA is protected as such – that is, as a chemical substance – only where it performs the function for which it was patented. In his view, those are the only circumstances in which the protection also covers the ‘material’ in which the DNA sequence is contained.

The Advocate General concludes that the protection for a patent relating to a DNA sequence is limited to the situations in which the genetic information is currently performing the functions described in the patent. That holds true both as regards the protection of the genetic information as such and as regards the protection of the materials in which the genetic information is contained.

In his view also, Directive 98/44/EC constitutes an exhaustive set of rules governing the scope of protection of patent claims for biotechnological inventions, which rules apply in the entire EU and preclude national legislation from conferring a wider scope of protection. The aim of the directive is to promote the market and competition and to prevent existing legislative differences in that area from having a negative effect on trade within the European Union.  

The final judgment of the ECJ, which often corresponds with the opinion of the A-G, is expected by August/September of this year.

In this case it is also noteworthy that five member states intervened, unanimously taking the position that Monsanto was overextending its patent rights. The Advocate General has now confirmed that Monsanto cannot invoke its patent rights in situations in which the genetic information does not perform any function at all.

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 important 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.

Please click here for the complete press release of the Court of Justice of the European Union.