Brussels, 09/03/2010 (Agence Europe) - According to his conclusions published on Tuesday 9 March in Case C-428/08 (Monsanto Technology LLC/Cefetra BV e. a.), Advocate General Paolo Mengozzi suggests to the European Court of Justice (ECJ) that it should rule that a patent relating to genetic sequence be protected in situations where the genetic information is currently performing the functions described in the said patent. This is the first time that the ECJ has been called on to interpret the scope of European legislation with regard to the protection of biotech inventions.
Since 1996 the Monsanto company has possessed a European patent on genetic sequence which, when introduced into the DNA of the soya plant, makes it resistant to glyphosate, a herbicide produced by the same company and marketed under the name of “Roundup”. The genetically modified soya, (“Soy RR”, namely, “Roundup ready”) is grown in different countries in the world but not in the EU. In 2005 and 2006 the defendant companies imported soy meal for animal feed production from Argentina (RR soya is grown on a large scale in this country but Monsanto does not have a patent on genetic sequence here). One analysis carried out at the request of Monsanto revealed traces of DNA containing RR characteristics, which attests that the imported meal was produced with genetically modified soya, for which Monsanto holds the European patent.
The Dutch court, called on by Monsanto to intervene, requested that the ECJ clarifies what protection the EU should grant to biotech inventions and, in particular, to patents on genetic information. This case involves determining whether genetic information is protected as such, namely the chemical elements, even when it is found in a sort of “residue” within a product (meal, for example) resulting from the processing of a biological product (soya plants).
In light of the 1998 directive on the legal protection of biotech inventions, Advocate General Paolo Mengozzi said that the DNA patented is not protected as such, that is to say, as a chemical substance, unless it performs the function for which it had been patented. In his opinion, it is only within this hypothesis that the “matter” in which the DNA is contained is protected. By taking into consideration the function performed by the DNA, the directive distinguishes between the “discovery” (the simple identification of a genetic sequence without any function being indicated) - which cannot be patented as such - and the “invention” (the discovery accompanied by indications into the product's functions) which, on the contrary, can be patented. Consequently, protecting genetic sequence in all its potential functions, even those that are not known at the time the patent is requested but would mean recognising the patent with regard to functions that were not known at the date of the request or, in other words, endorsing the patenting of a simple discovery, in violation of the principles governing patents.
The advocate general therefore believes that the protection conferred on patents with regard to genetic sequence is limited to situations in which genetic information is currently exercised in compliance with the functions described in the patent. This also applies to the protection of sequence as it stands and for the protection of matter in which it is contained. He also considers that the directive constitutes an exhaustive regulation covering protection of a biotech invention in the EU and does not admit that national legislation grants it more extensive protection. In effect, the directive aims to promote the market and competition and seeks to prevent legislative differences in this field having a negative impact on trade within the Union. The fact that the patent had been granted before the entry into force of the directive (on 30 July 1998) is irrelevant, according to the advocate general. In effect, the directive does not contain any provisional rule and results from the jurisprudence consistent with the obligation of interpreting the national law in compliance with Union law, which subsequently means that previous national provisions must also be considered with regard to the relevant provisions of the Union. Protection of the functions for which the genetic sequence was patented is guaranteed by the directive and is not under challenge.
The conclusions of the advocate general are not binding on the ECJ application for material losses, which would be decided by the courts of the member states as part of the litigation they are pursuing and allow them to consult the ECJ with regard to the interpretation of Union law or the validity of an act of the Union. The Court does not rule in cases of national litigation. This is up to the national court to decide itself. (L.C./transl.fl)