In the context of a preliminary ruling of a Dutch court the ECJ decided on July 06, 2010 on the question to which extent protection is conferred to a product that contains or consists of genetic information.
Monsanto Technology LLC is he holder of European patent EP 0 546 090 since 1996. The patent claims the gene of a modified enzyme that is rendered resistant, i.e. inhibitable to glyphosate as opposed to its natural occurring variant. Glyphosate is a popular, non-selective herbicide. Monsanto introduced the claimed gene sequence into a soybean plant resulting in the so-called RR soybean plant (“roundup ready”). The RR soybean plant is resistant to glyphosate since it contains the modified enzyme facilitating herbicide treatment of soy plant acreage. In Argentina the RR soybean plant is cultivated on a large scale. In 2005 and 2006 Cefetra amongst others traded with soy meal produced from the RR soybean that was imported it into the Netherlands. “Soy meal” is the solid residue after hot pressing or extracting ground soy beans. Following the extraction, soy meal is heated to destroy harming proteins.
The national court especially wanted to know whether importing soy meal into the Netherlands represented an infringement of said patent. The soy meal contains undoubtedly the genetic information (DNA sequence) patented by Monsanto. The genetic information in the soy meal, treated as described above, is inactive.
The referred questions relate to Article 9 of the European Directive 98/44/EC of July 06, 1998 on the legal protection of biotechnological inventions, which is reflected in the Netherlands Law on patents of 1995 and reads as follows:
“The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material … in which the product in incorporated and in which the genetic information is contained and performs its function.”
The primary question was whether this exclusive right comprises also material which contains genetic information that does no longer perform its function at the time of the alleged infringement but has indeed its function (in the soy plant) or would possibly again be able to perform its function after it has been isolated from that material and inserted into an organism.
This is denied by the ECJ: due to present tense phrasing of the law (“… and performs its function.”) the protection provided in Article 9 of the Directive is not available when the genetic information has ceased to perform the function. Would the genetic material indeed be transferred into a new cell of an organism, protection would only be provided in relation to this material.
The line of argumentation by the patentee Monsanto that its principal claim would be the protection of the patented genetic information (DNA sequence) as such which in accordance with Article 1(1) of the Directive were protected by national patent law and that the applicable national patent law would confer protection independent of the performance of its function, was not accepted by the ECJ. A mere DNA sequence without indication of a function would according to the recitals not be a patentable invention. Accordingly, protection is not provided to a patented DNA sequence which is not able to perform the specific function for which it was patented and consequently protection would also not extend to material that contains this patented DNA sequence in inactive form.
Regarding another question of the national court, the ECJ judges referring to the recitals of the Directive that Article 9 of the Directive would represent an exhaustive harmonisation, with the result that it precludes national patent legislation from offering a function independent, absolute protection to the patented product as such. The Directive therefore denies the national legislator to provide such an absolute protection; national patent law needs according Article 1(1) sentence 2 of the Directive be adjusted if necessary.
The ECJ also states that the provisions of the Directive would immediately apply to the future effects of a situation which arose under the old rule. The Directive is therefore applicable to the present case, although the patent was already granted in 1996, i.e. prior to the adoption of the Directive.
Lastly, the EJC ruled that the interpretation of Article 9 of the Directive would not be in contradiction to Articles 27 and 30 of the TRIPS Agreement since Article 9 of the Directive governs the scope of the protection conferred by a patent on its holder, whilst Articles 27 and 30 of the TRIPS Agreement concern, respectively, patentability and the exceptions to the rights conferred by a patent.
The decision is of great importance for patents on genetically modified plants and the nucleic acids they contain. The court makes the attributed function of the “genetic information” (the DNA sequence) in exactly this product a conditional for the protection of the genetic information described in the patent. The open question now is to which extent this function at a given point in time (the time of the putative patent infringement) may not be performed. As the national court rightly stated it should be borne in mind that a gene in an organism is also not permanently active but may only be activated under certain (extreme) conditions. Future jurisdiction will show how active the genetic information within a material really needs to be to still fall within the scope of protection of the patent.