Addressing the interpretation and effect of Article 9 of Directive 98/44/EC on the legal protection of biotechnological inventions (OJ 1998 L 213, 13) (the Directive), the European Court of Justice (ECJ) has held, inter alia, that the protection provided by a patent relating to genetic information does not extend to cover that genetic information as contained in soy meal, where it does not perform the function for which it is patented, even though it did perform that function previously in the soy plant itself. Monsanto Technology LLC v. Cefetra BV, Cefetra Feed Service BV, Cefetra Futures BV and State of Argentina and Monsanto Technology LLC v. Vopak Agencies Rotterdam BV and Alfred C. Toepfer International GmbH (Case No. 428/08) (EU Ct. of Justice, Luxembourg).
Monsanto is the proprietor of a European patent relating to glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthases. The patent describes certain enzymes that are not sensitive to the herbicide glyphosate (an ingredient in Roundup). Plants containing such enzymes survive exposure to glyphosate, whereas weeds are killed. Monsanto inserted genes for those enzymes into a soybean plant it called Roundup Ready (RR). RR soybean plants are resistant to Roundup.
Cefetra and Toepfer traded in soy meal prepared from RR soybean grown in Argentina, where there is no patent protection for the Monsanto invention. Monsanto applied for an injunction to the Court of the Hague to prevent what they argued was patent infringement. The Court of the Hague stayed the case and referred questions on the interpretation and effect of Article 9 of the Directive to the ECJ.
Article 9 of the Directive states “The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material … in which the product is incorporated and in which the genetic information is contained and performs its function.”
In response to four specific questions referred to it by the Court of the Hague, the ECJ held as follows:
- Article 9 of the Directive is to be interpreted as not conferring patent right protection in circumstances such as those of the case in the proceedings in question, in which the patented product is contained in the soy meal, where it does not perform the function for which it is patented, but did perform that function previously in the soy plant, of which the meal is a processed product, or would possibly again be able to perform that function after it had been extracted from the soy meal and inserted into the cell of a living organism.
- Article 9 of the Directive effects exhaustive harmonization of the protection it confers, such that it precludes national patent legislation from offering absolute protection to the patented product as such, regardless of whether it performs its function in the material containing it.
- Article 9 of the Directive precludes the holder of a patent issued prior to adoption of the Directive from relying on the absolute protection for the patented product accorded to it under the national legislation then applicable.
- Articles 27 and 30 of the TRIPS Agreement do not affect the interpretation given of Article 9 of the Directive.