A recent European Court of Justice (ECJ) opinion in proceedings between Monsanto Technology LLC v. Cefetra BV & Others may inflict serious harm on the European biotechnology industry.
In its ruling, the ECJ interpreted the EU Biotechnology Directive (98/44/EC) on the legal protection of biotechnological inventions (“the Directive”) as not conferring patent protection in the circumstances of this case. In this instance, the patent protected product, a herbicide resistance gene, was contained in soy meal. However the resistance claimed by the patent did not operate in the soy meal. This function was previously performed in the soy plant, from which the soy meal is processed. Further, the resistance would possibly operate again after it had been extracted from the soy meal and inserted into the cell of a living organism.
The dispute underlying the ECJ’s opinion and its interpretation of the Directive arose from importation into Europe of soybean meal made from Argentinean plants engineered to express a herbicide resistance gene. Monsanto had obtained European patent protection (EP 0 546 090) covering a gene that conferred resistance to the herbicide glyphosate, but could not secure equivalent patent protection in Argentina. Due to its lack of patent rights in Argentina, Monsanto sued European importers of soybean meal coming from Argentina in Spain, the United Kingdom, Denmark and Holland.
The ECJ’s Ruling
The parties to the Dutch litigation referred four questions to the ECJ regarding the scope and interpretation of the Directive on the protection of biotechnological inventions. The ECJ decided that the patent protection relating to a DNA sequence is limited to situations in which the genetic information is currently performing the functions described in the patent. Accordingly, the ECJ imposed a functionality requirement on genetic information and products containing that genetic information, which applies to patent infringement claims in all member states.
Impact of the ECJ Opinion
As a result of the ECJ opinion, there is a significant risk that countless biotechnology products are not protected by enforceable patent claims. An accused infringer, for example could deny infringement by simply asserting that the patented polynucleotide or gene does not perform its function at the time of the alleged infringement. The ECJ’s decision suggests that a European biotechnology patent can only be relied upon with regard to an invention that actually performs the function for which it was patented. The ECJ’s opinion may severely undermine patent enforcement for many biotechnological inventions as many genes are only temporarily functional, or functional only in some tissues or organs, or have limited functions.
Biotechnology companies should immediately undertake a careful review of their options and intellectual property protection strategies.
For further information please contact Carol Plunkett of our Litigation Department.