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14 July 2010
European Court of Justice Ruling on Genetic Material
European Court of Justice rules that patent protection does not extend to genetic material that does not perform the function for which it is patented.
On 6 July 2010, the Court of Justice of the European Union [the judicial institution of the European Union and of the European Atomic Energy Community (Euratom)] issued a ruling in Case C-428/08 in the proceedings Monsanto Technology LLC v Cefetra & Others. In short, the Court of Justice has ruled that patent protection for biotechnological inventions does not extend to a patented product (in this case, a DNA sequence), which does not perform the function for which it is patented, even if it did perform that function previously or would possibly again be able to perform that function.
Background to the ruling
European Patent No 0546090 was granted on 19 June 1996 to Monsanto Company, and was directed to an isolated DNA sequence encoding a Class II EPSPS enzyme, as well as a method of producing genetically transformed plants, which are tolerant toward glyphosate herbicide, by inserting into the genome of a plant cell the DNA sequence encoding the Class II EPSPS enzyme.
Monsanto has produced a soybean plant, which produces a Class II EPSPS enzyme called CP4-EPSPS, and is resultantly glyphosate-resistant. This soybean plant is cultivated on a large scale in Argentina, but Monsanto do not have patent protection in force in Argentina.
Cefetra export soy meal from Argentina to the Netherlands, where EP 0546090 is in force. Monsanto tested imported samples; determined that CP4-EPSPS, and the DNA sequence encoding it, was present in the soy meal; and applied to the Rechtbank's-Gravenhage [the District Court of the Hague] for injunctions against Cefetra. However, the Rechtbank's-Gravenhage was unsure as to whether the presence of the enzyme and the DNA was sufficient to constitute infringement of EP (NL) 0546090. The Rechtbank's-Gravenhage decided to stay the proceedings and to refer to the Court of Justice for a preliminary ruling in relation to Article 9 of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, which deals with the patentability of biotechnological inventions.
Referred questions for a preliminary ruling
1. Must Article 9 of Directive 98/44/EC be interpreted as meaning that the protection provided under that provision can be invoked even in a situation, in which the product (the DNA sequence) forms part of a material (soy meal) imported into the EU and does not perform its function at the time of the alleged infringement, but has indeed performed 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 the cell of an organism?
2. On the basis that the DNA sequence described in Claim 6 of EP 0546090 is present in the soy meal imported by Cefetra, and that the DNA is incorporated in the soy meal and that it does not perform its function therein; does the protection of a patent on biological material as provided for under Article 9 preclude the national patent legislation from offering (in parallel) absolute protection to the product (the DNA) as such, regardless of whether that DNA performs its function, and must the protection as provided under Article 9 therefore be deemed to be exhaustive in the situation referred to in that provision, in which the product consists in genetic information or contains such information, and the product is incorporated in material which contains the genetic information?
3. Does it make any difference that EP 0546090 was applied for and granted prior to the adoption of Directive 98/44/EC; and is it possible, in answering the previous questions, to take into consideration the TRIPS Agreement, which states that patent rights are enjoyable without discrimination as to the place of invention, the field of technology, and whether products are imported or locally produced?
Conclusions of the preliminary ruling
1. In the case of genetic information, the function of the invention is performed when the genetic information protects the biological material against the effect of a product, which can cause that material to die, such as a herbicide in the present case; and it follows that the protection provided for in Article 9 is not available when the genetic information has ceased to perform the function it performed in the initial material from which the material in question (soy meal) is derived. The Court of Justice concluded that Article 9 must be interpreted as not conferring patent right protection in the circumstance in which the patented product is contained in the soy meal, where it does not perform the function for which it was patented.
2. The Court of Justice found that uniform protection appears to be the means to eliminate or prevent differences between EU Member States and it follows that the harmonisation effected by Article 9 of the Directive must be regarded as exhaustive, with the result that it precludes the 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.
3. The Court of Justice concluded that Article 9 precludes the holder of a patent issued prior to the adoption of that directive from relying on the absolute protection for the patented product accorded to it under the national legislation then applicable; and that articles of the TRIPS Agreement relating to patent rights being enjoyable without discrimination do not affect the interpretation given of Article 9.
Consequences of the preliminary ruling
Monsanto's EP 0546090 covered isolated DNA sequences, recombinant dsDNA molecules, a method of producing genetically transformed plants, a glyphosate-tolerant plant cell, and a method of selectively controlling weeds. However, there were no claims in EP 0546090 directed to a product derived from the genetically transformed plants (the soy meal per se). However, it is still unclear whether such a product claim would enjoy patent protection in light of the Court of Justice ruling, insofar as the generic material is biologically inactive or non-functional in the soy meal as such. The findings of the Court of Justice expose a potential gap in the patent protection afforded by claims directed solely to genetic material; and we wait to see if this ruling poses any retroactive effect with regard to existing patents.
We now await the decision of the Rechtbank's-Gravenhage, based on the ruling of the Court of Justice.
The full details of the preliminary ruling can be found here.
Donal M Kelly, Ph.D., FRKelly
