Dutch court refers Round Up patent dispute to ECJ
In a long standing battle[1] between Monsanto, Argentina and importers of soymeal, the District Court The Hague gave its (interim) judgment on March 19, 2008, referring the case to the ECJ for their interpretation of articles 8 and 9 of the 1998 Council Directive 98/44/EG relating to the protection of biotechnological inventions (“Biotechnology Directive”).
The facts
Monsanto is the owner of EP patent 0546090, relating to enzymes which, if expressed by a plant, confer resistance to a herbicide. In 1995 Monsanto introduced "Roundup Ready soy plants" soya meal that have had a copy of a gene from the bacterium, Agrobacterium sp. strain CP4, inserted into its genome that allows the transgenic plant to survive after being sprayed by Monsanto's this non-selective herbicide, Roundup. Glyphosate, the active ingredient in Roundup, kills conventional soy plants. The bacterial gene is EPSP (5-enolpyruvyl shikimic acid-3-phosphate) synthase. Regular Soy also has a version of this gene, but the regular version is sensitive to glyphosate, while the CP4 version is not.
The glyphosate works by inhibiting a certain enzyme called EPSPS which is present in the plant. This enzyme is important for the production of aromatic amino acids, these being necessary for the plant growth. The patent describes a class of EPSPS enzymes which are not sensitive to glyphosate, the so-called Class II enzymes. Glyphosate blocks the active centre of Class I EPSPS enzymes whereby the production of aromatic amino acids is disturbed. The plant cannot produce any or at least cannot produce sufficient proteins without these aromatic amino acids and therefore dies off. Plants possessing Class II EPSPS enzymes do not have this problem so they survive the use of glyphosate whilst the weeds around them die.
The Case
The defendants purchased soy beans in Argentina (where there was no patent protection), the beans being grown from plants carrying one of the genes disclosed in the patent. The beans, grown in Argentina, were imported by the defendants into the Netherlands as processed soy meal. Monsanto has no patent protection in Argentina. The patent claims are directed to isolated DNA sequences, a recombinant DNA molecule, a method of producing genetically transformed plants which are tolerant of certain herbicides and a herbicide-tolerant plant cell comprising the previously mentioned DNA molecule. Monsanto maintained that importation of the soybeans infringed its European (Netherlands) patent, the defendants disputed that.
Monsanto is the owner of EP patent 0546090, relating to enzymes which, if expressed by a plant, confer resistance to a herbicide. In 1995 Monsanto introduced "Roundup Ready soy plants" soya meal that have had a copy of a gene from the bacterium, Agrobacterium sp. strain CP4, inserted into its genome that allows the transgenic plant to survive after being sprayed by Monsanto's this non-selective herbicide, Roundup. Glyphosate, the active ingredient in Roundup, kills conventional soy plants. The bacterial gene is EPSP (5-enolpyruvyl shikimic acid-3-phosphate) synthase. Regular Soy also has a version of this gene, but the regular version is sensitive to glyphosate, while the CP4 version is not.
The glyphosate works by inhibiting a certain enzyme called EPSPS which is present in the plant. This enzyme is important for the production of aromatic amino acids, these being necessary for the plant growth. The patent describes a class of EPSPS enzymes which are not sensitive to glyphosate, the so-called Class II enzymes. Glyphosate blocks the active centre of Class I EPSPS enzymes whereby the production of aromatic amino acids is disturbed. The plant cannot produce any or at least cannot produce sufficient proteins without these aromatic amino acids and therefore dies off. Plants possessing Class II EPSPS enzymes do not have this problem so they survive the use of glyphosate whilst the weeds around them die.
The Case
The defendants purchased soy beans in Argentina (where there was no patent protection), the beans being grown from plants carrying one of the genes disclosed in the patent. The beans, grown in Argentina, were imported by the defendants into the Netherlands as processed soy meal. Monsanto has no patent protection in Argentina. The patent claims are directed to isolated DNA sequences, a recombinant DNA molecule, a method of producing genetically transformed plants which are tolerant of certain herbicides and a herbicide-tolerant plant cell comprising the previously mentioned DNA molecule. Monsanto maintained that importation of the soybeans infringed its European (Netherlands) patent, the defendants disputed that.
Core of the matter is, briefly, whether according to art.9 of the Directive, the scope of preotection for a biotechnology invention is determined on the basis of the generic information having been incorporated in the product and therein exercising its function. Consequently, protection to the plants may not be extended to the derived products in which the genetic information is residual and does not "exercise its (genetic) function".
Question is whether articles 8 and 9 of the Biotech Directive, implemented in Dutch law as article 53a Dutch Patent Act ("Rijksoctrooiwet", or "ROW") merely explicate the scope of protection awarded to biotechnology inventions, or actually limit the scope of these inventions to actively functioning DNA (sequences).
The Hague District Court judgment
In its interim judgment, the court firstly held that those claims covering an isolated DNA sequence constitute no infringement as the DNA is not present as isolated matter but is incorporated in the soy meal. The court rejected Monsanto’s reasoning that the DNA sequence has been taken out of its natural environment – the bacterial chromosome - and has been encoded in the DNA of the soy plant and, for this reason, the DNA in the soy meal should be regarded as an isolated DNA sequence, or, that it contains this. The average person skilled in the art would understand the term isolated DNA as DNA that has been retrieved from the cell (core) of an organism for further treatment in a manner as is usual in the relevant profession.
In its interim judgment, the court firstly held that those claims covering an isolated DNA sequence constitute no infringement as the DNA is not present as isolated matter but is incorporated in the soy meal. The court rejected Monsanto’s reasoning that the DNA sequence has been taken out of its natural environment – the bacterial chromosome - and has been encoded in the DNA of the soy plant and, for this reason, the DNA in the soy meal should be regarded as an isolated DNA sequence, or, that it contains this. The average person skilled in the art would understand the term isolated DNA as DNA that has been retrieved from the cell (core) of an organism for further treatment in a manner as is usual in the relevant profession.
Secondly the court rejected an interpretation that the soy meal can be regarded as a “directly obtained product” by application of the claimed methods according to some other claims of the Monsanto patent. Although soy plant and soy bean have been directly obtained by the patented method, the beans are subsequently then separated and subsequently “crushed” the beans are separated, in a number of treatment stages, and worked into different components, finally ending up as soy meal.
Thirdly, the court considered whether any product claims were infringed, which claims relate to a DNA sequence or a DNA molecule. The dispute focused around the question whether the DNA sequence which encodes for the synthesis of a Class II EPSPS enzyme was found in the samples taken from the cargo imported by defendants. Parties then argued on whether any of the DNA sequence was present in the soy meal, so imported. The importers, supported by the Government of Argentina, argued that the DNA sequence was at best present “in fragmented form”, caused by heating during the “crushing process” of the beans.
Thirdly, the court considered whether any product claims were infringed, which claims relate to a DNA sequence or a DNA molecule. The dispute focused around the question whether the DNA sequence which encodes for the synthesis of a Class II EPSPS enzyme was found in the samples taken from the cargo imported by defendants. Parties then argued on whether any of the DNA sequence was present in the soy meal, so imported. The importers, supported by the Government of Argentina, argued that the DNA sequence was at best present “in fragmented form”, caused by heating during the “crushing process” of the beans.
The major question then became whether, if any of the claims relating to genetic material are infringed, as Monsanto alleges, the soy meal contains at least genomic fragments of the Round Up Ready-DNA sequence?
Questions referred to the ECJThe court reviewed this question in relation to articles 8 and 9 of the 1998 Council Directive 98/44/EG on the protection of biotechnological inventions “the Biotechnology Directive”).
The first question of the court to the ECJ relates to the scope of art. 9 of the Biotechnology Directive, especially when DNA “performs its function”. Monsanto argued that the DNA found in the imported soybeans may not then and there “performs its function”, but in order to invoke patent protection under art. 9 of the Biotechnology Directive it would suffice for the DNA-sequence to - at any particular moment - have performed its function in the soya plant or that the DNA could again “perform its function” after having been isolated from the soy meal and inserted into living material again. The court wants to know from the ECJ whether this interpretation of Monsanto is correct.
The second question relates to the question whether or not the protection of a biological material by the Biotechnology Directive prevents the national Dutch Patent Act (art 53) from protecting next and above the protection conferred upon DNA as such ("classic product protection")irrespective of whether the DNA sequence it “performs its function”.
The third question is whether in answering the second question it makes any difference that the patent has been granted before the Directive came into force (artt. 27 and 30 TRIPS).
The first question of the court to the ECJ relates to the scope of art. 9 of the Biotechnology Directive, especially when DNA “performs its function”. Monsanto argued that the DNA found in the imported soybeans may not then and there “performs its function”, but in order to invoke patent protection under art. 9 of the Biotechnology Directive it would suffice for the DNA-sequence to - at any particular moment - have performed its function in the soya plant or that the DNA could again “perform its function” after having been isolated from the soy meal and inserted into living material again. The court wants to know from the ECJ whether this interpretation of Monsanto is correct.
The second question relates to the question whether or not the protection of a biological material by the Biotechnology Directive prevents the national Dutch Patent Act (art 53) from protecting next and above the protection conferred upon DNA as such ("classic product protection")irrespective of whether the DNA sequence it “performs its function”.
The third question is whether in answering the second question it makes any difference that the patent has been granted before the Directive came into force (artt. 27 and 30 TRIPS).
[1] See for an interesting resume of the history of Monsanto’s battle against Argentina patent policy, “Harvesting Royalties for Sowing Dissent? Monsanto's Campaign against Argentina's Patent Policy”, www.grain.org, and http://snipurl.com/23xnu
(with thanks to Erik de Vos, Nauta Dutilh, Amsterdam)
No comments:
Post a Comment