Monsanto Puts Biotech Directive Under the Spotlight

Claire Baldock, Boult Wade Tennant

This article first appeared in Volume 9, Issue 4 of the Bio-Science Law Review. Click here to read this article in PDF format.

Directive 98/44/EC on the legal protection of biotechnological inventions, more affectionately known as the 'Biotech Directive', has been in force in Europe for ten years now, although its implementation into the national laws of all of the Member States of the European Union was onlycompleted in 2007. The Directive has had a very long and controversial history, so it is no surprise to find that on the first occasion where its provisions had to be interpreted by a national court of a Member State, that court has found it necessary to refer questions as to its meaning and effect onnational laws to the European Court of Justice ('ECJ'). The case in question is that of Monsanto Technology LLC v Cefetra BV and the State of Argentina ¹ and the referral was indicated by the District Court of The Hague in March 2008.

The Background
Monsanto is the holder of European Patent No EP-B 0546090, which protects its 'Roundup Ready' or RuR technology in Europe concerning herbicide resistant plants. Specifically, the resistance is to glyphosate, a potent and commercially successful herbicide, which is marketed by Monsanto under the Trade Mark ROUNDUP® and whose mode of action is to interfere with the shikimate pathway, necessary for aromatic amino acid biosynthesis in plants and micro-organisms. The subject patent relates to an enzyme called 5-enolpyruvylshikimate synthase or EPSPS, in particular a class II EPSPS, and DNA encoding it, which confers glyphosate resistance to a plant in which the enzyme is expressed. Monsanto inserted a gene encoding this enzyme into, among other things, soy bean plants so that the glyphosate herbicide could be used during the growth of these plants to combat weeds without affecting the soy crop. Obviously, this confers a considerable economic advantage. Beans from the soy plant are used as basic material in the food industry. Soy oil is recovered by pressing the beans and residual material is processed into soy pellets and soy meal for animal feed. RuR soy beans are grown very extensively in Argentina where Monsanto wasunable to obtain a patent for the technology for procedural reasons and it is reported that about 99 per cent of the soy meal exported from Argentina comes from ROUNDUP READY® plants.

The Action
The Monsanto European Patent was granted in 1996 and survived an opposition proceeding at the European Patent Office ('EPO'). It has claims to isolated DNA sequences encoding a class II EPSPS with certain kinetic and immunological properties, specific DNA sequences withoutthe isolated limitation, double stranded DNA molecules, methods of making transgenic plants by inserting the EPSPS gene and transgenic plants so made. It does not include a claim to meal made from beans of the plants. In June 2005 and March 2006 Monsanto used the EU Anti-Piracy Regulation to have the cargo of two ships arriving in Amsterdam from Argentina detained by Customs while they took samples of the soy meal cargo for testing to see if the meal came fromRuR plants. They detected a DNA molecule in the meal of sufficient length to encode the class II EPSPS, which surprisingly had survived the rigorous high temperature and pressure processing involved in preparing the meal from the soy beans. On this basis Monsanto brought an action against the importer Cefetra BV in the District Court of The Hague for infringement of the DNA and method claims of the patent. Similar actions were also brought in the United Kingdom, Spain and Denmark, but in each case against a different defendant. The Hague case is significant, though, since by way of relief Monsanto sought an injunction prohibiting infringement of the patent in all European countries where the patent was in force. In view of the economic importance of the case to the Argentine agricultural industry, the State of Argentina was co-joined in the action on the side of Cefetra.

¹ District Court of The Hague, 249983/HA ZA 05/2885, 19 March 2008.