by Richard Taylor, DLA Piper, Yorkshire


Patents and GM food

Here's one for the Greens. Monsanto Technology LLC v (1) Cargill International SA (2) Cargill Plc [2007] EWHC 2257 concerned a patent relating to genetically modified soya beans. The patented invention worked by means of an enzyme called CP4R which, when expressed in the bean, made the bean tolerant of glycosate herbicides, including the well-known herbicide, Round Up. A field of Monsanto's 'Round Up Ready' GM soya can be sprayed with Round Up to kill other invading plants, but leaving the 'Round Up Ready' plants standing.



The GM plant has been extremely effective: an amazing 99% of soya bean meal exported from Argentina now comes from these 'Round Up Ready' plants. The defendant was one such importer from Argentina. Cargill had shipped 5,000 tonnes of processed soya meal to the UK. Monsanto claimed that this processed soya meal infringed its patent; Cargill claimed that it did not and also counter-claimed that Monsanto's patent was invalid.



Monsanto's patent, EP0546090, includes claims for (1) an isolated DNA sequence that encodes for the CP4R enzyme; (2) a recombinant DNA molecule that confers glycosate tolerance on a plant cell; and (3) a method (crucially) of producing glycosate-tolerant plants, through the insertion of the recombinant DNA molecule.



Process patents

Dealing with the last claim first, claims in patents to methods or processes enjoy a slightly different regime to claims in patents to products. The process of producing a glycosate-tolerant plant had been undertaken outside the UK, and so the patented process had not been directly infringed in the UK. Rather, the potentially infringing act was the importation into the UK of a product that was obtained from the patented process. In these circumstances, section 60(1)(c) of the Patents Act 1977 applies. The section says that where an invention is a process, it is an infringing act for a person to use or import any product 'obtained directly by means of that process'. The first question for the court was, therefore, whether the soya meal had been 'obtained directly' from the method of genetic modification, as required by section 60(1)(c).



The leading case on the point is the Court of Appeal's decision in Pioneer v Warner [1997] RPC 759. Here, the claimant owned a patent to a method of fabricating a 'master' compact disc by means of a vapour metal deposited at a particular pressure. The master CD so created could then be used to fabricate other CDs (although the downstream fabrication process did not form part of the patent). The defendant imported CDs into the UK, the production of which had involved a master CD produced by this method. However, the master CD was a long way up the production chain, and the allegedly infringing CDs had undergone at least three stages of manufacture after the master CD was used. The Court of Appeal held that the CDs could not be said to have been 'obtained directly' from the patented process, and so there was no infringement of Pioneer's patent.



Stopping there, it must be said that the court's position in Pioneer seems a little harsh. If a patented process is an integral link in the production process, then it is hard to see that the resulting product is not a direct result of the process, however far up the chain it might be. But the purpose of section 60(1)(c) is to limit the scope of patent protection for processes. The Court of Appeal's position is consistent with a number of decisions of other European courts, and so this appears to be fairly settled law.



The court in Monsanto came to the same conclusion in relation to these GM soya beans. The 'parent' plant might have been directly obtained by the process of genetic modification. However, the beans that had been processed into the meal in question were several plant generations down the line from the parent. The court said that Monsanto's argument, that the descendant soya beans should be regarded as having been obtained directly from the patented process because they retained the central genetic characteristics of the parent bean, was to confuse the informational content of what had passed between generations (ie the genomic sequence) with the product itself.



This finding could have a significant impact on the patent protection afforded to GM products. The judgment suggests that insofar as a patent to a GM product is a method of creating the product - that is, the process of modification itself - descendants of the parent organism will not constitute an infringement of the patent, even if the genetic material of the descendant is identical to the parent. A method patent in force in the UK might prevent you from genetically modifying the organism in the UK, but it would not prevent you from importing, breeding and commercialising descendants of the parent organism.



Product patents

Turning to the product claims, the court accepted that there were traces of the patented DNA sequence that encodes for the CP4R enzyme in the shipment of soya meal. However, the patent claimed an 'isolated' DNA sequence. The court took 'isolated' to mean 'separated from other molecular species in the form of a purified DNA fragment' (as opposed, presumably, to 'mashed up with 5,000 tonnes of other molecular species in a ship's cargo hold'). The court, therefore, found that there was no infringement of the claim to an isolated DNA sequence.



This finding too could have an important knock-on effect on gene patent claims in the UK and, in particular, on claims for DNA sequences derived from the human genome. The Biotech Directive (EC Directive 98/44/EC), which was introduced in 1998 in an attempt to harmonise biotechnology patenting practice in Europe, allows that gene sequences derived from the human body may be patented, but only where the sequence is 'isolated from the human body' (article 5.2). The intention behind this linguistic formula is to stop claims to genetic material as it occurs in nature, and its consequence is that patents to human gene sequences frequently claim only an 'isolated' sequence. You can see how the word 'isolated' could be effective in that context, but it could have wider consequences. For example, if an isolated gene sequence is deliberately mixed with other molecular species in a diagnostic kit, with the result that the sequence is no longer isolated, then could it lose its patent protection?



An anti-GM boost?

This judgment will please the anti-GM lobby. The '090 patent has been highly controversial and was opposed by Greenpeace when it was granted in 1996. It is difficult to see what value the patent now has in the light of this judgment, at least in the UK. As set out above, the practical impact of the judgment on claims to GM method patents and to isolated genetic sequences could be profound (and could be a reason for referring the judgment to appeal).



But the anti-GM lobby should only give it two cheers. Remember the second patent claim, above, to a recombinant DNA molecule. The court found that this claim had not been infringed either, but it made the finding on the facts of the case. In particular, there appears to have been a classic patent 'squeeze' over the claim to the DNA molecule, with Monsanto having to try, unsuccessfully, to impose a strained interpretation on the claim in order to avoid a piece of prior art which would otherwise have rendered the claim invalid. Without that squeeze, the molecule claim might well have been found infringed. Furthermore, Cargill's attacks on the validity of Monsanto's patent all failed. In other words, a different GM patent could produce a very different result.