Monsanto Technology LLC v Cargill International SA (No 2)
| Jurisdiction | England & Wales |
| Judge | THE HONOURABLE MR JUSTICE PUMFREY |
| Judgment Date | 21 December 2007 |
| Neutral Citation | [2006] EWHC 1679 (Pat),[2007] EWHC 2257 (Pat),[2007] EWHC 3113 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HC06C00585 |
| Date | 21 December 2007 |
[2007] EWHC 2257 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
The Honourable Mr Justice Pumfrey
Case No: HC06C00585
Christopher Floyd QC, Michael Tappin and James Whyte (instructed by Powell Gilbert) for the Claimant
Antony Watson QC and Colin Birss (instructed by Taylor Wessing) for the Defendants
Hearing dates: 13—29 June 2007
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Mr Justice Pumfrey:
Introduction
1. 1.This is an action for infringement of EP (UK) 0 546 090 which stands in the name of the claimants (‘Monsanto’). The invention is entitled ‘glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthases’ and is concerned with enzymes which, if expressed in a plant, confer resistance to the herbicide Round Up, which otherwise inhibits the so-called shikimate pathway in the synthesis of certain of the aromatic amino acids. The enzymes are referred to in the specification as EPSPSs.
2. 2.The defendants (‘Cargill’) buy soya beans grown from seed carrying the gene for one of the EPSPSs disclosed in the patent in Argentina, and from it they or others manufacture meal which they import into the United Kingdom. The cargo in issue in this action is 5000 tonnes shipped on the MV Podhale. The evidence was that the use of seed carrying a gene for an enzyme called CP4R, generally referred to as ‘Round Up Ready’ (‘RuR’) seed, had transformed the soya bean industry in Argentina, and represented a very substantial benefit to Argentinean growers and processors. I was told that 99% of soya bean meal exported from Argentina came from Round Up Ready plants carrying the CP4R gene. Given the structure of the claims, Cargill say that there is no infringement of the UK part of this patent. Validity is challenged on the grounds of anticipation, obviousness and insufficiency although Cargill accept that the discovery of the CP4 enzyme was an invention.
3. 3.Anticipation is alleged on the basis of a number of disclosures of EPSP synthases. Most important is that of Bacillus subtilis (‘ B subtilis’ or just ‘ subtilis’) said to be disclosed in a paper called Henner; and that of strain PG2982 of Pseudomonas aeruginosa (‘ P aeruginosa’) disclosed in a paper called Moore. Obviousness is alleged over Henner and Moore, and over a document called Fischer. A point of some general importance arises in relation to B subtilis EPSPS, because Cargill did no experiments of its own to show that that enzyme reacted with antibodies raised against the enzymes specified in claim 1. Without complying with the order for notices of experiments, it sought to rely on certain experiments performed on behalf of a third party, Syngenta, for use in opposition proceedings in the EPO. Kitchin J adjourned an application to admit these experiments, and I have to decide whether to admit them. A point of some interest also arises on the use of the contents of the EPO file in construing the specification.
4. 4.The priority date of the patent is 1990. The analytical techniques used in biochemistry and the techniques of genetic engineering which would be employed by the team of skilled scientists seeking to put this patent in effect have been described in detail in a number of judgments and I do not propose to set them out at length. So far as analytical techniques are concerned, for the genetic material there was a great forensic dispute as to the proper interpretation of Southern blots, and much time was spent on the interpretation of Western blots so far as the enzymes were concerned. No particular reference will be made to the general techniques of genetic engineering. One minor issue arises concerning the sequence encoding a chloroplast transit peptide which ensures that nucleus-expressed EPSPS finds its way to the chloroplast, where it is active. On the technical issues, Professor Bartlett, an expert in enzyme kinetics and Professor Lichtenstein, a molecular biologist, gave evidence on behalf of Monsanto. Professor Leaver, a plant biologist, and Dr Isaac, a molecular biologist, gave evidence for Cargill. Dr Isaac is the only witness to be subject to sustained criticism (Professor Lichtenstein is said to have been too much of an advocate) and it is convenient to deal with those criticisms where they arise.
5. 5.Monsanto apply to amend the patent in suit. The allowability of the amendments is disputed, and if they are allowable it is said that the court should not exercise its discretion to permit them to be made. On this issue Dr Padgette, one of the inventors and Dr von Menges, who prosecuted the patent through the EPO, gave evidence. They are not criticised as witnesses.
6. 6.The only other substantive issue raised by Cargill was an allegation that Monsanto was estopped by its acquiescence in the acts of importation complained of. This issue necessitated the examination of some of the commercial developments in Argentina, where Monsanto has no protection for Round Up Ready soya beans. On this issue, Mr Tobin gave evidence for Monsanto, and Mr Amado for Cargill. Mr Amado was an excellent witness.
The addressee of the specification
1. 7.This specification is concerned with an improvement to crops by way of making them resistant to glyphosate herbicide. To make a crop resistant to glyphosate permits destruction of weeds by use of glyphosate among the growing plants, so reducing the need for tillage. There was a measure of agreement that it is likely that the patent would be addressed to a team, including a post-doctoral molecular biologist. By 1990, I think that it was established that the techniques employed in the specification were normal in this area of research, and I shall return to this issue as necessary.
The common general knowledge of the skilled person
1. 8.At the priority date, the mode of operation of glyphosate, better known under the brand ‘Round up’, was well known. Glyphosate (which is N-phosphonomethylglycine) is an extremely successful herbicide, much of its success being attributable to its lack of effect on animals, its rapid decomposition to harmless products in the earth and its drastic effect on plants. Its mode of operation is by curbing the conversion of phosphoenolpyruvic acid (‘PEP’) and 3-phosphoshikimic acid to 5-enolpyruvyl-3-phosphoshikimic acid by inhibiting the enzyme 5-enolpyruvylshikimate synthase (‘EPSP synthase’). This enzyme is essential to aromatic amino acid biosynthesis in microorganisms and plants. The aromatic amino acids are essential components of proteins. It seems that EPSPSs differ from organism to organism to a greater or lesser extent.
2. 9.Specific enzymes catalyse specific chemical reactions, and possess an ‘active site’ at which one of the reagents will bond during the reaction. This reagent is called the enzyme's substrate. Competitive enzyme inhibitors work by binding to the enzyme's active site in preference to the substrate, so blocking the reaction. There are two ways of getting over this: make much more enzyme, or find a different one which will still catalyze the reaction of interest but will not bind to the inhibitor.
3. 10.At the priority date, the necessary techniques for identifying the enzyme of interest, for characterising it (including immunological techniques), for finding the DNA that encoded it, for transforming plants and for expressing the recombinant protein in their progeny were well established. The techniques are anything but straightforward, and they take, potentially, a lot of time. This potentially places a difficult burden on the draftsman of the specification who must identify with some precision which techniques and what conditions he says should be used. It also means that allegations of insufficiency have to be treated with caution.
The patent in suit
1. 11.The specification starts with a summary of the mode of operation of glyphosate.
2. 12.The specification acknowledges that transgenic plants have been produced ([0005]) in which a higher level of EPSP synthase has been produced, and in which the EPSP synthase has itself been modified. The key characterisation of these EPSPSs is as follows, references omitted:
‘It has been shown that glyphosate tolerant plants can be produced by inserting into the genome of the plant the capacity to produce a higher level of EPSP synthase in the chloroplast of the cell…which enzyme is preferably glyphosate tolerant. Variants of the wild-type EPSPS enzyme have been isolated which are glyphosate tolerant as a result of alterations in the EPSPS amino acid coding sequence. These variants typically have a higher K i for glyphosate than the wild-type EPSP enzyme which confers the glyphosate tolerant phenotype ‘Phenotype’ means the physical characteristics of the organism, as distinct from its genotype, which denotes its genetic make up., but these variants are also characterised by a high K m for PEP which makes the enzyme kinetically less efficient.'
This passage necessitates a short diversion into reaction kinetics.
1. 13.Absent glyphosate, the crucial step in the shikimate pathway is for present purposes the binding of PEP, the substrate, to EPSPS. A reaction catalysed by an enzyme can be characterised by the maximum rate at which a single molecule of the enzyme can process molecules of substrate. General considerations show that
where [ ES] is the concentration of the enzyme/substrate complex, [ E] and [ S] the concentrations of enzyme and substrate respectively, and K m a constant called the Michaelis constant. It can...
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