As reported on the environmental news and commentary site Grist here, Monsanto are due to face proceedings at the EPO this coming Thursday (3 May) in an appeal regarding their European patent on genetically modified soya.
Hope Shand, the research director of one of the opponents of the patent, the neo-Luddite green group "Action Group on Erosion, Technology and Concentration" or ETC, writes,
"Instead of fostering agricultural research, breathtakingly broad patents are shutting down competition and stifling research. Perhaps no patent symbolizes the brokenness of the patent system more than Monsanto's European patent on all genetically engineered soybean varieties and seeds -- European Patent No. 301,749. Critics call it a "species-wide" patent because its claims extend to all biotech soybean seeds-- irrespective of the genes used or the genetic engineering technique employed -- unprecedented in its broad scope"
On Thursday, ETC will attempt to have the patent revoked "because it is technically flawed and morally unacceptable", according to Hope Shand.
The patent itself (prosecution file available here) is directed to a particular method of inserting 'foreign' genes in soybean cells, involving firing small inert particles containing the foreign gene sequences into soybean cells at high speed, with the result that some of the cells then take up this material and can be propagated to produce stable genetically altered lines. This method was not known to work for soybeans at least before the filing date of the patent, 20 July 1988, but the technique had been described previously in published journal papers.
There are a number of other objections to the patent, but the main one appears to come down to the form of claim 17, which claims,
"A soybean seed which will yield upon cultivation a soybean plant comprising in its genome a foreign gene effective to cause the expression of a foreign gene product in the cells of the soybean plant"
This claim is clearly broader than the methods disclosed in the patent, and appears to cover any genetically modified soybean seed, i.e. one having a 'foreign' gene in its genome. None of the opponents were able, during opposition proceedings, to show that GM soybeans were known before the patent was filed.
The question appears to the IPKat to be whether such broad claims should be allowed, when only one particular way of doing it was disclosed in the patent. If nobody else had been able to do it before the patent was filed, does this give the patent holder the exclusive right to prevent others from making GM soybeans, by whatever route? Does this matter? Why is this different from allowing protection for new pharmaceutical products? Shouldn't the first invention in a new field be allowed a justifiably broader scope? The IPKat leaves these questions open for others to discuss, and looks forward to seeing how the appeal goes.
"A soybean seed which will yield upon cultivation a soybean plant comprising in its genome a foreign gene effective to cause the expression of a foreign gene product in the cells of the soybean plant"
ReplyDeleteMmmh, I'm not a specialist in biotech, but that reads as if it would cover not only every GM soybean seed, but even such seeds which naturally infected by a virus...Hasn't a single opponent thought of that argument?
I'm sure the opponents have thought of that argument, but it was determined during the opposition proceedings that 'foreign' was supposed to mean that the modification was as a result of artificially introducing exogeneous gene sequences. If you know of published work before 1988 that succeeded in creating artificially modified soybeans (whether by viruses or otherwise), I'm sure the opponents would be interested to see it.
ReplyDeleteThe patent was revoked (all claims invalid) at the hearing on 3 May. The product claim (all GM soya) were held not novel, the process claims insufficiently disclosed.
ReplyDeleteTim Roberts
Agent for the Opponents ETC
Many thanks Tim for this. If you have time to impart more of the details before the decision is published, please do let the IPKat know.
ReplyDeleteQuite satisfying to see the end of this patent after chasing it for 13 years. Daniel Alexander appeared at the Hearing for my clients, and the quality of his presentation made life very difficult for the patentee. The opposition was brought to knock out the product claims, which we regarded as ridiculous, and the success against the process claims was a bonus. But Monsanto were in difficulties. The patent was granted to Agracetus, and Monsanto were among the half-dozen original opponents. As opponents, they filed detailed and credible evidence that the disclosure was not repeatable. Then, three or four years into the opposition, they changed their minds and bought the patent from Agracetus.
ReplyDeleteThe grounds for the decision on novelty could be interesting. We argued (inter alia) that claim 17 was really a 'product-by-process' claim, distinguished from known soya only by the process by which it was made. If so, it covers (according to EPO ideas) products 'capable of being made by' that process - which (we argued) would include conventional soya. The only distinction from the prior art was the requirement for a 'foreign' gene. But can that be a proper way of distinguishing new from old? A claim to a known chemical compound substituted by a 'novel group' (not further specified) would surely be laughed out of court?
We didn't get to argue either obviousness, or other questions such as morality or overbreadth of claim, though the latter point may obviously be dealt with in the decision.
Enough for now...!
Cheers, Tim
Leuven, 5 May
The decision is now published. It deals mainly with the question of whether one of the opponents had proved he existed (Held, No - though no decision on whether he actually existed). On novelty, the term 'foreign gene', in the context, held to include genes introduced by means other than genetic transformation - which was known. Nothing on insufficient disclosure. Told that the Board intended to find against them on this point, the Proprietors withdrew all Auxiliary Requests - so having found the Main Request unsubstantiated, there was nothing further for the Appeal Board to decide. Devilish cunning!
ReplyDelete