Time-Lapse IVF - A53 decision

I last wrote about an opposition case I have been watching for a while, and reported last on a summons to oral proceedings that was issued in March (see here for my comments, and here for an earlier post about the issue). In brief, the opposed patent is about a method of assessing the viability of embryos by the timing of cell divisions, which is monitored by time lapse video microscopy. In simple terms, if the timings are within certain limits the embryo is more likely to be viable. One opponent had argued that this method was excluded for being a diagnostic method under Article 53(c) EPC. My view, as expressed at the outset, was that this argument was very probably wrong because it did not fit the test as laid out in G 1/04. This issue, along with others raised by another opponent, was to be discussed and decided upon by the opposition division at a hearing at the EPO in Munich scheduled for two days from 30 November 2015.

By a lucky coincidence I happened to be at the EPO on the 30 November (handling this case, which I won by the way). My work was done fairly quickly, so I popped along the corridor and slipped into the oral proceedings that were underway (which were, as is normal for opposition hearings, open to the public so anyone could have done the same). I unfortunately missed the arguments about Article 53, as these were dealt with first, but arrived in time to hear the opposition division issue their decision. Unsurprisingly, they decided that Article 53(c) did not prejudice the granting of the patent. The opponent who had raised the issue then indicated they would be appealing and left the proceedings, as they had nothing further to add.

I do not know yet what the outcome of the hearing was on the other issues, but this will appear on the register in due course. Whatever happens, it looks like the A53(c) issue will go to appeal, where the opponent will try to get a referral made to the Enlarged Board if they don't get their way (which, in my opinion, they won't). As I have indicated before, I think this is not going to happen. It will, however, be interesting to see what a Technical Board of Appeal make of it. There are, to my knowledge, no conflicting decisions from the Boards of Appeal on this point. There is, however, the possibility that the Board will consider the issue to relate to a "point of law of fundamental importance" (Article 112 EPC), but it seems unlikely to me that they will think the issue of whether a method of assessing viability of embryos is an excluded diagnostic method is of such importance that a referral would be needed. We will just have to wait and see.

UPDATE 3 March 2016: The interlocutory decision of the opposition division has now issued, and is available on the EP Register here. The OD has decided to maintain the patent in amended form, and confirm that the patented invention is not excluded under Article 53(c) EPC. The OD go into quite a lot of detail on the A53(c) issue, probably in the expectation that this will have to be gone over again on appeal. It looks like this will be one to revisit in a couple of years once the Board of Appeal have taken a look.

UPDATE 22 June 2016: As expected, opponent 2 (Sterckx et al., represented by Julian Cockbain) has filed an appeal against the decision. Their grounds of appeal have just appeared on the EP register, and can be found here. The sole point of appeal is the Article 53(c) issue, and the opponent now wants some questions to be referred to the Enlarged Board because they think that G 1/04 got it wrong. The questions are:

(A) Where a claim is directed to a method of diagnosis of condition X comprising gathering information from a human or animal and determining, on the basis of the information gathered, that the human or animal has (or has not) condition X, must a curative treatment for condition X be available for the method claimed to be a method of diagnosis excluded from patentability under Art. 53(c) EPC? 

(B) Where a claim is directed to a method of diagnosis of condition X comprising gathering information from a human or animal and determining, on the basis of the information gathered, that the human or animal has (or has not) condition X, must condition X be a disease for the method claimed to be a method of diagnosis excluded from patentability under Art. 53(c) EPC?

(C) Where a claim is directed to a method of diagnosis of condition X comprising gathering information from a human or animal and determining, on the basis of the information gathered, that the human or animal has (or has not) condition X, must the determination that the human or animal has (or has not) condition X be in itself fully sufficient to determine the appropriate course of action (or inaction) to be adopted by the physician for the method claimed to be a method of diagnosis excluded from patentability under Art. 53(c) EPC? (In other words, if other information may inform the physician's course of action is the claimed method still excluded from patentability?)

Although the argument sounds faintly plausible, I still think it is a bit of a stretch that there should be a referral because G 1/04 got it wrong. The Technical Board of Appeal in this case would need to conclude that the questions need to be asked to ensure uniform application of the law or if a point of law of fundamental importance arises (Article 112(1) EPC). Neither of these seem to fit. The law can be applied uniformly based on G 1/04, and there are no conflicting T decisions, so that doesn't seem to work, leaving the only option being whether the point is one of fundamental importance. Is it so important that a decision is made on whether a diagnostic method needs to be done "for curative purposes stricto sensu"? I don't know, but I'm fairly sure that the Technical Board of Appeal in this case will think not, not least because the reasoning for applying the same kind of test for diagnosis as for each of the other exclusions of surgery and therapy was that they all related to doing things for curative purposes. Whether or not a cure is actually possible is beside the point.

Time-Lapse IVF & Article 53 revisited

I wrote a while back about a journal article and subsequent opposition to European patent EP2430454, which claims a method of assessing competence of a human embryo through measurements of time intervals between the first few cell divisions (an illustration of cytokinesis is shown on the right, taken from this web page). The opposition, filed jointly by the European Society of Human Reproduction and Embryology and the authors of the journal article (one of whom happens to be a European Patent Attorney), argued that the patent claimed a diagnostic method that was excluded under Article 53(c) EPC. The problem with this, as I explained at the time, was that the Enlarged Board of Appeal determined in G 1/04 that for a claim to fall within the Article 53(c) exclusion (which at the time was Article 52(4)), it required all of the following features to be present:

(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise,
(ii) the preceding steps which are constitutive for making that diagnosis, and
(iii) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.

Step (i) of the requirements is clearly missing from the claimed invention, so it seemed fairly clear to me at the time that the opposition would inevitably fail, for the obvious reason that an opposition division would not make a decision that was clearly contrary to a decision of the Enlarged Board.

Following a response from the patent proprietor and a further response from the opponent, the opposition division has now decided to hold oral proceedings at 09:00 on 30 November 2015 at the EPO in Munich (which will be open to the public). The proceedings are expected to last two days.

The opponent's main argument is explained in my earlier post here, and is set out in their opposition here, as well as in the journal article here (to which I responded in a letter in the same journal here, to which the authors responded here, all of which are mentioned in the opposition proceedings as document D12). The opponent has, however, since then expanded on their reasoning as to why they consider the exclusion should apply. Their letter explaining this is available here on the EP register. Some of the argumentation is unusual, to say the least. In response to the argument that G 1/04 required there to be a diagnosis for curative purposes, the opponent has stated:

We accept that these requirements might possibly be inferred from opinion G-1/04. However, to the extent that that may be the case, we respectfully submit that the Enlarged Board erred in suggesting these requirements and we ask the opposition division to hold that these are not in fact requirements for a claimed method to be to an excluded method of diagnosis.

They then go on to explain why G 1/04 was wrong in deciding that a diagnosis would need to be made for curative purposes. In support of this, they have obtained signed statements from 29 physicians across Europe, who have all stated that there can be a medical diagnosis in a human subject without that condition being a disease condition, and even if no curative treatment is known.

The opponent seems to acknowledge that their chances of success are slim, as they then go on to state that "Whichever way you decide, an appeal will almost certainly be filed, and at the appeal stage we fully expect that a referral to the Enlarged Board will be sought. Addressing the Art. 53 EPC point now thus offers to expedite the final disposition of the opposition". How they think a referral to the Enlarged Board would be justified, given the decision in G 1/04, is beyond me but they are of course welcome to have a go. I would guess that any question would have to be along the lines of whether a "diagnosis for curative purposes" requires there to be a condition for which it is possible to determine a treatment.

For what it's worth, my prediction is that on 30 November the opposition division will decide to reject the A53(c) ground. If the opponent appeals the decision, the Board of Appeal will then, after about 2 or 3 years, decide to dismiss the appeal on the grounds that G 1/04 was quite clear on this point, and will not refer any question to the Enlarged Board. The patent might, however, be revoked on the more conventional grounds anyway, so this issue will probably not be up for discussion if the patent does not survive the novelty and inventive step attacks.

UPDATE 20 March 2015: Now that the summons itself has appeared on the register (here), it appears I was jumping the gun a bit in originally saying that the OD would only be considering the A53(c) objection at the summons. They will in fact be considering all grounds of opposition raised. The post above has consequently been edited a bit compared to the original version published yesterday. Interestingly, the OD will also be considering the additional ground of A53(a) of their own volition,  because neither opponent has raised it. The OD states that the claimed invention "may be regarded as involving the use of a human embryo for industrial or commercial purposes" (point 3 of the annex to the summons), and raise this for discussion without coming to an opinion one way or the other. It is surprising this was not picked up by the second opponent, although I can see why the first one would not want to raise it even if they had considered it. The preliminary view of the OD appears to be that the A53(c) exception does not apply, given the narrow scope indicated by G 1/04, but that A53(a) might.

Time-Lapse IVF - A non-patentable method of diagnosis?

Article 53(c) EPC states that European patents shall not be granted in respect of "methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body". As far as I am aware, all of the case law relating to this provision relates to methods applied on human or animal bodies in their fully formed state. What does not appear to have been considered previously is whether the provision would apply to methods applied to human or animal embryos. This intriguing possibility has been raised in an article to be published in the journal Reproductive Biomedicine Online, written by Sigrid Sterckx, Julian Cockbain and Guido Pennings. The second of these authors happens to be a European Patent Attorney, while the other two are from the Bioethics Institute in Ghent. The abstract of the article, which is currently available in full online here as a preprint, states:

European Patent No. 2430454 [EP Register here] of Stanford University is open to opposition before the European Patent Office if such opposition is filed by 23 October 2013. This is the European equivalent of the US Patent that raised such controversy in this journal in August 2013 as being a patent on time [the patent is presumably one of these: US7963906, US8323177 and US8337387, although the August 2013 article refers to publication number US 2011/092762. None of these are, of course, patents on time]. The European Patent, which is directed to a method of selecting embryos for implantation using the results of time-lapse microscopy, should, in the present authors’ opinion, be revoked as being directed to a method of medical diagnosis, which is unpatentable under European patent law. The only party currently opposing Stanford’s patent is a competitor, Unisense FertiliTech A/S which is itself seeking to patent similar methods in Europe; the objection that Stanford has patented a method of diagnosis has not been raised by Unisense FertiliTech. We submit that Stanford’s patent should be opposed to safeguard competition and to protect the freedom to operate of clinicians. In this paper we explain how Stanford’s patent should fail under European law.

The argument in the article, which is well worth reading in full, is quite well put and at least plausible, although very probably wrong. The main weakness in the argument seems to me to be whether an embryo can be considered to be a human body. Although there does appear to be support from the CJEU on this interpretation, I think it is possibly a bit of a stretch to apply this to the particular exclusion under Article 53(c). The case law of the EPO Boards of Appeal, in particular the decision in G 1/04 (see this section of the case law book), would also seem to suggest that such a method would not be within the exception because it does not provide a diagnosis for curative purposes. The test would instead only provide an indication of whether an embryo is 'good' or 'bad'. The argument therefore seems to me to be doomed to fail on at least two major points.

The article has, however, already had the desired effect of provoking another opposition. An opposition has recently been filed (here) which, by an amazing coincidence, names the authors of the article and the European Society of Human Reproduction & Embryology as joint opponents. As an aside, I am a bit puzzled as to why the opposition would be filed in this way, rather than using the qualified European attorney as the joint representative.

Regardless of the new opposition, it looks like the patent will probably be revoked, or at least substantially limited, as a result of the opposition that has already been filed, which is very extensive and relies only on conventional grounds of novelty and inventive step. As a point of interest, one of the prior public disclosures cited by Unisense Fertilitec is a YouTube video (see below), which apparently shows the patented method being carried out prior to the filing date. It will, however, be interesting to see how the additional ground for opposition is viewed, and whether it becomes at all relevant or is simply dismissed as being a no-hoper. One to watch for the long term, perhaps, given the long gestation period of EPO oppositions.



UPDATE 5 November 2013: Third party observations have now been filed by Galway Fertility (here) and jointly by the Association of Clinical Embyologists (ACE) & the Royal College of Nursing (RCN) (here), both sets of observations presumably having been prompted by the Sterckx et al article. Both make points based on ethical, rather than legal, grounds, so do not appear to add any further legal weight to the additional opposition. The support by ACE has also been announced on the ACE website here.

UPDATE 20 November 2013: My reply to the paper, which is to be published as a letter in the same journal, is currently in press and available here.

UPDATE 9 May 2014: The patent proprietor's representative has now responded to the oppositions. Their letter of response can be accessed on the EP register here. In brief, they seem to be in agreement with me (unsurprisingly) that the claimed invention is not a method of diagnosis within the meaning of Article 53(c), and for the same reasons. The main points are that i) the method is not a diagnosis of any kind, and ii) it does not result in any kind of treatment. G 1/04 is fairly decisive.