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.