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.

Opinions & Revocation

Since 1 October 2014, when section 16 of the Intellectual Property Act 2014 came into force, amending section 73 of the Patents Act 1977, it has been possible for the comptroller to revoke a patent following an opinion finding the patent to lack novelty or inventive step. This has substantially extended the comptroller's power to take action on his own initiative, which previously was only possible to prevent double patenting. Under the law as it stood prior to October 2014, the only other way to get a patent revoked would be to apply for revocation, either to the patent office or the court. Applying for revocation, however, is a tricky business and can lead to all kinds of complications, not least of which are high costs to pay for lawyers, together with potential exposure to at least some of the other side's costs if the case does not go your way. It is therefore not something to be taken lightly, even if your case seems to be watertight and the patent clearly invalid.

Under new section 73(1A)-(1C), if an opinion is issued that finds a patent to be not novel or to lack inventive step, the comptroller may revoke the patent. He must, however, wait until the patent holder has had an opportunity to request a review of the opinion, which can be done within 3 months of the opinion issuing, and cannot proceed until any review, and any subsequent appeal, has been disposed of. If, of course, the review finds the opinion to be wrong, it will be set aside and no action will be taken.

Once the comptroller decides to take action to revoke the patent, he has to give the patent holder an opportunity to make any observations and to amend the patent. Importantly, this procedure happens only between the Patent Office and the patent holder. The person who made the request for an opinion is no longer a party to the proceedings. They can, however, oppose any amendments requested under section 75, which are always advertised before they are made (although typically with a very limited 2 or 4 week period to file any opposition).*

The upshot of all this is that a person who has what they think is a solid case for knocking out a patent in the UK now has potentially an entirely risk-free way of getting rid of the patent by simply requesting an opinion on validity and waiting to see what happens. If the examiner agrees with the requester, the patent could then be knocked out, or at least amended, without any further action needed by the requester of the opinion and with no potential for a costs decision being made against them (even if the patent is only limited and not revoked in full). For those who do not want to get into an expensive procedure just to get rid of an inconvenient, but clearly invalid, patent, the new law seems to be a very good option indeed.

At the moment, we do not yet know how the new procedure will work in practice. The IPO have indicated that they will only act "in clear-cut cases where the patented invention clearly lacks novelty or an inventive step". What does "clear-cut" mean though? What is the difference between a patent lacking novelty and clearly lacking novelty? We may find out over the next few months, as two opinions have now issued that have found patents to lack novelty and inventive step.

The first of these, Opinion 23/14, was requested on 24 October 2014, and issued on 21 January 2015. The request was made regarding validity of GB2493904, granted to Actegy Limited and relating to an "apparatus for electrical stimulation of a foot" (or more likely a pair of feet, as seems to be clear from the illustration of the product shown on the right, and available here). The examiner found the  patent to be not novel over published Chinese utility model CN200973920Y relating to a "foot-care and body-beautifying machine with electromagnetic waves". According to Rule 98(1), the patent holder has until 21 April 2015 to request a review of the opinion. If no review is requested, or if any review does not result in the opinion being set aside, the comptroller may decide to revoke the patent.

The second is Opinion 25/14, which was requested on 13 November 2014 and issued on 11 February 2015. The request was made regarding validity of GB2497956, granted to J. C. Bamford Excavators Limited (more widely known as JCB, famous for making machines like the one shown on the left) and relating to a hydraulic system with kinetic energy recovery and storage device. The examiner found that the independent claims of the patent were not novel over US3485037 and were obvious over other documents cited by the requester. The patent holder has until 11 May 2015 to request a review.

In each case, the examiner's finding seems to be pretty clear in finding a lack of novelty of at least the independent claims of the patent. If the opinions are not set aside following a review, I would have difficulty seeing how either case could be anything other than "clear-cut" cases where revocation under section 73(1A) would be inevitable. We will, however, have to wait and see to find out whether the comptroller agrees.

*This turns out not to be correct. Any amendments made as a result of objections under section 73 are not advertised and are not subject to opposition. Only proposed amendments under sections 75 and 27 are advertised.