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.

Partial Priority - An opposing view

Regular readers will know that I have been concerned with the issue of partial priority under Article 88 EPC, and how far it can be applied, because this has serious implications regarding the extent to which a European patent or application can be held to lack novelty over its own priority application. I have consistently expressed the view that it should not be possible for a European patent to be held to lack novelty over its own priority application if the effect of Article 88 EPC in combination with Article 54(3) EPC is properly applied. My view, which has support from the EPC and the case law of the Boards of Appeal, is detailed in previous posts (the main one being here). There is, however, an opposing view that can also be said to have support from the EPC and case law, which has been expressed and discussed in comments on this blog and elsewhere. It is not yet clear which view will eventually win out, and I think it will need a referral to the Enlarged Board to settle it.

This opposing view has been detailed by one of the opponents in the Nestec case T 1674/12, which unfortunately will not be the case that settles the issue because a referral to the Enlarged Board has not been made. As noted last week, the Board decided in the end to revoke the patent, and will be issuing their written decision later. Whether their reasons will take into account the partial priority issue is not yet known. I suspect they will simply bypass the issue because the patent was invalid for other reasons anyway [Update 19/10/13: It appears my suspicions were correct; the Board did not even get to the issue of partial priority at the hearing, so it will definitely not feature in the reasons for the decision]. For the time being, it is interesting (to me at least) to see how the other side's view on the partial priority issue has been expressed.  The following is a rough translation of the relevant portion from the opponent's letter from 9 September 2013, which I have annotated with hyperlinks where appropriate. The original is available on the register here. My apologies for any errors or omissions resulting from my less than ideal language skills. If you can come up with a better translation, I would be happy to replace it.

2 . On the issue of partial priority

The patentee seeks, in its letter of 15 July 2013, to criticize the British decision of Nestec v Dualit especially regarding the issue of the invalidity of the priority of claim 1 (and by default novelty vis-à-vis document D1).

2.1. Position of the proprietor

The incumbent continues to assert that claim 1 has a partial priority that immunizes against the lack of novelty vis-à -vis document D1 . In support of this assertion , the owner cited and commented on a recent decision T 1222/11, which also refers to a part of the preparatory work of the EPC 1973, namely a memorandum of FICPI, mentioned in the reasons of the Enlarged Board of Appeal G 2/98.

G 2/98 accepted the principle of allocating separate priority dates for different subject matter covered by the same generic type of claim, provided that it leads to "a claim having a clearly defined limited number of alternatives".

According to the proprietor, the decision T 1222/11 as well as the memorandum of FICPI lends credence to the theory that the above condition posed by the Enlarged Board of Appeal is satisfied if it is possible to "identify conceptually" alternative objects by comparing the claim and the contents of the priority documents.

The approach proposed by the holder should not be followed for the following reasons.

2.2. Neither decision T 1222/11, nor the contents of the memorandum of FICPI, is authoritative

First, the decision T 1222/11 (by Board 3.3.7) is an isolated decision. In point 11.5 of the reasons, it is explicitly stated that the Board departs from the approach that has been followed in previous decisions T 1877/08 (by Board 3.3.10 ), T 476/09 (Board 3.3.9 ), T 1443/05 (Board 3.3.1 ) and T 1127/00 (Board 3.3.8) . We can add to this list the decision T 70/05 (Board 3.3.8) , which confirms the reasoning in T 1127/00.

Thus the decision T 1222/11 is opposed to the dominant jurisprudence of the Boards of Appeal. If only for that reason, it should not be followed by the present Board.

With regard to this Memorandum of FICPI, it is true that the opinion G 2/98 states in 6.4 that we can consider that it "express[es] the legislative intent underlying Article 88(2), second sentence, EPC". The purpose of the memorandum was indeed to suggest that the legislature can allocate multiple priorities in a claim. The proposal was accepted , and it is in this (narrow) sense that the memorandum reflects the ratio legis of Article 88.

Specifically, the Enlarged Board takes up the distinction made in the memorandum between the claims of "AND" type and claims of "OR" type. Only the second type can lead to the allocation of multiple priorities (paragraphs 6.5 to 6.7 of the reasons).

However, the Enlarged Board of Appeal has not expressed the opinion that the detailed content of the memorandum should be taken as is, without changing anything or adding an assessment of whether, for a given generic claim, partial priority can actually be recognized for a portion of the claim.

The Enlarged Board has actually implicitly taken a contrary position when said in the passage quoted in the opinion, at the end of Section 6.7 of the reasons that "The use of a generic term or formula in a claim for which multiple priorities are claimed in accordance with Article 88(2), second sentence, EPC is perfectly acceptable under Articles 87(1) and 88(3) EPC, provided that it gives rise to the claiming of a limited number of clearly defined alternative subject-matters". Indeed, this condition of a "limited number of clearly defined alternative subject matters" is not listed in the Memorandum of FICPI. It is therefore a condition that was added to the memorandum by the Enlarged Board of Appeal , when analyzing the situation of type "OR" claims.

Consequently, it is not correct to take the examples cited in the memorandum of FICPI and indicate that the Enlarged Board approved the allocation of multiple priorities for these examples. The Enlarged Board has only taken over the general framework of the memorandum of FICPI (distinction between claims of type "OR" and "AND"), adding the condition of a "limited number of clearly defined alternative subject matters" regarding claims of "OR" type, without any comment on the illustrations of "OR" type claims presented in the memorandum.

Only the decision T 1222/11 has taken over the sample claims of "OR" type mentioned in the memorandum, but in doing so it follows an approach in contradiction to Boards 3.3.1 , 3.3.8 , 3.3.9 and 3.3.10 .

In addition, on the merits, the approach of the proprietor, which is based on the decision T 1222/11 and the Memorandum of FICPI taken in its entirety, is not consistent with the view G 2/98 as is shown below.

2.3 . The faulty reasoning of the decision T 1222/11 and part of the memorandum FICPI

In section 11.4 of the reasons for the decision T 1222/11, Board 3.3.7 is critical of the jurisprudence of Boards 3.3.1 , 3.3.8 , 3.3.9 and 3.3.10 of the fact that this jurisprudence has held that the requirement for the Enlarged Board on the "limited number of clearly defined alternative subject matters" characterizes the manner in which the subject of an "OR" claim must be defined. In point 11.5.2 of the reasons, Board 3.3.7 offers its own interpretation of the condition laid down by the Enlarged Board, that this condition simply refers to the ability to identify conceptually, by a comparison of the claimed subject matter with priority documents, a limited number of clearly defined alternative subject. This theory is also extended to the case of partial priority (paragraph 11.6 of the reasons).

But this interpretation cannot be correct because it leads to rendering meaningless the condition "limited number of clearly defined alternative subject matters" posed by the Enlarged Board. Indeed, it is always possible to divide conceptually (that is to say abstractly and thus artificially) a generic object into two objects of type A and non-A. Also, one wonders in what situations allocating multiple priorities (or partial priority) should not be accepted, following this approach. In other words, to follow the proposed T 1222/11 interpretation, the condition imposed by the Enlarged Board had simply no reason to be: it is not a requirement.

In addition, the Board 3.3.7 reviews examples in the memorandum of FICPI, and sees a confirmation of its theory (Section 11.5.8 of the reasons). But in fact, at least some of these examples are problematic.

The first example cited (listed in Section 11.5.5 of the reasons) seems consistent with G 2/98. In this example, a first priority document discloses subject matter with the element chlorine, a second priority document discloses subject matter with the elements bromine, iodine and fluorine, and a generic claim in the subsequent request is subject matter with a halogen. In this case, the generic claim has the first priority in terms of chlorine, and the second priority that is bromine, iodine and fluorine.

This first example appears to conform to the G 2/98, since the generic term "halogen" corresponds to a limited number of clearly defined alternative subject , namely the four elements chlorine, bromine, iodine and fluorine.

The situation is different when a generic claim covers a continuum of embodiments . This is particularly the case in the third example of the memorandum of FICPI in point 11.5.7 of the reasons of T 1222/11.

In this example, a first priority document discloses a method of coating the interior of a pipe, and a second priority document discloses a method of coating the walls of bottles or any other hollow body. The memorandum suggests that the provision of the EPC proposed on multiple priorities will permit a generic claim in a subsequent application of a method of coating the inner walls of a hollow body. The memorandum justifies this approach by the desire to avoid having to unnecessarily increase the number of claims of patent applications.

The memorandum states in this regard: "if multiple priorities are not allowed for a single claim, the applicant must write parallel claims, one on the method of coating inner walls of the pipe, which will benefit from the first priority, and the other on the method of coating inner walls of hollow body other than the pipes, which will benefit from the second priority".

But this position is completely incompatible with the position of G 2/98, that for the condition of the "same invention" to be met for a claim to be eligible for the priority of an earlier application means that: "the person skilled in the art [must ], using common general knowledge, directly and unambiguously deduce the purpose of the claim of the previous application as a whole".

According to the reasoning of the memorandum of FICPI, a putative claim "on the method of coating inner walls of bodies other than hollow pipes" is supposed to benefit from priority in the second priority document. The second document priority only describes a "method of coating walls of bottles or any other hollow body" and therefore does not describe a method of "coating internal walls of hollow bodies other than pipes". According to G 2/98 - and the application has been made consistently by the Boards of Appeal - this claim devised by the FICPI memorandum therefore cannot benefit from the second priority. It is necessary that the second priority document itself describes a "method of coating inner walls of bodies other than hollow pipes" for priority to be validly claimed.

Correspondingly, the generic claim proposed in the third example of the memorandum of FICPI cannot benefit from the multiple allocation of the first priority and the second priority. Not that the claim was a generic form - since this does not raise any difficulty in the case of first example of halogens, but the fact that the concept of cladding inner walls of hollow bodies covers a multitude of possibilities (while G 2/98 requires a limited number of subject matters), which are not clearly defined (although the G 2/98 requires that the objects are clearly defined). Thus, this claim cannot really benefit from the second priority, which is the only one to disclose the generic concept of cladding hollow bodies, a concept that is not divisible by a limited alternative objects clearly defined number.

In fact, the Board 3.3.7 seems to have identified the contradiction between the third example of the memorandum of FICPI and the position of G 2/98. But for the Board, the position of G 2/98 does not apply just to the situation of multiple or partial priorities .

It is true that the question that the Enlarged Board of Appeal responded to did not specifically concern the situation of multiple or partial priorities . Nevertheless, the principle laid down by the Enlarged Board has a very broad application and also covers claims of type "OR" with multiple or partial priorities. Thus, the allocation of a certain effective date of only part of the subject matter of a claim assumes that the subject matter can be directly and unambiguously derived by the skilled person from the relevant reference document .

To decide otherwise would be to establish an exception to the test for disclosure that was developed by the Enlarged Board of Appeal over the years including G 3/89, G 11/91, G 2/98, G 1/03 and G 2/10 - while nothing justifies such an exception.

This approach, termed the "gold standard" in G 2/10, is indeed precisely considering the coherent separate questions of the validity of the right of priority (Art. 87 EPC ), the extension of subject matter (Art. 123(2) and 76(1) EPC) and novelty (Art. 54 EPC).

And, in this consistent approach, the central criterion is direct and unambiguous disclosure for the skilled person. This is why the reference to the possibility of identifying conceptually alternative subject matters proposed by T 1222/11 and endorsed by the patentee has no place in this coherent approach. It is, in effect trying to implement a so-called rule of logic to conclude in a systematic way the possibility of benefiting from the allocation of multiple or partial priorities.

However, using a rule of this type of logic has been firmly rejected by the Board of Appeal, in a related context, that of the evaluation of disclaimers. The Enlarged Board [in G 2/10] concluded that it was not possible to make a case by case evaluation of the direct and unambiguous disclosure of relevant subject matters.

The memorandum of FICPI was written in 1973 , well before the establishment of the "gold standard" mentioned above. It is not surprising that it is not fully compliant with this standard. It is for this reason that the Enlarged Board of Appeal made clear in the G 2/98, the condition of a "limited number of clearly defined alternative subject matters", the only way to ensure consistency of the whole practice of the EPO .

2.4. Conclusion concerning claim 1

In view of the foregoing, the reasoning of the patent holder cannot be followed. Claim 1 of the main request does not cover a "limited number of clearly defined alternative subject matters". In fact the claim covers an infinity of subject matters that are not identifiable to each other - as has already been explained above. This claim cannot therefore benefit from the claimed priority, even partially. So there is a lack of novelty vis-à -vis D1.

This opposing view looks at least superficially persuasive, citing much relevant case law in support. The main flaw in the argument, however, is the assertion that the Enlarged Board in G 2/98 did not consider that all of the examples in the FICPI memorandum could justify a claim having a valid claim to partial priority under Article 88 EPC. If this was the case, it is very strange that the Board made no mention of this in their reasons. The Board clearly approved the memorandum and its justification for Article 88 EPC, so the argument that the criterion of "a limited number of clearly defined alternative subject matters" somehow makes some of the examples in the memorandum invalid is to my mind implausible. If instead we take all of the examples in the memorandum, which the Board in G 3/98 certainly at least considered, to be valid then the opponent's argument must fall away and a claim to partial priority of the kind in the Nestec case must be valid.

Nespresso European Patent Revoked

Following my previous post on the subject of the appeal case in T 1672/12, the hearing for which was held in Munich over the past couple of days, a press release from Nestec has announced that the Board of Appeal has decided to revoke the patent (thanks to IPCopy for prompting me with a link). Nestec's press release states:

Nestlé Nespresso SA acknowledges the decision today of the Appeals Board of the European Patent Office (EPO) to revoke a patent related to the Nespresso system. The decision overrules a decision by the EPO [opposition division] from April 2012, which maintained the patent in an amended form. We believe that the decision fails to recognise the unique innovations inherent in the design of the Nespresso system. 

While disappointing, the ruling does not have any impact on the current competitive situation. Nespresso has brought legal cases against producers of generic capsules, although there are currently no prohibitions on their sale based on this patent. The decision, therefore, does not change the status quo. 

The protection of our intellectual property is an important component of our business strategy. However, our success will continue to be driven by our ability to exceed consumer expectations by delivering products and services of exceptional quality. This focus has allowed us to maintain our position as the reference in the portioned coffee category and it is why consumers continue to choose the unique Nespresso experience over the 100 other portioned coffee offerings in the market globally. 

We will await the written decision of the EPO ruling before determining next steps in the pending legal cases.

This presumably means that the Board has decided not to refer the partial priority issue to the Enlarged Board, which is doubly disappointing. The reasons behind the Board's decision will not be known until the written decision issues, which could take a few months. It will certainly be interesting to see how the Board managed to tackle (or perhaps avoid?) the issue.

UPDATE 19 October 2013: I have heard from a very reliable source that the issue of partial priority did not come into play at the hearing. The deciding factor was instead that of added matter (Article 123(2) EPC). The Board got no further than this, deciding to refuse all requests on this basis and revoke the patent.

UPDATE 22 November 2013: The minutes of the oral proceedings have now appeared on the EP register here. The minutes confirm that the patent was revoked for not complying with Article 123(2). The Board stated:

"Après délibéré, la chambre a conclu que l'objet de la revendication 1 selon la requête principale ne satisfait pas aux exigences de l'article 123(2) CBE, en particulier du fait de la suppression de deux caractéristiques ("position intermédiaire selon un axe de manière décalée et/ou inclinée" et- "la capsule asymétrique"), et du rajout des deux caractéristiques finales prises en isolation dans la description (collerette passe "en dessous des moyen d'arrêt" et "de façon à ce que dans son mouvement, la partie mobile agisse sur la capsule pour la descendre")"

UPDATE 6 January 2014: The decision has now issued, and has been expertly summarised here at K's Law. Not a word about toxic priority, of course.

Coffee pods at the ready

The hearing in appeal case T 1674/12 relating to Nestec's European patent EP2103236 is due to be held tomorrow, 9 October 2013, at the EPO in Munich. For readers unfamiliar with the case, see my earlier post here. Since I last posted on the subject there has been further correspondence, the most interesting bit of which to my eyes is a letter filed just a few days ago by one of the opponents. This letter raises a question that the opponent submits "depending on whether certain issues arise during the oral hearing". The opponent asks:

1) How is the proviso in G 2/98 [point 6.7] that "The use of a generic term or formula in a claim for which multiple priorities are claimed in accordance with Article 88(2), second sentence, EPC is perfectly acceptable under Articles 87(1) and 88(3) EPC, provided that it gives rise to the claiming of a limited number of clearly defined alternative subject-matters" to be applied?
2) What is the test in law for a "limited number of clearly defined subject matters"?

The question, similar to that raised in my last post, goes to the heart of the partial priority issue on which a significant part of the appeal depends, and on which there is now a clear discrepancy in the case law of the EPO Boards of Appeal. Although it would obviously delay resolving the issue for quite a while, a referral to the Enlarged Board would seem to me to be a necessary next step so that this issue can be properly addressed.

Given that the Board of Appeal will issue a decision at the hearing, but which will not appear in writing for a while, any information on how the case goes would be gratefully received, either as comments to this post (anonymous if necessary) or by email to me at tuftythecat@gmail.com.

UPDATE 11 October: According to a press releases here, picked up by the WSJ here, the Board of Appeal has revoked the patent. This presumably means that the Board did not consider it worth referring a question to the Enlarged Board on the partial priority issue. This could perhaps be because the patent was invalid for other reasons, but we will not know for sure until the Board issue their written decision.