Friday, 18 October 2013

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: US7963906US8323177 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.

15 comments:

  1. Forgive my ignorance, but could you explain what a 'patent on time' is please? Googling for the phrase "patent on time" in quotation marks brings up a lot of seemingly irrelevant pages about renewing patents on time, and this blog post appears in the first page of results.

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    1. A good question, but one that I think you would need to ask the authors of the article in question, not me.

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    2. Did you not add the text in red, which states "None of these are, of course, patents on time"? It doesn't appear in the linked abstract.

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    3. Yes, that was me. As far as I understand it a "patent on time" would have a claim to time itself, which is ridiculous as well as being not novel and not what the patent claims.

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    4. Ah, I think I get it now: a patent on (i.e. granting a monopoly over) time. I agree with the author that such a patent would be fairly controversial, but I doubt one would ever be granted (even by the USPTO!).

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  2. Interpreting it as a diagnosis on the embryo (or its precursor) is only one way of interpreting the claim. Another albeit more far-fetched would be to interpret the claim objectively as a therapeutic step to prevent hazardous conditions during pregnancy. Then the standards of T820/92 or T82/93 could be applied. Worth the try?

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    1. An interesting idea, although I think that is even more far-fetched than the idea that the claim is a method of diagnosis. The claim does not include the step of embryo transfer, so could presumably not be considered to be either therapy or surgery for at least this reason.

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  3. What can one say? You are patent attorneys - don't be so lazy. Read the original article and not some recontextualised version. It's downloadable for free from the journal's website and you should be capable of seeing the flaws in the review above without my help. Julian Cockbain

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    1. Thank you for your comment Julian. Could you please point out the flaws in my review? Having read your article and the notice of opposition I am still of the opinion that it is bound to fail. Your article does not mention that G 1/04 requires a diagnostic method to include a "diagnosis for curative purposes stricto sensu". Could you comment on this?

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    2. In relation to your accusation of laziness against fellow professional representatives, please refer to point 5(a) of the Code of Conduct of the Institute of Professional Representatives before the European Patent Office (OJ EPO 2003, 523). I would appreciate not being addressed in such terms.

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  4. Dear Dr Pearce - You went there first - the last lines of your letter to RMBO were quite simply insulting. Julian

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    1. I am sorry you think that. I don't think they were insulting, and certainly weren't meant to be. A robust dialogue is one thing, name-calling is quite another.

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  5. Dear David - I did not suggest that EPAs are lazy - indeed I know that they are not. Perhaps we can close this dialogue with a friendly good-bye. Julian

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  6. The UK-IPO biotech guidelines state:

    “Human totipotent cells have the potential to develop into the entire human body. In view of this potential, such cells are not patentable because the human body at various stages of its formation and development is excluded from patentability…”.

    Seems to relate to recital 42 of the biotech directive. If totipotent stem cells are considered a human body (a big if), then human embryos should be even more so.

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