Shire Pharmaceutical Contracts Ltd & Anor v Mount Sinai School of Medicine of New York University

This action concerns European Patent UK number 1,942,189, entitled "Method for producing secreted proteins". It is held by Mount Sinai School of Medicine of New York University. It relates to an enzyme called alpha-galactosidase-A, which is used to treat a rare condition called Fabry disease.

Shire Pharmaceutical Contracts Limited contend the patent is invalid. One of the allegations is that it is anticipated by a paper entitled Affinity Purification of alpha-Galactodidase A From Human Spleen, Plasma, Placenta and Elimination of Pyrogen Contamination. The two authors of that paper are Bishop and Desnick.

Shire's case includes an allegation of inevitable result, in other words an allegation that the claim in question lacks novelty because the inevitable result of carrying out the teaching of the prior art is to produce a product within the claim.

Mount Sinai contends that Shire's product, which is called Replagal, infringes the patent. The action in the United Kingdom therefore consists of allegations of patent infringement and invalidity. The trial is due to be heard in May of 2012.

Shire have also opposed the patent in the European Patent Office. I do not have handy the precise date on which the opposition was filed but it was some while ago.

Claim 3 of the patent calls for a secreted human alpha 2,6 sialylated alpha-galactosidase-A containing mannose-6-phosphate ("M6P"). Shire conducted an experiment aimed to prove that the galactosidase produced inevitably by Desnick and Bishop falls within claim 3. They contend that the molecule produced has both the sialic acids and the mannose phosphate residues required by the claim. That experiment involves taking a fraction of blood plasma (I gather the blood plasma used is out of date and, therefore, not available for use in patients), which is then purified and analysed. In doing so, they made a sample of alpha-galactosidase-A. They said of that sample that it was being kept in order for it to be available for future testing.

Shire deployed the experiment in the United Kingdom and the EPO. In the EPO they filed a letter in September of 2011, well after the nine month opposition period, which included full details of the experiment. The hearing in the EPO is scheduled for March 2012.

In the United Kingdom, Shire served a notice of experiments on 11th October 2011. It is likely that there will be repeats of these experiments, which are currently scheduled, as I understand it, for February 2012. As I said, the trial in this case will take place in May 2012.

Mount Sinai seek an order for samples of certain products. The controversy relates to a particular sample of the alpha-galactosidase-A. There is also, I believe, an application for samples of other matters, in particular I believe antibodies, but as I understand it, there is no controversy about that. The issue is about the sample of alpha-galactosidase-A.

Before me today Mr. Alexander QC appears for Mount Sinai, instructed by Jones Day. Mr. Meade QC appears with Ms. Charlotte May for Shire, instructed by Linklaters.

I have read witness statements of Mr. McCulloch, for Jones Day and Mr. Liyanage, for Linklaters.

There are two issues. First of all, should I order production of the samples at all? Second, if I do, are they covered by an implied obligation not to use them for a collateral purpose outside these proceedings, and, if they are so covered, should I lift that obligation and allow Mr. Alexander's clients to use the samples, or use results from testing of those samples, in the proceedings in the European Patent Office?

The first matter I will get out of the way is the question of delay. It has been suggested in the written materials that Mr. Alexander's clients delayed in making the requests for what they are seeking here. That is not right. In the context of this case, the matters have proceeded expeditiously and it does not seem to me to be a case which turns on any question of delay.

The first question is whether I should order the production of samples. In Mayne v. Debiopharm [2006] EWHC 164 Pat., Pumfrey J (as he then was) was faced with a case in which there were some experiments which were relied upon to prove an anticipation. The question concerned disclosure of work-up experiments which related to the experiments which had been the subject of the notice of experiments. In that judgment, Pumfrey J resolved a relatively long-standing dispute on the authorities which had existed at that time between the judgment of Jacob J (as he then was) in Honeywell v. Appliance Components and the judgment of Laddie J in Electrolux v. Black & Decker. Pumfrey J's decision was that work-up experiments, in so far as they might have been privileged, were not privileged following service of a notice of experiments because, in his judgment, a notice of experiments waived any privilege by being served. Accordingly, that meant the work-ups were available for disclosure in the case before him.

In the case before me, it is fair to say that the samples are not exactly the same as work-up experiments but it seems to me that similar principles apply. Mr. Meade did not suggest that the samples in question were privileged and he was right not to do so. The question is only whether I should order the production of those samples, having regard to what one might describe as the ordinary case management questions of proportionality and the general conduct of these proceedings.

Mr. Meade puts forward two reasons why I should not order production of these samples in order for them to be tested, first relating to degradation of the sample and second in relation to timing.

As regards degradation, Mr. Meade relies on the evidence of Dr. Angela Norton. Essentially, her evidence comes to this. The sample in question has been frozen at -80°C and that process may or may not have led to degradation of the sample itself. Her evidence indicated that the degradation may be relevant to a repeat of what was called Stage III of the experiment. Stage III is where one tests to see whether the sialic residues and the mannose phosphate are present in the same molecule. But Mr. Alexander says he does not want to repeat Stage III.

In any event, it seems to me that that is not the relevant point. The relevant point, as I read Dr. Norton's evidence, is, understandably in the circumstances, not that the sample has degraded, but simply that it may or may not have done. If it has, that may or may not have an effect on whatever tests are to be carried out.

Mr. Meade also made the point that it was incumbent on Mr. Alexander's clients to explain what it was they wanted to do with the samples. I agree up to a point. It seems to me that it is right that Mr. Alexander did need to explain, at least in general terms, why he wanted the samples, but it seems to me that his explanation that he wanted to do tests on them and his short explanation of what those tests are is quite satisfactory. It is not necessary for a party to say more than that they wish to conduct some sort of tests on the samples. Otherwise, one gets into a tangle about privilege because, as Mr. Alexander said, until one has at least conducted some tests, one does not know whether one may or may not wish to conduct further tests.

On the evidence I have before me, conducting tests on these samples may or may not open up what one might call a "second front" relating to the possible degradation of the samples. That seems to me to be possible but, on the evidence I have, it is not a reason why I should not order a disclosure of the samples. The determining factor, to my mind, is that when Shire deployed the experiments in the EPO they specifically made the point that the sample was being kept in order possibly to be tested in future. It seems to me that degradation is potentially a problem, i.e. it may or may not be a problem. In the end, we will have to see. In my judgment, that is not a reason not to order production of the sample.

As regards timing, Mr. Meade submits that Mr. Alexander's clients should wait for the repeat experiments. At that stage there will be available a sample of the alpha-galactosidase which will not be frozen. While I do not doubt that that is true as a matter of fact, of course if the experiments are repeated there should be a sample of that kind, it does not seem to me that that is a reason not to order production of this sample at this stage. Apart from anything else, Mr. Alexander submitted to me that it may lead to it not being necessary to conduct the repeats at all.

I have to say, I regarded Mr. Alexander's submission with some scepticism. This has all the hallmarks of litigation in which every party is taking every point open to them and while it might be that hope springs eternal and perhaps testing the samples will lead to the repeats not being necessary, I rather think that that will not happen and, accordingly, that in itself does not strike me as being a strong point.

However, the more important point is the general point that these samples relate to the notice of experiments and investigation of them will allow the defendants (that is to say, Mount Sinai) to understand the experiments that are deployed against them and, perhaps, to explain the results which have been put to them. It seems to me that that is a quite sufficient reason, on the facts of this case, to order production of the samples at this stage. Whether more samples will be required from the repeats is another matter.

I have decided the samples should be produced for the purposes of these proceedings. The next questions I have to resolve, therefore, are the basis are they being ordered and if they are covered by an implied obligation not to use them for a collateral purpose. If they are then should I, as Mr. Alexander submits, find that there are special circumstances in this case which mean that I should lift that obligation?

The parties were not entirely clear before me precisely which power the court was exercising in making the order that I have just indicated I will make. Mr. Meade helpfully pointed to CPR Part 25 and submitted that the power is the power in Part 25 to order production of objects and things for the purposes of conducting experiments on them. He may well be right about that. In any event, there is no doubt that the parties agree that I have the power to make the order that is required. The only question is whether it comes under Part 25 or somewhere else.

Whether it comes under Part 25 or not, it seems to me that logic dictates that the obligation which is generally regarded as arising in relation to disclosure or discovery also applies in this case. I am fortified in that view by the judgment of Laddie J in Dendron GmbH v. The Regents of the University of California [2004] EWHC 589, at paragraph 33. In that paragraph, Laddie J, considered the implied obligation set out in the well-known case of Alterskye v Scott. He came to the view that, on the facts of the case before him, it was not provided for by the CPR and decided that the fact that it was not provided for in the rules of the CPR did not mean that it did not arise.

Although it is fair to say the CPR was intended to be a definitive code relating to all matters, the facts before him appeared to be a situation for which the CPR did not provide. That did not mean that the obligation did not arise, but it meant that the common law obligation did still arise in the circumstances before Laddie J.

Just as before Laddie J in Dendron, before me it is fair to say that the CPR, as written, does not provide for a restriction on the collateral use of the results of tests which Mr. Alexander's clients wish to perform on the sample I have ordered. However the logic of that principle applies in this case. Mr. Meade's clients are being ordered by me to produce those samples and to that extent there is an element of compulsion. I appreciate that it can be said that there was no compulsion in relation to Mr. Meade's clients choosing to deploy these experiments in the first place but that does not seem to me to be the relevant point.

The relevant point is that he is being ordered by the court to produce samples in the course of this litigation and it seems to me that in those circumstances, the general rule that was identified in Alterskye v Scott applies in this case and, therefore, apart from an order of the court, or if the matters are read or referred to in open court, the obligation not to use them for a collateral purpose outside the purpose of these proceedings applies.

That means that the provisions as to when that obligation should be lifted also apply. In that respect, the principle can be regarded as that set out in Smithkline Beecham plc v. Generics (UK) Ltd [2003] EWCA Civ 1109, cited by Laddie J in Dendron, as follows:

"The court will not release or modify the implied undertaking given on discovery, save in special circumstances and where the release or modification would not occasion injustice to the person giving discovery."

Of course, in this case, to be precise, Mr. Meade is not giving discovery but the principle is applicable none the less.

I am also reminded of the observations of Jacob LJ in Human Genome Sciences v. Eli Lilly [2010] RPC 14, in which he said that:

"Co-operation between national courts should as far as possible extend to all stages of the procedure in both national courts and in the Opposition Division and Boards of Appeal of the EPO."

Mr. Alexander put that to me as part of assisting his case as to why I should find that there are special circumstances here.

What Jacob LJ was talking about in Human Genome Sciences v. Eli Lilly is not really the same thing as is arising in this case and I do not place reliance on what Jacob LJ said. It is not that I disagree with it. If I may say so, with respect, it is entirely right, but it is not germane to the issue I have to decide.

Mr. Meade says that there are no special circumstances in this case; all this is a usual case in which there is parallel litigation in the EPO. The EPO can look after themselves. He did not suggest, and he was right not to, that the EPO would ever order his clients to produce the sample in question. Whether they could is another matter. Even if the EPO have the power to make an order of that kind (and it is not clear to me that they do) it is, as far as I am aware, unheard of and can effectively be discounted.

The special circumstances which Mr. Alexander relies on are these. He submits that Shire themselves deployed the experiments in question in the UK at the same time as they deployed them in the EPO. He also points out that the EPO hearing is currently set for a date in March, which is before the trial in this case, in May. Of course if the EPO hearing had taken place after the trial in this case, then it is, I will at least say likely, and certainly possible, that any information which was produced as a result of analysing the samples would have been used in the EPO, because it is likely that it would have been read or referred to in open court at the trial if it was relevant. I say that specifically because, as far as I am aware, there is nothing confidential about this material. The material is not suggested to consist of internal confidential documents or anything of that kind.

It seems to me that the special circumstances, if they are to exist, must relate to the particular facts of this case. It does not seem to me that this case is like the case of Tassilo Bonzel & Schneider (Europe) AG v. Intervention Limited and A Or. [1991] RPC 43, in which Aldous J (as he then was) refused to make an order lifting the implied obligation which would cover the use of confidential disclosure documents. In that case, as Aldous J pointed out at page 50 of the report, the EPO themselves did not have a wide jurisdiction to keep documents confidential and in any case, he pointed out:

"Discovery in patent actions is a heavy burden and requires disclosure of documents which in the normal course of business would be considered as highly sensitive. To make the order in this case would be a real disincentive to full discovery by litigants. The documents are the plaintiffs and the information should be kept to them in so far as is possible in the interests of justice in the United Kingdom and so that justice can both be done and be seen to be done."

Those considerations seem to me not to be applicable to the case before me.

This is not a case, as I have already said, of disclosure of confidential documents. This material is part and parcel of the experimental work which Shire chose to deploy in the EPO and, as I have already mentioned, they referred to the purpose of retaining the sample as being to allow for possible further testing.

In the circumstances, fairness dictates that Mr. Alexander's clients should be permitted to use the results of any tests they wish to perform on these experiments in the European Patent Office. Whether the European Patent Office themselves admit the experiments into their proceedings is a matter for them and I should make it absolutely clear that this judgment is not an invitation to the EPO to admit the material; nor is it a suggestion that they should not. It is a matter entirely for the EPO to control their own procedure but it seems to me that, as I said, fairness dictates that the obligation which does apply to these experiments can and should be lifted in this case.

Mr. Alexander says that he can do the tests in time for the EPO. I should also add that Mr. Meade's clients are perfectly entitled to point out at the EPO, if no results appear, that Mr. Alexander's clients have had the opportunity to test those materials and if they choose not to put any material before the EPO, well then inferences can be drawn from that.

Accordingly, as I have said, I will make the order that Mr. Alexander seeks. The samples will be provided and I will lift the collateral obligation in relation to them, in which case Mr. Alexander's clients are permitted to use the results in the European Patent Office.