Shire Pharmaceutical Contracts Ltd and another (Claimant/Part 20 Defendants) v Mount Sinai School of Medicine of New York University (Defendant/Part 20 Claimant)
| Jurisdiction | England & Wales |
| Judge | JUDGE BIRSS QC |
| Judgment Date | 06 December 2011 |
| Neutral Citation | [2011] EWHC 3492 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 06 December 2011 |
| Docket Number | Case No: HC 10 C 04270 |
[2011] EWHC 3492 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
7 Rolls Buildings, Fetter lane
London, EC4A 1NL
His Honour Judge Colin Birss QC
(Sitting as a Judge of the High Court)
Case No: HC 10 C 04270
MR. RICHARD MEADE QC and MS. CHARLOTTE MAY (instructed by Linklaters LLP) for the Claimant/Part 20 Defendants
MR. DANIEL ALEXANDER QC (instructed by Jones Day LLP) for the Defendant/Part 20 Claimant
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...
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