Resolution Chemicals Ltd v H. Lundbeck A/S
| Jurisdiction | England & Wales |
| Judge | The Hon Mr Justice Arnold,Mr Justice Arnold |
| Judgment Date | 22 October 2013 |
| Neutral Citation | [2013] EWHC 3160 (Pat) |
| Docket Number | Case No: HC12C04455 |
| Court | Chancery Division (Patents Court) |
| Date | 22 October 2013 |
[2013] EWHC 3160 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice, Rolls Building
Fetter Lane, London, EC4A 1NL
The Hon Mr Justice Arnold
Case No: HC12C04455
Tom Weisselberg (instructed by Olswang LLP) for the Claimant
Richard Gordon QC and Stuart Baran (instructed by Wragge & Co LLP) for the Defendant
Hearing date: 15 October 2013
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Introduction
I have before me what is in substance an application by the Defendant ("Lundbeck") that I should recuse myself from hearing the trial of this claim. The application is strenuously opposed by the Claimant ("Resolution").
By the claim, Resolution seeks revocation of SPC/GB02/049 ("the SPC") for escitalopram in the name of Lundbeck on the grounds of the alleged invalidity of the basic patent on which the SPC is based, namely European Patent (UK) No. 0 347 066 ("the Patent").
The claim was started on 7 November 2012. On 23 January 2013 Roth J made an order ("the Order") which among other things gave directions for the trial of the claim. Paragraph 30 of the Order provided:
"The trial of this action shall be listed on an expedited basis before Mr Justice Arnold if available on the earliest possible dated after 11 November 2013, with a time estimate of 8 days and pre-reading estimate of 2 days with a technical complexity rating of 4."
Patent actions are listed for trial in accordance with their technical complexity rated on a scale from 1 (simplest) to 5 (most complex). Cases with a technical complexity rating of 4 or 5 are listed before one of the two judges of the Patents Court who have science degrees and have specialised in intellectual property law throughout their career, whereas cases with a technical complexity rating of 1 to 3 may be listed before one of the other assigned judges of the Patents Court who do not have those attributes.
At the time the Order was made, the two specialist judges were Floyd J (as he then was) and myself. Floyd J was debarred from hearing the case because (as Christopher Floyd QC) he had represented the claimants at the trial of a previous claim for revocation of the Patent which was heard by Kitchin J (as he then was). It is for this reason that the Order provided for the trial to be listed before me. Shortly afterwards, the matter was duly listed in a window commencing on 11 November 2013. Since then, Floyd J has been promoted to the Court of Appeal and replaced by Birss J. I have been informed by Birss J that he is unable to hear the case due to a conflict of interest.
Formally, Lundbeck seeks a variation of paragraph 30 of the Order so that it provides that the action is listed for trial "not before Mr Justice Arnold". The practical effect of the variation would be that the claim would have to be tried either by one of the non-specialist assigned judges of the Patents Court or by a specialist Deputy High Court Judge.
Background
The general background to the matter is set out in my judgment dated 12 April 2013 [2013] EWHC 739 (Pat) (an appeal from part of which was dismissed by a judgment of the Court of Appeal dated 29 July 2013 [2013] EWCA Civ 924) and in the judgment of Kitchin J in Generics (UK) Ltd v H. Lundbeck A/S [2007] EWHC 1040 (Pat), [2007] RPC 32. For the purposes of the present judgment, I will take those two judgments as read and summarise the background as shortly as I can.
As explained in my previous judgment, Resolution attacks the validity of the Patent on two grounds. The first ground is obviousness in the light of United States Patent No. 4,650,884 ("884"). The second ground is obviousness in the light of an article entitled "Quantitative structure-activity in a series of selective 5-HT uptake inhibitors" by Allan J. Bigler et al published in the May/June 1977 edition of the European Journal of Medicinal Chemistry ("Bigler").
So far as the first ground is concerned, there are four steps in Resolution's argument:
i) it was obvious to seek to prepare the enantiomers of citalopram;
ii) one obvious way to achieve that was to seek to resolve a chiral precursor (or a derivative thereof) into its enantiomers and then convert those enantiomers stereospecifically into the enantiomers of citalopram;
iii) 884 discloses a route to racemic citalopram in which the precursor is the diol, and the skilled person would regard the diol as a good candidate for resolution into its enantiomers;
iv) the skilled person would expect to be able to convert the enantiomers of the diol stereospecifically to escitalopram and its enantiomer by an SN2 ring closure reaction.
In the previous proceedings, Kitchin J accepted steps (i)-(iii), but not (iv). In relation to step (iv), he said that the crucial question was "whether it would have been obvious to the skilled person that the ring of the resolved diol could be closed without risking loss of stereochemistry". He considered evidence relating to that issue from Dr Roger Newton for the claimants and from Professor Steve Davies for Lundbeck. Prof Davies was then, and remains, the Waynflete Professor of Chemistry at Oxford. Part of the disagreement between Dr Newton and Prof Davies concerned the applicability of Baldwin's Rules, which were devised by Prof Davies' predecessor as Waynflete Professor, Professor Sir Jack Baldwin FRS. In his judgment Kitchin J concluded that the approach of the person skilled in the art would have been in accordance with Prof Davies' opinion.
One of the applications which I dealt with in my previous judgment was an application by Lundbeck for summary judgment dismissing this ground of invalidity on the basis that it bore no real prospect of success. As explained in my previous judgment, Resolution contended that it had a real prospect of success because there was a substantial and weighty body of expert opinion (in addition to Dr Newton) which was contrary to the view of Prof Davies that was accepted by Kitchin J. In support of this contention, Resolution relied upon expert reports prepared for the purposes of foreign proceedings by three chemists, one of whom was Prof Baldwin. I concluded that Resolution's contention did have a real prospect of success, and there was no appeal against that part of the judgment.
It is not necessary for the purposes of this judgment to explain Resolution's case based on Bigler. It is sufficient to note that: (a) this case was not advanced by the claimants at the trial before Kitchin J; (b) it involves desmethylcitalopram; (c) it depends in part upon experiments as well as expert evidence; and (d) I concluded that it had a real prospect of success, and so Resolution should be permitted to amend its statement of case to introduce it. Again, there was no appeal against that part of the judgment.
The genesis of the present application
During the course of the hearing of the applications which were the subject of my previous judgment, the following exchange took place between counsel for Resolution and myself on 14 March 2013:
"MR TAPPIN: … we have an expert opinion of Professor Sir Jack Baldwin which he provided for the Canadian proceedings. I am sure my Lord knows Professor Baldwin, or knows of Professor Baldwin.
Mr Justice ArnoldWell, more than that.
MR TAPPIN: I rather thought that. I know which college my Lord went to.
Mr Justice ArnoldHe was my Part 2 supervisor.
MR TAPPIN: Anyway, for present purposes I do not think that —-
Mr Justice ArnoldI do not think that has any bearing on anything whatsoever, but it means I know who the man is."
Also during the course of that hearing, counsel for Lundbeck made the point that Resolution had not committed itself to calling Prof Baldwin (or either of the other two experts whose opinions it relied on). In response to this, counsel for Resolution said:
"I cannot say at this stage that I will be calling Professor Baldwin, but I have no reason to think that he would not be prepared to give evidence."
In June 2013 Resolution disclosed documents which made it clear that Prof Baldwin had devised an experimental protocol on behalf of Resolution. On 2 July 2013 Resolution's solicitors wrote to Lundbeck's solicitors in the following terms:
"You will be aware from the information provided in relation to the experiments that our client has been assisted by two experts. Professor Gerard Coquerel and Professor Sir Jack Baldwin, neither of whom were working in the pharmaceutical industry in 1988. In the previous case, the Court noted it was assisted by having expert input from someone in industry who had been involved in such issues at the relevant time. Our client therefore proposes calling a third expert to give evidence in relation to this aspect of the case. As such, the Order of Roth J dated 24 January 2013 would need to be amended to allow for a third expert to be called. If necessary our client will seek the Court's permission to call a third expert at the hearing seeking an Order for further directions. Please confirm by return whether your client will consent to such an application."
On about 19 July 2013 Resolution made an application for permission to call a third expert. This application was supported by a witness statement made by Campbell Forsyth of Resolution's solicitors on 19 July 2013 in which he stated:
"18. For the purpose of the experiments it was necessary for Resolution to obtain protocols provided by two different experts, Professor Sir Jack Baldwin and Professor Gerard Coquerel. Professor Sir Jack Baldwin is an organic chemist and designed the...
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