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England and Wales High Court (Patents Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Resolution Chemicals Ltd v H Lundbeck A/S  EWHC 3160 (Pat) (22 October 2013)
Cite as:  EWHC 3160 (Pat)
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Fetter Lane, London, EC4A 1NL
B e f o r e :
| RESOLUTION CHEMICALS LIMITED
|- and -
|H. LUNDBECK A/S
Richard Gordon QC and Stuart Baran (instructed by Wragge & Co LLP) for the Defendant
Hearing date: 15 October 2013
Crown Copyright ©
MR JUSTICE ARNOLD :
"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."
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.
The genesis of the present application
"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 ARNOLD: Well, more than that.
MR TAPPIN: I rather thought that. I know which college my Lord went to.
MR JUSTICE ARNOLD: He was my Part 2 supervisor.
MR TAPPIN: Anyway, for present purposes I do not think that ---
MR JUSTICE ARNOLD: I do not think that has any bearing on anything whatsoever, but it means I know who the man is."
"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."
"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."
"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 protocol relating to steps 1, 2 and 5 of the experiments (synthesis of desmethylcitalopram and conversion of enantiomers of desmethylcitalopram to enantiomers of citalopram). Professor Gerard Coquerel is a physical chemist and designed the protocol relating to steps 3 and 4 of the experiments (resolution of desmethylcitalopram). In light of Lundbeck's response to Resolution's Notice of Experiments set out above it will be necessary to call both these experts to give evidence at the trial of this action on the nature of their instructions and the outcome of the experiments themselves.
19. At present, Roth J's Order for Directions dated 24 January 2013 provides that each party may only call two expert witnesses to give evidence at the trial of this action. However, both parties will need to call an expert to assist the Court in deciding the issue of whether a motive to resolve citalopram existed at the priority date of the Patent."
The nature and extent of my connection with Prof Baldwin
"Where a judge is faced with an application that he should recuse himself on the ground of apparent [bias] it is in my judgment incumbent on him to explain in sufficient detail the scale and content of the professional or other relationship which is challenged on the application. The parties are not in the position of being able to cross-examine the judge about it and he is likely to be the only source of the relevant information. Without this, it becomes difficult if not impossible properly to apply the informed bystander test set out by Lord Hope in his speech in Helow v Home Secretary  1 WLR 2416."
The role of expert witnesses in patent actions
"6. The 'man skilled in the art' is invoked at many critical points of patent law. The claims of a patent must be understood as if read by that notional man—in the hackneyed but convenient phrase, the 'court must don the mantle of the skilled man'. Likewise many questions of validity (obviousness, and sufficiency for instance) depend upon trying to view matters as he would see them. He indeed has statutory recognition—Arts 56, 83 and 100 of the EPC expressly refer to 'the person skilled in the art'.
7. It is settled that this man, if real, could be very boring—a nerd. Lord Reid put it this way in Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd  R.P.C. 346 at p.355:
'… the hypothetical addressee is a skilled technician who is well acquainted with workshop technique and who has carefully read the relevant literature. He is supposed to have an unlimited capacity to assimilate the contents of, it may be, scores of specifications but to be incapable of a scintilla of invention. When dealing with obviousness, unlike novelty, it is permissible to make a 'mosaic' out of the relevant documents, but it must be a mosaic which can be put together by an unimaginative man with no inventive capacity.'
8. The no-mosaic rule makes him also very forgetful. He reads all the prior art, but unless it forms part of his background technical knowledge, having read (or learnt about) one piece of prior art, he forgets it before reading the next unless it can form an uninventive mosaic or there is a sufficient cross-reference that it is justified to read the documents as one.
9. He does, on the other hand, have a very good background technical knowledge—the so-called common general knowledge. Our courts have long set a standard for this which is set out in the oft-quoted passage from General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd  R.P.C. 457 at 482 which in turn approves what was said by Luxmoore J. in British Acoustic Films Ltd v Nettlefold Productions (1936) 53 R.P.C. 221 at 250. For brevity I do not quote this in full—Luxmoore J.'s happy phrase 'common stock of knowledge' conveys the flavour of what this notional man knows. Other countries within the European Patent Convention apply, so far as I understand matters, essentially the same standard.
10. The man can, in appropriate cases, be a team—an assembly of nerds of different basic skills, all unimaginative. But the skilled man is not a complete android, for it is also settled that he will share the common prejudices or conservatism which prevail in the art concerned.
11. None of the above is controversial. However, sometimes the requirement that the skilled man be uninventive is used by counsel for a patentee in an attempt to downgrade or dismiss the evidence of an expert called to say that a patent is obvious—'my witness is more nerdlike than his' is the general theme. I do not find this a helpful approach. It is frequently invoked and Mr Waugh Q.C. invoked it in this case in an effort to downgrade Rockwater's expert evidence on obviousness given by Professor Witz. Mr Waugh said his witness, Mr Nash, was more appropriately qualified than Professor Witz, and that the latter, because he had patents in his name, 'was of an inventive turn of mind'.
12. I must explain why I think the attempt to approximate real people to the notional man is not helpful. It is to do with the function of expert witnesses in patent actions. Their primary function is to educate the court in the technology—they come as teachers, as makers of the mantle for the court to don. For that purpose it does not matter whether they do not approximate to the skilled man. What matters is how good they are at explaining things.
13. But it also is permissible for an expert witness to opine on an 'ultimate question' which is not one of law. I so held in Routestone Ltd v Minories Finance Ltd  BCC 180 and see s.3 of the Civil Evidence Act 1972. As regards obviousness of a patent Sir Donald Nicholls V.C. giving the judgment of the Court of Appeal in Mölnlycke AB v Procter & Gamble Ltd (No.5)  R.P.C. 49 at p.113 was explicit on the point:
'In applying the statutory criterion [i.e. as to whether an alleged inventive step was obvious] and making these findings [i.e. as to obviousness] the court will almost invariably require the assistance of expert evidence. The primary evidence will be that of properly qualified expert witnesses who will say whether or not in their opinions the relevant step would have been obvious to a skilled man having regard to the state of the art.'
14. But just because the opinion is admissible,
'it by no means follows that the court must follow it. On its own (unless uncontested) it would be 'a mere bit of empty rhetoric' Wigmore, Evidence (Chadbourn rev) para.1920. What really matters in most cases is the reasons given for the opinion. As a practical matter a well-constructed expert's report containing opinion evidence sets out the opinion and the reasons for it. If the reasons stand up the opinion does, if not, not. A rule of evidence which excludes this opinion serves no practical purpose. What happens if the evidence is regarded as inadmissible is that experts' reports simply try to creep up to the opinion without openly giving it. They insinuate rather than explicate' (Minories at p.188).
15. Because the expert's conclusion (e.g. obvious or not), as such, although admissible, is of little value it does not really matter what the actual attributes of the real expert witness are. What matters are the reasons for his or her opinion. And those reasons do not depend on how closely the expert approximates to the skilled man."
"Article 6: Right to a Fair Trial
1. In the determination of his civil rights and obligations or of any criminal charge against him, everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal established by law."
i) Actual bias – where the tribunal is found, after inquiry, to have acted in a fashion which is in fact biased.
ii) Predetermination – is often treated as a subset of actual bias, though it is in fact more common than actual bias. Predetermination must be found to exist in fact, if it is to prompt a change in tribunal. This is not a test of apparent bias, but of real bias in fact.
iii) Apparent bias implied by operation of law – which may arise where, for example, a judge sits in his own cause. This results in immediate disqualification of the tribunal.
iv) Apparent bias which is apparent following inquiry – this may arise where, for example, a judge knows a witness. It requires no finding of bias in fact.
"The question is whether the fair-minded and informed observer, having considered the facts, would conclude that there was a real possibility that the tribunal was biased."
"… As Lord Clarke said in Rimmer v HM Advocate (unreported) 23 May 2001, the question of impartiality, actual or perceived, has to be judged from the very moment when the judge or tribunal becomes first seized of the case. It is a question which, at least in a case of perceived impartiality, stands apart from any questions that may be raised about the character, quality or effect of any decisions which he takes or acts which he performs in the proceedings."
"1. My Lords, the fair-minded and informed observer is a relative newcomer among the select group of personalities who inhabit our legal village and are available to be called upon when a problem arises that needs to be solved objectively. Like the reasonable man whose attributes have been explored so often in the context of the law of negligence, the fair-minded observer is a creature of fiction. Gender-neutral (as this is a case where the complainer and the person complained about are both women, I shall avoid using the word 'he'), she has attributes which many of us might struggle to attain to.
2. The observer who is fair-minded is the sort of person who always reserves judgment on every point until she has seen and fully understood both sides of the argument. She is not unduly sensitive or suspicious, as Kirby J observed in Johnson v Johnson (2000) 201 CLR 488, 509, para 53. Her approach must not be confused with that of the person who has brought the complaint. The 'real possibility' test ensures that there is this measure of detachment. The assumptions that the complainer makes are not to be attributed to the observer unless they can be justified objectively. But she is not complacent either. She knows that fairness requires that a judge must be, and must be seen to be, unbiased. She knows that judges, like anybody else, have their weaknesses. She will not shrink from the conclusion, if it can be justified objectively, that things that they have said or done or associations that they have formed may make it difficult for them to judge the case before them impartially.
3. Then there is the attribute that the observer is 'informed'. It makes the point that, before she takes a balanced approach to any information she is given, she will take the trouble to inform herself on all matters that are relevant. She is the sort of person who takes the trouble to read the text of an article as well as the headlines. She is able to put whatever she has read or seen into its overall social, political or geographical context. She is fair-minded, so she will appreciate that the context forms an important part of the material which she must consider before passing judgment."
"The greater the passage of time between the event relied on as showing a danger of bias and the case in which the objection is raised, the weaker (other things being equal) the objection will be."
See also Howell v Lees-Millais  EWCA Civ 720 at  (Sir Anthony Clarke MR).
"The court is invited in this case to examine the allegation of apparent bias after the proceedings that are said to have been affected by it have taken place. But the principles to be applied are the same as those which determine the question whether, because of things he has said or done previously, the judge should recuse himself. …"
"Most of the leading authorities were appeals arising from hearings that had already taken place or were under way and an objection to the judge was based on facts discovered during the course of, or only after the end of, the hearing. Although this is a different case, as the hearing has not yet started, the same principle applies. Where the hearing has not yet begun, there is also scope for the sensible application of the precautionary principle. If, as here, the court has to predict what might happen if the hearing goes ahead before the judge to whom objection is taken and to assess the real possibility of apparent bias arising, prudence naturally leans on the side of being safe rather than sorry."
"5. Upholding the bias objection on the eve of the trial would cause considerable disruption: the trial would have to be adjourned, as there would be practical problems in finding a new trial judge at such short notice; the parties would suffer additional costs resulting from the adjournment; and there would be delay in fixing a new trial date.
6. Inconvenience, costs and delay do not, however, count in a case where the principle of judicial impartiality is properly invoked. This is because it is the fundamental principle of justice, both at common law and under article 6 of the Convention for the Protection of Human Rights. If, on an assessment of all the relevant circumstances, the conclusion is that the principle either has been, or will be, breached, the judge is automatically disqualified from hearing the case. It is not a discretionary case management decision reached by weighing various relevant factors in the balance."
"14. … there is now no difference between the common law test of bias and the requirements under article 6 of the Convention of an independent and impartial tribunal, the latter being the operative requirement in the present context. The small but important shift approved in Porter v Magill  2 AC 357 has at its core the need for 'the confidence which must be inspired by the courts in a democratic society': Belilos v Switzerland (1988) 10 EHRR 466, 489, para 67; Wettstein v Switzerland (Application No 33958/96), para 44; In re Medicaments and Related Classes of Goods (No 2)  ICR 564, 591, para 83. Public perception of the possibility of unconscious bias is the key. …
20. The correct analysis is as follows. One starts by identifying the circumstances which are said to give rise to bias. In the present case the evidence is limited to the facts set out at the beginning of this opinion, namely that a Queen's Counsel appearing on an appeal before the appeal tribunal had sat as a part-time judge in the appeal tribunal with one or both lay members hearing the appeal. In such cases there may be substantial variations in the extent to which the part-time judge and the wing members had sat together in the appeal tribunal and how recently. These differences are, however, not material. The House must concentrate on a systemic challenge and apply a principled approach to the facts on which it is called to rule.
21. The principle to be applied is that stated in Porter v Magill, namely whether a fair-minded and informed observer, having considered the given facts, would conclude that there was a real possibility that the tribunal was biased. Concretely, would such an observer consider that it was reasonably possible that the wing member may be subconsciously biased? The observer is likely to approach the matter on the basis that the lay members look to the judge for guidance on the law, and can be expected to develop a fairly close relationship of trust and confidence with the judge. The observer may also be credited with knowledge that a recorder, who in a criminal case has sat with jurors, may not subsequently appear as counsel in a case in which one or more of those jurors serve. Despite the differences between the two cases, the observer is likely to attach some relevance to the analogy because in both cases the judge gives guidance on the law to laymen. But the observer is likely to regard the practice forbidding part-time judges in the employment tribunal from appearing as counsel before an employment tribunal which includes lay members with whom they had previously sat as very much in point. The editor of the Industrial Relations Law Reports  IRLR 225 has argued that 'A rule to the same effect is even more necessary in the Employment Appeal Tribunal'. In favour of this view there is the fact that the appeal tribunal hears only appeals on questions of law while in the employment tribunal the preponderance of disputes involve matters of fact. The observer would not necessarily take this view. But he is likely to take the view that the same principle ought also to apply to the appeal tribunal."
"Professor Baldwin has been instructed to advance expert evidence on the approach the skilled person would have taken to resolve citalopram at the relevant time. He is also giving evidence on how he devised an experimental protocol in relation to aspects of the experiments carried out in relation to the first ground set out above."
Thus it appears that Prof Baldwin will be giving evidence in relation to both 884 and Bigler. Mr Forsyth also explains the nature of the evidence being given by Resolution's other two expert witnesses. It is clear from this that Prof Baldwin will be an important witness for Resolution even though he does not cover the whole of the case.