IpsofactoJ.com: International Cases [2002] Part 15 Case 5 [CAEW]


COURT OF APPEAL, ENGLAND & WALES

Coram

Aktiebolaget Hässle

- vs -

Cairnstores Ltd

LORD JUSTICE ALDOUS

LORD JUSTICE TUCKEY

LORD JUSTICE LONGMORE

22 OCTOBER 2002


Judgment

Lord Justice Aldous

  1. This is the judgment of the Court.

  2. On 6th March 2002, Laddie J handed down his judgment in the conjoined actions for revocation of Aktiebolaget Hässles’ (Hässle) European Patents (UK) Numbers 0247983 and 0496437. The claimants seeking revocation were Cairnstores Ltd and Generics (UK) Limited.

  3. The judge held both patents obvious and therefore invalid. Against that conclusion Hässle appeal. In their notice of appeal their main ground of appeal was based on their view of the way the judge behaved during the trial. They asserted that the conduct of the judge during the trial and in particular during the cross-examination of their expert, Dr Rees, was such as to create an appearance of bias. In effect he descended into the arena on the side of the claimants. The result was that the judge’s conduct during the cross-examination of Dr Rees deprived him of the advantage of a calm and dispassionate observation of the demeanour of the witness. They also claimed that the judge’s conduct had meant that they had not had a fair trial. We will come later to those grounds of appeal, but must first deal with the background, the patents and the judgment.

    The background

  4. The patents are concerned with formulation of an oral preparation for the administration of a drug known as omeprazole. It is a potent inhibitor of the secretion of acid in the stomach. It has been widely marketed under the name “Losec” for the treatment of gastric ulcers and other gastro-intestinal diseases. The patents for omeprazole were applied for in the 1970’s. They have expired, but they were covered by supplementary protection certificates that expired in April 2002.

  5. Omeprazole is taken orally in the form of a tablet. It has to pass through the stomach and into the intestines of the patient to be absorbed into the patient’s bloodstream so as to the reach the sites in the body which control secretion of gastric juices.

  6. Omeprazole is acid labile, that is to say it is very sensitive to and can be degraded by acid. The contents of the stomach are acid and therefore the active ingredient needs to reach the intestines without suffering significant degradation. It therefore has to be in a form which protects it during its passage through the stomach to the intestines. The inventions, the subject of the patents, provide a form of oral administration of the drug which is resistant to stomach acid but which is biodegradable in the intestines.

  7. There are differences between the patents, but they were not significant to the issues the judge had to decide. Therefore the parties and the judge considered only the 983 patent. The position is the same on appeal.

    The 983 Patent

  8. The patent claims priority of 30th April 1986. It is entitled “New Pharmaceutical Preparation for Oral Use”. The specification starts by stating that the present invention relates to a new stable pharmaceutical preparation containing omeprazole for oral use and to a method for the manufacture of such a preparation.

  9. The specification then records that omeprazole was a substance known to be a potent inhibitor of gastric secretion useful for the treatment of gastric and duodenal ulcers. It continues at page 3 line 8:

    Omeprazole is however susceptible to degradation/transformation in acid reacting and neutral media. The half-life of omeprazole in water solutions at pH-values less than four is shorter than ten minutes. Also at neutral pH-values the degradation reaction proceeds rapidly, e.g. at pH = 7 the half-life of omeprazole is about 14 hours, while at higher pH-values the stability in solution is much better (Pilbrant and Cederberg, Scand. J. Gastroenterology 1985; 20 (suppl. 108) p. 113-120). The stability profile is similar in solid phase. The degradation of omeprazole is catalyzed by acidic reacting compounds and is stabilized in mixtures with alkaline reacting compounds. The stability of omeprazole is also affected by moisture and organic solvents.

    From what is said about the stability properties of omeprazole, it is obvious that an oral dosage form of omeprazole must be protected from contact with the acid reacting gastric juice in order to reach the small intestine without degradation.

    In human pharmacological studies it was found that the rate of release of omeprazole from a pharmaceutical dosage form can influence the total extent of absorption of omeprazole to the general circulation (Pilbrant and Cederberg, Scand. J. Gastroenterology 1985; 20 (suppl. 108) p. 113-120). A fully bioavailable dosage form of omeprazole must release the active drug rapidly in the proximal part of the gastrointestinal canal.

    In order to obtain a pharmaceutical dosage form of omeprazole which prevents omeprazole from contact with acidic gastric juice, the cores must be enteric coated.

  10. The specification goes on to point out that ordinary enteric coatings are made of acidic compounds and that, if omeprazole is covered with a conventional enteric coating, it rapidly decomposes by direct or indirect contact with the result that the preparations become badly discoloured and lose omeprazole content with the passage of time.

  11. The specification states that in order to enhance the storage stability of cores which contain omeprazole, they must also contain alkaline reacting constituents. The specification continues at page 3 line 30:

    When such an alkaline core is enteric coated with an amount of a conventional coating polymer such as for example, cellulose acetate phthalate, that permits the dissolution of the coating and the active drug contained in the cores in the proximal part of the small intestine, it also will allow some diffusion of water of gastric juice through the enteric coating into the cores, during the time the dosage form resides in the stomach before it is emptied into the small intestine. The diffused water of gastric juice will dissolve parts of the core in the close proximity of enteric coating layer and there form an alkaline solution inside the coated dosage form. The alkaline solution will interfere with the enteric coating and eventually dissolve it.

  12. The article by Pilbrant and Cederberg is then referred to. It is said to describe a conventional enteric coated dosage form of omeprazole which had an acceptable storage stability for clinical studies. However, the specification points out that it was later found that the stability of this dosage form was insufficient during long-term storage required for a marketed pharmaceutical dosage form.

  13. The specification then sets out at page 3 line 43 the problem that the patentees faced.

    If a conventional formulation of omeprazole is made, the stability is not satisfactory, particularly in resistance to humidity, and special moisture-proof packing has been adopted to minimise the troubles. However, this provides no satisfactory solution to the problems in today’s drug distribution system, and also leads to increased costs. Under the circumstances, there has been a demand for the development of new enteric preparations of omeprazole with better stability.

  14. The object of the invention is stated in these terms:

    The object of the present invention is to provide an enteric coated dosage form of omeprazole, which is stable to discolouration and which is resistant to dissolution in acid media and which dissolves rapidly in neutral to alkaline media and which has a good stability during long-term storage.

  15. There follows a description of the invention which in essence sets out claim 1 which is in this form:

    An oral, pharmaceutical preparation stable to discolouration containing omeprazole as the active ingredient characterized in that it is composed of core material in the form of small beads or tablets containing omeprazole together with an alkaline reacting compound, or an alkaline salt of omeprazole optionally together with an alkaline reacting compound, and on said core material one or more inert reacting subcoating layers comprising tablet excipients which are soluble or rapidly disintegrating in water, or polymeric, water soluble, filmforming compounds, optionally containing pH-buffering, alkaline compounds between the alkaline reacting core and an outer layer, which is an enteric coating.

  16. The solution as claimed in claim 1 is the protection of the acidic enteric coating from reaction with the omeprazole core by keeping them apart by use of a separating layer which breaks down in the intestines. To do this it must be either water soluble or dispersible.

    The judgment

  17. Having reviewed the patent, the judge came to consider the witnesses. He concluded that Dr Rue, the claimants’ expert witness, was “an impressive and reliable witness”. He rejected the submission that because he did not have direct experience of enteric coatings, he was not qualified to give evidence upon the issues in this case.

  18. As to Dr Rees, he said:

    23.

    The other witness was Dr Rees. He clearly is highly qualified and has great experience in the formulation field. There was no attack on his expertise. However Mr Floyd did suggest that Dr Rees’ approach was more akin to that of an advocate than an expert. He said that this might well have been because of over exposure to the patentee’s case, having been involved on Hässle’s side in similar litigation in Australia, Canada, Norway, Israel and the EPO.

    24.

    It would have been much more pleasing to say that Dr Rees was as impressive a witness as Dr Rue, but I cannot. He was cross-examined with courtesy but great precision by Mr Floyd. The overwhelming impression on me was of an able man who was acting as an advocate for the defendant’s case. Reading the transcript does not give a full feel for how the cross-examination went. As it progressed, Dr Rees appeared to experience growing difficulty in answering questions. Towards the end there were frequent and embarrassingly long pauses while he tried to find answers to simple, but telling, questions put to him by Mr Floyd. Furthermore, when one looks at his evidence as a whole, the impression is given of an attempt, no doubt unwitting, to think up as many alternatives as possible to the use of a separating layer between the enteric coating and the omeprazole-containing core. All of these were then said to be more likely to be thought of than the use of a separating layer. Indeed, he said that he did not believe that, before the priority date, the skilled formulator would have thought of using any kind of subcoat (Bundle G Tab 1 paragraph 155). This resulted in him advocating possible alternative routes which were obviously untenable. Some of these I will have to touch upon later in this judgment. At this stage it might be useful to refer to just a few examples of the difficulties with his evidence.

  19. The judge went on to deal, as he said he would, with a few examples of Dr Rees’ evidence. He concluded this part of his judgment in this way.

    32.

    Mr Floyd relied on other areas where he said that Dr Rees’ evidence appeared to be unbalanced. Some of those will be mentioned below. In his reply speech he submitted that Dr Rees’ evidence must be treated with caution and that it is to be contrasted with that of Dr Rue which was straightforward, objective and fair. I accept that submission.

  20. The claimants’ case that claim 1 was obvious had the advantage of simplicity. They alleged that the skilled person seeking to produce an oral formulation for omeprazole would carry out studies designed to find out at an early stage whether there were likely to be any unacceptable problems in making the dosage form of the drug. The first thing that would be done was a literature search. Thereafter the stability of the active substance would be investigated with the result that it would become clear that omeprazole was prone to degradation by acid and moisture, as the patent says. From that it would become clear that an enteric coating would have been needed. Pre-formulation studies would then be carried out to establish compatibility between omeprazole and each of the standard excipients used in oral dosage forms. The studies would have included examination of mixtures of the product with each excipient to see whether there was any effect and in particular degradation. Those studies would have shown that discolouration occurred which would not have been avoided by reducing the moisture content. Thus the problem would have become apparent from the normal preformulation studies. The solution was obvious as the only obvious way forward was separation, particularly as the use of separating layers to prevent reactions between the components was well-known.

  21. There was no dispute between the parties as to the need for an enteric coating. However Hässle contended, with the support of the evidence of Dr Rees, that the typical formulation team would not discover that there was incompatibility between omeprazole and the enteric coating with a consequence that the team would not turn their minds to solving the problem. In effect they asserted that there was invention in ascertaining the problem. That submission the judge rejected relying upon the evidence of Dr Rue that preformulation studies were the first thing that a normal team would carry out. The judge’s view is encapsulated in the following paragraph from his judgment.

    46.

    However, I am not satisfied that the approach suggested by Dr Rees would have been that adopted by the notional skilled addressee in 1986. Dr Rue gave compelling and convincing evidence that the simple and logical course, and the course which would be adopted by virtually all formulators, would be to test the new drug against excipients before they are all combined into a dosage formulation, i.e. at the pre-formulation stage. This view was supported by a number of standard textbooks which were referred to in the trial and put to the witnesses.

  22. The judge also rejected Dr Rees’s evidence that even if compatibility studies were carried out, they would not be carried out using enteric coating materials. He accepted Dr Rue’s evidence that the skilled team could not assume that the coating material was compatible with the new drug. He said:

    57.

    I have found it difficult to accept Dr Rees’ evidence on this issue. It is based on his theory that the enteric coating is stable and will not react with the new drug. This, in turn, appears to be based on his experience of a single enterically coated product at Abbott. However, as Dr Rue pointed out (see paragraph 39 above), each drug is a novel chemical whose chemical reactivity is little understood. Dr Rees’ theory involves an assumption that all excipients will be stable and will not react with any new drug, no matter what its reactivity. Even ignoring the contents of Pharmaceutical Dosage Forms (Tablets) and other basic literature in this field, which I will turn to in a moment, I do not accept that it would have been regarded as safe to assume that the new drug and an enteric coating material would not interact. Dr Rue said that no such assumption would or could be made by a skilled worker. I accept that evidence which accords with common sense. It also accords with the published literature. The passage from Pharmaceutical Dosage Forms (Tablets)....

  23. The judge then came to consider whether, once it was discovered that there was incompatibility between the enteric coating and the omeprazole, it was obvious to solve the problem by making a dosage form falling within claim 1.

  24. Before turning to the detailed evidence on this issue, the judge stated that it was worth bearing in mind just how basic the concept was. He said:

    69.

    Once again, the claimants’ case is simple. Use of multi-layer tablets was well known. Physical separation of ingredients in a tablet was known. It was obvious to try to overcome the incompatibility between a new drug and the coating film by keeping them apart. Use of an intermediate layer between them was an obvious route to try. Indeed, the claimants argue that this suggestion was made in a number of publications before the priority date. Before turning to the detailed evidence on this issue, it is worth bearing in mind just how basic the concept is. The idea of placing a physical barrier between two reacting chemicals is the rationale behind the use of enteric coatings. They create a physical barrier between the acid in the stomach and the acid-sensitive drug in the tablet. As already noted, this was so well known that it was taught to undergraduates.

    70.

    Furthermore it was common knowledge that one could physically separate components which have a tendency to react with each other. I have already referred to the knowledge of enteric coatings, but there is more. For example it was well known that if two proposed ingredients in a tablet core were incompatible, they could be separated by leaving one in the core and dispersing the other in a coating layer. Dr Rees accepted that this was well known (Transcript Day 3 p 278). It was also well known that one could make multi-layered tablets to keep incompatible components away from each other. ....

  25. Dr Rees in his evidence put forward a number of reasons as to why the apparently simple answer to the problem of discolouration was not obvious. They were challenged in cross-examination. His impartiality as an expert was also attacked. In particular he was asked to explain differences between his report filed in these proceedings and affidavits filed in the Australian proceedings.

  26. After reviewing the evidence and the documents the judge’s conclusion was:

    80.

    Dr Rue’s evidence was that at the priority date well known uses of separating layers, which could be made in a variety of ways with a variety of materials, included separating components, for example as in the case of layered tablets where non-reactive pharmaceutical excipients would be used to form the separating layer. I accept that evidence which is consistent with all the documents in the case, including Dr Rees’ Australian evidence. It is only contradicted by Dr Rees’ evidence given in these proceedings, evidence which I do not find convincing.

  27. The judge went on to consider the alternative ways that the obviousness case was put forward. He concluded that claim 1 was obvious having regard to the disclosure in a number of the pleaded documents.

    The Appeal

  28. On the appeal, Hässle did not pursue its appeal against the judge’s finding of obviousness in the event that this Court rejected the main ground of appeal which related to the conduct of the judge during the cross-examination of Dr Rees.

  29. On behalf of Hässle, Mr Thorley QC submitted that the judge’s interventions during the cross-examination of Dr Rees, when taken cumulatively, were such that the properly informed observer at the trial would have concluded that the judge was biased. That, he submitted, amounted to what has become known as “apparent bias”. He also submitted that those interventions resulted in an unfair trial, with the result that his clients had been deprived of a basic right.

  30. There was no dispute that Hässle were entitled to a fair trial. That right stems both from our common law and now Article 6 of the European Convention on Human Rights. It is also at the heart of the CPR which provides a procedural code “with the overriding objective of enabling the court to deal with cases justly” and requires the court to seek to give effect to that objective. Further CPR 52.11(3) specifically provides that “the appeal court will allow an appeal when the decision of the lower court was – .... (b) unjust because of a serious procedural or other irregularity in the proceedings in the lower court.”

  31. Mr Thorley referred us to Porter v Magill [2001] UKHL 67, [2002] 1 All ER 465 where the respondents in the House of Lords contended that the statements of the auditor who carried out the relevant investigation indicated an appearance of bias on his part. Mr Thorley accepted that the facts of that case were far removed from the present case, but he submitted that the same principles applied. The test was as stated by Lord Hope at 507F:

    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.

  32. Mr Thorley then proceeded to the observations of Laws LJ in paragraph 37 and 38 of his judgment in Sengupta v Holmes [2002] EWCA Civ 1104 as to who is the fair-minded and informed observer.

  33. Mr Floyd QC did not dispute the basic propositions on apparent bias advanced by Mr Thorley. However he drew our attention to observations of this Court in Jaffray v Society of Lloyd’s [2002] EWCA Civ. 1101 where the allegation was that the trial was unfair due to inequality of representation. The court said:

    493.

    In our judgment, those principles are not directly applicable to the question whether a trial was fair, but they are of assistance. They are not directly applicable because the question is not whether there was a real possibility or real danger that the trial was unfair, but whether it was unfair. We can see no reason why this court (or any court of review) should not be able to judge whether or not the trial was in fact unfair, once it has considered all the relevant circumstances.

    494.

    The principles are, however, of assistance because they stress that the question must be viewed through the eyes of the reasonable observer or litigant. The same principle seems to us to apply here. Thus the question is not whether a disappointed litigant thinks the trial was unfair, but whether a reasonable person in his or her position would think so, having regard to all the circumstances of the case. The circumstances are of importance because, before concluding that a trial is unfair, the court must consider all the relevant circumstances. As appears below, this is in our opinion important on the facts of the case.

  34. Mr Floyd also stressed that the House of Lords had decided in R v Gough [1993] 2 All ER 727, [1993] AC 646 that what was meant by bias was extraneous prejudice and predilection. That decision as Sir Thomas Bingham MR pointed out in R v Inner West London Coroner ex parte Dallaglio[1994] 4 All ER 139 at 162:

    .... shows .... that the description ‘apparent bias’ traditionally given to this head of bias is not entirely apt, for if despite the appearance of bias the court is able to examine all the relevant material and satisfy itself that there was no danger [possibility] of the alleged bias having in fact caused injustice, the impugned decision will be allowed to stand. The famous aphorism of Lord Hewart CJ in R v Sussex Justices, ex p McCarthy [1924] 1 KB 256 at 259, [1923] All ER Rep 233 at 234 that ‘justice .... should manifestly and undoubtedly be seen to be done’ is no longer, it seems, good law, save of course in the case where the appearance of bias is such as to show a real danger of bias. In the present case the court’s task is to ascertain the relevant circumstances and ask itself whether, having regard to these circumstances, there was a real danger of bias on the part of HM Coroner for Inner West London in the sense that he might have unfairly regarded with disfavour the cases of the applicants as parties to an issue under consideration by him.

  35. In the present case Hässles’ complaint was that the judge’s interventions during the cross-examination of Dr Rees showed apparent bias due to the unfair interventions. The complaint was not that an appearance of bias showed a real possibility of bias. In those circumstances we conclude that we should consider all the relevant circumstances which involves looking at the trial as a whole and of course looking carefully at the cross-examination of Dr Rees. We then need to decide whether what happened would be seen to provide a real danger of injustice.

  36. Although Mr Thorley argued part of his case under the heading of apparent bias, he accepted that at the heart of the appellants’ case was the submission that they had not had a fair trial. He submitted, and we agree, that we should adopt the approach advocated by the European Court of Human Rights in C.G. v The United Kingdom [2002] 34 EHRR 31 at paragraph 35:

    35.

    The central question raised is whether the nature and frequency of the trial judge’s interventions, combined with the deficiencies found by the Court of Appeal in his summing-up, were such as to render the proceedings against the applicant unfair. The Court recalls that, in determining issues of fairness of proceedings for the purposes of Article 6 of the Convention, the Court must consider the proceedings as a whole, including the decision of the appellate court (see, for example, the above-mentioned Edwards judgment, § 34).

  37. The true question under this part of the case is – were the nature and extent of the judge’s interventions during the cross-examination of Dr Rees such as to render the proceedings unfair? Mr Floyd agreed and submitted that the question should be answered in the negative.

  38. Before coming to his detailed submissions, Mr Thorley reminded us of the judgment of Lord Greene MR in Yuill v Yuill [1945] All ER 183 at page 189 B:

    A judge who observes the demeanour of the witnesses while they are being examined by counsel has from his detached position a much more favourable opportunity of forming a just appreciation than a judge who himself conducts the examination. If he takes the latter course he, so to speak, descends into the arena and is liable to have his vision clouded by the dust of the conflict. Unconsciously he deprives himself of the advantage of calm and dispassionate observation. It is further to be remarked, as everyone who has had experience of these matters knows, that the demeanour of a witness is apt to be very different when he is being questioned by the judge to what it is when he is being questioned by counsel, particularly when the judge’s examination is, as it was in the present case, prolonged and covers practically the whole of the crucial matters which are in issue.

  39. As a preliminary to considering the cross-examination of Dr Rees, Mr Thorley took us through the cross-examination of Dr Rue. He submitted that the questions asked by the judge, amounting in length to about 7% of the cross-examination, were reasonable in amount and proper in context in that they were designed to clarify and amplify the evidence. He contrasted that with the nature and extent of the questions asked of Dr Rees by the judge. He submitted that the contrast supported his submission that the part played by the judge meant that Hässle had not had a fair trial. He submitted that the judge had failed to take advantage of his position to observe the demeanour of the witness as suggested to be correct by Lord Greene MR. He had descended into the arena.

  40. There was a difference in extent of the questions asked by the judge of Dr Rees to those asked of Dr Rue. The judge’s questions to Dr Rees amounted to about 14% of the total length. There was also a slight difference of attitude. But that does not mean that the questions put by the judge to Dr Rees were unfair or oppressive or that Hässle did not have a fair hearing or even that he had deprived himself of calm and dispassionate observation. Both the extent and the nature of the evidence must be viewed in the light of the nature of the evidence given by the witness and the cross-examination.

  41. Mr Thorley took us in detail through the cross-examination of Dr Rees. The extent of the judge’s questions was not Mr Thorley’s primary complaint. That was directed to the nature and timing of the questions asked by the judge. He concentrated on 11 passages in the evidence where the judge had intervened. He submitted they should be considered cumulatively. They, he submitted, occurred at important times during the cross-examination and they appeared to and did put pressure on the witness. In effect they constituted hostile cross-examination, not questions designed to amplify and clarify. Mr Thorley called it “judicial brow-beating”. He accepted that it was for this Court to consider Dr Rees’ evidence as a whole, in context of the disputes between the parties, and decide whether the part that the judge took meant that Hässle had not had a fair trial or that would been seen to have been the result. It was, he accepted, a matter of impression to be decided by this Court.

  42. Mr Floyd submitted that the questions asked by the judge were completely proper, taking into account that Dr Rees was an experienced expert who had given evidence and had been subject to cross-examination twice before. The judge’s questions were apt to enable the witness to explain his theories and the explanations that he had given.

  43. Although Mr Thorley was at pains to emphasise that it is the cumulative effect of the judicial interventions which rendered the trial unfair, we will give two examples of them on which Mr Thorley particularly relied, so that the flavour of his arguments can be appreciated.

    1. On Day 3 at pages 300-3 Mr Floyd was cross-examining Dr Rees about two potentially inconsistent passages between his original written evidence (paras 127-128) and his written evidence in reply (para 25) in relation to the observation of discolouration or degradation in the course of the formulation of an omeprazole-containing core by the technique of wet granulation. Dr Rees’ answer at 309 lines 12-21 appeared to say that his original evidence was correct viz. that the formulator would see discolouration rather than his reply in evidence to the effect (based on the Pilbrant data referred to in the patent) that minimal degradation could be expected. Mr Floyd then asked:

      On what basis do you now predict, contrary to what you say you predict from Pilbrant, that you would see that [discolouration]?

      Dr Rees replied:

      The reason for saying that was on the basis of an assumption that, under the circumstances described, that the discolouration would occur.

      The judge:

      Dr Rees, it is very important because in this court experts are here to help the court, that is their primary function. I am afraid to say that you have left me very confused. I thought I understood you to say that as a result of the material in the Pilbrant you would expect there to be degradation on wet granulation, that is what you said first. Mr Floyd put to you paragraph 25 in your second statement, which appears to say the reverse. Obviously, Mr Floyd is going to suggest to me at some stage that that is an inconsistency, which somebody is going to have to resolve. I want you to explain to me now what makes you believe that there would have been more than minimal degradation if there had been a wet granulation. What is the source of your belief that there would be, if it is still your belief. If it is that having looked at all of this material you do not think it is your belief tell me. If it is your belief that there would have been, would you please explain to me why?

      Mr Thorley submitted that this intervention by the judge completely disconcerted Dr Rees and, indeed, his answer to the judge is not at all easy to follow.

    2. On day 3 at pages 343-348 Mr Floyd asked questions about the prior art as contained in a publication of 1969 “Up-to-date Pharmaceutical Technology Series ‘No 1’ Coating of Drugs”. That appeared, on one view, to say that a substance called TC-5 was used as an undercoating agent for the purpose of preventing coatings from reacting with active components. Dr Rees denied this could be obvious because, he said, the 1969 publication had been written in the context of sugar coating. When pressed on the question whether someone experienced in the field would do tests on the substance to see if it could be used for omeprazole, he said he would go back to the manufacturer rather than embarking on a work of uncertain outcome. The judge then intervened in the following terms:

      Can you help me with this, Doctor. I understand you are saying that some of these things may have been covered with sugar layers. Assume that it is true that on the outside of the enteric preparation there is a sugar layer, what does that have to do with this teaching? This is talking about a reaction between the enteric base and the active ingredient which says we can stop that by putting something in between. What difference does it make if there is sugar on the outside? This is talking about stopping a reaction between an enteric layer that kept the film there and the active ingredient. What difference does it make if there is sugar? I am having a difficulty understanding the significance. This is just teaching you that wherever the reaction is we can stop it. Will you explain to me the fact that it may have something to do with sugar coating, what does that have to do with teaching of this?

      Mr Thorley submitted that this was a series of 4 questions, which counsel would never have been allowed to ask together before waiting for a reply; he, moreover, characterised the intervention as judicial brow-beating.

  44. As far as these two interventions are concerned, we consider Mr Thorley’s submissions unjustified. The interventions were in no way intemperate. In the first example, the judge was concerned to know what of two apparently inconsistent bits of evidence was the actual considered evidence of Dr Rees. Mr Floyd’s cross-examination had not produced a clear (or, indeed, any) answer and the judge was, in our view, entitled to probe the matter further to see if there was an answer to the inconsistency. In the second example, although four questions appear in the transcript, they are in real terms the same question (viz. what does the fact that the coating was a sugar coating have to do with the problem?). Again the judge was correctly encouraging the witness to give a clear answer to a difficult question.

  45. Although a few of the questions that the judge asked Dr Rees could be seen as not directed to clarifying or to amplifying an answer previously given, we have no doubt that, when considered in context, the judge’s part in the action as a whole was not and would not be seen to be such as to render the trial unfair. Dr Rees was an experienced expert, and as such would have realised the need to be able to explain to the judge the reasons why he held the views expressed in his two reports. That being so, the questions, even though asked by the judge, were such that he should have been able to answer without feeling oppressed. Further the answers he gave do not show the alleged pressure. For those reasons we dismiss this appeal.

  46. Mr Floyd submitted in the alternative that even if the trial had been unfair, Hässle had by the time of the conclusion of Mr Thorley’s final speech to the judge waived their right to object. In a case such as this, where the complaint is against the conduct of the judge during the trial, that submission raises difficult questions of policy and law. In view of the conclusion that the appeal should be dismissed on the merits, we believe that those questions are best left for decision in circumstances where an unfair trial has taken place.

  47. We realise that losing parties often feel aggrieved by the result. This case falls into that category, but it differs from many in that the appellants, wrongly in our view, believe that they did not get a fair hearing. That is unfortunate, particularly in the patents court where the issues raised do not normally involve personal relations and therefore the losing party, e.g. Hässle, usually accepts the result without such a belief. We hope that it will not be necessary for this Court to consider such a case as this again.


Representations

Mr Simon Thorley QC and Mr Colin Birss (instructed by Simmons and Simmons) for the Appellant/Defendant.

Mr Christopher Floyd QC and Mr Michael Tappin (instructed by S.J. Berwin) for the Respondent/Claimant Cairnstores.

Mr Christopher Floyd QC and Mr Adrian Speck (instructed by Taylor Wessing) for the Respondent/Claimant Generics (UK) Ltd.


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