SmithKline Beecham Plc v Generics UK Ltd

JurisdictionEngland & Wales
CourtCourt of Appeal (Civil Division)
JudgeLord Justice Aldous,Lord Justice Chadwick,Lord Justice Latham
Judgment Date24 Jul 2003
Neutral Citation[2003] EWCA Civ 1109
Docket NumberCase No: A3/2003/1441;1451

[2003] EWCA Civ 1109





Royal Courts of Justice


London, WC2A 2LL


Lord Justice Aldous

Lord Justice Chadwick and

Lord Justice Latham

Case No: A3/2003/1441;1451

Smithkline Beecham Plc
Generics (uk) Limited
And Between
Basf Ag
Smithkline Beecham Plc

Mr Justin Turner and Geoffrey Pritchard (instructed by Simmons & Simmons) for the Appellants

Mr Simon Thorley QC and Thomas Hinchliffe (instructed by S.J. Berwin) for the Respondents

Lord Justice Aldous

There are before the court two appeals against orders of Pumfrey J which had the effect of preventing SmithKline Beecham Plc (SB) from using certain documents in their case against Apotex which is currently before the judge. Before coming to the issues raised in the appeals it is necessary to set out the background.


SB are the patentees of UK patent no. 2247550 relating to a process for producing paroxetine hydrochloride anhydrate (PHA). That is a pharmaceutical sold in large quantities by SB.


Back in 2001 SB started proceedings against Generics (UK) Limited for infringement of the patent. Generics denied infringement and alleged that the patent was invalid. Around the same time BASF AG commenced proceedings to revoke the patent upon similar grounds to those raised by Generics in their attack upon validity.


One of the main contentions of BASF and Generics was that the patent lacked novelty and was obvious having regard to the disclosure in the SB application no. 85–26407 (407). Example 1 of 407 contained details of how to produce PHA and it was contended that that example made available to the public the invention claimed in claim 11 of the patent or made available a process of production which. if altered in an obvious way, would result in PHA. SB contended that if you carried out example 1 of 407, PHA was not obtained and that the alteration needed to produce PHA was not obvious.


Example 1 of 407 set out a recipe for obtaining PHA. It included the instruction that the "acetate salt was dissolved in isopropanol (2.4 litres) and treated with a mixture of hydrochloric acid (75 ml) and more isopropanol". The main dispute between the parties revolved around how much "more isopropanol" the skilled person would add if he sought to carry out example 1. BASF and Generics, for reasons that I need not go into, submitted that about 2 litres of isopropanol would be added. SB's case was that the amount would be well below 1 litre.


In his judgment [2002] EWHC 1373 (Ch), the judge accepted the submission of SB and held that if the notional skilled person carried out example 1 of 407 he would not obtain PHA and therefore example 1 of 407 did not make available to the public claim 11 of the patent. Thus claim 11 did not lack novelty. He also held that claim 11 was not obvious having regard to the disclosure in 407. This Court upheld those decisions of the judge (see [2003] EWCA Civ 872).


The proceedings against Generics and by BASF were not consolidated, but they came on for hearing at the same time. On the first day of the trial, SB and Generics settled their differences and the case was adjourned to enable the papers to be rearranged. On the second day SB sought permission to use two sets of documents which had been disclosed by Generics in the BASF proceedings. I will refer to those documents as the Sumika and Darmstadt documents respectively. I will come later to the relevance of those documents and the decision of the judge to allow the documents to be used, but first must explain how they came to be produced by Generics.


The Darmstadt documents had initially been referred to in certain e-mails that had been disclosed in Generics' list of documents. They were requested by SB's solicitors by letter dated 20th December 2001. Production was resisted because they were not in the possession of Generics. They were however obtained from an associated company of Generics and then produced on about 21st January 2002. They were produced under a cloak of confidence to those in the "confidentiality club". They were also referred to in the expert report of Professor Mullin who was to be called as a witness by Generics. He said:

"96. Finally I have been asked to comment on certain experimental runs performed, I understand, in a laboratory in Darmstadt in Germany. I attach a translation of the experiment's notebooks as exhibit JWM 4."


He went on to make a general comment upon the disclosure in the documents and expressed an opinion on one point.


The Sumika documents were also referred to in Professor Mullin's report. In paragraph 65 of his witness statement he said that the exact manner in which an addressee might perform example 1 of 407 was not possible to predict. There were many minor variations in techniques that different skilled addressees, applying their ordinary general knowledge, might apply. It was his view that it was not feasible to say what the skilled addressee would have done, but only what he might have performed. In paragraph 66 he recounted how he had been asked initially to suggest a reasonable starting point for putting example 1 of 407 into practice. His view was set out in an annex to his report. He said that it represented his opinion as to the likely way that the skilled addressee at the relevant date might have started seeking to produce PHA in accordance with example 1 of 407. He said his view represented but one logical starting point and it would not have surprised him if his protocol did not produce PHA in significant quantities or, possibly, at all. He said that the development of protocols of this type was part of the routine work of the skilled addressee, but it took time. He continued:

"I was therefore shown a draft protocol which I was told by S.J. Berwin[Generic's solicitors] had already been worked up to the produce the anhydrate. This is in substance the protocol contained in GUK's notice of experiments (the GUK protocol). I was asked to consider the differences between it and my protocol. Because of the brief nature of example 1, it would have been very unlikely if I had chosen precisely the same protocol as GUK. However for reasons which I set out below, I believe the GUK protocol represents the type of routine development from my protocol which the addressee might have devised to perform example 1 if initial experiments had resulted (wholly or partially) in the production of the hemihydrate."


Upon receipt of the witness statement of Professor Mullin, SB's solicitors wrote seeking under CPR 31.14 the documents referred to by Professor Mullin. They were provided in February 2002 and were in substance the Sumika documents. To make them complete certain e-mails were supplied as requested. Those documents were also provided by Generics under a cloak of confidence and were therefore only available to those in the "confidentiality club".


The judge heard SB's application to be able to rely upon the documents in the BASF action. It was resisted. In his judgment he said that his decision depended upon a number of factors. First, whether they would have been obtainable on an application for discovery against a third party; second the materiality of the documents; third the strength of the case of confidentiality and fourth fairness on the party whose documents they were. He concluded that the interests of the owners of the documents could be preserved by ensuring the documents were kept confidential. As to materiality he said:

"To rebut the inference which superficially arises on such facts may require a large number of small bricks. I do not know – and it would not be right to speculate any further than that at this stage. I would therefore be unwilling to exclude a priori any use of these documents provided I was satisfied that the interests of the owners of those documents were adequately protected. I believe that I can adequately protect the interests of the owners of these documents in the way I have indicated and therefore I am going to give leave for them to be used."


He therefore admitted SB's documents on terms that they would be dealt with in private. He made an order over trial under CPR 31.22 (2). They were subsequently used in cross-examination which took place in private. He referred to them in paragraph 61 of his judgment handed down after trial. He said:

"61. SB also relied on certain experiments which had been put in by Generics before the action between them and SB settled. These also, Mr Waugh QC said, had been carefully "worked up" so as not to represent a fair repetition. The clear evidence is that the experimenter responsible for working up these experiments had found that he had obtained the hemihydrate if concentrated hydrochloric acid was used. He appears to have started by using comparatively small quantities for "more isopropanol". There was also evidence of experiments conducted in Germany by associates of Generics which had the same result."


Shortly after the judgment in the BASF action, Generics sought on 17th July 2002 an order that further use of the Sumika and Darmstadt documents should be permanently prohibited by an order under CPR 31.22 (2) and also that copies should be delivered up to Generics. That application came before the judge on 25th July 2002 when SB submitted that no such order should be made. Despite a letter to him reminding him of the need to give judgment, no judgment was delivered in 2002.


Whilst the proceedings against BASF were proceeding, SB started...

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