Mayne Pharma Pty Ltd & Anor v Debiopharm SA & Anor

This is an application by Debiopharm SA and Sanofi-Synthelabo who are the defendants in an action for revocation of four patents. The action is brought by Mayne Pharma, a well-known pharmaceutical manufacturer, and seeks revocation of each of the four patents. This application is for disclosure of documents relating to any experiments which may have been performed as part of the "workup" or preliminary investigation leading to the experiment forming the subject matter of a notice of experiments put in by Mayne.

The context is as follows. The patents in suit relate to a pharmaceutical, oxaliplatin, which is employed in the treatment of colorectal cancer. One of the patents, European patent UK 1308454, claims a method or preparing oxaliplatin in which the conditions in which the reaction takes place are controlled to a pH between 3.0 and 6.0 (claim 1) and pH 4.0-5.0 (claim 2).

One of Mayne's objections is that the prior art in the form of US patent 4169846 (which has been referred to as "Kidani") and a scientific paper in the journal of Inorganic Biochemistry (which has been referred to for short as "Khokar") both disclose synthetic processes which, if carried out, will inevitably fall at least within claim 1 of '454 and also probably within the narrower claim, claim 2. I shall concentrate on Kidani.

The allegedly anticipating disclosure is contained in example 4(i), which itself employs the method of example 3. Example 3 makes no reference to pH, but, say Mayne, if you follow the directions you end up within the claim, inevitably.

Anticipation by inevitable result is described in detail in General Tire v Firestone [1972] RPC 457 and explained by the House of Lords in the recent case of Synthon v SKB [2005] UKHL 59. For present purposes it is necessary only to note that it is not sufficient to show that the prior disclosure enables the skilled man to come within the claim, but it is necessary on the contrary that, in following the instructions contained in the prior disclosure, he will inevitably do so.

Thus, if one turns to the notice of experiments, the facts sought to be proved are stated as follows:

"(2)

That during the carrying out of the protocol in accordance with the methods of Experiment 1 ... the pH of the reaction mixture immediately before adding potassium oxalate is less than 3.

(3)

That during the carrying out of the protocol in accordance with the methods of Experiment 1 (set out at Annex 1) the pH of the reaction mixture after adding potassium oxalate is within the range of: (a) 3 to 6; and (b) 4 to 5."

The defendants have done an experiment on this example themselves. The experiment was performed by Prof. Ward in 2002 and he says he could not get it to work. The defendants’ expert, Prof. Davies, identifies a number of what he considers differences in the manner in which the Kidani experiment as performed does not follow the disclosure. He feels, however, that he cannot comment on the effect of those differences without knowing why the experiment conducted by the claimants was conducted as it was.

Finally, I should note that it seems that the protocol for Mayne's experiment was not devised by their expert, Dr. Cleare. Paragraph 79 of his report indicates that he merely approved the protocol. He says this:

"I did not devise the experimental protocols used to carry out the synthesis of oxaliplatin according to the methods described in example 4(i) of the Kidani patent and the Khokar paper but was asked by Taylor Wessing to review the protocols. In my opinion the protocols appear to be a fair and reasonable representation of how a process chemist of ordinary skill would carry out the teaching of Kidani and Khokar."

This approach to the preparation of experimental evidence consisting, as it does, of presenting to the expert a fait accompli in the form of a completed experimental protocol is in my view always subject to the risk that it will be unhelpful, both in the general case and certainly in any case where anticipation by inevitable result is alleged. Indeed, it is difficult to conceive of any more effective way of leading an expert witness than to place in front of him a protocol for the performance of an experiment and ask a question of the form: That is all right, is it not?

In paragraph 74-78 of the judgment in SKB v Apotex [2004] EWCA Civ 1568, [2005] FSR 23, Jacob LJ criticised the deployment of contrived experimental repetitions of the prior art, no matter how susceptible to justification ex post facto, as what he vividly described as litigation chemistry. He said you should give the disclosure to the experimenters and tell them to get on with it. If this course is followed, the court will know from them themselves when they come to give evidence what ranging experiments or workup was necessary: and what the purpose of the workup was. It is certainly not the law that an experiment which requires to be worked up is not capable of demonstrating anticipation by inevitable result.

But if Jacob LJ's advice is not followed, the ranging experiments are potentially entitled to privilege, and what may be an important element in the proper analysis of the results will not be available. Of course, this is not fatal. There is the possibility of inspection, and of course also there is the opportunity to perform a corresponding experiment in reply. But the former may well be of little assistance and the latter will be open to the same criticisms as the principal experiment: how were the precise conditions selected?

The problem which confronts me is not a new problem. There exist two cases: Honeywell Ltd v Appliance Components Ltd, which is unreported, a judgment delivered on 22nd February 1996 by Jacob J (as he then was) and Electrolux Northern Ltd and Another v Black & Decker [1996] FSR 595, a decision of Laddie J.

In these two cases widely different views were expressed by the two judges on the possibility of ordering disclosure of experiments not the subject of a notice. Jacob J said this at page 17, line 14 to page 17, line 27 of his judgment: 

"It may be noted that I have referred to two lots of experiments conducted by ACL for the purpose of this action which were not put in. One only emerged in the course of cross-examination. I think it highly desirable in future, if experiments are conducted which are not relied on that the opposite party is told of this. This seems to me to be an exact parallel to what is done in relation to experiments by way of opinion polls in trade mark and passing off cases, see Imperial Tobacco v Philip Morris [1984] RPC 293. Indeed, the principle would seem to apply to all cases (not just intellectual property cases) where a party seeks to rely upon experiments. It can hardly be right that a party can put forward an argument (whether supported by experiments or not) and suppress experiments he has conducted which do not support that argument or indeed undermine or destroy it. I do not say that experiments not relied upon should be placed before the court. But the opposite party should know about them, as in trade mark cases. It may well be that, at least in some cases, leave to adduce evidence of experiments conducted for the purpose of the action should only be given on condition that all such experiments are disclosed to the opposite party."

On the other hand, in a long discussion of Jacob J's approach, starting on page 612 of the report, Laddie J says this in regard to the passage which I consider to be the nub of the problem:

"The central reason for suggesting this course is to be found in the following sentence in Honeywell: 'It can hardly be right that a party can put forward an argument (whether supported by experiments or not) and suppress experiments he has conducted which do not support that argument or indeed undermine or destroy it.'

As I pointed out above, the inference that this is the reason for withholding experiments, in my view, will be unjustified in most cases. But ignoring that, if this reason holds in respect of experiments, why should it not hold in respect of witnesses, including expert witnesses? If, as is normal in a patent action, a party interviews five or six experts with a view to finding one who will best support the case on obviousness, can it be right to put forward arguments based on his evidence and to suppress the draft witness statements of other interviewed experts? It is possible that some of those others do not support that argument or indeed undermine or destroy it. I have difficulty in seeing why different principles should apply in this area. For much the same reasons as are set out in relation to the disclosure of abandoned experiments, I cannot believe it is in the interests of the administration of justice to force parties to disclose all the other unfruitful avenues they have pursued on the off chance that some might be arguably supportive of their opponent's case.

For these reasons I am afraid I cannot agree with the broad thrust of the Honeywell decision. I should mention that I have not thought it appropriate to consider, in the absence of argument, whether the same reservations apply to the decision in Imperial Group PLC v Philip Morris Ltd [1984] RPC 293."

I think, with respect, that the suggested parallel with experts is wide of the mark. Experimental evidence is intended to provide a degree of objective confirmation or corroboration of the subjective views of the experts. It is evidence of a kind different from that advanced as experts' opinions. It may provide, and from time to time does provide, a fixed point against which the experts may themselves be assessed. It is the one place in litigation of this class where an appeal to scientific technique is directly made. It is employed because it trumps the experts, however cogent their views may be.

I take the view that the opinion generally expressed by Jacob J in the passage, to which I have referred, reflects a need to reveal the full story rather than just its culmination in the context with which I am presently concerned; which is to say the workup of an experiment. I do not wish to be taken to be expressing a view in any other context at all.

On the hypothesis that workup experiments at least are in principle subject to legal professional privilege, the question for me is whether disclosure should be ordered. It is unfortunate that neither Jacob J nor Laddie J, no doubt the former by reason of the deficiencies of counsel, were shown the relevant authorities or addressed on the correct question of waiver of privilege, although it is clear that Jacob J was concerned with a really wider question than mere workup experiments and Laddie J was concerned with experiments which had been abandoned.

As I say, I am concerned only with the narrow question of workup. It is contended before me that service of the notice of experiments waives the privilege in workup experiments for that experiment on the basis identified by Mustill J in Nea Karteria Maritime Company Limited v Atlantic & Great Lake Steamship Corporation and Cape Breton Development Corporation and others, (No. 2) [1981] Com L.R. 138.

As is usual in these reports, this report consists of both quotation and indirect speech. I quote from the judgment at page 139:

"As stated in the reasons which I gave for my previous ruling, I believe that in summary and in perhaps not very concise terms one can see a rule of positive law being stated in the interests of justice, that where a party chooses to deploy evidence which would otherwise be privileged the court and the opposition must, in relation to the issue in question, be given the opportunity to satisfy themselves that they have the whole of the material and not merely a fragment. Thus I must start by asking myself what are the issues in relation to which the material has been deployed? Of course, the prime issue is whether and, if so, in what circumstances, the seaman accepted the truth of an account of events different from one which on two other occasions he has put forward. This involves the question whether he did give the answers recorded in document P35, whether that document represents a complete record of what happened and of what might be termed the general atmosphere of the meeting, having regard to the seaman's evidence that he signed the statement to get rid of the lawyers."

The report continues as a report:

"It was essential, therefore, for the court to see the meeting as a whole, and for that purpose the Judge's view was that the whole of the substance of the meeting was 'a legitimate subject for disclosure and for cross-examination'".

The rationale identified by Mustill J, as he then was, for holding that there was here a waiver of privilege in matters collateral to the material which had already been disclosed is in fact the same rationale as that stated by Jacob J and, in my judgment, strongly supports the argument of waiver, at least in respect of material directly associated with or underlying the evidence sought to be adduced.

It is observed in Hollander on Documentary Evidence at 17-45 and following paragraphs that Mustill J's phrase relevant to the issue in question controls the extent of the waiver. The scope of the waiver in any particular case is a question of fact. I have no difficulty in saying that the waiver in the present case, which is effected by the giving of the notice of experiments in relation to an experiment conducted on the instruction of the lawyers for the purposes of litigation, extends to the workup of the particular experiment forming the subject matter of the notice. Whether it extends further, I am more doubtful and I will not express a view.

Accordingly, I prefer to accept the statements of principle of Mustill J and Jacob J. Laddie J's view is, in my judgment, less satisfactory but, of course, he did not have the benefit of a citation of the Nea Karteria Maritime case.

Given that the purpose of this experiment is to show anticipation by inevitable result and having regard to the considerations which I have set out above, I will be willing to declare that any legal professional privilege otherwise attaching to documents relating to workup experiments for the experiment in the notice of experiments has been waived by service of the notice of experiments.