Baxter Healthcare Corp & Anor v Abbott Laboratories & Anor

In about a week’s time I will hear an action between Baxter Healthcare Corporation and Baxter Healthcare Limited, the claimants, and Abbott Laboratories and Central Glass Company Limited, the defendants, in which the claimants (to whom I shall collectively refer as “Baxter”) seek a declaration of non infringement in respect of European Patent UK 0967975 and seek also to revoke that patent.

The subject matter of the patent is particularly an anaesthetic product called sevoflurane and the nature of the invention appears from claim 2, which is a method of preventing degradation by Lewis acid of a quantity of sevoflurane. The method comprising the steps are providing a quantity of sevoflurane, providing a Lewis acid inhibitor in an amount sufficient to prevent degradation of said quantity of sevoflurane by Lewis acid, and combining said quantity of sevoflurane and said Lewis acid inhibitor.

The application before me today is an application for further disclosure which arises in slightly unusual circumstances. These proceedings were started when Baxter did not have a sevoflurane product but the first defendant (to whom I shall refer as “Abbott”) did. Baxter have had to seek the usual regulatory approvals for their sevoflurane and having obtained them they began to market it. Both parties, as I understand it, supply their sevoflurane in vaporisers made by one manufacturer.

In the week of 5^th September 2006 a product information notice was issued in respect of Baxter sevoflurane in that manufacturer’s vaporisers. The evidence of Dr. Jerome Justin Sebastian Watts, the solicitor acting on behalf of the defendants, includes the initial notice together with a further warning which is good for the United Kingdom, and a limited medical advice recall which appears to have taken place in Australia, the recall in question being limited to a small number of product codes and, as I understand it, a very limited number of batches of the product.

The difficulty which has been identified with the Baxter sevoflurane in these vaporisers is degradation. Dr. Watts seeks disclosure on a basis now substantially reduced in argument by Mr. Turner before me today of documents relating to a batch of sevoflurane, which is the batch used to fill the vaporisers which have been either withdrawn or in relation to which there is a warning in existence. What he seeks, put shortly, are documents including laboratory notebooks which record tests which have been carried out to discover the nature of the degradation that has taken place in these vaporisers.

The reason that he assigns for making this disclosure is that Baxter have said in evidence that has been advanced in the proceedings that “under normal operating conditions Baxter would not anticipate that its sevoflurane is exposed to Lewis acid either during its manufacturing process or while in the container,” and if I may add to that, that provides a reason, Baxter’s reason, for not bothering to include in its preparation any obvious Lewis acid inhibitor.

Put shortly, there are two ways to dealing with Lewis acid induced degradation of sevoflurane: you can either accept that some Lewis acid will come in contact with the sevoflurane and use an inhibitor accordingly or you can take elaborate steps to ensure that the sevoflurane is never brought into contact with Lewis acids at all. Baxter are adamant that that is their approach and their product description in the proceedings is intended to demonstrate that no Lewis acid inhibitor can be identified in their product.

The third possibility, which is the one I think to which Abbott presently incline, is that you may well not deliberately introduce an added Lewis acid inhibitor but there may be sufficient Lewis acid inhibitors around anyway to do the job for you. There has been much discussion in these proceedings of such matters as, and what I have in a previous judgment referred to as, the dampness of the sevoflurane water being for these purposes a Lewis acid inhibitor.

Now, what is said is that the history of the degradation of what I will call for shortness and for shortness only since this does not accurately reflect its status the withdrawn material is relevant to the issues in these proceedings because it will demonstrate, or may demonstrate, that Baxter do not in fact have enough Lewis acid inhibitor from whatever source to inhibit the sort of degradation that can reasonably be expected in the ordinary course of business if caused by Lewis acids.

One would therefore expect that it would be Baxter who seek to advance this material and Abbott who would seek to resist its admission. The reverse is the case. Abbott seek to have the material disclosed and Baxter say that it is both troublesome and in an insufficiently developed state to make it of use to the court. The reason advanced before me by Mr. Turner for its disclosure is that while no doubt relevant to the question of a declaration of non infringement he says that the materials are extremely relevant to a potential decision not to continue with Abbott’s resistance to the proceedings so far as they seek a declaration of non infringement.

This contention comes as something of a novelty since it is not clearly mentioned by Dr. Watts in his witness statement but one could perhaps understand from the commercial perspective why if not only do Baxter say that they do not add any Lewis acid inhibitors but that when you get out into the wide world their sevoflurane does, even on a single occasion, undergo a Lewis acid mediated degradation, and Abbott might well think that the game was not worth the candle.

I do not at present, however, accept the argument that these documents are relevant to any identified issue in these proceedings. Now, of course I use “relevance” as shorthand for the criteria for disclosure in the Civil Procedure Rules but it has to be remembered that this is an action for a declaration of non-infringement. A declaration of non-infringement is sought in relation to a formal description of a product or process which the applicant contends does not infringe a relevant claim of the patent.

At first sight, therefore, the issues are circumscribed by the written description of the product and process. The evidence will therefore consist of an expert’s analysis of what the product and process description discloses, together with the expert’s reasons for saying there are or are not sufficient Lewis acid inhibitors present to satisfy the claim. Either side may, working off the written product and process description, wish to perform experiments, particularly so far as the defendants are concerned, with a view to showing that a product or process encompassed within the scope of the written product and process description does in fact satisfy the requirements of the claim.

What I am extremely uneasy about is the suggestion that the real world can be used to supplement either inadequacies in the product and process description on the one hand, or to supplement a proof of infringement, or a proof of non-infringement, by materials otherwise falling within the claim. I accept, of course, entirely that the experiments performed upon the withdrawn sevoflurane would not be experiments done for the purpose of litigation and would therefore in principle be disclosable if they were relevant. But I cannot see as at present advised why this material is relevant to any issue in the action. No assertion of infringement of any material falling within the product description has been made otherwise than by way of expert evidence. There is no counterclaim for infringement in relation to the real materials and I understand that the one opportunity that the defendants have had to consider the product of the claimants has been disregarded.

There remain two further matters. The first is whether, notwithstanding my view that this is not relevant to the issues in the action, I should be prepared at least to doubt that conclusion sufficiently to encourage compromise by making an order for disclosure with that end in view. I am aware that there is some authority on this subject albeit under the Rules of the Supreme Court but as at present advised I would pause long before requiring any party to make disclosure which was not required to be made by an orthodox exercise of the discretion having regard to the existing issues in the action itself. Accordingly, because I am not satisfied that this documentation is relevant to the issues in the action, I would not make the disclosure requested.

There are further reasons for not making this disclosure. The events are comparatively recent. Albeit that this application is made on 6^th November. the defendants have been aware of the problem since they entered into correspondence with the manufacturer of the vaporisers, part of which I have been shown by Mr. Turner this morning, in a letter from the manufacturer dated 12^th September 2006. I do not know whether it was open at that stage for the defendants themselves to obtain samples of the defective vaporisers and carry out their own analysis, but be that as it may the investigations so far as the claimants are concerned are at an early stage.

Miss Macdonald, the solicitor for the claimants, says, first in paragraph 3 of her witness statement, that so far as the claimants are concerned they are going to carry on selling the sevoflurane included in the withdrawn samples once they are satisfied that it is in conformance with their authorised product specification; secondly, in paragraph 4, that they are trying to investigate a number of aspects of the vaporisers in question; then in paragraph 8, that they are conducting detailed investigations to determine what they might call the root cause of the problem. Since this paragraph has given rise to some discussion I should read it:

“So far they have determined that the sevoflurane in the problem vaporisers that they have tested has degraded to a small degree resulting in components consistent with there having been a Lewis acid mediated degradation.” She then gives an example. “However,” she continues, “it is not known how [the example which she gives] had occurred in the first place and various aspects of the vaporiser and its use are being investigated by the claimants at this time to determine the root cause of the problem.”

She gives a list of a number of possible sources for the problem and then in paragraph 9 she gives project time lines for the investigation. The first of these investigations is a further stability test. Now, like all stability tests it takes time and she expects the final report from the stability test to appear in February 2007. Then in the second line are compatibility tests which are vaporiser components which are actually in contact with the sevoflurane. The final sample of these is going to be taken on 18^th January 2007 and then a compatibility study with the whole device carried out. She reports that one entire vaporiser has been cooked at 55 degrees Centigrade on 20^th September 2006 and after one week the material included was out of specification, and that the complete analytical work is ongoing, including the usual sort of high precision analytical techniques. She says it will have to be done twice more for confirmation purposes.

Mr. Speck submits on behalf of the claimants that the one thing the court should not do is start making disclosure orders or further information orders in relation to ongoing experimental work before a final conclusion has been arrived at by those charged with the task of doing the experiments. All that will happen, he submits, is that we will have disputable and uncertain results coming into the action in a week’s time without any means of attributing to them the correct degree of weight.

For this reason alone I would refuse this application since I am quite satisfied that to disclose experimental results until the experiments which underlay them are complete and reported on is intrinsically unsatisfactory. One should not, I think, subject scientists who are actually carrying on investigatory work, however banal that investigatory work may appear to be, to the additional burden of requiring them to give their interim results to a court to be speculated on by a bunch of lawyers and experts.

Accordingly, for these two reasons, lack of relevance and inconvenience and disproportionality, I will refuse this application.