Abbott Laboratories Ltd v Medinol Ltd

This is an application for specific disclosure in a patent action. It being the vacation, and since I have another substantial matter waiting to be heard, I must regrettably give my reasons for decision more shortly than I would otherwise do.

The background in brief is that the claimant (“Abbott”) seeks revocation of three patents in the name of the defendant (“Medinol”). These concern stents. There are also claims for declarations of non-infringement in relation to all three patents and a counterclaim for infringement of one of them. There is an issue between the parties on infringement of claim 12 of the '902 patent and claim 1 of the '901 patent which, briefly put, relates to the question of whether loops in the Abbott stents expand in accordance with the requirements of those claims under particular conditions.

On 1 July 2010 Kitchin J made an order for specific disclosure in the following terms:

“The claimant do within 7 days provide disclosure of all relevant extracts of the documents submitted to the FDA in relation to the Claimant's medium Vision medium Multi-Link 8 stent that show whether or not the loops referred to by the Claimant as the FLEXALINK loops in the Vision stent (and the equivalent loops in the Multi-Link 8 stent), widen longitudinally upon expansion of those stents on a bend or, if the documents submitted to the FDA are not sufficient to show this, such other documents that are sufficient to show the same.”

In response to that order, on 6 July 2010 Abbott disclosed a single document, being a document entitled "Appendix 7.1(k) Finite Element Analysis - Medium". As the title suggests, this is a finite element analysis. It was submitted to the FDA to obtain regulatory approval of at least one of Abbott’s stents. Of particular relevance for present purposes are pages 36 and 37 of the document, and figures 19 and 20, which show stresses in the Abbott stent after first expansion and then bending.

The present application, which was made after somewhat desultory correspondence between the parties' solicitors, was launched by an application notice of 2 September 2010. It is for specific disclosure of the following classes of documents:

“(a)

The finite element vessel stent models of Appendix

7.1(k)

(b)

Records of inputs made and conditions applied to models to achieve the bending described in at page 35 and

(c)

The data underlying the analysis shown in figures 19 and 20, in particular the data enabling the components of the stress to be understood in the corresponding coordinate system that they refer to, data allowing the displacement vectors to be ascertained for the elements of the mesh in the second loops.”

The application is resisted by Abbott on three grounds. The first ground, which was encapsulated by counsel for Abbott in the submission that disclosure is not necessary, is that the issue of fact between the parties as to whether the loops in question are, in the words of one of the claims expandable in the longitudinal direction”, is addressed in Abbott's re-amended product description which now has annexed to it a series of photographs taken by or on behalf of Abbott of the stents in issue. Furthermore, the photographs in question have recently been the subject of a notice of experiments and that experiment was recently repeated in the presence of Medinol's representatives. Yet further, Abbott’s engineering expert Professor McHugh has carried out an exercise in his second report of taking measurements based on the photographs. It is Abbott's contention that all of those matters are sufficient to address the issue of fact between the parties.

So far as that contention is concerned, I do not accept it. It is correct that Abbott were entitled to, and did, serve a product description in lieu of giving standard disclosure. As counsel for Abbott rightly accepted, that does not preclude an order for specific disclosure being made. I am completely unsatisfied that the re-amended product description is conclusive with regard to the issue of fact between the parties. On the contrary, knowing as little as I presently do about the case, it seems to me that it is completely undeterminative of that issue. The experiment and the evidence of Professor McHugh go somewhat further, but, needless to say, they are not accepted by Medinol. I see no reason why the court at this stage should accept that Abbott's case based on that evidential material is necessarily correct. There is quite plainly a live issue between the parties as to what happens to these loops in situ. Accordingly, it seems to me there is no reason why, if the documents sought are sufficiently relevant and proportionate, disclosure should not be ordered.

The second and perhaps most important objection raised by Abbott is that the documents sought are not relevant. So far as that is concerned, there are unsurprisingly issues between the parties as to the construction of the relevant claims. Counsel for Abbott accepts that I cannot possibly resolve the issues of construction today and must proceed on the basis that each side's contentions are arguable. She submits, however, that so far as the factual issue is concerned, the documents sought simply do not assist to resolve it. In short, the basis for that submission is that what is shown in Appendix 7.1(k) is, as I indicated earlier, a stent which have been first expanded and then bent, and the stresses in the stent as a result. Accordingly, that is prima facie what the data of which disclosure is sought will show.

Counsel for Abbott points out that what one does not have within Appendix 7.1(k), and accordingly would not expect to find within the underlying data, is any comparator consisting of an unexpanded bent stent. Counsel says that Abbott admit that the loops in question widen if the stent is bent before being expanded. She submits, however, that the key question is whether the loops widen if the bent stent is then expanded. For that purpose one needs the comparator of the unexpanded bent stent.

It seems to me that there is considerable force in that submission in that it is clearly correct that there is no such comparator within Appendix 7.1(k). Accordingly, prima facie it seems unlikely that the data of which disclosure is sought will yield information enabling that comparison to be made.

However, I am not persuaded that it follows that the data in and of itself is irrelevant. It is accepted in paragraph 32 of the fourth witness statement of Mr. Vickers of Abbott's solicitors that it should be possible to use some of the data in question to obtain a measurement of the width of the loops on the outside of the bend. Such measurements, it seems to me, may well shed some light upon the issue of fact between the parties, in particular because such measurements can then be compared with the measurements taken by Professor McHugh.

It is fair to say, as Mr. Vickers goes on, that it does not follow from that that all of the data which is sought to be disclosed would be relevant. But, on the other hand, I think it is quite hard to draw a line between the data that would be relevant on that basis and that which would not. Broadly speaking, I take the view that there is at any rate a sufficiently arguable case on relevance of all the data to justify an order for disclosure.

Moreover, the matter does not end there. Let it be assumed that Abbott is correct in saying that the underlying data contains no comparator and, indeed, enables no conclusions to be drawn with regard to a comparison between an unexpanded bent stent and an expanded bent stent. In those circumstances Medinol's secondary position is, that if the FEA model is disclosed, that will enable it in fairly short order to carry out further computer modelling using that model which will assist in resolving the issue of fact. Accordingly, it says that, even if the data of which it seeks disclosure do not in and of themselves assist the court in answering the question, they will enable Medinol to carry out what counsel for Medinol accepted in the light of the decision of Pumfrey J in the case of ConsafeEngineering (UK) Ltd v Emtunga UK Ltd [1989] RPC 154 would amount to a further experiment, which will assist the court.

So far as that point is concerned I did not understand counsel for Abbott seriously to dispute that disclosure of the data sought would in principle enable a further experiment to be done which might shed light on the factual issue between the parties. But this takes me to her third submission in answer to the application, namely that the disclosure is not proportionate. In short, she argued that it was not proportionate to order disclosure with a view to a further experiment being done. In support of that submission she pointed out that Medinol have not yet specified precisely what they propose to do in terms of any such further experiment and that there was no certainty that any such further experiment would be of assistance. She also pointed out that in principle it would have been open to Medinol to conduct an FEA experiment of its own at any time since the action started in April 2009, but time is now pressing given that this case is set down for trial in a window starting on 11 October 2010. Despite that, it has taken Medinol some two months to bring this application on since Appendix 7.1(k) was disclosed.

At this stage I should make it clear that I am not intending to rule upon any question which may arise as to whether Medinol should have permission to serve a further notice of experiments out of time or, if it should have permission, as to the consequences thereof. It is certainly possible that, if Medinol serves a further notice of experiments, that will have consequences including the need for a repetition, service of a counter-notice by Abbott, repetition of the counter-notice experiment and further experts’ reports on both sides. That is plainly a matter of concern, given the imminence of the trial date. On the other hand, it is fair to acknowledge that, as counsel for Medinol pointed out, the bulk of the expert evidence is already in and thus that is not something which parties are presently having to work on. Moreover, I understand that the parties' preparations for trial are at a reasonably advanced stage. Be all of that as it may, the one thing which I am not presently in a position to do is to form any concluded view one way or the other as to whether the existing trial date can be maintained if there are to be FEA experiments and further expert evidence. That seems to me to be an issue further down the line.

At this stage the question which I have to decide is whether the documents of which disclosure is sought are sufficiently relevant to justify disclosure and whether it would be proportionate so to order.

In my judgment, they are relevant on the grounds both that, first, the data may in and of itself shed light on the issue of fact between the parties, and secondly, even if it does not in and of itself shed light on the issue of fact, it may enable further computational modelling to be carried out which does assist the court to resolve that question.

Furthermore, I consider that the disclosure is proportionate. This is a substantial patent action. There is no doubt that the documents exist. Moreover, they were brought into existence otherwise than for the purposes of litigation, which has obvious advantages. They can be disclosed quickly and without burden. The evidence adduced by Medinol is that its consultant on FEA modelling should be able to do any further modelling using the data within a short space of time. Thus it may be possible for FEA experiments to be done and further expert evidence adduced in time for the existing trial date.

For all of those reasons, I will order the disclosure as sought.