Teva UK Ltd and Another v Icos Corporation (a company incorporated under the laws of Israel Washington, USA) Eli Lilly and Company (a company incorporated under the laws of Indiana, USA) (Third Party)

JUDGMENT APPROVED

This judgment contains passages which have been blanked out or edited to preserve matters agreed to be confidential as relevant to trade secrets. The blanked out or edited parts are all marked in square brackets, sometimes with italics.

This is a claim concerning a drug called tadalafil. Tadalafil has a marketing authorisation for the treatment of male erectile dysfunction and benign prostatic hyperplasia and for those indications is sold under the brand name Cialis. It also has a marketing authorisation for pulmonary arterial hypertension and for that indication is sold under the brand name Adcirca.

There is an SPC on the compound based on a patent whose validity is not being challenged in these proceedings and which expires in November 2017.

The trial is due to start in June, in about two or three weeks' time, and this is the pre-trial review. Three patents are in issue at that trial and it consists of parallel but distinct actions between the defendant (ICOS) and third party (Lilly) on one side and the claimants and various generic pharmaceutical companies on the other. ICOS and Lilly will be referred to in this judgment as Lilly. The generic companies are Teva, Actavis, Generics UK (Mylan) and Actelion. The precise positions of the generics differ in detail.

This application relates to the dispute with Teva and the issue arises in relation to EP (UK) 1,200,090 entitled "Pharmaceutical formulation comprising a beta-carboline and its use for treating sexual dysfunction". The validity of that patent is not in issue. The only issue is infringement.

Lilly seeks an order requiring Teva to provide samples of its tadalafil product so that the samples can be tested. Samples of […] are also sought but the issue really focuses on […]. If I make such an order it will be inevitable that the 090 patent cannot be dealt with at the trial. If I require samples and therefore necessarily adjourn part of the trial, Mr. Abrahams submits that I should direct that the point of construction of the 090 patent should be dealt with at the trial in any event. I will come back to that.

Each side blames the other for this predicament. Lilly says that the Product and Process Description (PPD) served by Teva was effectively conclusory in the sense that it was based on Teva's approach to claim construction. Lilly submits that Teva did not provide the information necessary to decide infringement on Lilly's approach to claim construction.

[ Teva contends a relevant characteristic to determine infringement is feature A] On that basis its PPD explains what [ feature A is.] […] Teva submits that as a result it does not infringe. Lilly says that the relevant [ characteristic is feature B], the PPD does not state what that is and so, until samples are analysed, one cannot tell.

Teva says that Lilly has known about Teva's position all along and has known about the nature of the information which was actually available and is in the PPD for months, and Lilly only has itself to blame. Teva also submits strongly that the correct construction of the claim is [ that the relevant characteristic is feature A].

Moreover, Teva submits that even on Lilly's construction (which it says is wrong) [ Teva's product does not] infringe this claim anyway. Really this is all a delaying tactic to try to put off the trial and interfere with Teva's proper attempts to clear the way in good time for the expiry of the SPC in November 2017. The timing of the trial date has taken into account not only a trial at first instance but also the possibility of appeals. So I should refuse this application.

First, I will deal with the patent. The patent is concerned with small particles for the drug. […]

[…]

The relevant parts of claim 1 are as follows:

"A pharmaceutical formulation comprising an active compound having the structural formula (I) [formula] wherein said compound is provided as particles of a free drug wherein at least 90% of the particles have a particle size of less than 10 microns; a water-soluble diluent; a lubricant; a hydrophilic binder selected from the group consisting of a cellulose derivative, povidone, and a mixture thereof; and a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and a mixture thereof, wherein wherein free drug refers to solid particles not intimately embedded in a polymeric co-precipitate; wherein the formulation is not [tables]."

The formula and tables which are not included have been removed for convenience, not confidentiality.

Teva's point is that […] is a clear indication that, although literally one may read the claim as if it is talking about [feature B], in reality what it is talking about is [feature A]. […] Therefore on the facts of that case there was no infringement. […]

In my judgment, Teva has a good arguable case on construction in general and that there are factors of the kind which applied in […] which could well lead to the same conclusion.

However, in my judgment, Lilly also has a good arguable case that the claim could be construed to refer to [feature B]. […] This may gain some support from the evidence of the two experts available for this application. They are Prof. Douromis for Teva and Prof. Frijlink for Lilly. […]

I will turn next to the evidence about the product in issue and infringement. Prof. Douromis expressed the clear view that the claim needs to be read as referring to [feature A] and on that basis there is no possible claim for infringement. I can see the force in the Professor's opinion in that clearly, if Teva's case on construction is right, then the conclusion follows. However the debate is about the premise.

As regards Lilly's construction Prof. Douromis says that it is very difficult to [determine infringement if the claim refers to feature B] and he also says that given […], it is unlikely that [feature B would be satisfied anyway]. In this respect also there is a measure of agreement between him and Prof. Frijlink. The latter also agrees that it is difficult to [determine infringement if the claim refers to feature B] but expressed a view that it can be done and refers to a number of techniques which he would like to develop in order to achieve that result. These issues are ones for debate at trial and Teva will seek to rely on them to support its construction. However, as I have already found, both sides' constructions are at least properly arguable.

As for […], Prof. Frijlink says that while he agrees that it is not likely, he maintains that it is possible that [there will be infringement if the claim refers to feature B]. Prof. Frijlink's opinion is that one cannot form a concluded view about [infringement if the claim refers to feature B] based on the information in the PPD and he wishes to test samples.

Now, as I think I may have already said, each side blames their opponent for the predicament that we have reached, which is that on the basis of Lilly's case on construction, it is plain that the matter cannot be decided at the trial in three weeks' time.

Before I get into the correspondence and how we have arrived at where we are, there are two matters which I wish to address.

First, ultimately, the overriding objective (CPR r1.1) is what counts. That is to deal with cases justly and at proportionate cost. Two particular points which are important in that regard:

i) This is clearly a case of some commercial significance. From what I have learned from reading the materials and having heard the rest of the pre-trial review before this application (which involved more parties than the two parties to this application) this is a dispute about a pharmaceutical market which obviously is of significant value.

ii) Second the compound SPC does not expire until November 2017. There is still time, even if this action were to be adjourned for a period, to ensure that a first instance trial could be heard in...