Daiichi Sankyo Company Ltd v Comptroller General of Patents

This is an application by Novartis AG to be joined as a party into the appeal brought by Daiichi and in respect of which I have given a judgment earlier this afternoon.

The position taken by Novartis is that they too have an interest in the issue of law arising out of the proper interpretation of the Regulation which will affect them in their business to a very significant degree. They therefore seek to be joined as a party, not because they have a direct interest in the grant or refusal of the particular SPC which is in issue in the appeal, but because of wider interests which the question of law will have an impact on.

The provision under which it is sought to make this application is CPR 19.2(2) which provides:

Novartis rely only on ground (a) recognising as they do that there is no issue in these proceedings which is between the new party, that is to say Novartis, and the existing party, which makes it desirable that they be joined in order to for it to be resolved. However, they do draw attention to the contrast between rules (a) and (b) to point out this, that it cannot be a requirement of sub-rule (a) that such an issue needs to be established.

In Football Association Premier League Ltd and others v QC Leisure and another [2009] 1 WLR 1603, [2008] EWHC 2897 (Ch), Kitchin J had to consider an application by a number of parties who sought to be joined in national court proceedings in order to take part in a preliminary reference which had already been ordered. That application too was founded on CPR 19.2(2). In paragraph 5, Kitchin J said this:

Miss May (who appears on behalf of Novartis) has suggested that I should consider the nature of the interest and the outcome of the case, Novartis' ability to assist the court, and any practical or procedural consequences. That is how I propose to approach this.

Miss May submitted that the outcome of the case will have a very considerable impact on the business of Novartis. She said that the company Teva have sued Novartis in Italy, Belgium and the Netherlands, alleging the invalidity of Novartis' own SPC for a combination of Valsartan and HCTZ, or HTC, as I called it in my earlier judgment. They maintain in those proceedings that the SPC is invalid because the product in question is not protected by the basic patent. That raises a question under Article 3(a) of the regulation. Similarly, there are proceedings in Belgium where it is said that a generic combination product could not infringe the SPC for Valsartan alone. That raises a question under Article 4 of the regulation, which will need to be decided in those proceedings.

Miss May submitted that any judgment on the reference which I propose to make in the present case will be of direct relevance at least to some of those proceedings. She drew attention to the size of the market in the European Union for the Valsartan product and asserted, supported by the evidence of Mr. Cordery, that it has not to date been possible for Novartis to seek a reference in any of those proceedings.

Those considerations seem to me to be irrelevant to the question which I have to decide under CPR 19.2(2). That rule is directed to considering whether it is desirable that the new party be added in order to resolve the matters in dispute in the proceedings. Those considerations, it seems to me, are directed to a different question, namely whether it is desirable for Novartis to be added in order that they can have a say in the outcome of an issue of law which may affect them in other proceedings.

Far more relevant was the suggestion made by Miss May that Novartis will bring something new to the present proceedings. She says just as I have indicated that Daiichi may bring a different perspective to the matters already referred in the Medeva reference, so also will Novartis be able to bring a new perspective to the matters referred here. Quite plainly, she says, the perspective will be different from that of the Comptroller who, by the submissions advanced on his behalf by Mr. Mitcheson today, has made clear that he still supports the Gilead/Takeda/Astellas approach and not the infringement approach.

She also submitted that Novartis would bring a different approach from that to be advanced by Daiichi. She indicated that the claims in issue in the Valsartan proceedings were different from those in issue in this case. Unlike the Daiichi case, which uses the word "at least", all that Novartis have to rely on is the word "comprising". She suggests therefore that it may be that Novartis will have a fallback position which would not be entirely in conformity with any alternative position which Novartis might wish to advance.

For the Comptroller, Mr. Mitcheson drew my attention to the response of the President of the Court of Justice to the order which Kitchin J made in the case to which I have already referred. The position in that case was that the parties who had been added had to make an application to the Court of Justice to be allowed to submit written observations. As I understand it, the time for doing so had passed by the time they were joined as parties to the action. The upshot of the order made by the President in relation to that application was that UEFA, Sky, Setanta and MPA were refused permission to participate in the reference.

The operative part of the order reads as follows:

“Article 267 TFEU entrusts to the Court the duty of assisting in the administration of justice in the Member States by meeting objective requirements inherent in the resolution of genuine disputes. In exercising its jurisdiction, the Court must have regard to the proper working of the procedure laid down in that provision(see, to that effect, Foglia, paragraphs 18 and 19).

Although the five legal persons in question have a definite interest in the answers to be given by the Court to the questions referred by the national court, that does not mean that they are to be accorded the status of parties for the purposes of Article 23 of the Statute of the Court. Such a provision would moreover be pointless if any party having an interest were recognised as having the right to participate in the proceedings provided for under Article 267 TFEU (see, to that effect, the order in Biogen, paragraph 6).

The joinder of the parties in FA Premier League v QC Leisure did not have the effect, at least at that stage, of allowing those parties to participate in the proceedings.

However, the question before me, as is emphasized in paragraph 4 of Kitchin J's judgment, to which I have already referred, is a question of national law. The criteria of national law, which are relevant to the application are those set out in CPR 19.2(2)(a). It is therefore, as it seems to me, not necessary at this stage to consider the attitude of the Court of Justice if permission were granted for Novartis to be joined as a defendant.

Nevertheless it does not seem to me that the requirements of CPR 19.2(2)(a) are satisfied in the present case. I am not satisfied on the material before me that with the presence of the existing parties, the matters in dispute in these proceedings cannot be adequately and properly resolved. I am not in any way persuaded that it needs Novartis to assist either me or the Court of Justice to reach a conclusion. Novartis' interest is solely in the question of law. Submissions on that question of law will be made to the Court of Justice not only by Daiichi but by the Comptroller as well. I am wholly unsatisfied that the addition of additional parties will have any beneficial effect on the ability of this court or the Court of Justice to resolve the matters in dispute.

What is more, although the effect may not incrementally be a very large one, the addition of Novartis as a party would undoubtedly add to the burden of the case before the Court of Justice. In my view, it is unnecessary to do so.

Mr. Mitcheson suggested that to allow an order in the present case would open the floodgates. There is no doubt the whole of the pharmaceutical industry is interested in its outcome. I do not know whether that is true or not, but I am wholly unsatisfied that the provisions of CPR 19.2(2)a) are satisfied in the present case.

I should add only this. It does seem to me that as Novartis' interest principally arises out of the dispute which it has with Teva, it is potentially undesirable for matters of law which are said directly to influence the outcome of those proceedings, to be argued by Novartis in the absence of Teva. It does seem to me that to open the door to Novartis in the present case would be undesirable as it would lead to the case effectively becoming a case concerned in addition with the dispute between Novartis and Teva which it is not at the moment and should not become. But for those brief reasons, I propose to dismiss this application.