"No, no, Novartis", says court, you can't join in!

Daiichi Sankyo Co Ltd v Comptroller General of Patents [2010] EWHC 2898 (Pat) is a decision of Mr Justice Floyd (Patents Court, England and Wales) almost exactly a month ago, on 5 November. Perhaps because it is a small decision and was not made available on BAILII, it slipped past The SPC Blog, which thanks Mr Justice Arnold for pointing out that the decision has remained unnoticed on the blogosphere.

Under Article 3(a) of Regulation 469/2009

"A certificate shall be granted if, ...

(a) the product is protected by a basic patent in force".

This was an application by Novartis, under the Civil Procedure Rules (CPR) r.19.2(2)(a), for an order that it be joined as a party to proceedings in which questions were to be referred to the Court of Justice of the Euroepan Union on the interpretation of Article 3(a) of Regulation 469/2009. Under r.19

""The court may order a person to be added as a new party if -
"(a) it is desirable to add the new party so that the court can resolve all the matters in dispute in the proceedings; or
"(b) there is an issue involving the new party and an existing party which is connected to the matters in dispute in the proceedings, and it is desirable to add the new party so that the court can resolve that issue".

What had happened here is that Daiichi had appealed against the Comptroller's decision to refuse to grant an SPC in relation to a combination of olmesartan medoxomil and hydrochlorothiazide (olmesartan medoxomil being one of a range of compounds disclosed in one of Daiichi's European patents, while the diuretic hydrochlorothiazide was used as an anti-hypertensive agent but was not one of the claimed agents).  While Daiichi's SPC application was turned down as being non-compliant with Article 3(a), the court proposed to refer questions to the Court of Justice for a preliminary ruling on the interpretation of that article.

What, then, was Novartis's interest? Teva was suing Novartis in Italy, Belgium and the Netherlands, alleging that Novarrtis's SPC for a combination of Valsartan and hydrochlorothiazide was invalid since the product in question was not protected by the basic patent -- thus also raising a question under Article 3(a). There were also proceedings in Belgium in which it was argued that a generic combination product could not infringe the SPC for Valsartan alone.  According to Novartis, therefore, that any judgment on the reference which was to be made in Daiichi's case would be of direct relevance at least to some of the proceedings which it faced, and joining Novartis would bring "a new perspective" to these proceedings.

Mr Justice Floyd rejected the application, having concluded that it was not appropriate to join Novartis as a party since the requirements of CPR.19.2(2)(a) were not satisfied. It could not be said that, with the presence of the existing parties, the matters in dispute in the present proceedings could not be adequately and properly resolved and Novartis had failed to show that its involvement was needed in order to assist either the Patents Court or the Court of Justice to reach a conclusion.

The judge added that Novartis's interest was solely in the outcome of a question of law, on which submissions would be made both by Daiichi and by the Comptroller.  Adding extra parties would not have any beneficial effect.