Eli Lilly and Company v. Genentech Inc., Reference for a preliminary ruling, 5 September 2019, Case C‑239/19

“[T]he justification for a reference for a preliminary ruling is not that it enables such opinions to be delivered but rather that it is necessary for the effective resolution of a dispute concerning EU law (judgment of 13 December 2018, Rittinger and Others, C‑492/17, EU:C:2018:1019, paragraph 50 and the case-law cited).

“In this case, as is apparent from the information provided by the referring court set out in paragraph 9 of this order, that court held that the claims of the basic patent were invalid, which was liable to render the SPC application based on that patent invalid. Whilst acknowledging, in those circumstances, the hypothetical nature of this request for a preliminary ruling, that court nonetheless considers that the request is necessary.

“First, it is submitted that it is likely that Genentech will appeal against the decision of the referring court before the Court of Appeal (England & Wales) (United Kingdom). However, because of the notification by the United Kingdom of Great Britain and Northern Ireland of its intention to withdraw from the European Union pursuant to Article 50 TEU, it is highly probable that the Court of Appeal will cease to have jurisdiction to refer a question for a preliminary ruling to the Court of Justice, so that it is necessary that the referring court refer such a question now.

“Second, it is contended that, even on the assumption that the basic patent is invalid, the question that is the subject of this request for a preliminary ruling would be relevant. Eli Lilly and Genentech are in dispute on this issue not only in the United Kingdom but also in other Member States, where Genentech has filed parallel applications for SPCs based on the basic patent and the MA for ixekizumab.

“Third, it is stated that this issue has arisen in other previous cases in which the courts in question have not deemed it necessary to refer a question for a preliminary ruling to the Court of Justice. This issue has also been discussed by commentators.

“It must be held that those grounds are not capable of justifying that this request for a preliminary ruling, notwithstanding its hypothetical nature, be declared admissible.

“In the first place, the need for an answer to this request cannot be justified by the eventuality that the Court of Appeal (England & Wales) will be deprived of the possibility of referring a question for a preliminary ruling to the Court because of the notification by the United Kingdom of its intention to withdraw from the European Union pursuant to Article 50 TEU.

“First, it should be pointed out that that justification is based on the hypothetical premisses that not only will Genentech lodge an appeal before the Court of Appeal (England & Wales) against the decision of the referring court declaring the claims of the basic patent invalid, but also that the appeal court will overturn that decision and will moreover consider it necessary to make a reference to the Court of Justice pursuant to Article 267 TFEU.

“Second, mere notification by a Member State of its intention to withdraw from the European Union does not have the effect of suspending the application of EU law in that Member State and, consequently, EU law continues in full force and effect in that Member State until the time of its actual withdrawal from the European Union (see, to that effect, judgment of 19 September 2018, RO, C‑327/18 PPU, EU:C:2018:733, paragraph 44). It follows that any court of a Member State which may be faced with a question concerning the interpretation of EU law is able to refer a question to the Court of Justice for a preliminary ruling, at least until that withdrawal.

“The circumstance, which is moreover purely hypothetical at this stage, that such a court might subsequently lose its jurisdiction to refer such a question because of that withdrawal, when that withdrawal takes effect, is not, in that regard, capable of justifying another court, such as the referring court, being able to refer that question pre-emptively, notwithstanding its hypothetical nature.

“In the second place, the existence of disputes in other Member States of the European Union or of previous disputes clearly does not support the conclusion that the interpretation of EU law that is sought is necessary for the resolution of the dispute which the court is called upon to resolve.

“It must therefore be held that the question referred is hypothetical for the purposes of the dispute in the main proceedings.

“In those circumstances, it must be held, pursuant to Article 53(2) of the Rules of Procedure, that this request for a preliminary ruling is manifestly inadmissible.”

The entire order can be read here.