ORDER OF THE COURT (Ninth Chamber)
5 September 2019 (*)
(Reference for a preliminary ruling — Article 53(2) of the Rules of Procedure of the Court of Justice — Supplementary protection certificate for medicinal products — Regulation (EC) No 469/2009 — Article 3(b) — Conditions for obtaining — Marketing authorisation — Authorisation issued to a third party — Manifest inadmissibility)
In Case C‑239/19,
REQUEST for a preliminary ruling under Article 267 TFEU from the High Court of Justice (England & Wales), Chancery Division (Patents Court) (United Kingdom), made by decision of 4 March 2019, received at the Court on 20 March 2019, in the proceedings
Eli Lilly and Company
v
Genentech Inc.,
THE COURT (Ninth Chamber),
composed of K. Jürimäe (Rapporteur), President of the Chamber, D. Šváby and S. Rodin, Judges,
Advocate General: M. Campos Sánchez-Bordona,
Registrar: A. Calot Escobar,
having regard to the decision taken, after hearing the Advocate General, to give a decision by reasoned order in accordance with Article 53(2) of the Rules of Procedure of the Court,
makes the following
Order
1 This request for a preliminary ruling concerns the interpretation of Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ 2009 L 152, p. 1).
2 The request has been made in proceedings between Eli Lilly and Company (‘Eli Lilly’) and Genentech Inc. concerning an application lodged by the latter with a view to obtaining a supplementary protection certificate (‘SPC’).
Legal context
3 Article 1 of Regulation No 469/2009 provides:
‘For the purposes of this Regulation, the following definitions shall apply:
(a) “medicinal product” means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
…
(c) “basic patent” means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a[n SPC];
…’
4 Article 2 of that regulation, entitled ‘Scope’, states:
‘Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [(OJ 2001 L 311, p. 67)] or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products [(OJ 2001 L 311, p. 1)] may, under the terms and conditions provided for in this Regulation, be the subject of a[n SPC].’
5 Article 3 of that regulation, entitled ‘Conditions for obtaining a[n SPC]’, provides:
‘A[n SPC] shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted …;
(c) the product has not already been the subject of a[n SPC];
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.’
The dispute in the main proceedings and the question referred for a preliminary ruling
6 Genentech is the proprietor of European Patent (UK) No 1 641 822, entitled ‘IL‑17A/F heterologous peptides and therapeutic uses thereof’ (‘the basic patent’), whose priority date is 8 July 2003. At present, Genentech does not have any product covered by that patent.
7 Eli Lilly markets a formulation of an antibody, called ‘ixekizumab’, to treat moderate to severe plaque psoriasis and psoriatic arthritis in adults. That formulation is marketed under the trade mark Taltz by virtue of marketing authorisation (MA) EU/1/15/1085 (‘the MA for ixekizumab’). Genentech contends that that formulation falls within the scope of protection of the basic patent.
8 Genentech filed an application for an SPC on the basis of the basic patent and of the MA for ixekizumab.
9 Eli Lilly seeks a declaration from the referring court that an SPC granted pursuant to such an application would not be valid. That court states that it examined that application in parallel with another application by which Eli Lilly disputed the validity of the basic patent. That court specifies that it gave its decision in that regard and held that the claims of that patent were invalid.
10 In the main proceedings, Eli Lilly contends that, if it is assumed that that patent is valid, two grounds preclude the grant of an SPC for ixekizumab. In the first place, it asserts that the SPC application at issue does not comply with Article 3(a) of Regulation No 469/2009, since the formulation which is the subject of the MA for ixekizumab is not protected by the basic patent. In the second place, it contends that that application does not comply with either Article 2 or Article 3(b) and (d) of that regulation, because the MA for ixekizumab is not a relevant MA, since it is owned by a third party and was relied upon without that party’s consent.
11 In those circumstances, the High Court of Justice (England & Wales), Chancery Division (Patents Court) (United Kingdom) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:
‘Does [Regulation No 469/2009] preclude the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent?’
Admissibility of the request for a preliminary ruling
12 Under Article 53(2) of the Rules of Procedure of the Court of Justice, where a request or an application is manifestly inadmissible, the Court may, after hearing the Advocate General, at any time decide to give a decision by reasoned order without taking further steps in the proceedings.
13 It is appropriate to apply that provision in the present case.
14 In accordance with the Court’s settled case-law, the procedure provided for by Article 267 TFEU is an instrument of cooperation between the Court of Justice and national courts and tribunals, by means of which the former provides the latter with interpretation of such EU law as is necessary for them to give judgment in cases upon which they are called to adjudicate (orders of 25 October 2018, Barba Giménez, C‑426/17, not published, EU:C:2018:858, paragraph 36, and of 17 January 2019, Rossi and Others, C‑626/17, not published, EU:C:2019:28, paragraph 20 and the case-law cited).
15 In the context of that cooperation, questions relating to EU law enjoy a presumption of relevance. However, a reference for a preliminary ruling made by a national court is to be rejected where it is quite obvious that the interpretation of EU law that is sought is unrelated to the actual facts of the main action or its object, where the problem is hypothetical, or where the Court does not have before it the factual and legal material necessary to give a useful answer to the questions submitted to it (order of 17 January 2019, Cipollone, C‑600/17, not published, EU:C:2019:29, paragraph 21 and the case-law cited).
16 In that regard, it is for the Court to examine the circumstances in which cases are referred to it by the national court in order to assess whether it has jurisdiction. The spirit of cooperation which must prevail in preliminary ruling proceedings requires the national court for its part to have regard to the function entrusted to the Court of Justice, which is to contribute to the administration of justice in the Member States and not to give opinions on general or hypothetical questions (judgment of 24 April 2012, Kamberaj, C‑571/10, EU:C:2012:233, paragraph 41 and the case-law cited).
17 Thus, the 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).
18 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.
19 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.
20 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.
21 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.
22 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.
23 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.
24 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.
25 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.
26 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.
27 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.
28 It must therefore be held that the question referred is hypothetical for the purposes of the dispute in the main proceedings.
29 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.
Costs
30 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court.
On those grounds, the Court (Ninth Chamber) hereby orders:
The request for a preliminary ruling from the High Court of Justice (England & Wales), Chancery Division (Patents Court) (United Kingdom), made by decision of 4 March 2019, is manifestly inadmissible.
Luxembourg, 5 September 2019.
A. Calot Escobar
K. Jürimäe
Registrar
President of the Ninth Chamber
* Language of the case: English.
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