Provisional text
ORDER OF THE PRESIDENT OF THE COURT
4 April 2017 (*)
(Expedited procedure)
In Case C‑121/17,
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 23 February 2017, received at the Court on 8 March 2017, in the proceedings
TEVA UK Limited,
Accord Healthcare Limited,
Lupin Limited,
Lupin Europe Limited,
Generics (UK) Limited
v
Gilead Sciences Inc.,
THE PRESIDENT OF THE COURT,
after hearing the Judge-Rapporteur, K. Jürimäe, and the First Advocate General, M. Wathelet,
makes the following
Order
1 This request for a preliminary ruling concerns the interpretation of Article 3(a) 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 Teva UK Limited, Accord Healthcare Limited, Lupin Limited, Lupin Europe Limited and Generics (UK) Limited, trading as Mylan, and Gilead Sciences Inc. concerning the validity of supplementary protection certificate SPC/GB05/041 (‘the SPC’), which was granted to the latter for the medicinal product marketed under the name Truvada, intended for the treatment of persons with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
3 The order for reference states that the claimants in the main proceedings wish to market generic alternative medicinal products to Truvada as soon as the patent protecting it expires on 24 July 2017. However, since Gilead Sciences owns the SPC, such marketing would constitute an infringement of a protected invention. The claimants in the main proceedings are therefore challenging the validity of the SPC before the referring court.
4 In that context, that court is seeking clarification of the meaning of one of the conditions for obtaining a supplementary protection certificate set out in Article 3 of Regulation No 469/2009. It is seeking, in particular, that the Court define the relevant criteria for determining whether ‘the product is protected by a basic patent in force’, within the meaning of Article 3(a) of that regulation.
5 The referring court has included with its request for a preliminary ruling a request that the reference be determined pursuant to an expedited procedure in accordance with Article 105(1) of the Rules of Procedure of the Court.
6 That provision provides that, at the request of the referring court or tribunal or, exceptionally, of his own motion, the President of the Court may, where the nature of the case requires that it be dealt with within a short time, after hearing the Judge-Rapporteur and the Advocate General, decide that a reference for a preliminary ruling is to be determined pursuant to an expedited procedure derogating from the provisions of the Rules of Procedure.
7 In support of its request that the present case be determined pursuant to an expedited procedure, the referring court states that, should the case not benefit from such a procedure, the case will not be resolved before the expiry of the patent at issue in the main proceedings. According to the referring court, this will inevitably put back the date on which generic medicinal products will be available for the National Health Service England and, in so doing, will entail higher costs for, and place a more onerous budgetary burden on, the latter.
8 In this connection, it is clear from the Court’s case-law that invoking economic interests, including those that are liable to have an impact on the public finances, does not justify the use of the expedited procedure (see, to that effect, order of the President of the Court of 31 March 2014, Indėlių ir investicijų draudimas and Nemaniūnas, C‑671/13, not published, EU:C:2014:225, paragraph 11 and the case-law cited).
9 Furthermore, it should be pointed out that the referring court has in no way referred to an imminent risk to public health which might constitute an exceptional circumstance such as to justify the use of the expedited procedure. Indeed, it is clear from the order for reference that whilst, according to the referring court, the use of the ordinary procedure to deal with the present case would delay the date of availability of generic medicinal products, it would nevertheless not affect the health of the patients concerned, who would continue to be treated by means of Truvada.
10 It follows that the request from the High Court of Justice (England & Wales), Chancery Division (Patents Court) that the present case be determined pursuant to an expedited procedure cannot be granted.
On those grounds, the President of the Court hereby orders:
The request from the High Court of Justice (England & Wales), Chancery Division (Patents Court), United Kingdom, that Case C‑121/17 be determined pursuant to the expedited procedure provided for in Article 105(1) of the Rules of Procedure of the Court of Justice is refused.
Luxembourg, 4 April 2017.
A Calot Escobar | | K. Lenaerts |