ORDER OF THE COURT (Ninth Chamber)

11 June 2020 ([\*](#Footnote*))

(Appeal — Article 181 of the Rules of Procedure of the Court of Justice — Service of the judgment under appeal by means of e-Curia — Appeal lodged out of time — Extension of the time limit — Precluded — Appeal manifestly inadmissible)

In Case C‐575/19 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 29 July 2019,

**GMP-Orphan SA,** established in Paris (France), represented by J. Mulryne and L. Tsang, Solicitors, and C. Schoonderbeek, advocaat,

appellant,

the other party to the proceedings being:

**European Commission,**

defendant at first instance,

THE COURT (Ninth Chamber),

composed of S. Rodin, President of the Chamber, D. Šváby and N. Piçarra (Rapporteur), Judges,

Advocate General: E. Sharpston,

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 181 of the Rules of Procedure of the Court of Justice,

makes the following

**Order**

1        By its appeal, GMP-Orphan SA (‘GMPO’) asks the Court of Justice to set aside the judgment of the General Court of the European Union of 16 May 2019, *GMPO* v *Commission* (T‐733/17, EU:T:2019:334; ‘the judgment under appeal’), by which the General Court dismissed its action seeking the partial annulment of Commission Implementing Decision C(2017) 6102 final of 5 September 2017 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1) for ‘Cuprior-trientine’, a medicinal product for human use (‘the decision at issue’), in so far as the European Commission considered, in Article 5 of that decision, that that medicinal product no longer satisfied the criteria laid down in Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1) to be registered as an orphan medicinal product and that the European Union Register of Orphan Medicinal Products should be updated accordingly.

**Legal context**

***The** **Statute of the Court of Justice** **of the European Union***

2        Under the second paragraph of Article 45 of the Statute of the Court of Justice of the European Union, no right is to be prejudiced in consequence of the expiry of a time limit if the party concerned proves the existence of unforeseeable circumstances or of *force majeure*.

3        The first paragraph of Article 56 of that statute provides:

‘An appeal may be brought before the Court of Justice, within two months of the notification of the decision appealed against, against final decisions of the General Court ...’

***The** **Rules of Procedure of the Court of Justice***

4        Article 49 of the Rules of Procedure of the Court, entitled ‘Calculation of time limits’, reads as follows:

‘1.      Any procedural time limit prescribed by the Treaties, the Statute or these Rules shall be calculated as follows:

...

(b)      a time limit expressed in weeks, months or years shall end with the expiry of whichever day in the last week, month or year is the same day of the week, or falls on the same date, as the day during which the event or action from which the time limit is to be calculated occurred or took place. ...

...

(d)      time limits shall include Saturdays, Sundays and the official holidays referred to in Article 24(6) of these Rules;

(e)      time limits shall not be suspended during the judicial vacations.

2.      If the time limit would otherwise end on a Saturday, Sunday or an official holiday, it shall be extended until the end of the first subsequent working day.’

5        Article 51 of the Rules of Procedure provides that the procedural time limits are to be extended on account of distance by a single period of 10 days.

6        Article 52 of the Rules of Procedure, entitled ‘Setting and extension of time limits’, provides, in paragraph 1:

‘Any time limit prescribed by the Court pursuant to these Rules may be extended.’

***The** **d****ecision of the General Court on the lodging and service of** **procedural documents by means of e-Curia***

7        Recitals 2 and 3 of the Decision of the General Court of 11 July 2018 on the lodging and service of procedural documents by means of e-Curia (OJ 2018 L 240, p. 72) state:

‘(2)      This application, which is based on an electronic authentication system using a combination of a user identification and a password, meets the requirements of authenticity, integrity and confidentiality of documents exchanged.

(3)      Having regard to the advantages of the immediacy of paperless communication offered by this application, its use has become mandatory for the lodging and service of procedural documents in proceedings before the General Court.’

8        Article 6 of that decision is worded as follows:

‘Procedural documents, including judgments and orders, shall be served by e‐Curia on the holders of access accounts in the cases which concern them.

The intended recipients of the documents served referred to in the preceding paragraph shall be notified by email of any document served on them by means of e‐Curia.

A procedural document shall be served at the time when the intended recipient (representative or assistant) requests access to that document. In the absence of any request for access, the document shall be deemed to have been served on the expiry of the seventh day following the day on which the notification email was sent.

...’

**Background to the dispute**

9        The background to the dispute is set out in paragraphs 1 to 9 of the judgment under appeal and may be summarised as follows.

10      On 19 March 2015, the Commission adopted a decision by which trientine tetrahydrochloride, sponsored by the appellant, was designated as an orphan medicinal product and entered into the European Union Register of Orphan Medicinal Products, in accordance with Regulation No 141/2000.

11      On 7 December 2015, GMPO submitted to the European Medicines Agency (EMA) an application for marketing authorisation (MA) for that medicinal product under the name Cuprior — trientine (‘Cuprior’).

12      On 20 September 2016, the appellant submitted a report to the EMA’s Committee for Orphan Medicinal Products, provided for in Article 4 of Regulation No 141/2000 (‘the COMP’), on the maintenance of the designation of Cuprior as an orphan medicinal product at the time the MA was granted.

13      On 23 May 2017, the COMP issued an opinion concluding that the criteria for designating Cuprior as an orphan medicinal product, set out in Article 3(1)(b) of Regulation No 141/2000, had not been met, on the ground that that medicinal product did not provide a significant benefit, in particular when compared with the reference medicinal product, which was granted market authorisation in the United Kingdom in 1985.

14      On 30 June 2017, the appellant requested the COMP, in accordance with Article 5(7) of Regulation No 141/2000, to revise its opinion of 23 May 2017.

15      On 20 July 2017, the COMP adopted a final opinion upholding the conclusions it had reached in its opinion of 23 May 2017 (‘the final opinion’) and stated that satisfactory methods for the treatment of the condition concerned had already been authorised in one Member State, the sponsor having failed to provide sufficient evidence to demonstrate the lack of availability of the reference medicinal product in the European Union.

16      On 5 September 2017, the Commission adopted the decision at issue, based on the COMP’s final opinion, leading to the removal of Cuprior from the European Union Register of Orphan Medicinal Products on 12 September 2017.

**The procedure before the General Court and the judgment under appeal**

17      By application lodged at the Registry of the General Court on 2 November 2017, the appellant brought an action seeking, first, annulment of Article 5 of the decision at issue and, second, an order by the General Court that the Commission designate Cuprior as an orphan medicinal product and, consequently, update the European Union Register of Orphan Medicinal Products.

18      In support of its action, the appellant put forward four pleas in law, alleging, first, an error of law in the interpretation of the concept of ‘significant benefit’ within the meaning of Article 3(1)(b) of Regulation No 141/2000, second, an error of law and a manifest error of assessment in the application of that provision, third, an error of law and a breach of the principles of the protection of legitimate expectations and procedural fairness and, fourth, a manifest error of assessment of the evidence submitted by the appellant.

19      By the judgment under appeal, the General Court dismissed the action. In the first place, it rejected the appellant’s claim for directions, on the ground that the General Court did not have jurisdiction to issue directions, before rejecting, in the second place, the claim for annulment, dismissing the first, third and fourth pleas as unfounded and the second plea as ineffective.

**Form of order sought by the appellant and the procedure before the Court of Justice**

20      By its appeal, GMPO claims that the Court should:

–        set aside the judgment under appeal;

–        annul Article 5 of the decision at issue;

–        refer the decision back to the Commission in order to designate Cuprior as an orphan medicinal product, on the basis of the COMP’s opinion, to the extent deemed appropriate;

–        in the alternative, refer the case back to the General Court; and

–        order the Commission to pay the costs.

21      The appellant relies on two grounds in support of its appeal. The first ground of appeal alleges an error of law in the interpretation of the concept of ‘significant benefit’ within the meaning of Article 3(1)(b) of Regulation No 141/2000. By its second ground of appeal, the appellant submits that the General Court erred in failing to find that the Commission had both erred in law and made an error of assessment, in reliance on the COMP’s opinion, when considering whether Cuprior provides a significant benefit to patients when compared with the authorised reference medicinal product.

22      When asked by the Registry of the Court of Justice about the date of service of the judgment under appeal, the appellant confirmed, by letter of 7 August 2019, that that judgment was served on it by e-Curia on 16 May 2019, a Thursday, ‘after normal office hours in Luxembourg’.

**The appeal**

23      Under Article 181 of the Rules of Procedure, where an appeal is, in whole or in part, manifestly inadmissible or manifestly unfounded, the Court may, at any time, acting on a proposal from the Judge-Rapporteur and after hearing the Advocate General, decide by reasoned order to dismiss that appeal in whole or in part, without opening the oral procedure, or, where appropriate, without serving notice of the appeal on the defendant.

24      It is appropriate to apply that provision in the present appeal.

***The appellant****’****s arguments on the admissibility of the appeal***

25      The appellant submits that, since the judgment under appeal was served on it on 16 May 2019, after normal office hours, that day should not be regarded as the day on which the action from which the two-month time limit available to the appellant to bring an appeal was to be calculated took place. Consequently, that two-month period, extended on account of distance by a single period of 10 days, pursuant to Article 51 of the Rules of Procedure, should have expired on Saturday 27 July 2019. The appellant then states that, in accordance with Article 49(2) of the Rules of Procedure, under which the expiry of a time limit on a Saturday, Sunday or official holiday is to be extended until the end of the first subsequent working day, the appeal was lodged on Monday 29 July 2019, namely before the expiry of the time limit for bringing proceedings.

26      The appellant nevertheless requests, in the event that the Rules of Procedure are interpreted as meaning that the appeal lodged on 29 July 2019 must be regarded as being out of time, an extension of the time limit for bringing proceedings, on account of an excusable error or ‘the unforeseeable and specific circumstances of the present case’, the unprecedented nature of the appeal and the related facts, the Commission’s conduct, and in accordance with the principle of proportionality and the right of access to justice and to an effective remedy.

27      According to the appellant, if the Commission were to grant the MA application submitted by a company competing with the appellant for a medicinal product comparable to that marketed by the appellant, the appeal brought against the judgment under appeal would be meaningless. According to the appellant, the Commission should therefore have suspended the procedure concerning that MA application in order not to prejudice the appellant’s interests and to ensure that the judgment which the Court will deliver on the appeal is not deprived of all practical effect. The appellant states that it tried, unsuccessfully, until 26 July 2019, to obtain information from the Commission on the state of that procedure, which would have enabled it, if necessary, to make an application for interim measures seeking suspension of the decision-making process in respect of that application. The appellant learned from public sources on 29 July 2019 that the MA applied for had been granted to that competitor company and, therefore, brought the appeal on the same day.

28      The appellant adds that the requested extension of the time limit for bringing proceedings is necessary in view of the legal issues raised by the appeal, in particular those relating, first, to the legal status of the guidelines the adoption of which is provided for by Regulation No 141/2000 and, second, those relating to whether or not the Commission has the power to apply standards differing from those laid down in those guidelines.

***Findings of the Court***

29      First of all, it is important to note that, in accordance with Article 56 of the Statute of the Court of Justice of the European Union, the time limit for bringing an appeal is two months from the date of notification of the decision appealed against; that time limit is, pursuant to Article 51 of the Rules of Procedure, to be extended on account of distance by a single period of 10 days.

30      In that respect, it follows from Article 49(1)(b) of the Rules of Procedure that, as regards measures requiring notification, the time limit for bringing proceedings runs from the end of the day of notification, regardless of the hour of day when notification of the measure at issue took place (see, to that effect, judgment of 15 January 1987, *Misset* v *Council*, 152/85, EU:C:1987:10, paragraph 7). It also follows from that provision that that time limit expires at the end of the day which, in the last month in which the time limit ends, bears the same number as the day from which time was set running, that is to say the day of notification (see judgment of 15 January 1987, *Misset* v *Council*, 152/85, EU:C:1987:10, paragraph 8, and order of 17 May 2002, *Germany* v *Parliament and Council*, C‐406/01, EU:C:2002:304, paragraph 14), a time limit to which is added a single period of 10 days on account of distance.

31      In the present case, since the judgment under appeal was served on the appellant by e-Curia on 16 May 2019, as the appellant itself acknowledges in its pleadings, the time limit for bringing the appeal started to run at midnight on 16 May 2019 and expired at midnight on Friday 26 July 2019.

32      Consequently, the present appeal, lodged at the Registry of the Court on 29 July 2019, was not lodged within the time limit laid down by those provisions.

33      As regards the appellant’s request for an extension of the time limit for lodging its appeal, it should be noted that, in accordance with the second paragraph of Article 45 of the Statute of the Court of Justice of the European Union, no derogation from the procedural time limits may be made save where the circumstances are quite exceptional, in the sense of being unforeseeable or amounting to *force majeure* (see, to that effect, order of 8 November 2007, *Belgium* v *Commission*, C‐242/07 P, EU:C:2007:672, paragraph 16, and judgment of 22 September 2011, *Bell & Ross* v *OHIM*, C‐426/10 P, EU:C:2011:612, paragraph 43).

34      The Court has had occasion to clarify that the concepts of unforeseeable circumstances and *force majeure* contain an objective element relating to abnormal circumstances unconnected with the trader in question, and a subjective element involving the obligation, on its part, to guard against the consequences of the abnormal event by taking appropriate steps without making unreasonable sacrifices. In particular, the trader must pay close attention to the course of the procedure set in motion and, in particular, demonstrate diligence in order to comply with the prescribed time limits. Those concepts do not apply to a situation in which, objectively, a diligent and prudent person would have been able to take the necessary steps before the expiry of the period prescribed for instituting proceedings (judgment of 19 June 2019, *RF* v *Commission*, C‐660/17 P, EU:C:2019:509, paragraphs 37 and 38 and the case-law cited).

35      Neither the Commission’s failure to take a decision on the MA application for another medicinal product before 26 July 2019, nor that institution’s failure to reply to the letters which the appellant sent to it, in order to obtain information in that regard, can be regarded as constituting unforeseeable circumstances or *force majeure* within the meaning of the second paragraph of Article 45 of the Statute of the Court of Justice of the European Union. None of those circumstances were such as to prevent the appellant from lodging the present appeal within the prescribed time limit (see, to that effect, judgment of 26 November 1985, *Cockerill-Sambre* v *Commission*, 42/85, EU:C:1985:471, paragraph 12).

36      Furthermore, in so far as the appellant also claims to have made an excusable error regarding its assessment of the time limit for bringing proceedings, it is important to note that it is clear from the Court’s case-law that, under EU rules on time limits for bringing proceedings, the concept of excusable error must be strictly construed and relates only to exceptional circumstances in which, in particular, the conduct of the institution concerned has been, either in itself or to a significant extent, such as to give rise to understandable confusion on the part of a party acting in good faith and exercising all the diligence required of a normally experienced trader (see order of the Vice-President of the Court of 5 July 2018, *Müller and Others* v *QH*, C‐187/18 P(I), not published, EU:C:2018:543, paragraph 42 and the case-law cited).

37      The conduct which the appellant complains of in relation to the Commission was clearly not such as to cause confusion as to the time limit within which the appeal had to be brought.

38      Finally, in so far as the appellant argues that it should be granted a derogation from the time limit for lodging the appeal, first, by virtue of its fundamental right of access to the courts and the principle of proportionality and, second, because of the special circumstances, the unprecedented nature of this appeal and the legal issues raised, it is important to note, first, that the strict application of procedural rules meets the requirement of legal certainty and the need to avoid any discrimination or arbitrary treatment in the administration of justice (order of 29 January 2014, *Gbagbo* v *Council*, C‐397/13 P, not published, EU:C:2014:46, paragraph 7 and case-law cited).

39      Second, as is apparent from the Court’s case-law, rules concerning time limits for bringing proceedings are mandatory and a derogation from those rules cannot be justified by the fact that fundamental rights are at stake (see, to that effect, order of 16 November 2010, *Internationale Fruchtimport Gesellschaft Weichert* v *Commission*, C‐73/10 P, EU:C:2010:684, paragraph 50 and the case-law cited).

40      As the Court has held, the right to effective judicial protection is in no way undermined by the strict application of EU rules concerning procedural time limits (see, inter alia, orders of 17 May 2002, *Germany* v *Parliament and Council*, C‐406/01, EU:C:2002:304, paragraph 20 and the case-law cited, and of 22 October 2010, *Seacid* v *Parliament* *and Council*, C‐266/10 P, not published, EU:C:2010:629, paragraph 30). Such time limits constitute, for the reasons relating to legal certainty referred to in paragraph 38 of the present order, an inherent limitation on the right of access to the courts (see, to that effect, order of 12 September 2013, *Ellinika Nafpigeia and 2. Hoern* v *Commission*, C‐616/12 P, not published, EU:C:2013:884, paragraph 31). Consequently, the principle of proportionality, even if it were applicable, cannot call into question such a limitation.

41      Third, although the appellant also puts forward, in support of its request for a special extension of the time limit for bringing proceedings, arguments based on the unforeseeable and special circumstances of the present case and the unprecedented nature of the present appeal, as well as the related facts and the legal issues raised, those arguments are not capable, objectively, of justifying a derogation from mandatory rules concerning time limits for bringing proceedings or from the requirements, underlying those rules, of legal certainty and the need to exclude any discrimination or arbitrary treatment in the administration of justice.

42      In the light of all the foregoing, the appeal must be dismissed as manifestly inadmissible because it was lodged out of time.

**Costs**

43      Under Article 137 of the Rules of Procedure, applicable to the procedure on appeal pursuant to Article 184(1) of those rules, a decision as to costs is to be given in the order which closes the proceedings. In the present case, since the present order has been made before the appeal was served on the defendant at first instance and, therefore, before the latter could have incurred costs, GMPO is to be ordered to bear its own costs.

On those grounds, the Court (Ninth Chamber) hereby orders:

1.      **The appeal is dismissed as being manifestly inadmissible.**

2.      **GMP-Orphan SA shall bear its own costs.**

Luxembourg, 11 June 2020.

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| A. Calot Escobar | | S. Rodin |

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| Registrar | | President of the Ninth Chamber |

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[\*](#Footref*)      Language of the case: English.