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Corte di giustizia UEsentenza

Corte di giustizia UE n. 141/2019

ECLI:EU:C:2019:639
Testo integrale del provvedimento

Testo integrale del provvedimento

[OSCURATO:PERSONA] ([OSCURATO:PERSONA])

29 July 2019 ( * ) (Appeal — [OSCURATO:PERSONA] (EC) No 141/2000 — [OSCURATO:PERSONA] medicinal products — [OSCURATO:PERSONA] 5 — Application for designation of a medicinal product as an ‘orphan medicinal product’ — Validation — Existence of a prior marketing authorisation (MA) for the same medicinal product)

[OSCURATO:PERSONA] C‑359/18 P

APPEAL under [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 1 June 2018,

[OSCURATO:PERSONA] (EMA),

represented initially by S. Marino, S. Drosos, T. Jabłoński and A. Spina, acting as Agents, and subsequently by S. Marino, S. Drosos and T. Jabłoński, acting as Agents, applicant, the other parties to the proceedings being:

[OSCURATO:PERSONA],

established in Dublin ([OSCURATO:PERSONA]), represented by G. Castle, Solicitor, D. Anderson QC and M. Birdling, Barrister and by S. Cowlishaw, Solicitor, applicant at first instance,

[OSCURATO:PERSONA],

represented by K. Petersen and A. Sipos, acting as Agents, intervener at first instance,

[OSCURATO:PERSONA] ([OSCURATO:PERSONA]),

composed of F. [OSCURATO:PERSONA], [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], J. [OSCURATO:PERSONA] and C.G. [OSCURATO:PERSONA] (Rapporteur), [OSCURATO:PERSONA],

[OSCURATO:PERSONA]: E. [OSCURATO:PERSONA],

[OSCURATO:PERSONA]: A. [OSCURATO:PERSONA],

having regard to the written procedure, having decided, after hearing the [OSCURATO:PERSONA], to proceed to judgment without an Opinion, gives the following

[OSCURATO:PERSONA]

1 By its appeal, the [OSCURATO:PERSONA] (EMA) asks the [OSCURATO:PERSONA] to set aside the judgment of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 22 March 2018,

[OSCURATO:PERSONA]

v EMA (T‑80/16, not published; ‘the judgment under appeal’, EU:T:2018:165), whereby the [OSCURATO:PERSONA] annulled the decision of the EMA of 15 December 2015 to refuse to validate the application submitted by [OSCURATO:PERSONA] (‘[OSCURATO:PERSONA]’) for the designation of Idursulfase-IT as an orphan medicinal product (‘the contested decision’).

Legal context

[OSCURATO:PERSONA] 141/2000

2 [OSCURATO:PERSONA] (EC) No 141/2000 of the [OSCURATO:PERSONA] and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1), as amended by [OSCURATO:PERSONA] (EC) No 596/2009 of the [OSCURATO:PERSONA] and of the Council of 18 June 2009 (OJ 2009 L 188, p. 14) (‘[OSCURATO:PERSONA] 141/2000’), lays down procedures for the designation of medicinal products as orphan medicinal products and for the marketing authorisation (MA) of such products. 3 Recital 4 of that regulation provides: ‘orphan medicinal products eligible for incentives should be easily and unequivocally identified; it seems most appropriate to achieve this result through the establishment of an open and transparent Community procedure for the designation of potential medicinal products as orphan medicinal products’. 4 [OSCURATO:PERSONA] 3(1) of that regulation is worded as follows: ‘A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (a) that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in [the [OSCURATO:PERSONA]] when the application is made, or that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in [the [OSCURATO:PERSONA]] and that without incentives it is unlikely that the marketing of the medicinal product in [the [OSCURATO:PERSONA]] would generate sufficient return to justify the necessary investment; and (b) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in [the [OSCURATO:PERSONA]] or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.’ 5 [OSCURATO:PERSONA] 5 of [OSCURATO:PERSONA] 141/2000 states: ‘1.

In order to obtain the designation of a medicinal product as an orphan medicinal product, the sponsor shall submit an application to the [EMA] at any stage of the development of the medicinal product before the [MA] is made.

2. The application shall be accompanied by the following particulars and documents: (a) name or corporate name and permanent address of the sponsor; (b) active ingredients of the medicinal product; (c) proposed therapeutic indication; (d) justification that the criteria laid down in [OSCURATO:PERSONA] 3(1) are met and a description of the stage of development, including the indications expected.

3. [OSCURATO:PERSONA] shall, in consultation with the [OSCURATO:PERSONA], the [EMA] and interested parties, draw up detailed guidelines on the required format and content of applications for designation.

4. The [EMA] shall verify the validity of the application and prepare a summary report to the [OSCURATO:PERSONA]. Where appropriate, it may request the sponsor to supplement the particulars and documents accompanying the application.

5. The [EMA] shall ensure that an opinion is given by the [OSCURATO:PERSONA] within 90 days of the receipt of a valid application.

6. When preparing its opinion, the [OSCURATO:PERSONA] shall use its best endeavours to reach a consensus.

If such a consensus cannot be reached, the opinion shall be adopted by a majority of two-thirds of the members of the [OSCURATO:PERSONA].

The opinion may be obtained by written procedure.

7. Where the opinion of the [OSCURATO:PERSONA] is that the application does not satisfy the criteria set out in [OSCURATO:PERSONA] 3(1), the [EMA] shall forthwith inform the sponsor.

Within 90 days of receipt of the opinion, the sponsor may submit detailed grounds for appeal, which the [EMA] shall refer to the [OSCURATO:PERSONA]. [OSCURATO:PERSONA] shall consider whether its opinion should be revised at the following meeting. …’ 6 [OSCURATO:PERSONA] 8 of that regulation sets out the conditions under which an MA may be granted to a medicinal product similar to an orphan medicinal product and states that the [OSCURATO:PERSONA] is to determine, by means of an implementing regulation, the definition of a ‘similar medicinal product’. [OSCURATO:PERSONA] (EC) No 847/2000 7 [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ (OJ 2000 L 103, p. 5) provides. ‘For the purposes of the implementation of [OSCURATO:PERSONA] 3 of [OSCURATO:PERSONA] (EC) No 141/2000 on orphan medicinal products, the following definition shall apply: – “significant benefit” means a clinically relevant advantage or a major contribution to patient care.’ Directive 2001/83 8 [OSCURATO:PERSONA] 1(2) and 3a of Directive 2001/83/EC of the [OSCURATO:PERSONA] 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), as amended by Directive 2011/62/UE of the [OSCURATO:PERSONA] and of the Council of 8 June 2011 (OJ 2011 L 174, p. 74) (‘Directive 2001/83’), define the concepts of ‘medicinal product’ and ‘active substance’ as follows: ‘2. [OSCURATO:PERSONA] product: (a) Any substance or combination of substances presented for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. … 3a.

Active substance: Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.’ Background to the dispute and the contested decision 9 It is apparent from paragraph 9 of the judgment under appeal that the main reason for the EMA’s adoption of the contested decision was that [OSCURATO:PERSONA]’s application for the designation of Idursulfase-IT, the active substance of which is idursulfase, as an orphan medicinal product for the treatment of [OSCURATO:PERSONA] syndrome, did not comply with [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000. 10 The EMA stated that the active substance idursulfase obtained designation as an orphan medicinal product for the treatment of [OSCURATO:PERSONA] in 2001, and that an MA as an orphan medicinal product for Elaprase, containing that active substance, had been issued in January 2007 for the treatment of patients suffering from [OSCURATO:PERSONA].

The procedure before the [OSCURATO:PERSONA] and the judgment under appeal 11 By an application lodged at the Registry of the [OSCURATO:PERSONA] on 23 February 2016, [OSCURATO:PERSONA] brought an action seeking the annulment of the contested decision. 12 In support of its appeal, [OSCURATO:PERSONA] relied on a single plea in law, claiming infringement of [OSCURATO:PERSONA] 141/2000. 13 By the judgment under appeal, the [OSCURATO:PERSONA] upheld that plea in law and annulled the contested decision.

Forms of order sought by the parties before the [OSCURATO:PERSONA] 14 The EMA claims that the [OSCURATO:PERSONA] should: – set aside the judgment under appeal; – dismiss the action for annulment as being unfounded, and – order [OSCURATO:PERSONA] to pay the cost of proceedings, including those incurred in the procedure before the [OSCURATO:PERSONA]. 15 [OSCURATO:PERSONA] contends that the [OSCURATO:PERSONA] should: – dismiss the appeal; and – order the EMA to pay the costs. 16 [OSCURATO:PERSONA] claims that the judgment under appeal should be set aside, the action for annulment should be dismissed and [OSCURATO:PERSONA] ordered to pay the costs.

The appeal The first ground of appeal, alleging infringement of [OSCURATO:PERSONA] 5 of [OSCURATO:PERSONA] 141/2000 Arguments of the parties 17 By the first part of its first ground of appeal, the EMA claims that the [OSCURATO:PERSONA], in paragraph 51 of the judgment under appeal, erred in law by interpreting separately rather than together [OSCURATO:PERSONA] 5(1) and (2) of [OSCURATO:PERSONA] 141/2000.

That error of law undermines the effectiveness of the provision. 18 The EMA considers that [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000 places on it an obligation to check whether an application for designation as an orphan medicinal product is already covered by an earlier application for an MA. [OSCURATO:PERSONA] 5(2) of that regulation sets out a list of documents to be submitted for that purpose.

The aim of that provision is to enable the EMA Secretariat to verify that the application for designation contains sufficient information for its scientific assessment by the [OSCURATO:PERSONA] for [OSCURATO:PERSONA] (‘COMP’) on the basis of easily applied criteria. 19 That interpretation is supported by recital 4 of [OSCURATO:PERSONA] 141/2000 which states that ‘orphan products eligible for incentives should be easily and unequivocally identified’.

The purpose of the term ‘eligible for’ is to determine whether a medicinal product can obtain orphan designation.

That designation is reserved for medicinal products which have not been the subject of a previous MA application.

It is essential that the EMA Secretariat is guided by an exhaustively defined set of simple and unequivocal criteria.

Such criteria are those set out in [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000. 20 The interpretation adopted by the [OSCURATO:PERSONA] is problematic having regard to the above.

In order to circumvent [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000, it would be sufficient for a company to allege inconsequential differences between the product included in the application for designation and a medicinal product for which an MA application had previously been lodged. 21 The EMA claims that the [OSCURATO:PERSONA] erred in appearing to accept, in paragraphs 62 and 64 of the judgment under appeal, that the excipients and the method of administration should be taken into account when examining the risk of an overlap with [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000.

According to the EMA, the [OSCURATO:PERSONA] interpretation would lead to such differences making it possible to validate an application for designation as an orphan medicinal product.

The EMA Secretariat cannot be expected to check whether medicinal products are to be considered to be identical on the basis of criteria that are not laid down in EU legislation. 22 By the second part of its first ground of appeal, the EMA claims that the [OSCURATO:PERSONA] erred in law, in paragraphs 58 and 64 of the judgment under appeal, by taking the concept of a ‘medicinal product’ defined in [OSCURATO:PERSONA] 1(2) of Directive 2001/83 as the relevant test in order to determine whether there is any overlap between an application for designation as an orphan medicinal product and a previous MA application.

That interpretation is contrary to [OSCURATO:PERSONA] 5(1) and (2) of [OSCURATO:PERSONA] 141/2000, from which, read together, it is clear that the relevant criteria for assessing whether an application for designation impinges on a previous MA application are the name of the sponsor, the active substance and the proposed therapeutic indication. 23 The concept of ‘medicinal product’, defined in [OSCURATO:PERSONA] 1(2) of Directive 2001/83, serves to determine which products fall within the scope of that directive.

The validation procedure that is the subject of [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000 has a different objective, namely to determine whether there is an overlap between an application for designation of an orphan medicinal product and a previous MA application.

It is not therefore appropriate to refer to the definition of the concept of ‘medicinal product’, derived from Directive 2001/83, but to define the concept of ‘sameness’ by referring to the legal instruments to which that concept is relevant. 24 According to the EMA, it is important not to conflate the notions of ‘sameness’ and ‘similarity’ of medicinal products.

Whereas the former is used in the context of the validation procedure laid down in [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000, and must meet the criteria of [OSCURATO:PERSONA] 5(2) of that regulation, the latter is used for the purposes of [OSCURATO:PERSONA] 8 of that regulation and was defined by [OSCURATO:PERSONA] 847/2000. 25 [OSCURATO:PERSONA] disputes those arguments. 26 [OSCURATO:PERSONA] maintains that the first ground of appeal is well founded.

Findings of the [OSCURATO:PERSONA] 27 In order to give a ruling on both parts of the first ground of appeal, it must be recalled that, when an application for the designation of a medicinal product as an orphan medicinal product is submitted to it, the EMA is required to verify its validity, under [OSCURATO:PERSONA] 5(4) of [OSCURATO:PERSONA] 141/2000.

That verification concerns compliance with the conditions laid down in [OSCURATO:PERSONA] 5(1) and (2) of that regulation. 28 [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000, an application for designation of a medicinal product as an orphan medicinal product must be submitted to the EMA ‘before the [MA application] is made’ for the same medicinal product.

It is therefore precluded that a medicinal product for which an MA application has previously been lodged can be the subject of an application for designation as an orphan medicinal product. 29 [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000 requires two categories of information to be supplied in support of the application for designation.

The first of these, under subparagraphs (a) to (c) of that provision, relates to the name of the sponsor, the active ingredient of the medicinal product and the proposed therapeutic indication.

It thus makes it possible to identify the essential characteristics of the medicinal product in question in order, in particular, to enable the EMA to ensure that that medicinal product has not already been the subject of an application for an MA. 30 The purpose of the second category of information referred to in [OSCURATO:PERSONA] 5(2)(d) of [OSCURATO:PERSONA] 141/2000 is to establish that the designation criteria in [OSCURATO:PERSONA] 3(1) of that regulation are met.

In that regard, that provision requires that the medicinal product for which designation is sought is intended for the diagnosis, prevention or treatment of a condition considered to be orphan and for which there is no satisfactory method already authorised in the [OSCURATO:PERSONA] or, if there is such a method, that the medicinal product will be of significant benefit to those affected by that condition. 31 It is thus apparent from a combined reading of [OSCURATO:PERSONA] 3(1) and [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000 that if, for a given therapeutic indication, there is already a medicinal product for which an MA has been issued, the sponsor seeking orphan designation for a further medicinal product in respect of that therapeutic indication must establish that the latter will be of significant benefit to patients in relation to the former medicinal product.

Furthermore, in the light of [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000, it is also for the sponsor in such a situation to show that the second medicinal product is not identical to the first medicinal product.

In the case of the same medicinal product, the consequence of the rule laid down in [OSCURATO:PERSONA] 5(1) of that regulation would be to invalidate the application for designation of that medicinal product as an orphan due to the fact that it already has a marketing authorisation. 32 By its first ground of appeal, the EMA submits that it follows from a combined reading of [OSCURATO:PERSONA] 5(1), (2) and (4) of [OSCURATO:PERSONA] 141/2000 that, when examining the validity of an application for designation, those provisions require it to ascertain whether the medicinal product in question is identical to a medicinal product already authorised by taking into consideration the active ingredients and therapeutic indications of those medicinal products, to the exclusion of all other factors.

The EMA submits that those criteria are the only criteria set out in [OSCURATO:PERSONA] 5(2)(b) and (c) of that regulation and that, because of their simplicity, they are the only ones that can be taken into consideration at that stage of the designation procedure. 33 However, it should be noted that verification of the criteria in [OSCURATO:PERSONA] 3(1) of [OSCURATO:PERSONA] 141/2000 does not fall within the scope of the EMA’s review of the validity of the application for designation.

Pursuant to [OSCURATO:PERSONA] 4 and [OSCURATO:PERSONA] 5(5) to (7) of that regulation, responsibility for that verification lies with the COMP. 34 The rationale for that allocation of powers lies in the technical and scientific nature of the criteria set out in [OSCURATO:PERSONA] 3(1) of that regulation.

Those criteria entail complex and nuanced analyses, particularly where it is a question of assessing whether the medicinal product in question provides a significant benefit for patients compared with a medicinal product which has already been authorised. 35 For the same reasons, taking account of the link established between [OSCURATO:PERSONA] 3(1) and [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000, the exclusive competence of the COMP extends to verifying the identity of the medicinal product which is the subject of the application for designation with a medicinal product which has already been authorised, in a situation such as that in the present case. 36 It is true that [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000 mentions only the active ingredients and the therapeutic indications among the matters to be provided in support of an application for designation.

However, this cannot lead to the conclusion that, in the situations described in paragraph 31 above, the fact that the medicinal products in question have the same active substance is sufficient for those medicinal products to be considered to be identical and, consequently, to the rejection of the application for designation. 37 As held by the [OSCURATO:PERSONA], in paragraph 58 of the judgment under appeal, the terms ‘medicinal product’ and ‘active substance’ cover two distinct concepts, defined in [OSCURATO:PERSONA] 1 of Directive 2001/83.

As the active substance is a component of a medicinal product, it should not be confused with the medicinal product itself.

It is therefore necessary to examine all other relevant factors, in addition to the active substance, in order to determine whether those medicinal products are identical. 38 That allocation of powers between the EMA and the COMP is without prejudice to the outcome of the designation procedure.

It is not therefore capable of undermining the effectiveness of [OSCURATO:PERSONA] 5(1) of that regulation. 39 [OSCURATO:PERSONA] did not therefore err in law in holding, in paragraph 51 of the judgment under appeal, that: ‘The EMA is required to verify, at this stage of the proceedings, the validity of the application, pursuant to [OSCURATO:PERSONA] 5(4) of [OSCURATO:PERSONA] 141/2000.

Thus, it must check, on the one hand, whether the application was submitted at any stage of the development of the medicinal product before the application for marketing authorisation was made, as required by [OSCURATO:PERSONA] 5(1) of that regulation and, on the other, whether the application is accompanied by the information and documents referred to in [OSCURATO:PERSONA] 5(2) of the regulation.

Following that verification, the EMA may, where appropriate, request the sponsor to supplement the particulars and documents accompanying the application.

If the application complies with the requirements laid down in [OSCURATO:PERSONA] 5(1) and (2) of [OSCURATO:PERSONA] 141/2000, the EMA is obliged to validate and transmit it, next, to the [OSCURATO:PERSONA] on [OSCURATO:PERSONA].’ 40 As regards the criticisms made in the context of the first ground of appeal against paragraphs 62 and 64 of the judgment under appeal, it must be stated that, in paragraph 62 of that judgment, the [OSCURATO:PERSONA] found, on the basis of the file before it, that ‘Elaprase differs from Idursulfase-IT in its composition, method of administration and therapeutic effects’.

After examining each of those points in turn in paragraphs 62 to 63 of the judgment under appeal, the [OSCURATO:PERSONA] reiterated, in paragraph 64 of that judgment, that ‘it does not appear, at the validation stage of the … application, that Idursulfase-IT is the same medicinal product as Elaprase.’ Those factual assessments are not subject to review by the [OSCURATO:PERSONA] of Justice in appeal proceedings.

The arguments of the EMA against paragraphs 62 and 64 of the judgment under appeal are therefore inadmissible. 41 It follows from all of those considerations that the first ground of appeal must be dismissed as in part inadmissible and in part unfounded.

The second ground of appeal, alleging infringement of [OSCURATO:PERSONA] 1(2) of [OSCURATO:PERSONA] 2001/83 Arguments of the parties 42 By its second ground of appeal, put forward in the alternative, the EMA disputes paragraphs 60 and 62 of the judgment under appeal.

It submits that the [OSCURATO:PERSONA] relied on an incorrect interpretation of the concept of ‘medicinal product’, as defined in [OSCURATO:PERSONA] 1(2) of Directive 2001/83. [OSCURATO:PERSONA] took the view that Elaprase and Idursulfase-IT are different medicinal products insofar as they do not have the same excipients or the same method of administration.

The concept of medicinal product defined in that provision refers neither to the excipients nor to the method of administration, but focuses on the concept of active substance.

Accordingly, the [OSCURATO:PERSONA] was not entitled to refer to those factors in order to conclude that there were differences between two products. 43 [OSCURATO:PERSONA] disputes that second ground of appeal. 44 [OSCURATO:PERSONA] maintains that the second ground of appeal is well founded.

Findings of the [OSCURATO:PERSONA] 45 In paragraph 60 of the judgment under appeal, the [OSCURATO:PERSONA] held that ‘a medicinal product also contains, in addition to one or more active substances, excipients, which are defined in [OSCURATO:PERSONA] 1(3b) of Directive 2001/83 as “any constituent of a medicinal product other than the active substance and the packaging material” ’ . 46 By its second ground of appeal, the EMA does not put forward any argument specifically to show that paragraph 60 of the judgment under appeal is vitiated by an error of law.

The second ground of appeal is therefore substantially the same as the first ground of appeal, which has been rejected as unfounded.

It must therefore, for the same reasons, be rejected as unfounded. 47 In view of the factual nature of the assessments made by the [OSCURATO:PERSONA] in paragraph 62 of the judgment under appeal, the line of argument directed against that paragraph is inadmissible, as has already been held in paragraph 40 above. 48 It follows that the second ground of appeal is in part inadmissible and in part unfounded and must, in consequence, be rejected. 49 Having regard to all of the foregoing considerations, the appeal must be dismissed in its entirety.

Costs 50 In accordance with the [OSCURATO:PERSONA] 184(2) of the Rules of Procedure of the [OSCURATO:PERSONA], where the appeal is unfounded, the [OSCURATO:PERSONA] is to make a decision as to costs. [OSCURATO:PERSONA] 138(1) of those rules, applicable to appeal proceedings by virtue of [OSCURATO:PERSONA] 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 51 [OSCURATO:PERSONA] 140(1) of the Rules of Procedure, which applies to the procedure on appeal by virtue of [OSCURATO:PERSONA] 184(1) thereof, provides that the [OSCURATO:PERSONA] and institutions which have intervened in the proceedings are to bear their own costs. 52 [OSCURATO:PERSONA] has applied for costs to be awarded against the EMA and the latter has been unsuccessful, it must be ordered to pay the costs. 53 [OSCURATO:PERSONA], intervener at first instance, must bear its own costs.

On those grounds, the [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) hereby:

1. Dismisses the appeal;

2. Orders the [OSCURATO:PERSONA] (EMA) to bear its own costs and to pay the costs incurred by [OSCURATO:PERSONA];

3. Orders the [OSCURATO:PERSONA] to bear its own costs. [OSCURATO:PERSONA] in open court in Luxembourg on 29 July 2019.

A. [OSCURATO:PERSONA]

F. [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] * Language of the case: English.

Anonimizzato ex art. 52 D.Lgs. 196/2003
[OSCURATO:PERSONA] ([OSCURATO:PERSONA]) 29 July 2019 ( * ) (Appeal — [OSCURATO:PERSONA] (EC) No 141/2000 — [OSCURATO:PERSONA] medicinal products — [OSCURATO:PERSONA] 5 — Application for designation of a medicinal product as an ‘orphan medicinal product’ — Validation — Existence of a prior marketing authorisation (MA) for the same medicinal product) [OSCURATO:PERSONA] C‑359/18 P APPEAL under [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 1 June 2018, [OSCURATO:PERSONA] (EMA), represented initially by S. Marino, S. Drosos, T. Jabłoński and A. Spina, acting as Agents, and subsequently by S. Marino, S. Drosos and T. Jabłoński, acting as Agents, applicant, the other parties to the proceedings being: [OSCURATO:PERSONA], established in Dublin ([OSCURATO:PERSONA]), represented by G. Castle, Solicitor, D. Anderson QC and M. Birdling, Barrister and by S. Cowlishaw, Solicitor, applicant at first instance, [OSCURATO:PERSONA], represented by K. Petersen and A. Sipos, acting as Agents, intervener at first instance, [OSCURATO:PERSONA] ([OSCURATO:PERSONA]), composed of F. [OSCURATO:PERSONA], [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], J. [OSCURATO:PERSONA] and C.G. [OSCURATO:PERSONA] (Rapporteur), [OSCURATO:PERSONA], [OSCURATO:PERSONA]: E. [OSCURATO:PERSONA], [OSCURATO:PERSONA]: A. [OSCURATO:PERSONA], having regard to the written procedure, having decided, after hearing the [OSCURATO:PERSONA], to proceed to judgment without an Opinion, gives the following [OSCURATO:PERSONA] 1 By its appeal, the [OSCURATO:PERSONA] (EMA) asks the [OSCURATO:PERSONA] to set aside the judgment of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 22 March 2018, [OSCURATO:PERSONA] v EMA (T‑80/16, not published; ‘the judgment under appeal’, EU:T:2018:165), whereby the [OSCURATO:PERSONA] annulled the decision of the EMA of 15 December 2015 to refuse to validate the application submitted by [OSCURATO:PERSONA] (‘[OSCURATO:PERSONA]’) for the designation of Idursulfase-IT as an orphan medicinal product (‘the contested decision’). Legal context [OSCURATO:PERSONA] 141/2000 2 [OSCURATO:PERSONA] (EC) No 141/2000 of the [OSCURATO:PERSONA] and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1), as amended by [OSCURATO:PERSONA] (EC) No 596/2009 of the [OSCURATO:PERSONA] and of the Council of 18 June 2009 (OJ 2009 L 188, p. 14) (‘[OSCURATO:PERSONA] 141/2000’), lays down procedures for the designation of medicinal products as orphan medicinal products and for the marketing authorisation (MA) of such products. 3 Recital 4 of that regulation provides: ‘orphan medicinal products eligible for incentives should be easily and unequivocally identified; it seems most appropriate to achieve this result through the establishment of an open and transparent Community procedure for the designation of potential medicinal products as orphan medicinal products’. 4 [OSCURATO:PERSONA] 3(1) of that regulation is worded as follows: ‘A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (a)      that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in [the [OSCURATO:PERSONA]] when the application is made, or that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in [the [OSCURATO:PERSONA]] and that without incentives it is unlikely that the marketing of the medicinal product in [the [OSCURATO:PERSONA]] would generate sufficient return to justify the necessary investment; and (b)      that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in [the [OSCURATO:PERSONA]] or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.’ 5 [OSCURATO:PERSONA] 5 of [OSCURATO:PERSONA] 141/2000 states: ‘1.      In order to obtain the designation of a medicinal product as an orphan medicinal product, the sponsor shall submit an application to the [EMA] at any stage of the development of the medicinal product before the [MA] is made. 2.      The application shall be accompanied by the following particulars and documents: (a)      name or corporate name and permanent address of the sponsor; (b)      active ingredients of the medicinal product; (c)      proposed therapeutic indication; (d)      justification that the criteria laid down in [OSCURATO:PERSONA] 3(1) are met and a description of the stage of development, including the indications expected. 3.      [OSCURATO:PERSONA] shall, in consultation with the [OSCURATO:PERSONA], the [EMA] and interested parties, draw up detailed guidelines on the required format and content of applications for designation. 4.      The [EMA] shall verify the validity of the application and prepare a summary report to the [OSCURATO:PERSONA]. Where appropriate, it may request the sponsor to supplement the particulars and documents accompanying the application. 5.      The [EMA] shall ensure that an opinion is given by the [OSCURATO:PERSONA] within 90 days of the receipt of a valid application. 6.      When preparing its opinion, the [OSCURATO:PERSONA] shall use its best endeavours to reach a consensus. If such a consensus cannot be reached, the opinion shall be adopted by a majority of two-thirds of the members of the [OSCURATO:PERSONA]. The opinion may be obtained by written procedure. 7.      Where the opinion of the [OSCURATO:PERSONA] is that the application does not satisfy the criteria set out in [OSCURATO:PERSONA] 3(1), the [EMA] shall forthwith inform the sponsor. Within 90 days of receipt of the opinion, the sponsor may submit detailed grounds for appeal, which the [EMA] shall refer to the [OSCURATO:PERSONA]. [OSCURATO:PERSONA] shall consider whether its opinion should be revised at the following meeting. …’ 6 [OSCURATO:PERSONA] 8 of that regulation sets out the conditions under which an MA may be granted to a medicinal product similar to an orphan medicinal product and states that the [OSCURATO:PERSONA] is to determine, by means of an implementing regulation, the definition of a ‘similar medicinal product’. [OSCURATO:PERSONA] (EC) No 847/2000 7 [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ (OJ 2000 L 103, p. 5) provides. ‘For the purposes of the implementation of [OSCURATO:PERSONA] 3 of [OSCURATO:PERSONA] (EC) No 141/2000 on orphan medicinal products, the following definition shall apply: –        “significant benefit” means a clinically relevant advantage or a major contribution to patient care.’ Directive 2001/83 8 [OSCURATO:PERSONA] 1(2) and 3a of Directive 2001/83/EC of the [OSCURATO:PERSONA] 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), as amended by Directive 2011/62/UE of the [OSCURATO:PERSONA] and of the Council of 8 June 2011 (OJ 2011 L 174, p. 74) (‘Directive 2001/83’), define the concepts of ‘medicinal product’ and ‘active substance’ as follows: ‘2.      [OSCURATO:PERSONA] product: (a)      Any substance or combination of substances presented for treating or preventing disease in human beings; or (b)      Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. … 3a.      Active substance: Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.’ Background to the dispute and the contested decision 9 It is apparent from paragraph 9 of the judgment under appeal that the main reason for the EMA’s adoption of the contested decision was that [OSCURATO:PERSONA]’s application for the designation of Idursulfase-IT, the active substance of which is idursulfase, as an orphan medicinal product for the treatment of [OSCURATO:PERSONA] syndrome, did not comply with [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000. 10 The EMA stated that the active substance idursulfase obtained designation as an orphan medicinal product for the treatment of [OSCURATO:PERSONA] in 2001, and that an MA as an orphan medicinal product for Elaprase, containing that active substance, had been issued in January 2007 for the treatment of patients suffering from [OSCURATO:PERSONA]. The procedure before the [OSCURATO:PERSONA] and the judgment under appeal 11 By an application lodged at the Registry of the [OSCURATO:PERSONA] on 23 February 2016, [OSCURATO:PERSONA] brought an action seeking the annulment of the contested decision. 12 In support of its appeal, [OSCURATO:PERSONA] relied on a single plea in law, claiming infringement of [OSCURATO:PERSONA] 141/2000. 13 By the judgment under appeal, the [OSCURATO:PERSONA] upheld that plea in law and annulled the contested decision. Forms of order sought by the parties before the [OSCURATO:PERSONA] 14 The EMA claims that the [OSCURATO:PERSONA] should: –        set aside the judgment under appeal; –        dismiss the action for annulment as being unfounded, and –        order [OSCURATO:PERSONA] to pay the cost of proceedings, including those incurred in the procedure before the [OSCURATO:PERSONA]. 15 [OSCURATO:PERSONA] contends that the [OSCURATO:PERSONA] should: –        dismiss the appeal; and –        order the EMA to pay the costs. 16 [OSCURATO:PERSONA] claims that the judgment under appeal should be set aside, the action for annulment should be dismissed and [OSCURATO:PERSONA] ordered to pay the costs. The appeal The first ground of appeal, alleging infringement of [OSCURATO:PERSONA] 5 of [OSCURATO:PERSONA] 141/2000 Arguments of the parties 17 By the first part of its first ground of appeal, the EMA claims that the [OSCURATO:PERSONA], in paragraph 51 of the judgment under appeal, erred in law by interpreting separately rather than together [OSCURATO:PERSONA] 5(1) and (2) of [OSCURATO:PERSONA] 141/2000. That error of law undermines the effectiveness of the provision. 18 The EMA considers that [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000 places on it an obligation to check whether an application for designation as an orphan medicinal product is already covered by an earlier application for an MA. [OSCURATO:PERSONA] 5(2) of that regulation sets out a list of documents to be submitted for that purpose. The aim of that provision is to enable the EMA Secretariat to verify that the application for designation contains sufficient information for its scientific assessment by the [OSCURATO:PERSONA] for [OSCURATO:PERSONA] (‘COMP’) on the basis of easily applied criteria. 19 That interpretation is supported by recital 4 of [OSCURATO:PERSONA] 141/2000 which states that ‘orphan products eligible for incentives should be easily and unequivocally identified’. The purpose of the term ‘eligible for’ is to determine whether a medicinal product can obtain orphan designation. That designation is reserved for medicinal products which have not been the subject of a previous MA application. It is essential that the EMA Secretariat is guided by an exhaustively defined set of simple and unequivocal criteria. Such criteria are those set out in [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000. 20 The interpretation adopted by the [OSCURATO:PERSONA] is problematic having regard to the above. In order to circumvent [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000, it would be sufficient for a company to allege inconsequential differences between the product included in the application for designation and a medicinal product for which an MA application had previously been lodged. 21 The EMA claims that the [OSCURATO:PERSONA] erred in appearing to accept, in paragraphs 62 and 64 of the judgment under appeal, that the excipients and the method of administration should be taken into account when examining the risk of an overlap with [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000. According to the EMA, the [OSCURATO:PERSONA] interpretation would lead to such differences making it possible to validate an application for designation as an orphan medicinal product. The EMA Secretariat cannot be expected to check whether medicinal products are to be considered to be identical on the basis of criteria that are not laid down in EU legislation. 22 By the second part of its first ground of appeal, the EMA claims that the [OSCURATO:PERSONA] erred in law, in paragraphs 58 and 64 of the judgment under appeal, by taking the concept of a ‘medicinal product’ defined in [OSCURATO:PERSONA] 1(2) of Directive 2001/83 as the relevant test in order to determine whether there is any overlap between an application for designation as an orphan medicinal product and a previous MA application. That interpretation is contrary to [OSCURATO:PERSONA] 5(1) and (2) of [OSCURATO:PERSONA] 141/2000, from which, read together, it is clear that the relevant criteria for assessing whether an application for designation impinges on a previous MA application are the name of the sponsor, the active substance and the proposed therapeutic indication. 23 The concept of ‘medicinal product’, defined in [OSCURATO:PERSONA] 1(2) of Directive 2001/83, serves to determine which products fall within the scope of that directive. The validation procedure that is the subject of [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000 has a different objective, namely to determine whether there is an overlap between an application for designation of an orphan medicinal product and a previous MA application. It is not therefore appropriate to refer to the definition of the concept of ‘medicinal product’, derived from Directive 2001/83, but to define the concept of ‘sameness’ by referring to the legal instruments to which that concept is relevant. 24 According to the EMA, it is important not to conflate the notions of ‘sameness’ and ‘similarity’ of medicinal products. Whereas the former is used in the context of the validation procedure laid down in [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000, and must meet the criteria of [OSCURATO:PERSONA] 5(2) of that regulation, the latter is used for the purposes of [OSCURATO:PERSONA] 8 of that regulation and was defined by [OSCURATO:PERSONA] 847/2000. 25 [OSCURATO:PERSONA] disputes those arguments. 26 [OSCURATO:PERSONA] maintains that the first ground of appeal is well founded. Findings of the [OSCURATO:PERSONA] 27 In order to give a ruling on both parts of the first ground of appeal, it must be recalled that, when an application for the designation of a medicinal product as an orphan medicinal product is submitted to it, the EMA is required to verify its validity, under [OSCURATO:PERSONA] 5(4) of [OSCURATO:PERSONA] 141/2000. That verification concerns compliance with the conditions laid down in [OSCURATO:PERSONA] 5(1) and (2) of that regulation. 28 [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000, an application for designation of a medicinal product as an orphan medicinal product must be submitted to the EMA ‘before the [MA application] is made’ for the same medicinal product. It is therefore precluded that a medicinal product for which an MA application has previously been lodged can be the subject of an application for designation as an orphan medicinal product. 29 [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000 requires two categories of information to be supplied in support of the application for designation. The first of these, under subparagraphs (a) to (c) of that provision, relates to the name of the sponsor, the active ingredient of the medicinal product and the proposed therapeutic indication. It thus makes it possible to identify the essential characteristics of the medicinal product in question in order, in particular, to enable the EMA to ensure that that medicinal product has not already been the subject of an application for an MA. 30 The purpose of the second category of information referred to in [OSCURATO:PERSONA] 5(2)(d) of [OSCURATO:PERSONA] 141/2000 is to establish that the designation criteria in [OSCURATO:PERSONA] 3(1) of that regulation are met. In that regard, that provision requires that the medicinal product for which designation is sought is intended for the diagnosis, prevention or treatment of a condition considered to be orphan and for which there is no satisfactory method already authorised in the [OSCURATO:PERSONA] or, if there is such a method, that the medicinal product will be of significant benefit to those affected by that condition. 31 It is thus apparent from a combined reading of [OSCURATO:PERSONA] 3(1) and [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000 that if, for a given therapeutic indication, there is already a medicinal product for which an MA has been issued, the sponsor seeking orphan designation for a further medicinal product in respect of that therapeutic indication must establish that the latter will be of significant benefit to patients in relation to the former medicinal product. Furthermore, in the light of [OSCURATO:PERSONA] 5(1) of [OSCURATO:PERSONA] 141/2000, it is also for the sponsor in such a situation to show that the second medicinal product is not identical to the first medicinal product. In the case of the same medicinal product, the consequence of the rule laid down in [OSCURATO:PERSONA] 5(1) of that regulation would be to invalidate the application for designation of that medicinal product as an orphan due to the fact that it already has a marketing authorisation. 32 By its first ground of appeal, the EMA submits that it follows from a combined reading of [OSCURATO:PERSONA] 5(1), (2) and (4) of [OSCURATO:PERSONA] 141/2000 that, when examining the validity of an application for designation, those provisions require it to ascertain whether the medicinal product in question is identical to a medicinal product already authorised by taking into consideration the active ingredients and therapeutic indications of those medicinal products, to the exclusion of all other factors. The EMA submits that those criteria are the only criteria set out in [OSCURATO:PERSONA] 5(2)(b) and (c) of that regulation and that, because of their simplicity, they are the only ones that can be taken into consideration at that stage of the designation procedure. 33 However, it should be noted that verification of the criteria in [OSCURATO:PERSONA] 3(1) of [OSCURATO:PERSONA] 141/2000 does not fall within the scope of the EMA’s review of the validity of the application for designation. Pursuant to [OSCURATO:PERSONA] 4 and [OSCURATO:PERSONA] 5(5) to (7) of that regulation, responsibility for that verification lies with the COMP. 34 The rationale for that allocation of powers lies in the technical and scientific nature of the criteria set out in [OSCURATO:PERSONA] 3(1) of that regulation. Those criteria entail complex and nuanced analyses, particularly where it is a question of assessing whether the medicinal product in question provides a significant benefit for patients compared with a medicinal product which has already been authorised. 35 For the same reasons, taking account of the link established between [OSCURATO:PERSONA] 3(1) and [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000, the exclusive competence of the COMP extends to verifying the identity of the medicinal product which is the subject of the application for designation with a medicinal product which has already been authorised, in a situation such as that in the present case. 36 It is true that [OSCURATO:PERSONA] 5(2) of [OSCURATO:PERSONA] 141/2000 mentions only the active ingredients and the therapeutic indications among the matters to be provided in support of an application for designation. However, this cannot lead to the conclusion that, in the situations described in paragraph 31 above, the fact that the medicinal products in question have the same active substance is sufficient for those medicinal products to be considered to be identical and, consequently, to the rejection of the application for designation. 37 As held by the [OSCURATO:PERSONA], in paragraph 58 of the judgment under appeal, the terms ‘medicinal product’ and ‘active substance’ cover two distinct concepts, defined in [OSCURATO:PERSONA] 1 of Directive 2001/83. As the active substance is a component of a medicinal product, it should not be confused with the medicinal product itself. It is therefore necessary to examine all other relevant factors, in addition to the active substance, in order to determine whether those medicinal products are identical. 38 That allocation of powers between the EMA and the COMP is without prejudice to the outcome of the designation procedure. It is not therefore capable of undermining the effectiveness of [OSCURATO:PERSONA] 5(1) of that regulation. 39 [OSCURATO:PERSONA] did not therefore err in law in holding, in paragraph 51 of the judgment under appeal, that: ‘The EMA is required to verify, at this stage of the proceedings, the validity of the application, pursuant to [OSCURATO:PERSONA] 5(4) of [OSCURATO:PERSONA] 141/2000. Thus, it must check, on the one hand, whether the application was submitted at any stage of the development of the medicinal product before the application for marketing authorisation was made, as required by [OSCURATO:PERSONA] 5(1) of that regulation and, on the other, whether the application is accompanied by the information and documents referred to in [OSCURATO:PERSONA] 5(2) of the regulation. Following that verification, the EMA may, where appropriate, request the sponsor to supplement the particulars and documents accompanying the application. If the application complies with the requirements laid down in [OSCURATO:PERSONA] 5(1) and (2) of [OSCURATO:PERSONA] 141/2000, the EMA is obliged to validate and transmit it, next, to the [OSCURATO:PERSONA] on [OSCURATO:PERSONA].’ 40 As regards the criticisms made in the context of the first ground of appeal against paragraphs 62 and 64 of the judgment under appeal, it must be stated that, in paragraph 62 of that judgment, the [OSCURATO:PERSONA] found, on the basis of the file before it, that ‘Elaprase differs from Idursulfase-IT in its composition, method of administration and therapeutic effects’. After examining each of those points in turn in paragraphs 62 to 63 of the judgment under appeal, the [OSCURATO:PERSONA] reiterated, in paragraph 64 of that judgment, that ‘it does not appear, at the validation stage of the … application, that Idursulfase-IT is the same medicinal product as Elaprase.’ Those factual assessments are not subject to review by the [OSCURATO:PERSONA] of Justice in appeal proceedings. The arguments of the EMA against paragraphs 62 and 64 of the judgment under appeal are therefore inadmissible. 41 It follows from all of those considerations that the first ground of appeal must be dismissed as in part inadmissible and in part unfounded. The second ground of appeal, alleging infringement of [OSCURATO:PERSONA] 1(2) of [OSCURATO:PERSONA] 2001/83 Arguments of the parties 42 By its second ground of appeal, put forward in the alternative, the EMA disputes paragraphs 60 and 62 of the judgment under appeal. It submits that the [OSCURATO:PERSONA] relied on an incorrect interpretation of the concept of ‘medicinal product’, as defined in [OSCURATO:PERSONA] 1(2) of Directive 2001/83. [OSCURATO:PERSONA] took the view that Elaprase and Idursulfase-IT are different medicinal products insofar as they do not have the same excipients or the same method of administration. The concept of medicinal product defined in that provision refers neither to the excipients nor to the method of administration, but focuses on the concept of active substance. Accordingly, the [OSCURATO:PERSONA] was not entitled to refer to those factors in order to conclude that there were differences between two products. 43 [OSCURATO:PERSONA] disputes that second ground of appeal. 44 [OSCURATO:PERSONA] maintains that the second ground of appeal is well founded. Findings of the [OSCURATO:PERSONA] 45 In paragraph 60 of the judgment under appeal, the [OSCURATO:PERSONA] held that ‘a medicinal product also contains, in addition to one or more active substances, excipients, which are defined in [OSCURATO:PERSONA] 1(3b) of Directive 2001/83 as “any constituent of a medicinal product other than the active substance and the packaging material” ’ . 46 By its second ground of appeal, the EMA does not put forward any argument specifically to show that paragraph 60 of the judgment under appeal is vitiated by an error of law. The second ground of appeal is therefore substantially the same as the first ground of appeal, which has been rejected as unfounded. It must therefore, for the same reasons, be rejected as unfounded. 47 In view of the factual nature of the assessments made by the [OSCURATO:PERSONA] in paragraph 62 of the judgment under appeal, the line of argument directed against that paragraph is inadmissible, as has already been held in paragraph 40 above. 48 It follows that the second ground of appeal is in part inadmissible and in part unfounded and must, in consequence, be rejected. 49 Having regard to all of the foregoing considerations, the appeal must be dismissed in its entirety. Costs 50 In accordance with the [OSCURATO:PERSONA] 184(2) of the Rules of Procedure of the [OSCURATO:PERSONA], where the appeal is unfounded, the [OSCURATO:PERSONA] is to make a decision as to costs. [OSCURATO:PERSONA] 138(1) of those rules, applicable to appeal proceedings by virtue of [OSCURATO:PERSONA] 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 51 [OSCURATO:PERSONA] 140(1) of the Rules of Procedure, which applies to the procedure on appeal by virtue of [OSCURATO:PERSONA] 184(1) thereof, provides that the [OSCURATO:PERSONA] and institutions which have intervened in the proceedings are to bear their own costs. 52 [OSCURATO:PERSONA] has applied for costs to be awarded against the EMA and the latter has been unsuccessful, it must be ordered to pay the costs. 53 [OSCURATO:PERSONA], intervener at first instance, must bear its own costs. On those grounds, the [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) hereby: 1. Dismisses the appeal; 2. Orders the [OSCURATO:PERSONA] (EMA) to bear its own costs and to pay the costs incurred by [OSCURATO:PERSONA]; 3. Orders the [OSCURATO:PERSONA] to bear its own costs. [OSCURATO:PERSONA] in open court in Luxembourg on 29 July 2019. A. [OSCURATO:PERSONA] F. [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] * Language of the case: English.
Sentenza Corte di giustizia UE n. 141/2019 — Fons Iuris — Fons Iuris