ORDER OF THE GENERAL COURT (Fourth Chamber)
7 February 2024 (*)
(Action for annulment – Medicinal products for human use – Marketing authorisation for the medicinal product Dimethyl fumarate Mylan – dimethyl fumarate – Letter of the Commission drawing conclusions from a judgment of the Court of Justice – Measure not actionable – Inadmissibility – Hypothetical acts – Manifest inadmissibility)
In Case T‑227/23,
Mylan Ireland Ltd, established in Dublin (Ireland), represented by K. Roox, T. De Meese, J. Stuyck, M. Van Nieuwenborgh and C. Dumont, lawyers,
applicant,
v
European Commission, represented by C. Valero and E. Mathieu, acting as Agents,
defendant,
THE GENERAL COURT (Fourth Chamber),
composed of R. da Silva Passos (Rapporteur), President, I. Reine and T. Pynnä, Judges,
Registrar: V. Di Bucci,
having regard to the written part of the procedure,
having regard to the order of 19 July 2023, Mylan Ireland v Commission (T‑227/23 R, not published, EU:T:2023:408),
makes the following
Order
1 By its action under Article 263 TFEU, the applicant, Mylan Ireland Ltd, seeks the annulment of the decision contained in the letter of the European Commission of 17 March 2023, with reference SANTE.DDG1.B.5/AL/mmc (2023) 2914698, concerning the interpretation and the consequences of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213) (‘the contested measure’).
Background to the dispute
2 The applicant is a pharmaceutical company that develops and markets various medicinal products, including generic medicinal products.
3 On 9 August 1994, the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices) granted Fumapharm AG two marketing authorisations concerning two strengths of a medicinal product, Fumaderm, indicated for the treatment of psoriasis. Fumaderm was authorised as a fixed combination medicinal product of dimethyl fumarate (‘DMF’) and various monoethyl fumarate salts. In accordance with Article 10(1) of 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), the regulatory data protection period of Fumaderm expired in 2004. Those marketing authorisations were ultimately transferred to Biogen Idec Ltd.
4 On 28 February 2012, Biogen Idec, pursuant to Article 4(1) of 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) submitted to the European Medicines Agency (EMA) an application for a marketing authorisation for the medicinal product for human use Tecfidera – dimethyl fumarate (‘Tecfidera’).
5 On 30 January 2014, the Commission adopted Implementing Decision C(2014) 601 final (‘the implementing decision of 30 January 2014’) granting a marketing authorisation for Tecfidera under Regulation No 726/2004. A summary of that implementing decision was published in the Official Journal of the European Union (OJ 2014 C 59, p. 1).
6 By that decision, Tecfidera was authorised as a mono-substance medicinal product, composed of DMF, and indicated for the treatment of multiple sclerosis. In the implementing decision of 30 January 2014, the Commission also decided that Tecfidera did not belong to the same global marketing authorisation as Fumaderm, within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83.
7 On 27 November 2017, Pharmaceutical Works Polpharma S.A. submitted a request to the EMA for confirmation that it was eligible to submit an application for a marketing authorisation under the centralised procedure in accordance with Article 3(3) of Regulation No 726/2004 for a generic medicinal product known as Dimethyl Fumarate Pharmaceutical Works Polpharma, derived from the reference medicinal product Tecfidera.
8 By decision of 30 July 2018 (‘the EMA decision of 30 July 2018’), the EMA informed Pharmaceutical Works Polpharma that it was unable to validate its application of 27 November 2017, referred to in paragraph 7 above. The EMA inter alia stated that, according to recital 3 of the implementing decision of 30 January 2014, Tecfidera and the already authorised medicinal product Fumaderm did not belong to the same global marketing authorisation within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83, on the ground that monoethyl fumarate and DMF were both active and did not correspond to the same active substance since the therapeutic moiety was not the same in each of those medicinal products. Consequently, the EMA took the view that Tecfidera benefited from its own eight-year regulatory data protection period and that that protection period had not yet expired.
9 By application lodged at the General Court Registry on 9 October 2018, Pharmaceutical Works Polpharma brought an action for annulment against the EMA decision of 30 July 2018. Pharmaceutical Works Polpharma asked the Court, first, for a declaration that the plea of illegality under Article 277 TFEU raised in respect of the implementing decision of 30 January 2014 was admissible and well founded, in so far as, in that implementing decision, the Commission found that Tecfidera was not covered by the same global marketing authorisation as Fumaderm and, secondly, for the annulment of the EMA decision of 30 July 2018.
10 By judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the Court upheld the plea of illegality raised by Pharmaceutical Works Polpharma and declared the implementing decision of 30 January 2014 inapplicable. Consequently, the EMA decision of 30 July 2018, which was based on the implementing decision of 30 January 2014, was unfounded and was annulled.
11 The Commission, Biogen Netherlands BV and the EMA each brought an appeal against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), registered as Cases C‑438/21 P, C‑439/21 P and C‑440/21 P, respectively.
12 By implementing decision of 13 May 2022, the Commission granted a marketing authorisation to the applicant for the medicinal product for human use Dimethyl fumarate Mylan – dimethyl fumarate (‘DMF Mylan’).
13 By application lodged at the General Court Registry on 17 May 2022, Biogen Netherlands brought an action for annulment against the Commission implementing decision of 13 May 2022, granting a marketing authorisation to the applicant for DMF Mylan. That action is currently pending before the Court (Case T‑279/22).
14 By judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), the Court of Justice set aside the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241). Ruling subsequently on the action at first instance, the Court of Justice rejected the single plea in law alleging illegality of the implementing decision of 30 January 2014 and, therefore, dismissed the action.
Forms of order sought
15 The applicant claims that the Court should:
– annul the contested measure, as well as any later decisions to the extent that they perpetuate and/or replace that measure, including any follow-up regulatory actions, in so far as they relate to the applicant;
– order the Commission to pay the costs of the proceedings.
16 The Commission contends that the Court should:
– dismiss the action as inadmissible;
– order the applicant to pay the costs.
Law
The applications for annulment
The admissibility of the action in so far as it is directed against the contested measure
17 Under Article 130(1) and (7) of the Rules of Procedure of the General Court, if the defendant so requests, the Court may give a decision on inadmissibility or lack of competence without going to the substance of the case. In the present case, since the Commission has requested a ruling that the action is inadmissible, the Court, taking the view that it has sufficient information from the material in the case file, has decided to give a ruling on that request.
18 In support of its objection of inadmissibility, the Commission raises a single plea of inadmissibility, alleging that the contested measure is not a challengeable act for the purposes of Article 263 TFEU, in so far as, having regard to its substance and to the powers of the Commission in that field, that measure is not binding and cannot affect the applicant’s legal position.
19 In support of the plea of inadmissibility that it raises, the Commission relies on five arguments. First, it argues that the substance of the contested measure shows that it is not legally binding and cannot therefore affect the applicant’s legal position. Secondly, the Commission claims that the context and the powers of the Commission to adopt measures in the medicinal products field confirm that the contested measure is not legally binding. Thirdly, it contends that the legally binding nature of a measure depends on the content of that measure and not on its author. The Commission therefore takes the view that the applicant’s argument that the contested measure is capable of producing legal effects because of its author’s power to grant marketing authorisations for medicinal products is ineffective, since the fact that the Commission is the authority in charge of granting marketing authorisations and is empowered by the co-legislators to adopt legally binding measures for that purpose does not mean that any document sent by the Commission to authorisation holders is a legally binding and challengeable act under Article 263 TFEU. Fourthly, the Commission also regards as ineffective the applicant’s claim that the contested measure has already produced legal effects, in the light, in particular, of the position the German authorities have adopted following the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), since such positions do not arise from the contested measure. Fifthly, the Commission maintains that there is no causal link between the opinion it provided in the contested measure concerning the consequences of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), and the fact that it may adopt legally binding measures following that judgment.
20 The applicant takes the view, by contrast, that the specific circumstances of the present case confer on the contested measure the nature of a challengeable act.
21 First, the applicant claims that the contested measure establishes unequivocally and definitively the position of the Commission concerning the consequences of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), and that it adversely affects its legal position by restricting its rights. It submits that, by its substance and since it is a letter from the Commission, the contested measure is capable of producing legal effects on account of that institution’s powers to grant a marketing authorisation which is emphasised by the fact that the Commission has itself requested a written commitment from the applicant in that regard and has, moreover, threatened to take follow-up regulatory actions, thus imposing on the applicant a de facto withdrawal or a revocation of the marketing authorisation for DMF Mylan.
22 Secondly, the applicant submits that the contested measure is an independent stand-alone decision and is therefore not a preparatory adoptive measure of a future revocation decision of the marketing authorisation for DMF Mylan, inasmuch as its aim was to implement the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), and, rather than revoking that marketing authorisation, to lead to a forced withdrawal from the market of the medicinal product produced by the applicant.
23 Thirdly, the applicant is of the opinion that recent actions by national authorities, in particular the Italian and German authorities, which a short time ago took similar steps to that of the Commission in the contested measure, confirm the binding nature of that measure.
24 In that regard, it is settled case-law that only measures the legal effects of which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in its legal position are acts or decisions which may be the subject of an action for annulment (see order of 14 May 2012, Sepracor Pharmaceuticals v Commission, C‑477/11 P, not published, EU:C:2012:292, paragraph 51 and the case-law cited). However, the form in which such acts or decisions are cast is, in principle, immaterial as regards the question whether they are open to challenge (judgment of 11 November 1981, IBM v Commission, 60/81, EU:C:1981:264, paragraph 9).
25 It also follows from well-established case-law that those binding legal effects must be assessed in the light of the substance of the measure in question and in accordance with objective criteria, such as the contents of that measure, taking into account, as appropriate, the context in which it was adopted, and the powers of the institution which adopted the measure (see order of 14 October 2021, Amazon.com and Others v Commission, T‑19/21, EU:T:2021:730, paragraph 17 and the case-law cited).
26 Accordingly, it is not only preparatory acts which fall outside the scope of the judicial review provided for in Article 263 TFEU but any act not producing legal effects which are binding on and capable of affecting the interests of the individual, such as confirmatory measures and implementing measures, mere recommendations and opinions and, in principle, internal instructions (see order of 14 May 2012, Sepracor Pharmaceuticals v Commission, C‑477/11 P, not published, EU:C:2012:292, paragraph 52 and the case-law cited).
27 Moreover, provisional measures intended to pave the way for the final decision do not, in principle, constitute acts which may form the subject matter of an action for annulment. Such provisional acts include, in particular, acts which express a provisional opinion of the institution (see order of 14 May 2012, Sepracor Pharmaceuticals v Commission, C‑477/11 P, not published, EU:C:2012:292, paragraph 55 and the case-law cited).
28 An action for annulment of measures expressing a provisional opinion of the Commission might make it necessary for the EU judicature to arrive at a decision on questions on which the institution concerned has not yet had an opportunity to definitively state its position and would as a result anticipate the arguments on the substance of the case, confusing the different stages of the administrative and judicial procedures. To allow such an action would thus be incompatible with the system of the division of powers between the Commission and the EU judicature and of the remedies laid down by the Treaty, as well as with the requirements of the sound administration of justice and the proper course of the Commission’s administrative procedure (see order of 14 May 2012, Sepracor Pharmaceuticals v Commission, C‑477/11 P, not published, EU:C:2012:292, paragraph 56 and the case-law cited).
29 In that regard, it should be noted that the powers of the Commission concerning the grant and the withdrawal of a marketing authorisation and the procedure concerning the exercise of those powers are set out in Regulation No 726/2004. First, according to Article 81 of that regulation, all decisions to vary, withdraw or revoke a marketing authorisation are to state in detail the reasons on which they are based and may not be taken except through the procedures set out in that regulation. Secondly, Article 10(1) of Regulation No 726/2004 provides that the Commission is required to prepare a draft of the decision to be taken and to forward that draft to the Member States and to the applicant.
30 It is therefore solely by complying with the provisions of Regulation No 726/2004, in particular, Articles 10 and 81 of that regulation, that the Commission may, not only grant, but also vary, suspend, withdraw or revoke a marketing authorisation.
31 In the present case, it is therefore necessary to determine, in the light of the case-law referred to in paragraphs 24 to 28 above, whether, by the contested measure, the Commission adopted a measure the legal effects of which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in its legal position for the purposes of Article 263 TFEU.
32 In that regard, in the first place, it should be noted that, in the contested measure, the Commission took formal note of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213).
33 In the second place, in that measure, the Commission requested the applicant to act in compliance with the duration period of the market protection of the reference medicinal product of DMF Mylan. The Commission requested the applicant to provide it, by 30 March 2023 at the latest, with a written commitment to that effect.
34 In the third place, in the contested measure, the Commission indicated that it reserved the right to take decisions as to any regulatory actions which could be taken on the basis of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213).
35 In the contested measure, the Commission therefore confined itself, first, to requesting the applicant to act in compliance with the duration period of the market protection of the reference medicinal product of DMF Mylan and to provide it, by 30 March 2023 at the latest, with a written commitment to that effect and, secondly, to reserving the right to take decisions as to any regulatory actions which could be taken on the basis of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213).
36 Therefore, in the contested measure, the Commission did not, – and, for that matter, could not, without infringing the provisions of Regulation No 726/2004, in particular, Articles 10 and 81 thereof – vary, suspend, withdraw or revoke the applicant’s marketing authorisation for DMF Mylan, which the applicant, moreover, does not dispute.
37 Furthermore, although the Commission stated in the contested measure that it reserved the right to take any further decision as to any follow-up regulatory actions to be taken following the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), it is not apparent either from the wording or from the content of that measure that the Commission thereby intended to initiate the procedure for the variation, suspension, withdrawal or revocation of the applicant’s marketing authorisation for DMF Mylan.
38 It must therefore be stated that, as, moreover, the applicant accepts, the contested measure cannot be regarded as being a preparatory measure for the purpose of adopting, in the context of the procedure set out in Article 10 of Regulation No 726/2004, a final decision which would vary, suspend, withdraw or revoke the marketing authorisation granted to the applicant for DMF Mylan. Likewise, the Commission also did not draft the contested measure in the context of a special procedure distinct from that set out in Regulation No 726/2004, which the applicant, furthermore, does not claim.
39 On the contrary, as the applicant has noted in its written observations, the Commission informed it of the ongoing procedure seeking to adopt an implementing decision revoking its marketing authorisation for DMF Mylan.
40 Nonetheless, the applicant takes the view that the contested measure is an independent stand-alone decision of the Commission, inasmuch as its aim is to implement the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), and, rather than revoking that marketing authorisation, to lead to a forced withdrawal of the medicinal product which the applicant produces.
41 In that respect, it is sufficient to note that, by the contested measure, the Commission merely sent its interpretation of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213) to the applicant and its opinion on the legal consequences of such a judgment, in particular in so far as it concerned the applicant. Although the Commission requested the applicant, following that judgment, to provide it with a written commitment for the purpose of complying with the duration period of the market protection of the reference medicinal product of DMF Mylan, it also stated that it reserved the right to adopt decisions concerning any regulatory measure which could be taken on the basis of the abovementioned judgment.
42 The content of the contested measure therefore shows that it could at most constitute a provisional indication of the Commission’s intentions regarding the draft decision that it might have submitted to the Member States, in particular following the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), in the context of the procedure, set out in Article 10(2) and in Article 81 of Regulation No 726/2004, for the purpose of adopting a final decision to vary, suspend, withdraw or revoke the applicant’s marketing authorisation for DMF Mylan.
43 It follows that the mere intention expressed by the Commission in the contested measure was not such as to prejudge with certainty the taking of a final decision as regards the applicant’s marketing authorisation for DMF Mylan, to be adopted under Article 10(2) and Article 81 of Regulation No 726/2004.
44 Therefore, the contested measure must be interpreted only as a recommendation or an opinion of the Commission, for the purposes of the case-law referred to in paragraph 26 above, concerning the interpretation and the consequences of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213) (see, to that effect and by analogy, judgment of 23 November 1995, Nutral v Commission, C‑476/93 P, EU:C:1995:401, paragraph 30). At the most, the contested measure could be interpreted as an intermediate measure which expresses a provisional opinion of the Commission, for the purposes of the case-law referred to in paragraph 27 above.
45 In an action for annulment brought under Article 263 TFEU against the decision adopted by the Commission following the procedure, which has in the meantime been initiated (see paragraph 39 above), for revoking the marketing authorisation granted to the applicant for DMF Mylan, the applicant will be able to challenge such a decision and, accordingly, be entitled to effective legal protection in respect of that marketing authorisation.
46 Consequently, it must be concluded that the contested measure does not constitute a measure the legal effects of which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in its legal position for the purposes of Article 263 TFEU.
47 That finding is not affected by the applicant’s claim that recent actions by national authorities, in particular the Italian and German authorities, which a short time ago took similar steps to that of the Commission in the contested measure, confirm the binding nature of that measure.
48 In that regard, as the Commission correctly contends, it is sufficient to note that the contested measure does not require any conduct on the part of national authorities, which are not even referred to in that measure.
49 Such steps on the part of the national authorities do not, accordingly, arise from the contested measure and therefore have no impact on whether that measure constitutes a measure the legal effects of which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in its legal position for the purposes of Article 263 TFEU, a fortiori, as the Commission correctly maintains, because such steps have been taken in respect of a company distinct from the applicant and for a medicinal product which is not produced by the applicant, namely ‘Dimethyl fumarate Hexal’, produced by Hexal AG.
50 It follows from the foregoing assessments that the contested measure is not a measure which produces binding legal effects for the purposes of Article 263 TFEU, with the result that the objection of inadmissibility raised by the Commission must be upheld and that, accordingly, the action must be dismissed as inadmissible in so far as it is directed against the contested measure.
The admissibility of the action in so far as it is directed against decisions taken after the action had been brought
51 Under Article 126 of the Rules of Procedure, where it is clear that the Court has no jurisdiction to hear and determine an action or where an action is manifestly inadmissible or manifestly lacking any foundation in law, the Court may, on a proposal from the Judge-Rapporteur, at any time decide to give a decision by reasoned order without taking further steps in the proceedings. In the present case, the Court, taking the view that it has sufficient information from the material in the case file, has decided to give a decision without taking further steps in the proceedings.
52 The applicant seeks the annulment of any decisions taken after the contested measure to the extent that they perpetuate and/or replace that measure, including any follow-up regulatory actions, in so far as they relate to the applicant.
53 In that regard, it follows from the case-law that such claims, which ask the Court to rule on the lawfulness of hypothetical measures which have not yet been adopted, are inadmissible and must be rejected (see judgment of 29 January 2020, Aquino and Others v Parliament, T‑402/18, EU:T:2020:13, paragraphs 38 and 39 and the case-law cited). Only actions for annulment of an act in existence adversely affecting the applicants may be brought before the Court (judgment of 16 September 2013, Bank Kargoshaei and Others v Council, T‑8/11, not published, EU:T:2013:470, paragraph 47).
54 It follows that the action is manifestly inadmissible in so far as it is directed against any decisions taken after the contested measure to the extent that they perpetuate and/or replace that measure, including any follow-up regulatory actions, in so far as they relate to the applicant.
55 In the light of all of the foregoing considerations, the action must be dismissed.
The request for a measure of organisation of procedure or for a measure of inquiry
56 In its written observations, the applicant asks the Court to order the Commission to produce the communications which the Commission exchanged with the Italian and German national authorities concerning the consequences of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213).
57 In that regard, it must be borne in mind that Article 90 of the Rules of Procedure provides that measures of organisation of procedure are to be prescribed by the Court. Furthermore, it is apparent from Article 92(1) of the Rules of Procedure that the Court has exclusive jurisdiction to assess the usefulness of measures of inquiry for the purpose of resolving the dispute (judgment of 10 July 2012, Interspeed v Commission, T‑587/10, not published, EU:T:2012:355, paragraph 81).
58 In the present case, since the present dispute may be resolved on the basis of the material in the case file, the measure of inquiry sought by the applicant is irrelevant for the resolution of the dispute. Accordingly, that request must be refused.
Costs
59 Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. As the applicant has been unsuccessful, it must be ordered to pay the costs, including the costs relating to the interim proceedings, in accordance with the form of order sought by the Commission.
On those grounds,
THE GENERAL COURT (Fourth Chamber)
hereby orders:
1. The action is dismissed as inadmissible in so far as it is directed against the decision contained in the letter of the European Commission of 17 March 2023, with reference SANTE.DDG1.B.5/AL/mmc (2023) 2914698, concerning the interpretation and consequences of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213).
2. The action is dismissed as manifestly inadmissible in so far as it is directed against any decisions taken after the decision contained in the letter of the European Commission of 17 March 2023, with reference SANTE.DDG1.B.5/AL/mmc (2023) 2914698, concerning the interpretation and the consequences of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), to the extent that they perpetuate and/or replace that decision, including any follow-up regulatory actions, in so far as they relate to the applicant.
3. Mylan Ireland Ltd shall bear its own costs and pay those incurred by the European Commission, including the costs relating to the interim proceedings.
Luxembourg, 7 February 2024.
V. Di Bucci | | R. da Silva Passos |