European Commission and Biogen Netherlands BV v European Medicines Agency.

• Jurisdiction: European Union
• Court: Court of Justice (European Union)
• ECLI: ECLI:EU:C:2023:213
• Docket Number: C-438/21,C-439/21
• Celex Number: 62021CJ0438
• Date: 16 March 2023

JUDGMENT OF THE COURT (Fourth Chamber)

16 March 2023 ( *1 )

(Appeal – Public health – Medicinal products for human use – Directive 2001/83/EC – Regulation (EC) No 726/2004 – Application for marketing authorisation for a generic version of the medicinal product Tecfidera – Decision of the European Medicines Agency (EMA) not to validate the application for marketing authorisation – Earlier European Commission decision taking the view that Tecfidera was not covered by the same global marketing authorisation as Fumaderm – Previously authorised combination medicinal product – Subsequent marketing authorisation for a component of the combination medicinal product – Assessment of the existence of a global marketing authorisation)

In Joined Cases C‑438/21 P to C‑440/21 P,

THREE APPEALS under Article 56 of the Statute of the Court of Justice of the European Union, brought on 14 July 2021 (C‑438/21 P and C‑439/21 P) and 15 July 2021 (C‑440/21 P),

European Commission, represented initially by S. Bourgois, L. Haasbeek and A. Sipos, and subsequently by L. Haasbeek and A. Sipos, acting as Agents,

appellant,

the other parties to the proceedings being:

Pharmaceutical Works Polpharma S.A., established in Starogard Gdański (Poland), represented by N. Carbonnelle, avocat, S. Faircliffe, Solicitor, and M. Martens, advocaat,

applicant at first instance,

European Medicines Agency (EMA), represented by S. Drosos, H. Kerr and S. Marino, acting as Agents,

defendant at first instance,

Biogen Netherlands BV, established in Badhoevedorp (Netherlands), represented by C. Schoonderbeek, advocaat,

intervener at first instance (C‑438/21 P),

and

Biogen Netherlands BV, established in Badhoevedorp, represented by C. Schoonderbeek, advocaat,

appellant,

the other parties to the proceedings being:

Pharmaceutical Works Polpharma S.A., established in Starogard Gdański, represented by N. Carbonnelle, avocat, S. Faircliffe, Solicitor, and M. Martens, advocaat,

applicant at first instance,

European Medicines Agency (EMA), represented by S. Drosos and S. Marino, acting as Agents,

defendant at first instance,

European Commission, represented initially by S. Bourgois, L. Haasbeek and A. Sipos, and subsequently by L. Haasbeek and A. Sipos, acting as Agents,

intervener at first instance (C‑439/21 P),

and

European Medicines Agency (EMA), represented by S. Drosos, H. Kerr and S. Marino, acting as Agents,

appellant,

the other parties to the proceedings being:

Pharmaceutical Works Polpharma S.A., established in Starogard Gdański, represented by N. Carbonnelle, avocat, S. Faircliffe, Solicitor, and M. Martens, advocaat,

applicant at first instance,

European Commission, represented initially by S. Bourgois, L. Haasbeek and A. Sipos, and subsequently by L. Haasbeek and A. Sipos, acting as Agents,

Biogen Netherlands BV, established in Badhoevedorp, represented by C. Schoonderbeek, advocaat,

interveners at first instance (C‑440/21 P),

THE COURT (Fourth Chamber),

composed of C. Lycourgos, President of the Chamber, L.S. Rossi, J.‑C. Bonichot, S. Rodin and O. Spineanu-Matei (Rapporteur), Judges,

Advocate General: L. Medina,

Registrar: R. Stefanova-Kamisheva, Administrator,

having regard to the written procedure and further to the hearing on 30 June 2022,

after hearing the Opinion of the Advocate General at the sitting on 6 October 2022,

gives the following

Judgment

1 By their respective appeals, the European Commission (C‑438/21 P), Biogen Netherlands BV (‘Biogen’) (C‑439/21 P) and the European Medicines Agency (EMA) (C‑440/21 P) seek to have set aside the judgment of the General Court of the European Union of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241; ‘the judgment under appeal’), by which the General Court annulled the EMA’s decision of 30 July 2018 not to validate the application submitted by Pharmaceutical Works Polpharma S.A. (‘Polpharma’) with a view to obtaining a marketing authorisation for a generic version of the medicinal product Tecfidera (‘the decision at issue’).

Legal context

Directive 2001/83/EC

2 Recitals 9 and 12 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), as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (OJ 2012 L 299, p. 1) (‘Directive 2001/83’), state: ‘(9) Experience has shown that it is advisable to stipulate more precisely the cases in which the results of toxicological and pharmacological tests or clinical trials do not have to be provided with a view to obtaining authorisation for a medicinal product which is essentially similar to an authorised product, while ensuring that innovative firms are not placed at a disadvantage. … (12) With the exception of those medicinal products which are subject to the centralised Community authorisation procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products [(OJ 1993 L 214, p. 1)] a marketing authorisation for a medicinal product granted by a competent authority in one Member State ought to be recognised by the competent authorities of the other Member States unless there are serious grounds for supposing that the authorisation of the medicinal product concerned may present a risk to public health. In the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken according to a Community standard, leading to a single decision on the area of disagreement binding on the Member States concerned. [That] decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States.’

3 Article 1 of Directive 2001/83 provides: ‘For the purposes of this Directive, the following terms shall bear the following meanings: … 2. Medicinal product: (a) Any substance or combination of substances presented as having properties 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. …’

4 Article 6(1) of Directive 2001/83 provides as follows: ‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with 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)] … When a medicinal product has been granted an initial marketing authorisation in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1).’

5 Article 10(1) and (2) of that directive provides: ‘1. By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the [European Union]. A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. … The ten-year period referred to in the second subparagraph shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies. 2. For the purposes of this Article: (a) “reference medicinal product” shall mean a medicinal product authorised under Article 6, in accordance with the provisions of Article 8; (b) “generic medicinal product” shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with...