Pharmaceutical Works Polpharma S.A. v European Medicines Agency.

• Jurisdiction: European Union
• ECLI: ECLI:EU:T:2021:241
• Date: 05 May 2021
• Celex Number: 62018TJ0611
• Court: General Court (European Union)
• Docket Number: T-611/18

JUDGMENT OF THE GENERAL COURT (Seventh Chamber, Extended Composition)

5 May 2021 ( *1 )

(Medicinal products for human use – Application for marketing authorisation for a generic version of the medicinal product Tecfidera – Decision of the EMA not to validate the application for marketing authorisation – Previous decision of the Commission taking the view that Tecfidera – Dimethyl fumarate was not covered by the same global marketing authorisation as Fumaderm – Plea of illegality – Admissibility – Previously authorised combination medicinal product – Subsequent marketing authorisation for a component of the combination medicinal product – Assessment of the existence of two different global marketing authorisations – Manifest error of assessment)

In Case T‑611/18,

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

applicant,

v

European Medicines Agency (EMA), represented by T. Jabłoński, S. Drosos and R. Pita, acting as Agents,

defendant,

supported by

European Commission, represented by A. Sipos and L. Haasbeek, acting as Agents,

and by

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

interveners,

APPLICATION, first, for a declaration that the plea of illegality raised in respect of Commission Implementing Decision C(2014) 601 final of 30 January 2014 granting marketing authorisation for Tecfidera – Dimethyl fumarate, a medicinal product for human use, is admissible and well founded in so far as, in that implementing decision, the Commission considers that Tecfidera – Dimethyl fumarate is not covered by the same global marketing authorisation as Fumaderm, and, second, based on Article 263 TFEU seeking annulment of the decision of the EMA of 30 July 2018 not to validate the application submitted by the applicant with a view to obtaining a marketing authorisation for a generic version of the medicinal product Tecfidera,

THE GENERAL COURT (Seventh Chamber, Extended Composition),

composed of R. da Silva Passos (Rapporteur), President, V. Valančius, I. Reine, L. Truchot and M. Sampol Pucurull, Judges,

Registrar: S. Spyropoulos, Administrator,

having regard to the written part of the procedure and further to the hearing on 13 July 2020,

gives the following

Judgment

I. Background to the dispute

1 The applicant, Pharmaceutical Works Polpharma S.A., is a pharmaceutical company that develops and markets various medicinal products, including generic medicinal products.

2 On 9 August 1994, the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices; ‘the BfArM’) granted Fumapharm AG two marketing authorisations concerning two strengths of a medicinal product known as ‘Fumaderm’. Fumaderm contains dimethyl fumarate (‘DMF’) and various monoethyl fumarate (‘MEF’) salts. First, Fumaderm prae, or Fumaderm initial, is intended to be used during a three-week initial phase to improve tolerance to treatment. It is available as tablets containing, inter alia, 30 mg of DMF, 67 mg of calcium MEF salt, 5 mg of magnesium MEF salt and 3 mg of zinc MEF salt. Second, Fumaderm is intended to be used at the end of the initial phase and is available as tablets containing, inter alia, 120 mg of DMF, 87 mg of calcium MEF salt, 5 mg of magnesium MEF salt and 3 mg of zinc MEF salt. Fumaderm is indicated for the treatment of psoriasis.

3 Those two marketing authorisations were successively transferred to Almirall Hermal GmbH, to Fumedica AG, and, finally, to Biogen Idec. In addition, in October 2003, Fumapharm granted Biogen Idec an exclusive licence to develop and market products containing DMF, then, in 2006, Biogen Idec acquired Fumapharm.

4 On 8 June 2011, Biogen Idec Ltd lodged with the European Medicines Agency (EMA) a request for eligibility for the grant of a marketing authorisation under the centralised procedure at EU level in accordance with Article 3(2)(b) 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). Article 3(2)(b) of Regulation No 726/2004 provides: ‘Any medicinal product not appearing in the Annex [to Regulation No 726/2004] may be granted a marketing authorisation by the [Union] in accordance with the provisions of [that] Regulation, if … the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with [that] Regulation is in the interests of patients or animal health at [Union] level.’

5 The request referred to in paragraph 4 above concerned a product containing DMF and intended for the treatment of multiple sclerosis. In the letter that accompanied that request, Biogen Idec set out the following information. First, it stated that DMF was an active substance which had not previously been approved or assessed as a mono-substance, namely as a single component of a medicinal product, for any indication. Second, it stated that it intended to submit a ‘full’ application for marketing authorisation, that is to say, an application accompanied by all the data referred to in Article 8(3) 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) and, in particular, the results of pre-clinical tests and clinical trials. Third, it stated that it was the holder of the marketing authorisation granted to Fumapharm in 1994 for Fumaderm, which contained DMF and MEF salts (see paragraph 2 above).

6 In those circumstances, first, Biogen Idec requested confirmation that the product for which it sought a marketing authorisation and which contained DMF did not fall within the scope of the global marketing authorisation for Fumaderm within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83.

7 Article 6(1) of Directive 2001/83 provides: ‘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 … 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).’

8 Article 10(1) of Directive 2001/83 provides: ‘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 first subparagraph shall also apply if the reference medicinal product was not authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application form the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month, a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference product and if necessary other relevant documentation. 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.’

9 Second, and in the light of the foregoing, Biogen Idec, on 8 June 2011, also requested the EMA to confirm that, if it was approved on the basis of a full application, the product for which it sought a marketing authorisation would benefit from the data-protection period provided for in Article 14(11) of Regulation No 726/2004, irrespective of whether or not the active substance it contained, DMF, was classified as a ‘new active substance’.

10 Article 14(11) of Regulation No 726/2004 provides: ‘Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data protection and a ten-year period of marketing protection, in...