CELEX: 62021CN0439
Language: en
Date: 2021-07-14 00:00:00
Title: Case C-439/21 P: Appeal brought on 14 July 2021 by Biogen Netherlands BV against the judgment of the General Court (Seventh Chamber, Extended Composition) delivered on 5 May 2021 in Case T-611/18, Pharmaceutical Works Polpharma v EMA

27.9.2021   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               C 391/13
            
         
      Appeal brought on 14 July 2021 by Biogen Netherlands BV against the judgment of the General Court (Seventh Chamber, Extended Composition) delivered on 5 May 2021 in Case T-611/18, Pharmaceutical Works Polpharma v EMA
      (Case C-439/21 P)
      (2021/C 391/19)
      Language of the case: English
      
         Parties
      
      
         Appellant: Biogen Netherlands BV (represented by: C. Schoonderbeek, advocaat)
      
         Other parties to the proceedings: Pharmaceutical Works Polpharma S.A., European Medicines Agency, European Commission
      
         Form of order sought
      
      The Appellant claims that the Court should:
      
                  —
               
               
                  grant the appeal;
               
            
                  —
               
               
                  set aside the judgment under the appeal.
               
            
         Pleas in law and main arguments
      
      First ground of appeal: the General Court misapplied Article 277 TFEU by failing to recognize that the plea of illegality raised against the Commission’s decision of 30 January 2014 granting marketing authorisation for the medicinal product Tecfidera was inadmissible because that decision could have been challenged directly by Polpharma since it is a regulatory act that does not entail implementing measures and was of direct concern to Polpharma.
      Second ground of appeal: in its assessment of the plea of illegality, the General Court misinterpreted and misapplied the concept of the global marketing authorisation laid down in Article 6(1) of Directive 2001/83/EC (1).
      Third ground of appeal: the General Court misinterpreted the legal requirements for the authorisation of combination medicinal products in 1994 and failed to recognize the renewal of the Fumaderm authorisation in 2013 in its consideration of the issue.
      Fourth ground of appeal: the General Court misinterpreted and misapplied the principle of mutual recognition of assessments and decisions adopted by national authorities by concluding that, in the case at hand, this principle did not apply to the EMA and Commission.
      Fifth ground of appeal: the General Court misapplied the applicable standard of judicial review in relation to scientific assessments and scientific evidence by making its own assessment of the scientific data in the file.
      
         (1)  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).