CJEU - T-472/13 / Judgment H. Lundbeck and Others v. European Federation of Pharmaceutical Industries and Associations

Key facts of the case:

Competition — Agreements, decisions and concerted practices — Market for antidepressant medicinal products containing the active pharmaceutical ingredient citalopram — Concept of restriction of competition ‘by object’ — Potential competition — Generic medicinal products — Barriers to market entry resulting from the existence of patents — Agreements concluded between a patent holder and generic undertakings — Article 101(1) and (3) TFEU — Errors of law and of assessment — Obligation to state reasons — Rights of defence — Legal certainty — Fines

Results (sanctions) and key consequences of the case:

THE GENERAL COURT (Ninth Chamber) hereby:

  1. Dismisses the action;
  2. Orders H. Lundbeck A/S and Lundbeck Ltd to bear their own costs and to pay the European Commission’s costs;
  3. Orders the European Federation of Pharmaceutical Industries and Associations (EFPIA) to bear its own costs.
Paragraphs referring to EU Charter: 
  1. It is necessary to take into account the principle of the presumption of innocence resulting in particular from Article 48 of the Charter of Fundamental Rights of the European Union. Given the nature of the infringements in question and the nature and degree of severity of the penalties which may ensue, the presumption of innocence applies, inter alia, to the procedures relating to infringements of the competition rules applicable to undertakings that may result in the imposition of fines or periodic penalty payments (see, to that effect, judgment in CISAC v Commission, cited in paragraph 105 above, EU:T:2013:188, paragraph 93 and the case-law cited).
  1. It must be recalled that observance of the rights of the defence is a fundamental right of EU law, enshrined in Article 41(2)(a) of the Charter of Fundamental Rights of the European Union, which requires observance of those rights in all proceedings.
  2. Respect for the rights of the defence thus requires that the undertaking concerned must have been afforded the opportunity, during the administrative procedure, to make known its views on the truth and relevance of the facts and circumstances alleged and on the documents used by the Commission to support its claim that there has been an infringement of the Treaty (see, to that effect, judgment in Aalborg Portland and Others v Commission, cited in paragraph 111 above, EU:C:2004:6, paragraph 66; see also, to that effect, judgment of 13 February 1979 in Hoffmann-La Roche v Commission, 85/76, ECR, EU:C:1979:36, paragraph 9)
  3. In that connection, Article 27(1) of Regulation No 1/2003 provides (i) that the Commission is to give the undertakings or associations of undertakings which are the subject of the proceedings conducted by the Commission the opportunity to be heard on the matters to which the Commission has taken objection and (ii) that the Commission is to base its decisions only on objections on which the parties concerned have been able to comment.
  1. In the present case, contrary to what the applicants claim, it was not unforeseeable that agreements by which the originator company was able to remove potential competitors from the market for a specified period, by means of significant reverse payments, might be contrary to Article 101(1) TFEU, whether or not they went beyond the scope of that company’s patents (see paragraphs 487 to 491).