Case C-611/16 P: Appeal brought on 25 November 2016 by Xellia Pharmaceuticals ApS, Alpharma, LLC, formerly Zoetis Products LLC against the judgment of the General Court (Ninth Chamber) delivered on 8 September 2016 in Case T-471/13: Xellia Pharmaceuticals ApS, Alpharma v European Commission
Date: 2016-11-25
Institutions: Court of Justice
Subjects: European patent, cartel, competition policy, control of restrictive practices, generic drug, market access, patent law, restriction on competition, rights of the defence, sanction (EU)








C_2017030EN.01003901.xml










30.1.2017   


EN


Official Journal of the European Union


C 30/39





Appeal brought on 25 November 2016 by Xellia Pharmaceuticals ApS, Alpharma, LLC, formerly Zoetis Products LLC against the judgment of the General Court (Ninth Chamber) delivered on 8 September 2016 in Case T-471/13: Xellia Pharmaceuticals ApS, Alpharma v European Commission
(Case C-611/16 P)
(2017/C 030/43)
Language of the case: English

Parties


Appellants: Xellia Pharmaceuticals ApS, Alpharma, LLC, formerly Zoetis Products LLC (represented by: D.W. Hull, Solicitor)

Other party to the proceedings: European Commission

Form of order sought

The appellants claim that the Court should:






—


Set aside in whole or in part the Judgment under appeal;










—


Annul in whole or in part the Decision;










—


Cancel or substantially reduce the fine;










—


In the alternative, refer the case back to the General Court for determination in accordance with the judgment of the Court of Justice;










—


Order the Commission to pay the costs of these proceedings and of the proceedings before the General Court.





Pleas in law and main arguments

The appellant relies on nine grounds of appeal based on errors of law by the General Court.






1)


The General Court applied the wrong legal standard to evaluate whether Alpharma was a potential competitor in the context where its products infringed Lundbeck’s patents. In the absence of evidence demonstrating that Lundbeck’s patents were weak, the patents must be presumed to be valid and entry with infringing product to be illegal.










2)


Despite acknowledging that Alpharma only discovered shortly before the settlement that Lundbeck’s patent would be granted and that its products infringed Lundbeck’s patents, the General Court failed to evaluate whether the Commission had proven that entry by Alpharma remained an economically-viable strategy in light of these additional barriers to entry. Instead, the General Court relied on evidence not cited in the Decision and incorrectly shifted the burden of proof onto the Appellants to disprove the Commission’s allegation that Alpharma was a potential competitor.










3)


The General Court applied the wrong legal standard to assessed whether the Settlement Agreement constituted a restriction of competition ‘by object’, as it failed to evaluate whether the Commission had demonstrated that the Settlement Agreement was sufficiently likely to have negative effects, and failed to take into account the fact that the Commission had no prior experience with this kind of patent settlement.










4)


The General Court failed to assess whether the Commission had proven its allegation that the restriction in the Settlement Agreement exceeded the scope of Lundbeck’s patents.










5)


The General Court applied the wrong legal standard in assessing whether the duration of the Commission’s investigation was excessive and violated the Appellants’ rights of defence.










6)


The General Court erred in upholding the Commission’s decision to address the Decision to Zoetis (now Alpharma LLC), but not to Merck Generics Holding GmbH, despite the Commission’s failure to provide any basis in the Decision for distinguishing between the situations of these two companies.










7)


The General Court erred in law in finding that the state of the law was sufficiently clear at the time of the Settlement Agreement that the Appellants could ascertain unequivocally what their rights and obligations were and take steps accordingly.










8)


The General Court erred in upholding the Decision despite the Commission’s clear failure to take the gravity of the alleged infringement into account in setting the fine as required under Article 23(3) of Regulation 1/2003 (1).










9)


The General Court applied the wrong legal standard in determining the relevant year for the calculation of the 10 % cap on the level of the fine imposed upon A.L. Industrier.






(1)  Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty

OJ 2003, L 1, p. 1