Lupin Ltd v European Commission.

• Jurisdiction: European Union
• Court: Court of Justice (European Union)
• ECLI: ECLI:EU:C:2024:545
• Docket Number: C-144/19
• Date: 27 June 2024

JUDGMENT OF THE COURT (First Chamber)

27 June 2024 (*)

(Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement)

In Case C‑144/19 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 20 February 2019,

Lupin Ltd, established in Mumbai (India), represented initially by M. Hoskins KC, V. Wakefield KC, S. Smith and A. White, Solicitors, and subsequently by B. Bär-Bouyssière, avocat, M. Hoskins KC, V. Wakefield KC, A. Politis, avocat, S. Smith and A. White, Solicitors,

appellant,

the other party to the proceedings being:

European Commission, represented initially by F. Castilla Contreras, B. Mongin and C. Vollrath, acting as Agents, and by B. Rayment, Barrister-at-Law, and subsequently by F. Castilla Contreras and C. Vollrath, acting as Agents, and by B. Rayment, Barrister-at-Law,

defendant at first instance,

supported by:

United Kingdom of Great Britain and Northern Ireland, represented initially by D. Guðmundsdóttir, acting as Agent, and subsequently by S. Fuller, acting as Agent,

intervener in the appeal,

THE COURT (First Chamber),

composed of A. Arabadjiev (Rapporteur), President of the Chamber, K. Lenaerts, President of the Court, acting as Judge of the First Chamber, P.G. Xuereb, A. Kumin and I. Ziemele, Judges,

Advocate General: J. Kokott,

Registrar: M. Longar and R. Şereş, Administrators,

having regard to the written procedure and further to the hearing on 20 and 21 October 2021,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

Judgment

1 By its appeal, Lupin Ltd seeks to have set aside the judgment of the General Court of the European Union of 12 December 2018, Lupin v Commission (T‑680/14, ‘the judgment under appeal’, EU:T:2018:908), by which the General Court dismissed its action seeking the annulment, so far as concerns Lupin, of European Commission Decision C(2014) 4955 final of 9 July 2014 relating to a proceeding under Article 101 and Article 102 [TFEU] (Case AT.39612 – Perindopril (Servier)) (‘the decision at issue’), and the cancellation or reduction of the fine imposed on it by that decision.

Legal context

2 Article 23 of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101] and [102 TFEU] (OJ 2003 L 1, p. 1) states, in paragraphs 2 and 3 thereof:

‘2. The [European] Commission may by decision impose fines on undertakings and associations of undertakings where, either intentionally or negligently:

(a) they infringe Article [101 or 102 TFEU] …

…

3. In fixing the amount of the fine, regard shall be had both to the gravity and to the duration of the infringement.’

Background to the dispute

3 The background to the dispute, as described, inter alia, in paragraphs 1 to 35 of the judgment under appeal, may be summarised as follows.

4 The appellant, established in India, is the ultimate parent company of the Lupin pharmaceutical group.

Perindopril

5 Servier SAS is the parent company of the Servier pharmaceutical group which includes Les Laboratoires Servier SAS and Servier Laboratories Ltd (individually or jointly, ‘Servier’). Les Laboratoires Servier is specialised in the development of originator medicines, and its subsidiary Biogaran SAS is specialised in the development of generic medicines.

6 Servier developed perindopril, a medicinal product primarily intended for the treatment of hypertension and heart failure. That medicinal product is one of the angiotensin-converting enzyme inhibitors. The active ingredient of perindopril takes the form of a salt. The salt used initially was erbumine.

7 Patent EP0049658, relating to the active ingredient of perindopril, was filed with the European Patent Office (EPO) by a company in the Servier group on 29 September 1981. That patent was due to expire on 29 September 2001, but its protection was prolonged in a number of Member States, including the United Kingdom, until 22 June 2003. In France, protection under that patent was prolonged until 22 March 2005 and, in Italy, until 13 February 2009.

8 On 16 September 1988, Servier filed a number of patents with the EPO relating to processes for the manufacture of the active ingredient of perindopril with an expiry date of 16 September 2008, namely: patents EP0308339, EP0308340, EP0308341 and EP0309324.

9 On 6 July 2001, Servier filed with the EPO patent EP1296947 (‘the 947 patent’), relating to the alpha crystalline form of perindopril erbumine and the process for its manufacture, which was granted by the EPO on 4 February 2004. Servier also filed with the EPO patent EP1294689, relating to the beta crystalline form of perindopril erbumine and the process for its manufacture, and patent EP1296948, relating to the gamma crystalline form of perindopril erbumine and the process for its manufacture.

10 On 6 July 2001, Servier also filed national patent applications in several Member States before they were parties to the Convention on the Grant of European Patents, which was signed in Munich on 5 October 1973 and entered into force on 7 October 1977. Servier filed, for example, patent applications relating to the 947 patent in Bulgaria (BG 107 532), the Czech Republic (PV 2003-357), Estonia (P200300001), Hungary (HU225340), Poland (P348492) and Slovakia (PP0149-2003). Those patents were granted on 16 May 2006 in Bulgaria, on 17 August 2006 in Hungary, on 23 January 2007 in the Czech Republic, on 23 April 2007 in Slovakia and on 24 March 2010 in Poland.

11 Between 2003 and 2009, a number of disputes arose between Servier and manufacturers preparing to market a generic version of perindopril.

The EPO decisions

12 In 2004, 10 manufacturers of generic medicines, including Lupin, filed opposition proceedings against the 947 patent before the EPO, seeking the revocation of that patent on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention.

13 On 27 July 2006, the EPO Opposition Division confirmed the validity of the 947 patent. That decision was challenged before the EPO Technical Board of Appeal. By a decision of 6 May 2009, that board of appeal annulled the EPO decision of 27 July 2006 and revoked the 947 patent. Servier’s request for a revision of that decision of the Technical Board of Appeal was rejected on 19 March 2010.

The decisions of the national courts

14 The validity of the 947 patent has been challenged before certain national courts by manufacturers of generic medicines, and Servier has brought infringement actions and applications for interim injunctions against those manufacturers. Most of those proceedings were closed before the courts seised could give a final ruling on the validity of the 947 patent as a result of settlement agreements entered into by Servier, between 2005 and 2007, with a number of those manufacturers of generic medicines.

15 In the United Kingdom, only the dispute between Servier and Apotex Inc. gave rise to a finding, by a court, that the 947 patent was invalid. On 1 August 2006, Servier brought an action for infringement of the 947 patent before the High Court of Justice (England & Wales), Chancery Division (patents court) (United Kingdom), against Apotex, which had begun to market a generic version of perindopril on the United Kingdom market. On 8 August 2006, Servier obtained an interim injunction against Apotex. On 6 July 2007, following a counterclaim by Apotex, that interim injunction was lifted and the 947 patent was declared invalid, thereby allowing that undertaking to place a generic version of perindopril on the market in the United Kingdom. On 9 May 2008, the decision declaring the 947 patent invalid was confirmed on appeal.

16 In the Netherlands, on 13 November 2007, Katwijk Farma BV, a subsidiary of Apotex, brought an action before a court of that Member State seeking a declaration of invalidity of the 947 patent. Servier made an application to that court for an interim injunction, which was rejected on 30 January 2008. That court, by a decision of 11 June 2008 in proceedings brought on 15 August 2007 by Pharmachemie BV, a company in the Teva group specialising in the manufacture of generic medicines, declared the 947 patent invalid in respect of the Netherlands. Following that decision, Servier and Katwijk Farma withdrew their claims.

The Lupin agreement

17 On 18 October 2006, Lupin brought an action before the High Court of Justice (England & Wales), Chancery Division (patents court), for a declaration of invalidity of the 947 patent and a declaration that the generic version of perindopril which it intended to market in the United Kingdom did not infringe that patent.

18 On 30 January 2007, Servier and Lupin brought an end to that dispute and to the proceedings between them before the EPO relating to the 947 patent, by means of a settlement agreement (‘the Lupin agreement’). That agreement contained a ‘non-challenge’ clause whereby Lupin undertook not to challenge Servier’s patents relating to perindopril. It also contained a ‘non-marketing’ clause. Under the latter clause, Lupin undertook to refrain from selling a generic version of ‘perindopril erbumine … and any salt thereof’. It is apparent from paragraph 20 of the judgment under appeal that ‘Lupin was, however, authorised to market products supplied by Servier or its own perindopril (i) in countries where a generic version of perindopril authorised by Servier was on the market, (ii) in the event that all Servier’s relevant patents had expired or (iii) in countries in which a third party had placed a generic version of perindopril on the market and in which Servier had not brought any application...