# Official Journal C 393/2016

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 393 |
| | |
| English edition | Information and Notices | Volume 5925 October 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 393

English edition

Information and Notices

Volume 5925 October 2016

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 393/01 | Euro exchange rates | 1 |
| 2016/C 393/02 | Opinion of the Advisory Committee on restrictive agreements and dominant position given at its meeting of 30 June 2014 regarding a draft decision relating to Case AT.39612(1) — Perindopril (Servier) — Rapporteur: Austria | 2 |
| 2016/C 393/03 | Opinion of the Advisory Committee on restrictive practices and dominant positions given at its meeting of 7 July 2014 regarding a draft decision relating to Case AT.39612(2) — Perindopril (Servier) — Rapporteur: Austria | 3 |
| 2016/C 393/04 | Final Report of the Hearing Officer — Perindopril (Servier) (AT.39612) | 4 |
| 2016/C 393/05 | Summary of Commission Decision of 9 July 2014 relating to a proceeding under Articles 101 and 102 of the Treaty on the Functioning of the European Union (Case AT.39612 — Perindopril (Servier)) (notified under document C(2014) 4955) | 7 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 393/01

Euro exchange rates

1

2016/C 393/02

Opinion of the Advisory Committee on restrictive agreements and dominant position given at its meeting of 30 June 2014 regarding a draft decision relating to Case AT.39612(1) — Perindopril (Servier) — Rapporteur: Austria

2

2016/C 393/03

Opinion of the Advisory Committee on restrictive practices and dominant positions given at its meeting of 7 July 2014 regarding a draft decision relating to Case AT.39612(2) — Perindopril (Servier) — Rapporteur: Austria

3

2016/C 393/04

Final Report of the Hearing Officer — Perindopril (Servier) (AT.39612)

4

2016/C 393/05

Summary of Commission Decision of 9 July 2014 relating to a proceeding under Articles 101 and 102 of the Treaty on the Functioning of the European Union (Case AT.39612 — Perindopril (Servier)) (notified under document C(2014) 4955)

(notified under document C(2014) 4955)

7

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| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2016/C 393/06 | Prior notification of a concentration (Case M.8250 — Ardian/Weber Automotive) — Candidate case for simplified procedure (
  1
  ) | 13 |
| 2016/C 393/07 | Prior notification of a concentration (Case M.8232 — Diamond Offshore Wind Holdings II/Eneco Wind Belgium/Elnu/Norther) — Candidate case for simplified procedure (
  1
  ) | 14 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2016/C 393/06

Prior notification of a concentration (Case M.8250 — Ardian/Weber Automotive) — Candidate case for simplified procedure (
  1
  )

1

13

2016/C 393/07

Prior notification of a concentration (Case M.8232 — Diamond Offshore Wind Holdings II/Eneco Wind Belgium/Elnu/Norther) — Candidate case for simplified procedure (
  1
  )

1

14

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| | |
| --- | --- |
| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 25.10.2016 | EN | Official Journal of the European Union | C 393/1 |
| --- | --- | --- | --- |

25.10.2016

EN

Official Journal of the European Union

C 393/1

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Euro exchange rates (1)

24 October 2016

(2016/C 393/01)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,0891 |
| JPY | Japanese yen | 113,29 |
| DKK | Danish krone | 7,4394 |
| GBP | Pound sterling | 0,89015 |
| SEK | Swedish krona | 9,7050 |
| CHF | Swiss franc | 1,0821 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,9855 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 27,021 |
| HUF | Hungarian forint | 308,53 |
| PLN | Polish zloty | 4,3166 |
| RON | Romanian leu | 4,5065 |
| TRY | Turkish lira | 3,3501 |
| AUD | Australian dollar | 1,4282 |
| CAD | Canadian dollar | 1,4547 |
| HKD | Hong Kong dollar | 8,4478 |
| NZD | New Zealand dollar | 1,5215 |
| SGD | Singapore dollar | 1,5159 |
| KRW | South Korean won | 1 234,29 |
| ZAR | South African rand | 15,1167 |
| CNY | Chinese yuan renminbi | 7,3775 |
| HRK | Croatian kuna | 7,5083 |
| IDR | Indonesian rupiah | 14 178,99 |
| MYR | Malaysian ringgit | 4,5444 |
| PHP | Philippine peso | 52,562 |
| RUB | Russian rouble | 67,7970 |
| THB | Thai baht | 38,119 |
| BRL | Brazilian real | 3,4200 |
| MXN | Mexican peso | 20,2263 |
| INR | Indian rupee | 72,7975 |

Currency

Exchange rate

USD

US dollar

1,0891

JPY

Japanese yen

113,29

DKK

Danish krone

7,4394

GBP

Pound sterling

0,89015

SEK

Swedish krona

9,7050

CHF

Swiss franc

1,0821

ISK

Iceland króna

NOK

Norwegian krone

8,9855

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

27,021

HUF

Hungarian forint

308,53

PLN

Polish zloty

4,3166

RON

Romanian leu

4,5065

TRY

Turkish lira

3,3501

AUD

Australian dollar

1,4282

CAD

Canadian dollar

1,4547

HKD

Hong Kong dollar

8,4478

NZD

New Zealand dollar

1,5215

SGD

Singapore dollar

1,5159

KRW

South Korean won

1 234,29

ZAR

South African rand

15,1167

CNY

Chinese yuan renminbi

7,3775

HRK

Croatian kuna

7,5083

IDR

Indonesian rupiah

14 178,99

MYR

Malaysian ringgit

4,5444

PHP

Philippine peso

52,562

RUB

Russian rouble

67,7970

THB

Thai baht

38,119

BRL

Brazilian real

3,4200

MXN

Mexican peso

20,2263

INR

Indian rupee

72,7975

---

(1)  Source: reference exchange rate published by the ECB.

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| 25.10.2016 | EN | Official Journal of the European Union | C 393/2 |
| --- | --- | --- | --- |

25.10.2016

EN

Official Journal of the European Union

C 393/2

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Opinion of the Advisory Committee on restrictive agreements and dominant position given at its meeting of 30 June 2014 regarding a draft decision relating to Case AT.39612(1) — Perindopril (Servier)

Rapporteur: Austria

(2016/C 393/02)

| 1. | The Advisory Committee agrees with the European Commission’s definition of the relevant market for perindopril formulations in the United Kingdom, France, the Netherlands and Poland and for perindopril API technology in at least the EU. |
| --- | --- |

1.

The Advisory Committee agrees with the European Commission’s definition of the relevant market for perindopril formulations in the United Kingdom, France, the Netherlands and Poland and for perindopril API technology in at least the EU.

| 2. | The Advisory Committee agrees with the Commission that Servier held a dominant position in the market for perindopril formulations in the United Kingdom, France, the Netherlands and Poland and in the at least EU-wide market for perindopril API technology, in the respective time periods. |
| --- | --- |

2.

The Advisory Committee agrees with the Commission that Servier held a dominant position in the market for perindopril formulations in the United Kingdom, France, the Netherlands and Poland and in the at least EU-wide market for perindopril API technology, in the respective time periods.

| 3. | The Advisory Committee agrees with the Commission that the respective parties concluded agreements that had the object of restricting competition within the meaning of Article 101 TFEU. |
| --- | --- |

3.

The Advisory Committee agrees with the Commission that the respective parties concluded agreements that had the object of restricting competition within the meaning of Article 101 TFEU.

| 4. | The Advisory Committee agrees with the Commission that the respective parties concluded agreements that had the effect of restricting competition within the meaning of Article 101 TFEU in the relevant Member States. |
| --- | --- |

4.

The Advisory Committee agrees with the Commission that the respective parties concluded agreements that had the effect of restricting competition within the meaning of Article 101 TFEU in the relevant Member States.

| 5. | The Advisory Committee agrees with the Commission that the agreements between Servier and the generic companies were capable of having an appreciable effect on trade between EU Member States within the meaning of Article 101 TFEU. |
| --- | --- |

5.

The Advisory Committee agrees with the Commission that the agreements between Servier and the generic companies were capable of having an appreciable effect on trade between EU Member States within the meaning of Article 101 TFEU.

| 6. | The Advisory Committee agrees with the Commission that the conditions of Article 101 paragraph 3 TFEU are not met. |
| --- | --- |

6.

The Advisory Committee agrees with the Commission that the conditions of Article 101 paragraph 3 TFEU are not met.

| 7. | The Advisory Committee agrees that Servier abused its dominant position by pursuing an exclusionary strategy combining the Azad technology acquisition and the conclusion of five patent settlement agreements, which together constitute a single and continuous infringement of Article 102 TFEU. |
| --- | --- |

7.

The Advisory Committee agrees that Servier abused its dominant position by pursuing an exclusionary strategy combining the Azad technology acquisition and the conclusion of five patent settlement agreements, which together constitute a single and continuous infringement of Article 102 TFEU.

| 8. | The Advisory Committee agrees with the Commission that the conditions of objective justification for the infringement of Article 102 TFEU are not met. |
| --- | --- |

8.

The Advisory Committee agrees with the Commission that the conditions of objective justification for the infringement of Article 102 TFEU are not met.

| 9. | The Advisory Committee agrees with the Commission’s draft Decision as regards the conclusion that the abuse was capable of having an appreciable effect on trade between EU Member States within the meaning of Article 102 TFEU. |
| --- | --- |

9.

The Advisory Committee agrees with the Commission’s draft Decision as regards the conclusion that the abuse was capable of having an appreciable effect on trade between EU Member States within the meaning of Article 102 TFEU.

| 10. | The Advisory Committee agrees with the Commission’s assessment as regards the duration of the infringements of Article 101 and Article 102 TFEU. |
| --- | --- |

10.

The Advisory Committee agrees with the Commission’s assessment as regards the duration of the infringements of Article 101 and Article 102 TFEU.

| 11. | The Advisory Committee agrees with the Commission’s draft Decision as regards all addressees of the Decision, specifically regarding parental liability. |
| --- | --- |

11.

The Advisory Committee agrees with the Commission’s draft Decision as regards all addressees of the Decision, specifically regarding parental liability.

| 12. | The Advisory Committee recommends the publication of its opinion in the Official Journal of the European Union. |
| --- | --- |

12.

The Advisory Committee recommends the publication of its opinion in the Official Journal of the European Union.

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| 25.10.2016 | EN | Official Journal of the European Union | C 393/3 |
| --- | --- | --- | --- |

25.10.2016

EN

Official Journal of the European Union

C 393/3

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Opinion of the Advisory Committee on restrictive practices and dominant positions given at its meeting of 7 July 2014 regarding a draft decision relating to Case AT.39612(2) — Perindopril (Servier)

Rapporteur: Austria

(2016/C 393/03)

| 1. | The Advisory Committee agrees with the Commission that fines should be imposed on the addressees of the draft decision. |
| --- | --- |

1.

The Advisory Committee agrees with the Commission that fines should be imposed on the addressees of the draft decision.

| 2. | The Advisory Committee agrees with the Commission on the final amounts of the fines for Servier. |
| --- | --- |

2.

The Advisory Committee agrees with the Commission on the final amounts of the fines for Servier.

| 3. | The Advisory Committee agrees with the Commission’s approach to base the calculation of fines for the generic undertakings on the value transferred. |
| --- | --- |

3.

The Advisory Committee agrees with the Commission’s approach to base the calculation of fines for the generic undertakings on the value transferred.

| 4. | The Advisory Committee agrees with the Commission on the final amounts of the fines for the generic undertakings. |
| --- | --- |

4.

The Advisory Committee agrees with the Commission on the final amounts of the fines for the generic undertakings.

| 5. | The Advisory Committee agrees with the Commission on the Commission’s Decision in its entirety. |
| --- | --- |

5.

The Advisory Committee agrees with the Commission on the Commission’s Decision in its entirety.

| 6. | The Advisory Committee recommend the publication of its opinion in the Official Journal. |
| --- | --- |

6.

The Advisory Committee recommend the publication of its opinion in the Official Journal.

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| 25.10.2016 | EN | Official Journal of the European Union | C 393/4 |
| --- | --- | --- | --- |

25.10.2016

EN

Official Journal of the European Union

C 393/4

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Final Report of the Hearing Officer (1)

Perindopril (Servier)

(AT.39612)

(2016/C 393/04)

Introduction

| 1. | This case concerns patent settlement agreements between the originator pharmaceutical producer Servier and five generic producers between 2005 and 2007 and a technology acquisition by Servier in 2004 in connection with the manufacture and sale of perindopril, a medicine to treat cardiovascular diseases. |
| --- | --- |

1.

This case concerns patent settlement agreements between the originator pharmaceutical producer Servier and five generic producers between 2005 and 2007 and a technology acquisition by Servier in 2004 in connection with the manufacture and sale of perindopril, a medicine to treat cardiovascular diseases.

| 2. | Following an ex officio investigation, the Commission initiated proceedings, on 2 July 2009, against Servier S.A.S., Servier Laboratories Limited, Les Laboratoires Servier, Adir and Biogaran (together ‘Servier’), Krka, tovarna zdravil, d.d., Novo mesto (‘Krka’), Lupin Limited (‘Lupin’), Mylan Laboratories Limited (2), Niche Generics Limited (‘Niche’) and Teva Pharmaceutical Industries Ltd. On 27 July 2012, proceedings were also opened against Teva Pharmaceuticals Europe B.V. and Teva UK Limited (3), Unichem Laboratories Limited (‘Unichem’) and Mylan Inc. (4) (all addressees together are referred to as ‘parties’). |
| --- | --- |

2.

Following an ex officio investigation, the Commission initiated proceedings, on 2 July 2009, against Servier S.A.S., Servier Laboratories Limited, Les Laboratoires Servier, Adir and Biogaran (together ‘Servier’), Krka, tovarna zdravil, d.d., Novo mesto (‘Krka’), Lupin Limited (‘Lupin’), Mylan Laboratories Limited (2), Niche Generics Limited (‘Niche’) and Teva Pharmaceutical Industries Ltd. On 27 July 2012, proceedings were also opened against Teva Pharmaceuticals Europe B.V. and Teva UK Limited (3), Unichem Laboratories Limited (‘Unichem’) and Mylan Inc. (4) (all addressees together are referred to as ‘parties’).

Statement of Objections

| 3. | The Commission adopted a Statement of Objections (‘SO’) on 27 July 2012. The SO preliminarily found that Servier and, respectively, Krka, Lupin, Mylan, Niche, Teva and Unichem had entered into anti-competitive reverse payment settlement agreements with the aim of foreclosing or delaying entry into the perindopril market in a number of EU Member States. Those patent settlement agreements were considered to amount to infringements of Article 101 TFEU. |
| --- | --- |

3.

The Commission adopted a Statement of Objections (‘SO’) on 27 July 2012. The SO preliminarily found that Servier and, respectively, Krka, Lupin, Mylan, Niche, Teva and Unichem had entered into anti-competitive reverse payment settlement agreements with the aim of foreclosing or delaying entry into the perindopril market in a number of EU Member States. Those patent settlement agreements were considered to amount to infringements of Article 101 TFEU.

| 4. | The SO also preliminarily established that Servier had abused its dominant position on the market for perindopril by the conclusion of the reverse payment patent settlement agreements and the acquisition of certain API (5) technologies. |
| --- | --- |

4.

The SO also preliminarily established that Servier had abused its dominant position on the market for perindopril by the conclusion of the reverse payment patent settlement agreements and the acquisition of certain API (5) technologies.

Access to the file

| 5. | In August 2012, the parties were granted access to the file in the form of DVD-ROMs. Additional access to the file via a data room was given to Servier, Lupin, Niche, Teva and Unichem in September 2012. |
| --- | --- |

5.

In August 2012, the parties were granted access to the file in the form of DVD-ROMs. Additional access to the file via a data room was given to Servier, Lupin, Niche, Teva and Unichem in September 2012.

Requests for additional access to the file

| 6. | In November 2012, I received three requests from Servier seeking access to certain documents in the Commission’s file to which DG Competition had denied access on the basis of confidentiality claims by the information providers. Servier also requested my intervention to verify that access to the file in the present case had been granted in accordance with the applicable rules and case-law. Servier submitted that systemic problems had damaged the access to file procedure to the extent that a complete resetting of the process was required. |
| --- | --- |

6.

In November 2012, I received three requests from Servier seeking access to certain documents in the Commission’s file to which DG Competition had denied access on the basis of confidentiality claims by the information providers. Servier also requested my intervention to verify that access to the file in the present case had been granted in accordance with the applicable rules and case-law. Servier submitted that systemic problems had damaged the access to file procedure to the extent that a complete resetting of the process was required.

| 7. | Upon my intervention, DG Competition disclosed to Servier most of the information requested. For a few documents, I rejected Servier’s request pursuant to Article 7 of Decision 2011/695/EU. In particular, I rejected its request for further access to a document that contained business secrets of another company and did not appear relevant for Servier’s defence. I also rejected its request for further access to information that (i) did not relate to products subject of the investigation or (ii) related to non-EEA jurisdictions. |
| --- | --- |

7.

Upon my intervention, DG Competition disclosed to Servier most of the information requested. For a few documents, I rejected Servier’s request pursuant to Article 7 of Decision 2011/695/EU. In particular, I rejected its request for further access to a document that contained business secrets of another company and did not appear relevant for Servier’s defence. I also rejected its request for further access to information that (i) did not relate to products subject of the investigation or (ii) related to non-EEA jurisdictions.

| 8. | In response to Servier’s general claim regarding ‘systemic problems’ in the access to file procedure, I noted that Servier had requested me to resolve a dispute that concerned only approximately 1 % of the documents deemed confidential by DG Competition. I could therefore not agree with Servier that there was a ‘systemic problem’. The mere fact that my involvement was required in order to obtain disclosure of almost all of the disputed documents did not imply that the access to file procedure was damaged and that a complete resetting of the process was needed. In that respect, it should be noted that the procedure under Article 7 of Decision 2011/695/EU, which provides for a system of control and resolution of disputes concerning access to the file, forms an integral part of the access to file procedure. |
| --- | --- |

8.

In response to Servier’s general claim regarding ‘systemic problems’ in the access to file procedure, I noted that Servier had requested me to resolve a dispute that concerned only approximately 1 % of the documents deemed confidential by DG Competition. I could therefore not agree with Servier that there was a ‘systemic problem’. The mere fact that my involvement was required in order to obtain disclosure of almost all of the disputed documents did not imply that the access to file procedure was damaged and that a complete resetting of the process was needed. In that respect, it should be noted that the procedure under Article 7 of Decision 2011/695/EU, which provides for a system of control and resolution of disputes concerning access to the file, forms an integral part of the access to file procedure.

Access to other parties’ replies to the SO

| 9. | DG Competition granted all parties access to copies of the non-confidential version of the other parties’ replies to the SO. The parties were given the opportunity to submit comments in writing prior to the oral hearing. Only Servier made use of that opportunity (6). |
| --- | --- |

9.

DG Competition granted all parties access to copies of the non-confidential version of the other parties’ replies to the SO. The parties were given the opportunity to submit comments in writing prior to the oral hearing. Only Servier made use of that opportunity (6).

Time limit to reply to the SO

| 10. | DG Competition initially set a deadline of three months to reply to the SO and extended it by 10 days for Krka, Lupin, Mylan and Servier. Shortly thereafter these parties referred the matter of the extension of the deadline for their reply to the SO to me. On the basis of their arguments, I also extended their respective deadlines to reply to the SO. |
| --- | --- |

10.

DG Competition initially set a deadline of three months to reply to the SO and extended it by 10 days for Krka, Lupin, Mylan and Servier. Shortly thereafter these parties referred the matter of the extension of the deadline for their reply to the SO to me. On the basis of their arguments, I also extended their respective deadlines to reply to the SO.

| 11. | Subsequently, I granted Servier a further extension until 14 January 2013 to allow it sufficient time to receive, review and respond to the documents received following its request for additional access to the file. |
| --- | --- |

11.

Subsequently, I granted Servier a further extension until 14 January 2013 to allow it sufficient time to receive, review and respond to the documents received following its request for additional access to the file.

Interested Third Persons

| 12. | Upon their request, I allowed the claimants in the case The Secretary of State for Health and Others v Servier Laboratories Limited and Others before the High Court of Justice of England and Wales to be heard as interested third persons. I considered they had demonstrated sufficient interest (7) because they form part of the English National Health Service, which has a major role in purchasing perindopril in England, and were the claimants in national proceedings which presented a significant overlap with the proceedings in case AT.39612. |
| --- | --- |

12.

Upon their request, I allowed the claimants in the case The Secretary of State for Health and Others v Servier Laboratories Limited and Others before the High Court of Justice of England and Wales to be heard as interested third persons. I considered they had demonstrated sufficient interest (7) because they form part of the English National Health Service, which has a major role in purchasing perindopril in England, and were the claimants in national proceedings which presented a significant overlap with the proceedings in case AT.39612.

| 13. | Following the request in their written comments, I also decided to allow the interested third persons to participate in the oral hearing. |
| --- | --- |

13.

Following the request in their written comments, I also decided to allow the interested third persons to participate in the oral hearing.

Oral hearing

| 14. | The oral hearing took place from 15 to 18 April 2013. All parties and the admitted interested third persons participated. |
| --- | --- |

14.

The oral hearing took place from 15 to 18 April 2013. All parties and the admitted interested third persons participated.

Letters of facts

| 15. | In December 2013, the Commission sent a letter of facts to all parties to which they responded in January 2014. Non-confidential versions of the replies to the letters of facts were circulated to all parties. |
| --- | --- |

15.

In December 2013, the Commission sent a letter of facts to all parties to which they responded in January 2014. Non-confidential versions of the replies to the letters of facts were circulated to all parties.

| 16. | In April 2014, the Commission sent out a second letter of facts to Mylan and to Niche/Unichem, including new evidence that the Commission intended to use in relation to the imputation of parental liability. In its reply to the letter of facts, Mylan complained that the Commission had used the letter of facts to reformulate and supplement its objections, and, in particular, that it had changed the basis of the finding of parental liability. Mylan therefore questioned whether the new evidence could be communicated in a letter of facts and did not necessitate the issuance of a Supplementary Statement of Objections (SSO), if the Commission intended to rely on it. |
| --- | --- |

16.

In April 2014, the Commission sent out a second letter of facts to Mylan and to Niche/Unichem, including new evidence that the Commission intended to use in relation to the imputation of parental liability. In its reply to the letter of facts, Mylan complained that the Commission had used the letter of facts to reformulate and supplement its objections, and, in particular, that it had changed the basis of the finding of parental liability. Mylan therefore questioned whether the new evidence could be communicated in a letter of facts and did not necessitate the issuance of a Supplementary Statement of Objections (SSO), if the Commission intended to rely on it.

| 17. | Although Mylan did not raise the issue with me, I have reviewed the claim in the light of the objections raised in the SO and the evidence included in the letter of facts. The letter of facts indeed introduced a new argument in relation to the imputation of parental liability that was of a different nature than the arguments set out in the SO. However, this new argument has in the end not been used in the draft decision. Mylan’s rights of defence have thus not been breached. |
| --- | --- |

17.

Although Mylan did not raise the issue with me, I have reviewed the claim in the light of the objections raised in the SO and the evidence included in the letter of facts. The letter of facts indeed introduced a new argument in relation to the imputation of parental liability that was of a different nature than the arguments set out in the SO. However, this new argument has in the end not been used in the draft decision. Mylan’s rights of defence have thus not been breached.

Additional access to the file after the oral hearing

| 18. | In January 2014, Servier made a request for further access to the file in relation to documents mentioned in the letter of facts. After DG Competition had initially rejected this request, Servier referred the matter to me (8). Following my intervention, DG Competition requested the information providers to reconsider their confidentiality claims. They agreed to provide revised non-confidential versions of the requested documents, which were subsequently disclosed to Servier. |
| --- | --- |

18.

In January 2014, Servier made a request for further access to the file in relation to documents mentioned in the letter of facts. After DG Competition had initially rejected this request, Servier referred the matter to me (8). Following my intervention, DG Competition requested the information providers to reconsider their confidentiality claims. They agreed to provide revised non-confidential versions of the requested documents, which were subsequently disclosed to Servier.

| 19. | In June 2014, when the administrative proceedings were already reaching the stage of the consultation of the Advisory Committee, Servier made a new request for further access to a document in the file. DG Competition rejected this request and, when Servier referred the matter to me, I confirmed this rejection. Access to the file is not an end in itself, but serves the purpose of allowing the addressee of a statement of objections effectively to express its views on the conclusions which the Commission provisionally reached in the statement of objections (9). Servier has received access to the file and has had ample opportunity to request further access to the file before responding to the SO as well as before responding to the letter of facts, and has on these occasions requested and received further access to the document in question. Further access to the file at this late stage of the proceedings would serve no purpose other than to make it more difficult for the Commission to comply with its obligation to adopt its decision within a reasonable time, in accordance with Article 41 of the EU Charter of Fundamental Rights. |
| --- | --- |

19.

In June 2014, when the administrative proceedings were already reaching the stage of the consultation of the Advisory Committee, Servier made a new request for further access to a document in the file. DG Competition rejected this request and, when Servier referred the matter to me, I confirmed this rejection. Access to the file is not an end in itself, but serves the purpose of allowing the addressee of a statement of objections effectively to express its views on the conclusions which the Commission provisionally reached in the statement of objections (9). Servier has received access to the file and has had ample opportunity to request further access to the file before responding to the SO as well as before responding to the letter of facts, and has on these occasions requested and received further access to the document in question. Further access to the file at this late stage of the proceedings would serve no purpose other than to make it more difficult for the Commission to comply with its obligation to adopt its decision within a reasonable time, in accordance with Article 41 of the EU Charter of Fundamental Rights.

The draft decision

| 20. | Pursuant to Article 16 of Decision 2011/695/EU, I have examined whether the draft decision deals only with the objections in respect of which the parties have been afforded the opportunity of making known its views, and I have come to a positive conclusion. |
| --- | --- |

20.

Pursuant to Article 16 of Decision 2011/695/EU, I have examined whether the draft decision deals only with the objections in respect of which the parties have been afforded the opportunity of making known its views, and I have come to a positive conclusion.

| 21. | Overall, I conclude that all parties have been able to effectively exercise their procedural rights in this case. |
| --- | --- |

21.

Overall, I conclude that all parties have been able to effectively exercise their procedural rights in this case.

Brussels, 7 July 2014.

Wouter WILS

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(1)  Pursuant to Articles 16 and 17 of Decision 2011/695/EU of the President of the European Commission of 13 October 2011 on the function and terms of reference of the hearing officer in certain competition proceedings (OJ L 275, 20.10.2011, p. 29).

1

(2)  Formerly Matrix Laboratories Limited.

2

(3)  Teva UK Limited, Teva Pharmaceuticals Europe B.V. and Teva Pharmaceutical Industries Ltd together are referred to as ‘Teva’.

3

(4)  Mylan Laboratories Limited and Mylan Inc. together are referred to as ‘Mylan’.

4

(5)  Active Pharmaceutical Ingredient.

5

(6)  In its letter, Servier also requested further access to several pages of a document. This resulted in a revised non-confidential version of the document, which DG Competition disclosed to all parties.

6

(7)  Pursuant to Article 27(3) of Council Regulation (EC) No 1/2003 (OJ L 1, 4.1.2003, p. 1); Article 13(1) of Commission Regulation (EC) No 773/2004 (OJ L 123, 27.4.2004, p. 18); and Article 5 of Decision 2011/695/EU.

7

(8)  Servier also requested further access to additional documents without first raising it with DG Competition as would normally be required pursuant to Article 7(1) in conjunction with Article 3(7) of Decision 2011/695/EU.

8

(9)  See, to that effect, Case T-25/95 etc. Cimenteries and Others v Commission EU:T:2000:77, paragraphs 156 and 142.

9

Cimenteries and Others

Commission

---

| 25.10.2016 | EN | Official Journal of the European Union | C 393/7 |
| --- | --- | --- | --- |

25.10.2016

EN

Official Journal of the European Union

C 393/7

---

Summary of Commission Decision

of 9 July 2014

relating to a proceeding under Articles 101 and 102 of the Treaty on the Functioning of the European Union

(Case AT.39612 — Perindopril (Servier))

(notified under document C(2014) 4955)

(Only the English and French texts are authentic)

(2016/C 393/05)

On 9 July 2014, the Commission adopted a decision relating to a proceeding under Articles 101 and 102 of the Treaty on the Functioning of the European Union. In accordance with the provisions of Article 30 of Council Regulation (EC) No 1/2003
   (1)
  , the Commission herewith publishes the names of the parties and the main content of the decision, including any penalties imposed, having regard to the legitimate interest of undertakings in the protection of their business secrets.

1.   INTRODUCTION

| (1) | The Perindopril (Servier) decision concerns (i) five patent settlement agreements between Servier (2), an originator pharmaceutical producer company, and five generic producers (2005-2007); and (ii) a technology acquisition by Servier (2004), which sought to delay generic entry in the perindopril market, a medicine to treat cardiovascular diseases. |
| --- | --- |

(1)

The Perindopril (Servier) decision concerns (i) five patent settlement agreements between Servier (2), an originator pharmaceutical producer company, and five generic producers (2005-2007); and (ii) a technology acquisition by Servier (2004), which sought to delay generic entry in the perindopril market, a medicine to treat cardiovascular diseases.

| (2) | The patent settlement agreements were signed between Servier and respectively:






  — | Niche Generics Limited (‘Niche’) and Unichem Laboratories Limited (‘Unichem’): an agreement covering all Member States except Italy and Croatia. The start date of the infringement was 8 February 2005 (3); and the end date was 15 September 2008 (4), |
| --- | --- | --- |

(2)

The patent settlement agreements were signed between Servier and respectively:

—

Niche Generics Limited (‘Niche’) and Unichem Laboratories Limited (‘Unichem’): an agreement covering all Member States except Italy and Croatia. The start date of the infringement was 8 February 2005 (3); and the end date was 15 September 2008 (4),

| — | Mylan Laboratories Limited (formerly known as Matrix Laboratories Limited) (‘Matrix’) and Mylan Inc. (‘Mylan’): an agreement covering all Member States except Italy and Croatia. The start date of the infringement was 8 February 2005 (5); and the end date was 15 September 2008 (6), |
| --- | --- |

—

Mylan Laboratories Limited (formerly known as Matrix Laboratories Limited) (‘Matrix’) and Mylan Inc. (‘Mylan’): an agreement covering all Member States except Italy and Croatia. The start date of the infringement was 8 February 2005 (5); and the end date was 15 September 2008 (6),

| — | Teva UK Limited, Teva Pharmaceutical Industries Ltd, and Teva Pharmaceuticals Europe B.V. (‘Teva’): an agreement covering the United Kingdom from 13 June 2006 to 6 July 2007, |
| --- | --- |

—

Teva UK Limited, Teva Pharmaceutical Industries Ltd, and Teva Pharmaceuticals Europe B.V. (‘Teva’): an agreement covering the United Kingdom from 13 June 2006 to 6 July 2007,

| — | Krka, tovarna zdravil, d.d., Novo mesto (‘Krka’): three agreements, which constitute a single and continuous infringement, covering all Member States except Croatia, the Czech Republic, Hungary, Latvia, Lithuania, Poland, Slovakia and Slovenia. The start date of the infringement was 27 October 2006 (7); and the end date was 6 May 2009 (8), |
| --- | --- |

—

Krka, tovarna zdravil, d.d., Novo mesto (‘Krka’): three agreements, which constitute a single and continuous infringement, covering all Member States except Croatia, the Czech Republic, Hungary, Latvia, Lithuania, Poland, Slovakia and Slovenia. The start date of the infringement was 27 October 2006 (7); and the end date was 6 May 2009 (8),

| — | Lupin Limited (‘Lupin’): an agreement covering all Member States except Croatia. The start date of the infringement was 30 January 2007 (9); and the end date was 6 May 2009 (10). |
| --- | --- |

—

Lupin Limited (‘Lupin’): an agreement covering all Member States except Croatia. The start date of the infringement was 30 January 2007 (9); and the end date was 6 May 2009 (10).

| (3) | Perindopril is an angiotensin converting enzyme (ACE) inhibitor product, used for the treatment of cardiovascular diseases such as hypertension. Perindopril became Servier's most successful product, with annual global sales for the years 2006 and 2007 exceeding USD 1 billion. |
| --- | --- |

(3)

Perindopril is an angiotensin converting enzyme (ACE) inhibitor product, used for the treatment of cardiovascular diseases such as hypertension. Perindopril became Servier's most successful product, with annual global sales for the years 2006 and 2007 exceeding USD 1 billion.

| (4) | The Commission investigated whether Servier had devised, updated and implemented a strategy to confront generic entry, which became possible due to the expiry of Servier's key compound patent in the period 2001-2005. Generic entry for products like perindopril typically leads to two notable changes in the market. First, there is a significant decrease in prices (as much as 90 %) and, secondly, there are substantial volume shifts from the originator company to generic companies. |
| --- | --- |

(4)

The Commission investigated whether Servier had devised, updated and implemented a strategy to confront generic entry, which became possible due to the expiry of Servier's key compound patent in the period 2001-2005. Generic entry for products like perindopril typically leads to two notable changes in the market. First, there is a significant decrease in prices (as much as 90 %) and, secondly, there are substantial volume shifts from the originator company to generic companies.

| (5) | The evidence showed that Servier devised a strategy to prolong its exclusivity over perindopril. Servier relied on and applied for a number of processes and crystalline form patents. In 2004, Servier bought from Azad technology to produce perindopril, removing a close source of competition out of the market, which went beyond simply meeting competition and legitimate defence of its intellectual property. Subsequently, Servier also asserted its patents and was involved in patent litigation with a number of its generic challengers, which believed there were chances that their perindopril products may not infringe Servier's patents, and/or that Servier's '947 patent was invalid. |
| --- | --- |

(5)

The evidence showed that Servier devised a strategy to prolong its exclusivity over perindopril. Servier relied on and applied for a number of processes and crystalline form patents. In 2004, Servier bought from Azad technology to produce perindopril, removing a close source of competition out of the market, which went beyond simply meeting competition and legitimate defence of its intellectual property. Subsequently, Servier also asserted its patents and was involved in patent litigation with a number of its generic challengers, which believed there were chances that their perindopril products may not infringe Servier's patents, and/or that Servier's '947 patent was invalid.

| (6) | In addition, between 2005 and 2007, Servier concluded five patent settlement agreements on the basis of significant inducements to the respective generic companies (so-called reverse payment patent settlements). These inducements most often took the form of direct payments, totalling possibly in excess of EUR 90 million. In the case of Krka, it took the form of a market sharing agreement whereby Servier granted a licence for Krka's core markets in return for Krka withdrawing from competition in Servier's biggest markets (in particular the United Kingdom and France). The five patent settlement agreements prohibited entry with the developed generic product before the lapse of the patents in suit, and discontinued a number of legal challenges to the validity of the '947 patent which was later annulled and described by a UK Court as ‘the sort of patent which can give the patent system a bad name.’ |
| --- | --- |

(6)

In addition, between 2005 and 2007, Servier concluded five patent settlement agreements on the basis of significant inducements to the respective generic companies (so-called reverse payment patent settlements). These inducements most often took the form of direct payments, totalling possibly in excess of EUR 90 million. In the case of Krka, it took the form of a market sharing agreement whereby Servier granted a licence for Krka's core markets in return for Krka withdrawing from competition in Servier's biggest markets (in particular the United Kingdom and France). The five patent settlement agreements prohibited entry with the developed generic product before the lapse of the patents in suit, and discontinued a number of legal challenges to the validity of the '947 patent which was later annulled and described by a UK Court as ‘the sort of patent which can give the patent system a bad name.’

| (7) | An overview of the acquisitions and settlements in question is provided below:











  Competitors | Azad | Niche/Unichem | Matrix | Teva | Krka | Lupin |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Practice | Technology acquisition | Patent settlement agreement |
| Area covered | EU | EU | EU | UK | 20MS | EU |
| Signing date | 9.11.2004 | 8.2.2005 | 8.2.2005 | 13.6.2006 | 27.10.2006 | 30.1.2007 |
| End date | n/a | Effects ended with the annulment of the so-called ‘alpha-crystalline’ patent
  (UK: 6.7.2007, NL: 12.12.2008, IT: 13.2.2009, EPO: 6.5.2009) (11) |
| Value transfer (in EUR million) | 13,4 | 17,2  (12) | 17,2 | 15,6 | Market sharing with duopoly profits in 7 MS (13) | 40
  (presented as payment for IPRs) |
| Infringement | Art. 102 | Art. 101/102 |

(7)

An overview of the acquisitions and settlements in question is provided below:

Competitors

Azad

Niche/Unichem

Matrix

Teva

Krka

Lupin

Practice

Technology acquisition

Patent settlement agreement

Area covered

EU

EU

EU

UK

20MS

EU

Signing date

9.11.2004

8.2.2005

8.2.2005

13.6.2006

27.10.2006

30.1.2007

End date

n/a

Effects ended with the annulment of the so-called ‘alpha-crystalline’ patent

(UK: 6.7.2007, NL: 12.12.2008, IT: 13.2.2009, EPO: 6.5.2009) (11)

Value transfer (in EUR million)

13,4

17,2  (12)

17,2

15,6

Market sharing with duopoly profits in 7 MS (13)

40

(presented as payment for IPRs)

Infringement

Art. 102

Art. 101/102

2.   PROCEDURE

| (8) | In November 2008, the Commission carried out unannounced inspections at the premises of Servier and several generic companies. On 2 and 27 July 2009, the Commission formally opened proceedings and adopted the Statement of Objections addressed to Servier, Niche/Unichem, Matrix/Mylan, Teva, Krka and Lupin, including certain group companies affiliated to these undertakings (together, the ‘Parties’). The Oral Hearing took place between 15 and 18 April 2013. A Letter of Facts was sent to the Parties on 18 December 2013 and, on 4 April 2014, Letters of Facts concerning the issue of parental liability were sent to Niche/Unichem and Matrix/Mylan. |
| --- | --- |

(8)

In November 2008, the Commission carried out unannounced inspections at the premises of Servier and several generic companies. On 2 and 27 July 2009, the Commission formally opened proceedings and adopted the Statement of Objections addressed to Servier, Niche/Unichem, Matrix/Mylan, Teva, Krka and Lupin, including certain group companies affiliated to these undertakings (together, the ‘Parties’). The Oral Hearing took place between 15 and 18 April 2013. A Letter of Facts was sent to the Parties on 18 December 2013 and, on 4 April 2014, Letters of Facts concerning the issue of parental liability were sent to Niche/Unichem and Matrix/Mylan.

| (9) | On 30 June 2014 and 7 July 2014, the Advisory Committee on Restrictive Practices and Dominant Positions issued a favourable opinion to the adoption of a Prohibition Decision pursuant to Articles 7 and 23 of Regulation (EC) No 1/2003. |
| --- | --- |

(9)

On 30 June 2014 and 7 July 2014, the Advisory Committee on Restrictive Practices and Dominant Positions issued a favourable opinion to the adoption of a Prohibition Decision pursuant to Articles 7 and 23 of Regulation (EC) No 1/2003.

| (10) | On 7 July 2014 the Hearing Officer issued his final report. |
| --- | --- |

(10)

On 7 July 2014 the Hearing Officer issued his final report.

3.   SUMMARY OF THE COMMISSION'S LEGAL ASSESSMENT

| (11) | The patent settlement agreements are assessed under Article 101 of the Treaty. With respect to Servier, those agreements, as well as the technology acquisition, are also assessed under Article 102 of the Treaty. |
| --- | --- |

(11)

The patent settlement agreements are assessed under Article 101 of the Treaty. With respect to Servier, those agreements, as well as the technology acquisition, are also assessed under Article 102 of the Treaty.

1.   Market definition and dominance

| (12) | The Commission found that perindopril constituted a separate relevant market in the United Kingdom, France, the Netherlands and Poland. |
| --- | --- |

(12)

The Commission found that perindopril constituted a separate relevant market in the United Kingdom, France, the Netherlands and Poland.

| (13) | While a certain degree of functional substitutability between perindopril and other ACE inhibitors was acknowledged with respect to first-time use patients, the Commission was led to its overall conclusion by the following observations related to the sales of perindopril: a non-negligible degree of differentiation between perindopril and other treatments, a nature of experience good exhibited by perindopril, important switching costs (because of associated risks, patients tended to stick to the successful treatment) affecting the bulk of perindopril patients, presence of loyalists among prescribers (who tended to prescribe the product that had proven to be successful for their previous patients), the general price insensitivity of demand for perindopril, the regulatory framework, which shielded perindopril from competitive pressures, and the fact that the price pressure over perindopril from its own generics was by several orders of magnitude greater than that exercised by alternative medicines. All those elements were found mutually reinforcing. |
| --- | --- |

(13)

While a certain degree of functional substitutability between perindopril and other ACE inhibitors was acknowledged with respect to first-time use patients, the Commission was led to its overall conclusion by the following observations related to the sales of perindopril: a non-negligible degree of differentiation between perindopril and other treatments, a nature of experience good exhibited by perindopril, important switching costs (because of associated risks, patients tended to stick to the successful treatment) affecting the bulk of perindopril patients, presence of loyalists among prescribers (who tended to prescribe the product that had proven to be successful for their previous patients), the general price insensitivity of demand for perindopril, the regulatory framework, which shielded perindopril from competitive pressures, and the fact that the price pressure over perindopril from its own generics was by several orders of magnitude greater than that exercised by alternative medicines. All those elements were found mutually reinforcing.

| (14) | Servier was found to be dominant on the market for perindopril in the United Kingdom, France, the Netherlands and Poland, for the period starting in 2000 and ending between 2007 and 2009 (depending on the specific national market). |
| --- | --- |

(14)

Servier was found to be dominant on the market for perindopril in the United Kingdom, France, the Netherlands and Poland, for the period starting in 2000 and ending between 2007 and 2009 (depending on the specific national market).

| (15) | The decision also delineates a market for the technologies to produce perindopril API. The conclusion was notably based on the inelasticity of demand as highlighted by several factors (for instance, the lack of possibility to use API technology for other medicines to make perindopril API). Servier was equally found to be dominant on the technology market at least in the period 2001-2007. |
| --- | --- |

(15)

The decision also delineates a market for the technologies to produce perindopril API. The conclusion was notably based on the inelasticity of demand as highlighted by several factors (for instance, the lack of possibility to use API technology for other medicines to make perindopril API). Servier was equally found to be dominant on the technology market at least in the period 2001-2007.

2.   Application of Article 101 of the Treaty to patent settlement agreements

(a)   Assessment as restrictions by object within the meaning of Article 101(1) of the Treaty

| (16) | Based on the jurisprudence of the Court of Justice of the European Union, the Commission found in its decision that patent settlements agreements, like any other agreements, are subject to Union competition law. The decision takes the view that an agreement which settles litigation and entails limitations on the generic company's commercial freedom in return for a value transfer may, in the specific circumstances of the case, be considered as a restriction of competition by object within the meaning of Article 101(1) of the Treaty. |
| --- | --- |

(16)

Based on the jurisprudence of the Court of Justice of the European Union, the Commission found in its decision that patent settlements agreements, like any other agreements, are subject to Union competition law. The decision takes the view that an agreement which settles litigation and entails limitations on the generic company's commercial freedom in return for a value transfer may, in the specific circumstances of the case, be considered as a restriction of competition by object within the meaning of Article 101(1) of the Treaty.

| (17) | In order to identify whether each agreement covered by the decision had the potential to restrict competition by its very nature, the Commission analysed the specific facts of the case relating to each agreement to determine whether:






  — | the generic undertaking and the originator undertaking were at least potential competitors, |
| --- | --- | --- |

(17)

In order to identify whether each agreement covered by the decision had the potential to restrict competition by its very nature, the Commission analysed the specific facts of the case relating to each agreement to determine whether:

—

the generic undertaking and the originator undertaking were at least potential competitors,

| — | the generic undertaking committed itself in the agreement to limit, for the duration of the agreement, its independent efforts to enter one or more EU markets with a generic product, and |
| --- | --- |

—

the generic undertaking committed itself in the agreement to limit, for the duration of the agreement, its independent efforts to enter one or more EU markets with a generic product, and

| — | the agreement was related to a transfer of value from the originator undertaking, as a significant inducement, which substantially reduced the incentives of the generic undertaking to independently pursue its efforts to enter one or more EU markets with the generic product. |
| --- | --- |

—

the agreement was related to a transfer of value from the originator undertaking, as a significant inducement, which substantially reduced the incentives of the generic undertaking to independently pursue its efforts to enter one or more EU markets with the generic product.

The Commission's assessment took into account the economic and legal context leading up to the agreement's conclusion, the actual content and objectives of the agreement, and each party's subjective intentions, as evidenced by the facts of the case.

| (18) | In the present case, other important factors were also taken into consideration.






  — | First, the restrictions either lasted throughout the entire period of the patent term, or did not contain any commitment by Servier to refrain from infringement proceedings in case of independent entry with the relevant generic products after the expiry of the agreement. |
| --- | --- | --- |

(18)

In the present case, other important factors were also taken into consideration.

—

First, the restrictions either lasted throughout the entire period of the patent term, or did not contain any commitment by Servier to refrain from infringement proceedings in case of independent entry with the relevant generic products after the expiry of the agreement.

| — | Second, in most, if not all, agreements, the value Servier transferred to generics took into consideration the turnover or the profit the generic undertaking expected if it had successfully entered the market. |
| --- | --- |

—

Second, in most, if not all, agreements, the value Servier transferred to generics took into consideration the turnover or the profit the generic undertaking expected if it had successfully entered the market.

| — | Third, the obligations on certain generic undertakings in the agreement went beyond the rights granted to patent holders, as the restrictions in some agreements went beyond what Servier could have legally obtained through successful enforcement of its patents in the underlying disputes/litigation. |
| --- | --- |

—

Third, the obligations on certain generic undertakings in the agreement went beyond the rights granted to patent holders, as the restrictions in some agreements went beyond what Servier could have legally obtained through successful enforcement of its patents in the underlying disputes/litigation.

| (19) | The Commission's analysis of the individual patent settlement agreements established that the content, objectives, and legal and economic context of the patent settlement agreements concluded between Servier and the generic companies constituted restrictions by object. |
| --- | --- |

(19)

The Commission's analysis of the individual patent settlement agreements established that the content, objectives, and legal and economic context of the patent settlement agreements concluded between Servier and the generic companies constituted restrictions by object.

(b)   Assessment as restrictions by effect within the meaning of Article 101(1) of the Treaty

| (20) | According to settled case law, there is no need to take account of the concrete effects of an agreement when it is established that it has as its object the restriction of competition. |
| --- | --- |

(20)

According to settled case law, there is no need to take account of the concrete effects of an agreement when it is established that it has as its object the restriction of competition.

| (21) | For the sake of completeness, the Commission analysed the likely restrictive effects of the patent settlement agreements on competition. In doing so, it took into account the actual conditions in which the agreements produced their effects, namely the economic and legal context, the nature of the product concerned, the real operating conditions and the structure of the market concerned; as well as, the existing and potential competition. |
| --- | --- |

(21)

For the sake of completeness, the Commission analysed the likely restrictive effects of the patent settlement agreements on competition. In doing so, it took into account the actual conditions in which the agreements produced their effects, namely the economic and legal context, the nature of the product concerned, the real operating conditions and the structure of the market concerned; as well as, the existing and potential competition.

| (22) | For the markets in the United Kingdom, France, the Netherlands and Poland (14), the Commission concluded that each of the patent settlement agreements (including related agreements) was likely to entail restrictive effects on competition in view of the competition that would have existed absent the agreement and the limited degree of remaining competition. |
| --- | --- |

(22)

For the markets in the United Kingdom, France, the Netherlands and Poland (14), the Commission concluded that each of the patent settlement agreements (including related agreements) was likely to entail restrictive effects on competition in view of the competition that would have existed absent the agreement and the limited degree of remaining competition.

(c)   Assessment under Article 101(3) of the Treaty

| (23) | None of the parties submitted the evidence necessary to show that all four conditions for the application of Article 101(3) of the Treaty had been met. |
| --- | --- |

(23)

None of the parties submitted the evidence necessary to show that all four conditions for the application of Article 101(3) of the Treaty had been met.

3.   Application of Article 102 of the Treaty to a technology acquisition and patent settlement agreements

| (24) | The decision established that Servier abused its dominant position by pursuing an exclusionary strategy consisting of a series of transactions (a technology acquisition and five patent settlement agreements). Servier's exclusionary strategy aimed at removing the closest sources of competition to its branded perindopril. |
| --- | --- |

(24)

The decision established that Servier abused its dominant position by pursuing an exclusionary strategy consisting of a series of transactions (a technology acquisition and five patent settlement agreements). Servier's exclusionary strategy aimed at removing the closest sources of competition to its branded perindopril.

| (25) | Concerning the technology acquisition, the decision found that the Azad technology to produce an API not covered by Servier's patents was potentially enabling and represented a potential source of competition on the API market and the final product market. The acquired technology was never put to use by Servier. Evidence shows that it was a part of Servier's ‘defence mechanism.’ Servier's acquisition foreclosed an important and very scarce source of potential competition. Competition was not removed on the merits of Servier's technology, but by an acquisition eliminating this independent source. This distorted the competitive structure of the perindopril markets identified by the Commission and contributed to the likely foreclosure effects of Servier's exclusionary strategy, making generic entry more difficult, or delayed. |
| --- | --- |

(25)

Concerning the technology acquisition, the decision found that the Azad technology to produce an API not covered by Servier's patents was potentially enabling and represented a potential source of competition on the API market and the final product market. The acquired technology was never put to use by Servier. Evidence shows that it was a part of Servier's ‘defence mechanism.’ Servier's acquisition foreclosed an important and very scarce source of potential competition. Competition was not removed on the merits of Servier's technology, but by an acquisition eliminating this independent source. This distorted the competitive structure of the perindopril markets identified by the Commission and contributed to the likely foreclosure effects of Servier's exclusionary strategy, making generic entry more difficult, or delayed.

| (26) | The technology acquisition was complemented by Servier's successive conclusion of five patent settlement agreements, which were capable of protecting or likely to protect Servier's market position and deviated from competition on the merits, and contributed to the overall effects of Servier's single and continuous infringement of Article 102 of the Treaty. |
| --- | --- |

(26)

The technology acquisition was complemented by Servier's successive conclusion of five patent settlement agreements, which were capable of protecting or likely to protect Servier's market position and deviated from competition on the merits, and contributed to the overall effects of Servier's single and continuous infringement of Article 102 of the Treaty.

| (27) | Servier's consistent and linear course of action in buying out potential sources of competition both by means of an intellectual property acquisition and reverse payment patent settlements was found to deviate from competition on the merits. Servier's efficiency claims concerning the technology acquisition and patent settlement agreements were unsubstantiated and did not meet the conditions for such conduct to be objectively justified. |
| --- | --- |

(27)

Servier's consistent and linear course of action in buying out potential sources of competition both by means of an intellectual property acquisition and reverse payment patent settlements was found to deviate from competition on the merits. Servier's efficiency claims concerning the technology acquisition and patent settlement agreements were unsubstantiated and did not meet the conditions for such conduct to be objectively justified.

| (28) | Servier's exclusionary strategy, implemented through the aforementioned six transactions concluded within the space of 27 months, thus constitutes a single and continuous infringement of Article 102 of the Treaty in the period 2004-2009 on the market for perindopril formulations in the United Kingdom, France, the Netherlands and Poland, and on the EU market for perindopril API technology. In the decision, none of the constitutive elements is found to constitute a stand-alone infringement of Article 102 of the Treaty. |
| --- | --- |

(28)

Servier's exclusionary strategy, implemented through the aforementioned six transactions concluded within the space of 27 months, thus constitutes a single and continuous infringement of Article 102 of the Treaty in the period 2004-2009 on the market for perindopril formulations in the United Kingdom, France, the Netherlands and Poland, and on the EU market for perindopril API technology. In the decision, none of the constitutive elements is found to constitute a stand-alone infringement of Article 102 of the Treaty.

4.   PARENTAL LIABILITY

| (29) | All subsidiaries of parent companies held liable for the relevant infringement were wholly-owned by their parent company, except Niche and Matrix. The Commission considered that the presumption of decisive influence applied in this case and held the parent jointly and severally liable with the subsidiary. |
| --- | --- |

(29)

All subsidiaries of parent companies held liable for the relevant infringement were wholly-owned by their parent company, except Niche and Matrix. The Commission considered that the presumption of decisive influence applied in this case and held the parent jointly and severally liable with the subsidiary.

| (30) | With respect to Niche, 60 % of its shares were owned by Unichem for part of the infringement period. As to Matrix, 71,5 % of its shares were acquired by Mylan during the infringement period. The Commission found that Unichem and Mylan exercised decisive influence over their respective subsidiaries, and held these parent companies jointly and severally liable for the fine. |
| --- | --- |

(30)

With respect to Niche, 60 % of its shares were owned by Unichem for part of the infringement period. As to Matrix, 71,5 % of its shares were acquired by Mylan during the infringement period. The Commission found that Unichem and Mylan exercised decisive influence over their respective subsidiaries, and held these parent companies jointly and severally liable for the fine.

5.   ADDRESSEES

| (31) | The following companies were addressees of the Commission's decision:






  — | Servier S.A.S. |
| --- | --- | --- |

(31)

The following companies were addressees of the Commission's decision:

—

Servier S.A.S.

| — | Servier Laboratories Limited |
| --- | --- |

—

Servier Laboratories Limited

| — | Les Laboratoires Servier |
| --- | --- |

—

Les Laboratoires Servier

| — | Biogaran |
| --- | --- |

—

Biogaran

| — | Niche Generics Limited |
| --- | --- |

—

Niche Generics Limited

| — | Unichem Laboratories Limited |
| --- | --- |

—

Unichem Laboratories Limited

| — | Mylan Laboratories Limited |
| --- | --- |

—

Mylan Laboratories Limited

| — | Mylan Inc. |
| --- | --- |

—

Mylan Inc.

| — | Teva UK Limited |
| --- | --- |

—

Teva UK Limited

| — | Teva Pharmaceuticals Europe B.V. |
| --- | --- |

—

Teva Pharmaceuticals Europe B.V.

| — | Teva Pharmaceutical Industries Ltd |
| --- | --- |

—

Teva Pharmaceutical Industries Ltd

| — | Krka, tovarna zdravil, d.d., Novo mesto |
| --- | --- |

—

Krka, tovarna zdravil, d.d., Novo mesto

| — | Lupin Limited |
| --- | --- |

—

Lupin Limited

6.   FINES

| (32) | Taking into account the gravity and duration of the infringements to Articles 101 and 102 of the Treaty, and pursuant to the Guidelines on fines (15), the Commission imposed on Servier a total of fines of EUR 330 997 200 for the infringements in question; and on the generic undertakings (and their parent companies) a total of fines of EUR 96 699 308 for the infringement of Article 101 of the Treaty. |
| --- | --- |

(32)

Taking into account the gravity and duration of the infringements to Articles 101 and 102 of the Treaty, and pursuant to the Guidelines on fines (15), the Commission imposed on Servier a total of fines of EUR 330 997 200 for the infringements in question; and on the generic undertakings (and their parent companies) a total of fines of EUR 96 699 308 for the infringement of Article 101 of the Treaty.

| (33) | Regarding Servier, the fines take into account Servier's actual perindopril sales. Regarding Servier's generic counterparts, the fines cannot be calculated on the basis of sales value, since the anti-competitive behaviour was aimed at keeping them off the market. Therefore, the decision applied paragraph 37 of the Guidelines on fines (16) and relied on the value transfer received by the generic counterparts. The amount of the value transfer made by the originator to the generic undertaking encompasses various aspects that the parties may have considered when entering into the agreement, notably the strength of the potential entry. The fine calculated for Niche/Unichem exceeds the 10 % turnover limit and therefore the final amount of the fine was reduced. For all other undertakings, the fine remains below the 10 % turnover limit. |
| --- | --- |

(33)

Regarding Servier, the fines take into account Servier's actual perindopril sales. Regarding Servier's generic counterparts, the fines cannot be calculated on the basis of sales value, since the anti-competitive behaviour was aimed at keeping them off the market. Therefore, the decision applied paragraph 37 of the Guidelines on fines (16) and relied on the value transfer received by the generic counterparts. The amount of the value transfer made by the originator to the generic undertaking encompasses various aspects that the parties may have considered when entering into the agreement, notably the strength of the potential entry. The fine calculated for Niche/Unichem exceeds the 10 % turnover limit and therefore the final amount of the fine was reduced. For all other undertakings, the fine remains below the 10 % turnover limit.

| (34) | The specific fines imposed for the infringement of Articles 101 and 102 of the Treaty were as follows:






  — | For the infringement between Niche/Unichem and Servier of Article 101 of the Treaty:






  (a) | Niche Generics Limited and Unichem Laboratories Limited, jointly and severally liable: EUR 13 968 773; |
| --- | --- | --- | --- |

(34)

The specific fines imposed for the infringement of Articles 101 and 102 of the Treaty were as follows:

—

For the infringement between Niche/Unichem and Servier of Article 101 of the Treaty:

(a)

Niche Generics Limited and Unichem Laboratories Limited, jointly and severally liable: EUR 13 968 773;

| (b) | Servier S.A.S.; Les Laboratoires Servier; Servier Laboratories Limited, and Biogaran, jointly and severally liable: EUR 131 532 600. |
| --- | --- |

(b)

Servier S.A.S.; Les Laboratoires Servier; Servier Laboratories Limited, and Biogaran, jointly and severally liable: EUR 131 532 600.

| — | For the infringement between Matrix/Mylan and Servier of Article 101 of the Treaty:






  (a) | Mylan Laboratories Limited: EUR 17 161 140, of which EUR 8 045 914, jointly and severally liable with Mylan Inc.; |
| --- | --- | --- |

—

For the infringement between Matrix/Mylan and Servier of Article 101 of the Treaty:

(a)

Mylan Laboratories Limited: EUR 17 161 140, of which EUR 8 045 914, jointly and severally liable with Mylan Inc.;

| (b) | Servier S.A.S. and Les Laboratoires Servier, jointly and severally liable: EUR 79 121 700. |
| --- | --- |

(b)

Servier S.A.S. and Les Laboratoires Servier, jointly and severally liable: EUR 79 121 700.

| — | For the infringement between Teva and Servier of Article 101 of the Treaty:






  (a) | Teva UK Limited; Teva Pharmaceuticals Europe B.V. and Teva Pharmaceutical Industries Ltd, jointly and severally liable: EUR 15 569 395; |
| --- | --- | --- |

—

For the infringement between Teva and Servier of Article 101 of the Treaty:

(a)

Teva UK Limited; Teva Pharmaceuticals Europe B.V. and Teva Pharmaceutical Industries Ltd, jointly and severally liable: EUR 15 569 395;

| (b) | Servier S.A.S.; Les Laboratoires Servier and Servier Laboratories Limited, jointly and severally liable: EUR 4 309 000. |
| --- | --- |

(b)

Servier S.A.S.; Les Laboratoires Servier and Servier Laboratories Limited, jointly and severally liable: EUR 4 309 000.

| — | For the infringement between Krka and Servier of Article 101 of the Treaty:






  (a) | Krka, tovarna zdravil, d.d., Novo mesto: EUR 10 000 000; |
| --- | --- | --- |

—

For the infringement between Krka and Servier of Article 101 of the Treaty:

(a)

Krka, tovarna zdravil, d.d., Novo mesto: EUR 10 000 000;

| (b) | Servier S.A.S. and Les Laboratoires Servier, jointly and severally liable: EUR 37 661 800. |
| --- | --- |

(b)

Servier S.A.S. and Les Laboratoires Servier, jointly and severally liable: EUR 37 661 800.

| — | For the infringement between Lupin and Servier of Article 101 of the Treaty:






  (a) | Lupin Limited: EUR 40 000 000; |
| --- | --- | --- |

—

For the infringement between Lupin and Servier of Article 101 of the Treaty:

(a)

Lupin Limited: EUR 40 000 000;

| (b) | Servier S.A.S. and Les Laboratoires Servier, jointly and severally liable: EUR 37 102 100. |
| --- | --- |

(b)

Servier S.A.S. and Les Laboratoires Servier, jointly and severally liable: EUR 37 102 100.

| — | For the infringement of Servier of Article 102 of the Treaty:






  (a) | Servier S.A.S. jointly and severally liable with Les Laboratoires Servier: EUR 41 270 000. |
| --- | --- | --- |

—

For the infringement of Servier of Article 102 of the Treaty:

(a)

Servier S.A.S. jointly and severally liable with Les Laboratoires Servier: EUR 41 270 000.

| (35) | The Commission ordered the undertakings concerned to refrain from repeating any act or conduct having the same or similar object or effect. |
| --- | --- |

(35)

The Commission ordered the undertakings concerned to refrain from repeating any act or conduct having the same or similar object or effect.

---

(1)  OJ L 1, 4.1.2003, p. 1.

(2)  Companies of the Servier group will be referred to as ‘Servier.’

(3)  Except as regards: Latvia, where the infringement started on 1 July 2005; Bulgaria and Romania, where the infringement started on 1 January 2007; and Malta, where the infringement started on 1 March 2007.

(4)  Except as regards: the United Kingdom, where the infringement ended on 6 July 2007; and the Netherlands, where the infringement ended on 12 December 2007.

(5)  See footnote 3. Mylan Inc.'s infringement started on 8 January 2007 until the end date of the infringement.

(6)  See footnote 4.

(7)  Except as regards: Bulgaria and Romania, where the infringement started on 1 January 2007; Malta, where the infringement started on 1 March 2007; and Italy, where the infringement started on 13 February 2009.

(8)  See footnote 4.

(9)  Except as regards: Malta, where the infringement started on 1 March 2007; and Italy, where the infringement started on 13 February 2009.

(10)  Except as regards: the United Kingdom, where the infringement ended on 6 July 2007; the Netherlands, where the infringement ended on 12 December 2007; and France, where the infringement ended on 16 September 2008.

(11)  With regard to Lupin, the end date in France was 16.9.2008, which was the last day before limited-scale generic entry freed Lupin from the non-entry obligation.

(12)  Niche concluded an additional deal with Biogaran, Servier's generic subsidiary, for an extra GBP 2,5 million as part of ‘the overall settlement consideration.’

(13)  Followed by an IPR purchase by Servier for EUR 30 million on 5 January 2007.

(14)  The Teva patent settlement agreement was only found to restrict competition in the United Kingdom, and the Krka patent settlement agreements in the United Kingdom, France and the Netherlands.

(15)  Guidelines on the method of setting fines imposed pursuant to Article 23(2)(a) of Regulation (EC) No 1/2003 (OJ C 210, 1.9.2006, p. 2) (‘Guidelines on fines’).

(16)  Paragraph 37 of the Guidelines on fines foresees that ‘the particularities of a given case or the need to achieve deterrence in a particular case may justify departing from [the general] methodology.’

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V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 25.10.2016 | EN | Official Journal of the European Union | C 393/13 |
| --- | --- | --- | --- |

25.10.2016

EN

Official Journal of the European Union

C 393/13

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Prior notification of a concentration

(Case M.8250 — Ardian/Weber Automotive)

Candidate case for simplified procedure

(Text with EEA relevance)

(2016/C 393/06)

| 1. | On 17 October 2016, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Ardian SAS (‘Ardian’, France) will acquire sole control over Weber Automotive GmbH (‘Weber Automotive’, Germany) within the meaning of Article 3(1)(b) of the Merger Regulation, by way of a purchase of shares. |
| --- | --- |

1.

On 17 October 2016, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Ardian SAS (‘Ardian’, France) will acquire sole control over Weber Automotive GmbH (‘Weber Automotive’, Germany) within the meaning of Article 3(1)(b) of the Merger Regulation, by way of a purchase of shares.

| 2. | The business activities of the undertakings concerned are:






  — | Ardian is an independent private investment firm based in Paris, which manages several funds that specialise in private equity investment and asset management for institutional investors. |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

Ardian is an independent private investment firm based in Paris, which manages several funds that specialise in private equity investment and asset management for institutional investors.

| — | Weber Automotive manufactures and sells automotive components, in particular, machined power train components, including engine blocks, cylinder heads, transmission housings and casings. The company also assembles drive trains for vehicles. |
| --- | --- |

—

Weber Automotive manufactures and sells automotive components, in particular, machined power train components, including engine blocks, cylinder heads, transmission housings and casings. The company also assembles drive trains for vehicles.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference M.8250 — Ardian/Weber Automotive, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference M.8250 — Ardian/Weber Automotive, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

(2)  OJ C 366, 14.12.2013, p. 5.

---

| 25.10.2016 | EN | Official Journal of the European Union | C 393/14 |
| --- | --- | --- | --- |

25.10.2016

EN

Official Journal of the European Union

C 393/14

---

Prior notification of a concentration

(Case M.8232 — Diamond Offshore Wind Holdings II/Eneco Wind Belgium/Elnu/Norther)

Candidate case for simplified procedure

(Text with EEA relevance)

(2016/C 393/07)

| 1. | On 14 October 2016, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Eneco Wind Belgium NV (‘EWB’, Belgium) controlled by Eneco Holding NV, Elnu NV (Belgium) controlled by Elicio NV, and Diamond Offshore Wind Holdings II BV (‘DOWH’, Belgium) controlled by Mitsubishi Corporation, acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of Norther NV (‘Norther’, Belgium) by way of purchase of shares. |
| --- | --- |

1.

On 14 October 2016, the Commission received notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Eneco Wind Belgium NV (‘EWB’, Belgium) controlled by Eneco Holding NV, Elnu NV (Belgium) controlled by Elicio NV, and Diamond Offshore Wind Holdings II BV (‘DOWH’, Belgium) controlled by Mitsubishi Corporation, acquire within the meaning of Article 3(1)(b) of the Merger Regulation joint control of Norther NV (‘Norther’, Belgium) by way of purchase of shares.

| 2. | The business activities of the undertakings concerned are:






  — | EWB is active in Belgium in the production of electricity from wind energy. EWB participates in and manages both ‘onshore’ and ‘offshore’ wind farm projects. For onshore wind farms, EWB is active at both the development stage and the exploitation stage, for offshore wind farms, EWB is in Belgium currently only active at the development stage. |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

EWB is active in Belgium in the production of electricity from wind energy. EWB participates in and manages both ‘onshore’ and ‘offshore’ wind farm projects. For onshore wind farms, EWB is active at both the development stage and the exploitation stage, for offshore wind farms, EWB is in Belgium currently only active at the development stage.

| — | Elnu is a 100 % subsidiary of Elicio NV (‘Elicio’). In Belgium, Elicio (through its subsidiaries) generates electricity from operational onshore wind farms and is developing various projects relating to the production of biomass and wind energy (including offshore wind farms). Elicio is a subsidiary of Nethys SA. |
| --- | --- |

—

Elnu is a 100 % subsidiary of Elicio NV (‘Elicio’). In Belgium, Elicio (through its subsidiaries) generates electricity from operational onshore wind farms and is developing various projects relating to the production of biomass and wind energy (including offshore wind farms). Elicio is a subsidiary of Nethys SA.

| — | DOWH is a vehicle set up by Diamond Generating Europe Limited, a 100 % subsidiary of Mitsubishi Corporation (‘MC’). MC is a Japanese company active at global level in various industries. It currently does not have any activities in Belgium in the wind sector. |
| --- | --- |

—

DOWH is a vehicle set up by Diamond Generating Europe Limited, a 100 % subsidiary of Mitsubishi Corporation (‘MC’). MC is a Japanese company active at global level in various industries. It currently does not have any activities in Belgium in the wind sector.

| — | Norther is an existing joint venture between EWB and Elnu. Norther will own, operate and maintain a wind farm located in the North Sea. |
| --- | --- |

—

Norther is an existing joint venture between EWB and Elnu. Norther will own, operate and maintain a wind farm located in the North Sea.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of the Merger Regulation. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in this Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference M.8232 — Diamond Offshore Wind Holdings II/Eneco Wind Belgium/Elnu/Norther, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference M.8232 — Diamond Offshore Wind Holdings II/Eneco Wind Belgium/Elnu/Norther, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

(2)  OJ C 366, 14.12.2013, p. 5.

---