# C_2016393EN.01000401.xml

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

EN

Official Journal of the European Union

C 393/4

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Final Report of the Hearing Officer (1)

1

Perindopril (Servier)

(AT.39612)

(2016/C 393/04)

Introduction

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. |
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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’). |
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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’).

ex officio

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Statement of Objections

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. |
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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. |
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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.

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Access to the file

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. |
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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

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. |
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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. |
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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. |
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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

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). |
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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).

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Time limit to reply to the SO

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. |
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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. |
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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

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. |
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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.

The Secretary of State for Health and Others

Servier Laboratories Limited and Others

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

Oral hearing

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

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

Letters of facts

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. |
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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. |
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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. |
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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

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. |
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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.

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| 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. |
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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.

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The draft decision

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. |
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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. |
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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).

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(2)  Formerly Matrix Laboratories Limited.

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

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

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(5)  Active Pharmaceutical Ingredient.

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(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.

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(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.

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(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.

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

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Cimenteries and Others

Commission

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