Final Report of the Hearing Officer – Case AT.40588 – Teva Copaxone
Date: 2024-10-29
Institutions: Directorate-General for Competition, European Commission
Subjects: EU competition policy, control of restrictive practices, disease of the nervous system, dominant position, medicinal product, sanction (EU)




C_202501679EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/1679


19.3.2025






Final Report of the Hearing Officer (1)

Case AT.40588 – Teva Copaxone
(C/2025/1679)

1.   INTRODUCTION









1.


The draft decision concerns an abuse of a dominant position by Teva Pharmaceutical Industries Ltd and Teva Pharmaceuticals Europe B.V., (together ‘Teva’). The Commission takes issue with Teva’s conduct related to the medicine glatiramer acetate (‘GA’), branded under the name ‘Copaxone’, used to treat the most common form of multiple sclerosis. The infringement, as established in the draft decision, concerns two types of anti-competitive conduct: 1) misuse of patent procedures before the European Patent Office (‘EPO’), by creating multiple divisional patents, staggering their filing and strategically withdrawing them to obstruct their effective review and prolong legal uncertainty; and 2) engaging in disparagement practices, to discredit the only competing GA medicine available and hinder or delay its market entry and uptake.




2.   INVESTIGATION PHASE









2.


Between 24 to 28 October 2019, the Commission carried out unannounced inspections pursuant to Article 20(4) of Regulation 1/2003 (2) at Teva’s premises in the Netherlands, Germany, and the United Kingdom based on market information, which suggested that Teva might have been abusing its dominance within the field of multiple sclerosis medicines. In the period from December 2019 until February 2020, a continued inspection of Teva’s documents took place in the Commission’s premises in the presence of Teva representatives.












3.


From 3 June 2020 to 13 July 2022, the Commission sent six requests for information (‘RFIs’) to Teva, pursuant to Article 18(2) of Regulation 1/2003. In addition, on 25 May 2023, the Commission addressed a request for information by decision pursuant to Article 18(3) of Regulation 1/2003 to Teva. After the initiation of proceedings, the Commission also sent RFIs to the manufacturer and licensees of the only competing GA medicine, health care authorities, and health insurance bodies.












4.


On 4 March 2021, the Commission initiated proceedings against Teva pursuant to Article 2 of Regulation 773/2004. (3)













5.


On 5 May 2021 and on 5 October 2022, the Commission held state of play meetings with Teva.




3.   FORMAL COMPLAINANTS









6.


In accordance with Articles 7(2) of Regulation 1/2003 and 5(1) of Regulation 773/2004, between 7 October 2022 and 8 December 2022, three legal persons submitted formal complaints in this case: […] (*1) (‘[…]’), […], which after a merger operates under the name […] (‘[…]’ or ‘[…]’), and […], the holding company of the […] (‘[…]’), (together, the ‘Complainants’). […] and […] submitted a joint complaint on 7 October 2022 (the ‘[…] complaint’), whereas […] submitted a complaint on 8 December 2022 (together, the ‘complaints’ or ‘formal complaints’).












7.


These formal complaints followed the submissions made by […] and […] on 7 April 2017 (4) and engagement with the Complainants throughout the investigation and prior to the adoption of the Statement of Objections (‘SO’), since as early as 2016.












8.


On 15 November, 29 November and 19 December 2022, […], […] and […] (respectively) received a non-confidential version of the SO, in accordance with Article 6(1) of Regulation 773/2004, and they all submitted their responses on 18 January 2023. Moreover, they received a non-confidential version of Teva’s reply to the statement of objections (‘SO Reply’) on 1 March 2023.




4.   WRITTEN PROCEDURE

4.1.   Statement of Objections









9.


The Commission adopted the SO addressed to Teva on 10 October 2022, which was notified to it on 11 October 2022.












10.


In the SO, the Commission preliminarily found that Teva had committed two different abuses of a dominant position (on the one hand, divisional patent strategic filings and withdrawals and, on the other hand, disparagement) that each infringe Article 102 TFEU and that together constitute a single and continuous infringement of the same Article.




4.2.   Access to the File









11.


Teva was granted access to the file on 19 October 2022 (the ‘Initial Access to File’), Moreover, Teva received a copy of the non-confidential version of the two formal complaints on 3 November 2022 (for […] and […]) and on 16 December 2022 (for […]).












12.


On 19 January 2023, Teva received a copy of the Complainants’ written comments on the SO. Teva addressed the Complainants’ written comments in the SO Reply.












13.


Up to the submission of the SO Reply, Teva did not submit to the Commission any request to be granted further access to file.




4.3.   Written Reply to the SO









14.


DG Competition originally granted Teva a period of eight weeks from the working day following access to the file to submit its written SO Reply. The original deadline was therefore set on 15 December 2022.












15.


Teva made three requests before DG Competition for an extension of the time limit to reply to the SO, on 9 November 2022, 13 December 2022 and 23 January 2023. As a result, DG Competition granted three subsequent extensions – to 13 January, to 3 February and finally to 8 February 2023. In practice, therefore, the total time granted for Teva to reply to the SO (including all extensions) was 17 calendar weeks and one day.












16.


On 8 February 2023, Teva submitted the SO Reply.












17.


In the SO Reply, Teva raised a series of concerns of a procedural nature. (5) Teva’s overarching procedural claim was that the Commission was in breach of its duty of impartiality. According to Teva, this breach was evidenced by two aspects of the procedure: (i) the handling of the complaints by the Commission, (6) and (ii) certain elements in the file showing “a clear bias against Teva”. (7)













18.


In addition, and in connection with its claim on lack of impartiality, in the SO Reply Teva submitted that, by failing to “take notes of a meeting or call that has as its purpose the intention to gather information relevant to the investigation[,] or take sufficiently detailed notes[,] or include meeting notes in the case file”, the Commission has committed a procedural error, (8) ultimately breaching Teva’s rights of defence. (9)













19.


In that regard, Teva specifically listed a total of 23 meetings or calls that, based on the documents available in the file, appeared to have taken place in the course of the proceedings, noting that minutes had only been provided for seven of those meetings or calls, thus implying that minutes were missing for 16 meetings or calls. (10) Teva also noted that there was insufficient detail in the file for Teva to determine with certainty the dates of calls and meetings which took place in the course of the Commission’s investigation, and whether any discussions constituted information gathering for which meeting notes should have been recorded and provided in the case file. Therefore, Teva submitted that was unable to review and confirm if the content of such discussions could be relevant to its defence. (11)













20.


In the SO Reply, Teva requested to be heard orally.




4.4.   Oral Hearing









21.


The oral hearing took place on 24 March 2023 and was attended by representatives of Teva and the Complainants ([…], […] and […]). The Complainants were represented each by their own executives and in-house counsel, and jointly represented by external counsel, who made a joint presentation for the Complainants.












22.


On the eve of the oral hearing, Teva complained about the fact that the Complainants’ presentation rebutted Teva’s SO Reply, as explained and addressed later in this report.












23.


Following up from the oral hearing, on 24 April 2023 Teva submitted further written comments on the presentations made by the Complainants during the oral hearing, making use of the possibility afforded by me during the oral hearing pursuant to Article 12(4) of Decision 2011/695/EU. Teva’s comments were subsequently shared with all other participants in the oral hearing, on 28 April 2023.




4.5.   Developments after the oral hearing









24.


In reaction to Teva’s procedural concern set out in the SO Reply that the Commission had failed to give access to records of contacts between the Commission and the Complainants mentioned in paragraph 18 above, DG Competition carried out an extensive review of contacts between the Commission and third parties during the investigation, including, but not limited to, certain instances of possible contacts mentioned by Teva in the SO Reply. (12)













25.


As a result of that review, on 19 July 2023, Teva was granted supplemental access to file (the ‘Supplemental Access to File’) to (i) additional email correspondence, and their attachments, between DG Competition and the Complainants’ counsel that had not been registered as part of the file by DG Competition before, and (ii) additional records, in the form of Commission minutes approved by the Complainants, for 24 oral exchanges between the case team and the Complainants or their external counsels (the ‘Ex-Post Minutes’). (13) The Ex-Post Minutes had all been drafted in late June 2023 and approved by the Complainants’ counsel on 13 July 2023. They corresponded to 23 calls and one in-person meeting. (14)













26.


On 9 November 2023, Teva submitted observations on the Supplemental Access to File (the ‘Observations’) including a request for further access to the Commission’s file, concerning: (15)







(i)


the following categories of “contemporaneous email exchanges with the Complainants”:






a.


contemporaneous records or “detailed minutes” of meetings with the Complainants that either (a) were used to prepare the Ex-Post Minutes or (b) record meetings for which no note had been provided to Teva;










b.


any email exchanges between the Commission and the Complainants relating to the Ex-Post Minutes, including the “underlying mark-ups” to the Ex-Post Minutes; and














(ii)


notes or minutes of certain specified meetings between the Commission and the Complainants that Teva identified as missing in the Observations. Specifically, Teva identified 8 additional “meetings” for which no record had been provided to Teva. (16) In addition, Teva noted that meeting records had still not been provided to Teva for 8 out of the 16 calls or meetings listed by Teva in the SO Reply as not having any corresponding minutes. (17)

















27.


On 9 February 2024, the Commission issued a first Letter of Facts to Teva (‘First Letter of Facts’).












28.


With the First Letter of Facts, the Commission granted Teva access to additional documents in the case file. These included at least 227 exchanges between the Commission and the Complainants (mostly emails and their attachments) that took place after the Initial Access to File in October 2022. (18)













29.


On 26 March 2024, Teva submitted a written reply to the First Letter of Facts (19) (‘Reply to the First Letter of Facts’), which included claims in relation to the incompleteness of the access to file granted to Teva. Specifically, Teva claimed that the Commission did not, and could not, remedy after the oral hearing its “failure” to provide full access to file to Teva.












30.


On 17 May 2024, the Commission issued a second Letter of Facts to Teva (‘Second Letter of Facts’) and granted Teva access to file documents collected or created since the First Letter of Facts.












31.


On 11 June 2024, Teva submitted a written reply to the Second Letter of Facts. (20)













32.


On 5 July 2024, the Commission sent to Teva a letter addressing Teva’s procedural concerns as expressed in the SO Reply, the Observations and the Reply to the First Letter of Facts, explaining in detail the actions undertaken by the Commission to address those concerns (in particular those regarding the records of exchanges and contacts between the Commission and the complainants), and dismissing the further access to file request contained in Teva’s Observations, beyond the further access granted with the First Letter of Facts (‘Letter on Further Access’).












33.


On 19 July 2024, Teva replied to the Letter on Further Access, elaborating on the reasons why it considered that the Commission had committed procedural errors by failing to disclose adequate records of certain contacts between the Commission and the Complainants, in breach of Teva’s rights of defence (‘Letter of 19 July 2024’). With the Letter of 19 July 2024, and following a review of the documents to which it had so far received access, Teva pointed at 24 additional possible “meetings” between the Commission and the Complainants, and requested access to adequate records of those “meetings”. (21)













34.


On 2 September 2024, the Commission sent a letter to Teva, rebutting again Teva’s arguments on the issue of the records of calls and meetings and Teva’s claim that its rights of defence had not been respected (‘Letter of 2 September 2024’). With this letter, the Commission rejected as unfounded Teva’s request for further access to file contained in the Letter of 19 July 2024.












35.


On 16 September 2024, Teva made a further submission to the Commission on the issue of the records of calls and meetings, in response to the Letter of 2 September 2024 (‘Submission of 16 September 2024’). In this submission, Teva no longer insisted on its request for records of five alleged contacts that it had listed in the Observations and the Letter of 19 July 2024, which never took place according to the Commission’s Letter of 2 September 2024. (22)













36.


All calls and meetings for which Teva requested access to adequate records, and for which no records within the meaning of Article 19 of Regulation 1/2003 have been produced or considered necessary by the Commission are referred to in this report as the ‘Additional Contacts’. These include: (i) 7 contacts specified by Teva in the SO Reply, and for which no Ex-Post Minutes were provided, (23) (ii) 8 contacts specified, additionally, by Teva in the Observations, (24) and (iii) 24 contacts specified by Teva in the Letter of 19 July 2024. (25) Overall, a total of 39 Additional Contacts were specified by Teva through the proceedings. However, I do not need to consider in this report the five Additional Contacts for which Teva did not insist on obtaining records in the Submission of 16 September 2024. (26) Therefore, no more than 34 Additional Contacts are considered in this report.












37.


On 20 September 2024, the Commission replied via email to Teva’s Submission of 16 September 2024 (‘Email of 20 September 2024’). In light of Teva’s remarks made in the Submission of 16 September of 2024 that no Commission internal records were available to Teva in the case file concerning a number of contacts held between the Commission and the Complainants, the Commission noted that internal documents are not accessible pursuant to Art. 27(2) of Regulation 1/2003, reminding Teva that this applies also to internal notes about contacts which the Commission has no obligation to record.












38.


On 25 September 2024, Teva replied to the Commission’s Email of 20 September of 2024, drawing attention to alleged contradictions or lack of clarity it the Commission’s use of internal notes and its request for the Complainants’ own recollection of calls and meetings for the purposes of identifying contacts for which records should be provided to Teva (‘Email of 25 September 2024’).












39.


No further written exchanges took place between the Commission and Teva concerning Teva’s access to file concerns after 25 September 2024.












40.


Throughout the proceedings, Teva did not submit to me any request for further access to file pursuant to Article 7(1) of Decision 2011/695/EU.












41.


On 27 September 2024, the Commission held a state of play meeting with Teva, in anticipation of the adoption of a decision pursuant to Article 7 of Regulation 1/2003.












42.


On 16 October 2024, the Commission issued a third Letter of Facts to Teva (‘Third Letter of Facts’), informing Teva about additional “evidence” (namely certain preliminary opinions and decisions of the Opposition Division of the EPO) on which the Commission could rely in the anticipated decision pursuant to Article 7 of Regulation 1/2003 to rebut certain claims made by Teva through the proceedings. This “evidence” had not been previously made available to Teva by the Commission, but was obtained from publicly available sources and related to patent proceedings involving Teva. Teva was then given until close of business on 21 October 2024 to respond to the Third Letter of Facts.












43.


On 18 October 2024, Teva requested an extension of the deadline to respond to the Third Letter of Facts until 31 October 2024. On the same day, DG Competition partially granted an extension, until close of business on 22 October 2024. On 21 October 2024 (and having announced its intentions on 19 October 2024), Teva asked me to grant a further extension of the deadline to respond to the Third Letter of Facts until at least 28 October 2024. I granted an extension until noon (Brussels time) on 28 October 2024.












44.


By noon on 28 October 2024, Teva submitted a written reply to the Third Letter of Facts.




5.   PROCEDURAL ARGUMENTS OF NOTE









45.


As mentioned, starting with the SO Reply Teva made a number of claims concerning alleged procedural errors in these proceedings and breaches of Teva’s rights of defence, which are discussed in this section.












46.


By way of introduction, and as noted in paragraphs 17 and 18 above, all these claims stem, to some extent, from Teva’s assertion that the Commission did not act impartially through the investigation, as demonstrated, according to Teva, by the Commission’s extensive reliance on the arguments and evidence provided by the Complainants and the content and spirit of certain communications with the Complainants. For instance, it is essentially in this context, or in light of its concern about the Commission’s lack of impartiality, that Teva complained about its late access to the “informal complaint” and it requested further access to the exchanges (namely emails and records of calls and meetings) between the Commission and the Complainants.












47.


It is therefore useful to address Teva’s complaint regarding the alleged breach of the Commission’s duty of impartiality first, before dealing with other procedural concerns in turn.




5.1.   Lack of impartiality









48.


Teva complained, in the SO Reply (27) and at the oral hearing, that the Commission violated its duty of impartiality and fair administration. These claims were further expanded as and when Teva had access to further correspondence between the Commission and the Complainants through the Supplemental Access to File and upon adoption of the First Letter of Facts.












49.


Teva claimed that the Commission directed the Complainants towards certain responses, that would give rise to findings in support of an infringement, and selectively chose facts which support its conclusions, instead of impartially seeking and examining the full evidence.












50.


As an example, in the SO Reply Teva pointed in particular to an email to the Complainants of 11 June 2019, which includes a statement from a Commission official that it is "important that we are able to convincingly rebut any argument that while Synthon/[…] GA may be therapeutically equivalent…this does not mean that patients who have been taking Copaxone successfully and without adverse effects can be switched…" (28). Teva criticises this type of language as inappropriate for an investigation, and notes that the Commission should have asked, in this instance, open questions about whether there could be adverse effects associated with switching and the prevailing scientific knowledge at the relevant time.












51.


As a further example, in the Observations, Teva drew attention to an email of 20 August 2019, where, in connection with a request for the Complainants to submit certain market share data, the Commission clarified that: "[t]he main point is simply to know whether Teva would still be dominant if the product market were larger than just MS medicines having GA as their active ingredient. We suspect that this might not be the case, but would appreciate your client’s assessment of this". (29) Teva described this as evidence that the Commission had prejudged the outcome of the investigation.












52.


Furthermore, Teva submits that there was no critical assessment by the Commission of the Complainants’ allegations. For instance, Teva referred in the SO Reply to the allegation that Teva fostered the development of the terms “Non-Biological Complex Drug” and “Follow-on GA product” to create prejudice against the entry of new GA drugs. Teva argued that the fact that the terms were used not only by manufacturers, but also by regulators, and that the Commission did not seek the opinions of other stakeholders on their perception of these terms, proves bias towards the Complainants’ narrative.












53.


More generally, Teva submits that the Commission’s “biased” investigation and approach is evidenced by a number of preliminary conclusions of the SO with which Teva disagrees, such as the allegation that encouraging patients to switch to Copaxone 40mg from 20mg was part of a strategy to evade competition. Teva also finds support for this claim in alleged contradictions by the Commission (e.g., between recognising Teva’s legitimate interest in intervening in regulatory and scientific debate to achieve a proper assessment of other GA products, and the description of such behaviour as a disparagement abuse), and in the allegedly selective use of evidence (e.g., on occasions where the Commission gives more weight to evidence provided by the Complainants than to evidence provided by Teva).












54.


I do not consider that the Commission has breached its obligations of impartiality and sound administration in the present case. The Commission may legitimately accept the Complainants’ arguments, if it finds them convincing, instead of Teva’s. The fact that Teva provides a different explanation as to the scope or nature of its conduct does not, by itself, force the Commission to agree with Teva’s submission or to proceed to further investigation.












55.


It is established case law that it is for the Commission to evaluate the evidence gathered through the investigation. The Commission has also discretion as to whether it is appropriate to adopt further investigative measures. An expression of the Commission’s bias cannot be inferred in the abstract from the existence of such a discretion as to how to conduct the investigation. (30) The Commission may dispute or reject an undertaking’s argument and this behaviour is not in itself proof that the Commission was biased. (31) Therefore, it is for the undertakings to put forward arguments specifically to demonstrate that certain conclusions could be explained only by the Commission’s bias and not by the Commission’s legitimate exercise of its discretion in conducting the investigation. (32) I do not think this has been done by Teva.












56.


As for the emails of 11 June 2019 and 20 August 2019 mentioned above, cited in this report as examples of the type of evidence relied upon by Teva to complain about the Commission’s lack of impartiality, it is true that they distil a proactive attitude on the part of DG Competition, which anticipated counterarguments of Teva in order to obtain, to the extent possible, undisputable evidence of an infringement. The emails also suggest that DG Competition was very transparent, in exchanges with the Complainants, about the type of objections that the evidence under consideration would attract. However, this does not necessarily mean that the discussions with the Complainants were inappropriate, or that the evidence obtained was tainted by the use of leading questions. An alternative interpretation of this type of communications could be that, in the context of their interaction with the Complainants (who are, by definition, consciously putting forward arguments against Teva), DG Competition tried to ensure that their accusations were backed by sufficiently robust evidence. This would have been entirely appropriate.




5.2.   Belated access to the “informal complaint”
                        









57.


Teva complained, in the SO Reply (33) and at the oral hearing, about the Commission not providing timely and full information of the “informal complaint” against it, and engaging in the preparation of its case in coordination with the Complainants, without informing Teva of the existence of any complaint, thereby infringing Teva’s procedural rights.












58.


Teva submitted, based on the information obtained through access to file, that the Commission commenced discussions with the Complainants in 2016, while the first formal complaint, by […], was submitted only on 7 October 2022 – that is, four days before the adoption of the SO. In the meantime, the Commission would have had extensive engagement with the Complainants, leading to the various investigative steps followed in the case (including unannounced inspections, RFIs, etc). In Teva’s view, the Commission should have considered the “informal complaint” a formal one and it should have shared a non-confidential version of it with Teva much earlier in the investigation, in line with the Antitrust Best Practices Notice. (34)













59.


Teva submitted that the late submission of formal complaints was a tactic that allowed the Commission and the Complainants to communicate and prepare their case for several years, without seeking the necessary engagement of Teva. According to Teva, had the “informal complaint” been considered a formal one, Teva would have had better access to information for its defence and it could also have stopped its allegedly infringing behaviour at an earlier point, thus preventing the duration of the alleged infringement from being prolonged.












60.


The mechanisms set out in the Antitrust Best Practices Notice establish, principally, that the Commission will, in cases based on a formal complaint, provide the parties subject to the proceedings the opportunity to comment on the complaint at the latest shortly after the opening of proceedings. (35) Whereas it would have been desirable for the Complainants to have submitted a formal complaint much earlier during the investigation so as to trigger the mechanisms set out in the Antitrust Best Practices Notice, the Commission has no power to force third parties to file formal complaints. It is a third party’s right to choose whether and at what stage it formally files a complaint and the Commission cannot deprive it of this choice, which entails certain rights and obligations for the complainant. The Commission may only encourage a complainant to make its complaint a formal one, insofar as this will enable the Commission to seek views from the parties under investigation, “in the spirit of encouraging an open exchange of views”. (36) In this case, all Complainants decided not to submit formal complaints until around the time of the SO.












61.


In any event, it is established case law that it is only at the SO stage that the rights of defence are fully engaged, (37) so as to avoid compromising the effectiveness of the Commission’s investigation. As for the claims that Teva would have had better access to information for its defence and could have put an early end to its conduct, should it have been informed earlier of the “informal complaint”, these arguments cannot be accepted. A party infringing competition law cannot find excuses for the infringement in the way the investigation is conducted, or wait for an investigation to be opened and communicated to it before it ceases to infringe the law.












62.


As for Teva’s argument that it could have had better access to information for its defence, I note that Teva knew that an investigation was in progress since the unannounced inspections carried out between 24 and 28 October 2019 took place. As the Court has held, account should be taken of the general duty of care attaching to any undertaking or association of undertakings, by virtue of which they are required to ensure the proper maintenance, in their books or files, of information enabling details of their activities to be retrieved, in order, inter alia, to have the necessary evidence available in the event of legal or administrative proceedings. (38) Therefore, as from 24 and 28 October 2019 it was incumbent on Teva to act with greater diligence and to take all appropriate measures in order to preserve such evidence as might reasonably be available to it.












63.


Therefore, I do not think that Teva’s rights of defence have been infringed as a result of the late submission of formal complaints.




5.3.   Irremediable errors in access to file









64.


In the SO Reply, and through several submissions made thereafter in these proceedings (Observations, Reply to the First Letter of Facts, Letter of 19 July 2024, Submission of 16 September 2024 and Email of 25 September 2024), Teva claimed that the Commission has failed to grant full access to file, and developed such concern at length.












65.


Teva’s allegations are, in essence, that: (i) it has not been given access to records of certain calls and meetings between the Commission and the Complainants, or access was given to records that were produced too late or lacked detail; and (ii) it required further access to correspondence between the Commission and the Complainants.












66.


Teva claims that its rights of defence have been irremediably breached as a result of the incompleteness of access to file.












67.


A distinction can be drawn between Teva’s claims concerning the process of access to file, and those that affect the completeness of access to certain types of information in the file. I will address the process of access to file in this section. The issues of completeness of access are addressed in turn in sections 5.4 and 5.5 below, dealing respectively with the issue of records of calls and meetings, and with Teva’s request for access to other classes of documents in the file.












68.


As regards the process, Teva has claimed that certain documents concerning the interactions between the Commission and the Complainants were disclosed too late for Teva to properly exercise its rights of defence.












69.


Teva referred in particular, in the context of its Observations, to the documents received through the Supplemental Access to File (including further correspondence between the Commission and the Complainants and the Ex-Post Minutes), noting that “[h]ad Teva received, at an earlier stage of the investigation, the highly relevant contemporaneous emails and complete and accurate minutes, it would have relied on them in its substantive written and oral submissions to better ensure its rights of defence. That opportunity is now lost. The breaches to Teva's rights of defence are thus irremediable.” (39) Teva also submitted that “[t]he Commission's failure to provide full access to file in the [Initial Access to File], and its delay providing the [Supplementary Access to File], has prevented Teva from expressing its views effectively on the Commission's SO and better ensuring its rights of defence. That breach to Teva's rights of defence is, by this point, irremediable.” (40) Finally, Teva insisted that “[e]ven if the Commission gathers that information now, it is too late – Teva has lost the opportunity to make further substantive representations on the Commission's lack of impartiality. On that basis, the Commission's breach of its duty of impartiality is irremediable, and any decision finding an infringement must be annulled.” (41)













70.


While it is true that certain correspondence and the Ex-Post Minutes were only provided to Teva after it submitted its Reply to the SO, I note that Teva has had an opportunity to express its views in writing every time it has had access to further information after the Initial Access to File. As set out in section 4.5 above, Teva has made ample use of this opportunity, notably through the Observations, the Reply to the First Letter of Facts, its reply to the Second Letter of Facts, the Letter of 19 July 2024, the Submission of 16 September 2024 and, finally, the Email of 25 September 2024.












71.


Respect for the rights of the defence requires that the undertaking concerned must have been afforded the opportunity, during the administrative procedure, to make known its views on the truth and relevance of the facts and circumstances alleged and on the documents used by the Commission to support its claim that there has been an infringement of the Treaty. (42) This has been the case of Teva.












72.


As for Teva’s specific concern that it could not rely during the oral hearing on any of the evidence that was provided since then, I recall that the right to be heard does not mean that the person concerned must be given the opportunity to express his or her views orally, since the opportunity to provide comments in writing also allows that right to be observed. (43) As mentioned, Teva had the possibility to react in writing to all additional information made accessible, which it systematically did. Moreover, Teva never addressed a request to the Hearing Officer or to DG Competition for a second oral hearing.












73.


Finally, I draw attention to the fact that Teva has only submitted two concrete requests for further access to file in these proceedings, both addressed to DG Competition after the submission of the SO Reply. (44) Teva raised concerns about the alleged procedural errors in access to file for the first time in the SO Reply, without having sought a solution to those alleged errors up to that point. Immediately after the SO Reply and the oral hearing, and without Teva making an actual request to that end (as in the SO Reply Teva merely criticized the alleged procedural error), DG Competition undertook to assess and remedy possible deficiencies in the Initial Access to File, as a result of which it gave to Teva Supplemental Access to File.












74.


The first, actual request for further access to the file was then submitted by Teva through the Observations (to certain categories of “contemporaneous email exchanges with the Complainants” and notes or minutes of 16 Additional Contacts). Later on, having received the Commission’s explanations on the Supplemental Access to File and its reply to the request for further access contained in the Observations through the Commission’s Letter on Further Access, Teva submitted a second request for further access (to records of 24 further Additional Contacts) through the Letter of 19 July 2024.












75.


These facts also contradict any possible claim that the documents (mainly correspondence and Ex-Post Minutes) that were provided to Teva after the SO Reply, either as a reaction to its criticism of the deficiencies in access to file or in response to its requests for further access, were disclosed too late for Teva to effectively exercise its rights of defence. Firstly, it appears that, in spite of its criticism of the deficiencies of access to file, Teva considered that it had sufficient information on the file at the time of submitting the SO Reply. Otherwise, it would have made a request for further access to DG Competition (and, if denied, to me), so as to obtain the missing documents before submitting its main defence through the SO Reply. Secondly, Teva cannot attribute to the Commission the allegedly irremediable lateness in access, when the fact that further access was granted only after the SO Reply is primarily due to Teva’s own choice not to request further access to file earlier.












76.


In any event, the procedure followed by DG Competition has provided Teva with the opportunity to examine the documents in the file which may be relevant for its defence and to provide its views on those documents during the administrative procedure.












77.


I therefore do not consider that Teva’s rights of defence have been breached as a result of having received access to additional file documents, including correspondence between the Commission and the Complainants and the Ex-Post Minutes, after submitting the SO Reply. This is without prejudice to the question as to whether those rights have been breached as a result of the alleged incompleteness of the file, stemming in particular from the absence of records of certain calls and meetings, which is addressed in the next section.




5.4.   Absence of records of calls and meetings









78.


In the SO Reply, Teva referred to a number of potential contacts between the Commission and the Complainants for which minutes of an interview within the scope of Article 19 of Regulation 1/2003 should have been provided in the Initial Access to File, as required by the recent line of case law of the EU Courts starting with Intel. (45) Teva submitted, in essence, that failure to take notes of a meeting or call that has as its purpose to gather information relevant to the investigation, or take sufficiently detailed notes, or include meeting notes in the case file, constituted all a breach of Article 19(1) of Regulation 1/2003 and could amount to a procedural error. (46)













79.


Teva specifically listed 23 meetings or calls that appeared to have taken place in the course of the proceedings, noting that minutes had only been provided for seven of them. (47) Teva also noted that there was insufficient detail in the file for Teva to determine with certainty the dates of calls and meetings which took place in the course of the Commission’s investigation, and whether any discussions constituted information gathering for which meeting notes should have been recorded and provided in the case file. Therefore, Teva submitted that it was unable to review and confirm if the content of such discussions could be relevant to its defence. (48)













80.


In reaction to the claims made by Teva in the SO Reply, DG Competition undertook to identify any possible calls and meetings for which records might be missing, as mentioned in section 14.1 of the draft decision and explained to Teva in the Letter on Further Access. (49) This exercise included a review of the case file and DG Competition’s contemporaneous internal notes, and a call for the Complainants and their counsel to share their recollection of any contacts had with the Commission during the investigation with a view to complementing DG Competition’s own internal records. This exercise was not confined to contacts held by DG Competition for the purposes of collecting information related to the subject-matter of the investigation, but looked amply into any calls or meetings, as a first step to then determine whether during those contacts the Commission may have collected information in the sense of Article 19 of Regulation 1/2003.












81.


Once this research exercise was completed, the Commission took a second step, to prepare the Ex-Post Minutes, concerning a total of 24 contacts (23 phone calls and one meeting at DG Competition’s premises). (50) As mentioned in section 14.1 of the draft decision, and in the spirit of comprehensiveness of the prior research exercise, not all Ex-Post Minutes referred to contacts held by DG Competition for the purposes of collecting information related to the subject-matter of the investigation, i.e., the Commission also provided Ex-Post Minutes for certain contacts that did not appear to constitute interviews within the meaning of Article 19 of Regulation 1/2003.












82.


The Commission finally sought the Complainants’ approval on the draft Ex-Post Minutes. As a result, all Ex-Post Minutes were corrected (where necessary) and approved by the Complainants’ external counsel on 13 July 2023. On 19 July 2023, Teva was given access to the Ex-Post Minutes, in the context of the Supplemental Access to File referred in paragraph 25 above. (51)













83.


Teva expressed its views on the Supplemental Access to File, first, through the Observations, and second, with the Reply to the First Letter of Facts, submitted on 26 March 2024. Through the Observations, Teva requested, inter alia, notes or minutes of 16 Additional Contacts. (52)













84.


Teva subsequently developed its concerns about the absence of records of calls and meetings in the Reply to the Letter of Facts, the Letter of 19 July 2024, the Submission of 16 September 2024 and the Email of 25 September 2024. With the Letter of 19 July 2024, Teva requested access to records of a further 24 Additional Contacts. (53)













85.


The Commission rebutted Teva’s concerns, in turn, in the Letter on Further Access, the Letter of 2 September 2024 and the Email of 20 September 2024. Teva’s requests for access to records of Additional Contacts were all rejected through those steps.












86.


Teva’s concerns regarding the absence of records of calls and meetings may be summarized as follows.












87.


First, in Teva’s view the Ex-Post Minutes do not meet the requirements established in case law for the recording of calls and meetings, and therefore are not capable of remedying the Commission’s procedural error committed by the Commission when it failed to record and give access to the records of the relevant calls or meetings. More specifically, Teva claimed that: (a) the Ex-Post Minutes were created a long time after the calls and meetings took place (in some cases up to several years), and therefore could not be claimed to accurately record the information provided by the Complainants during these calls and meetings; and (b) the Ex-Post Minutes are too vague to serve as complete records of discussions between the Commission and the Complainants, noting that many of them contain a limited amount of text and do little more than provide a brief overview of topics which were discussed. (54) Moreover, Teva criticized the Commission’s ample reliance on the Complainants’ recollection of the contacts held with them to identify the missing records in the file and restore their content. (55)













88.


Second, the Commission has not provided appropriate records of all its contacts with the Complainants, and specifically of the Additional Contacts, which Teva submits would also be subject to the duty to make records pursuant to Article 19 of Regulation 1/2003.












89.


In Teva’s view, Teva’s rights of defence have been breached as a result of the above procedural errors. In this regard, Teva submitted that, given the inadequacy of the Ex-Post Minutes, it is impossible for Teva to identify instances where the Complainants, in their “central role in the Commission’s investigation” may, during their contacts with the Commission, have provided exculpatory evidence that contradicts the Commission’s proposed theory of harm, or where there may have been an “absence of inculpatory evidence”, which Teva could have used to substantiate and better ensure its defence. (56) In this vein, Teva also argued that the Ex-Post Minutes are but a failed attempt to enable the reconstruction of what might have been discussed at the calls and meetings to which they relate. (57) As for the records of the Additional Contacts, allegedly missing in the Commission’s file, Teva plainly notes that, absent those records, it has no way of identifying any possibly exculpatory information they may contain. (58)





5.4.1.   Case law on the recording of interviews pursuant to Article 19 of Regulation 1/2003









90.


According to the case law of the EU Courts, ‘the Commission is required to record, in a form of its choosing, any interviews which it conducts, under Article 19 of Regulation 1/2003, for the purpose of collecting information relating to the subject-matter of an investigation’. (59)













91.


The Court of Justice emphasised that ‘it is important to note that a distinction must be drawn on the basis of the subject-matter of the interviews carried out by the Commission, and that only those seeking to collect information relating to the subject-matter of a Commission investigation fall within the scope of Article 19(1) of Regulation 1/2003 and, therefore, the obligation to record’. (60) Meetings and calls with third party information providers that fulfil this condition are to be considered interviews within the meaning of Article 19 of Regulation 1/2003.












92.


As regards the content of the obligation to record, the EU Courts have consistently held that it is ‘not sufficient for the Commission to make a brief summary of the subjects addressed during the interview’, but rather ‘the Commission must be in a position to provide an indication of the content of the discussions which took place during the interview, in particular the nature of the information provided during the interview on the subjects addressed’. (61)













93.


As regards the inferences to be drawn from procedural errors made in relation to records of interviews in the sense of Article 19, the General Court in Qualcomm (exclusivity payments) and Google Android clarified that it is necessary to establish whether, in the light of the specific factual and legal circumstances of each case, the undertaking has ‘adequately demonstrated that it would have been better able to ensure its defence had there been no procedural error’. (62) If that is not demonstrated, no infringement of the rights of defence can be established. (63)













94.


Such an infringement, according to the General Court, ‘would be demonstrated where the content of undisclosed evidence may be neither determined nor determinable’, as in this case ‘the undertaking cannot be expected to bear the impossible burden of proving the content of such document’. (64)













95.


On the other hand, ‘where the content of the evidence to which access was restricted can be determined a posteriori, the undertaking cannot be relieved of the burden of proving that it did not have access to the incriminating or exculpatory evidence and of explaining the inferences to be drawn from that with regard to the exercise of its rights of defence. That is so where the undertaking can at least give an indication of the authors and nature and content of the documents which have been withheld from it’. (65)













96.


The General Court also has clarified that, in case of undisclosed incriminating evidence, the undertaking must show that ‘the outcome of the procedure would have been different, assuming that that incriminating evidence had been disclosed’; while in the event of undisclosed exculpatory evidence, the undertaking concerned ‘must establish that it would have been able to use such evidence for its defence, in the sense that, had it been able to rely on it during the administrative procedure, it would have been able to invoke evidence which was not consistent with the inferences made at that stage by the Commission and therefore could have had an influence, in any way at all, on the assessments made by the Commission in its decision’. (66)













97.


In this regard, the General Court has also interpreted that where it is, overall, possible to deduce from the notes sent by the Commission the content of the interviews in question, a party must put forward detailed arguments in order to establish that it would have been better able to defend itself had it not been for the procedural irregularity identified (in the case at stake, that the notes of a meeting were too brief to meet the requirements of Article 19 of Regulation 1/2003). (67)













98.


On this basis, for me to report on the effective exercise of procedural rights, I must consider three consecutive questions, with regard to each of the calls and meetings, whose records (or absence thereof) Teva complains about: first, whether the disputed calls and meetings constituted interviews under Article 19 of Regulation 1/2003, thus an obligation arose for the Commission to record their contents; second, whether that obligation was adequately fulfilled by the Commission; and, third, where a procedural irregularity was committed (that is, if a duty to record existed and was not adequately fulfilled), whether an infringement of Teva’s rights of defence can be established.




5.4.2.   Whether the calls and meetings qualified as interviews under Article 19 of Regulation 1/2003









99.


As mentioned, the obligation to record under Article 19(1) of Regulation 1/2003 is only applicable to interviews in which the Commission seeks to ‘collect information relating to the subject-matter of a Commission investigation’. (68)













100.


It follows that not all oral exchanges between the Commission and external interlocutors trigger an obligation to record the contents of the conversation.












101.


For instance, a conversation on certain procedural or formal aspects of the proceedings that does not concern the substance of a case (such as a meeting dedicated exclusively to discussing confidentiality claims) should in my view not be considered an interview within the meaning of Article 19 of Regulation 1/2003. This type of exchanges are not conducted for the purpose of collecting information relating to the subject-matter of the proceedings. Therefore, they are not expected to yield information that could serve as indicia or evidence that can inform the substantive assessment of the case. It is that latter type of information that must be recorded pursuant to Article 19 of Regulation 1/2003, so that it can be made accessible to the undertakings subject to competition proceedings and enable them to defend themselves fully with regard to the contents of the oral submissions collected.












102.


Similarly, I consider that calls and meetings in which the Commission is exclusively providing information to a third party, instead of collecting information on the subject-matter of an investigation from that third party, should not be considered as constituting interviews within the scope of Article 19 of Regulation 1/2003. (69)













103.


Moreover, the interviews in question have to relate to the ‘subject-matter of the proceedings’. According to established case law, it is ‘permissible to exclude from the administrative procedure evidence which has no relation to the allegations of fact and of law in the statement of objections and which therefore has no relevance to the investigation’. (70) This applies also with regard to meetings where the substance of the discussions is unrelated to the subject-matter of the investigation. (71)













104.


Against this background, I have examined whether the contacts mentioned in Teva’s submissions fall outside the scope of Article 19 of Regulation 1/2003. This examination is concerned, primarily, with the Additional Contacts, which DG Competition does not deem to constitute interviews for the purposes of Article 19 of Regulation 1/2003, and for which it has, therefore, not produced records under that Article. Additionally, I have considered whether the calls and meeting recorded through the Ex-Post Minutes constitute interviews for the purposes of Article 19 of Regulation 1/2003. In this regard, I note that, whereas DG Competition endeavoured to produce records of those contacts in light of Article 19 of Regulation 1/2003, it did so following a cautious approach – that is, producing “minutes” even if, in some instances, DG Competition was not entirely convinced that the contacts in question could qualify as interviews under Article 19 of Regulation 1/2003. However, as regards the calls and meeting for which Ex-Post Minutes have in any event been prepared, I have not attempted to conclude on the applicability of Article 19 of Regulation 1/2003 to the contacts recorded through Ex-Post Minutes. Instead, I have merely identified examples of Ex-Post Minutes corresponding to meetings that are likely to be outside the scope of Article 19 of Regulation 1/2003. (72)













105.


My examination of whether any of the Additional Contacts were correctly considered by DG Competition to fall outside the scope of Article 19 of Regulation 1/2003, hence not entailing an obligation for the Commission to make a record pursuant to the case law referred to in section 5.4.1 above, has been based on a review of: (i) the explanations given by the Commission to Teva as regards those meetings in the Letter on Further Access, (73) the Letter of 2 September 2024 (74) and the Email of 20 September 2024; (ii) Teva’s remarks on individual Additional Contacts made in the Observations, the Reply to the First Letter of Facts, the Letter of 19 July 2024, the Submission of 16 September 2024 and the Email of 25 September 2024; (iii) the Complainants’ own recollection of the Additional Meetings, in particular as reflected in their “Updated overviews” of calls and meetings; (75) and (iv) DG Competition’s internal documents, where necessary and relevant.












106.


I consider it pertinent to take into account all of the information above, in order to ascertain whether the Additional Contacts may have been held for the purpose of collecting (or have resulted in the collection of) information relating to the subject-matter of the investigation in the sense of Article 19 of Regulation 1/2003. By and large, Teva relies on the fact that there are no records of the conversations held during the Additional Contacts to dismiss the Commission’s contention that these may not be considered contacts held pursuant Article 19 of Regulation 1/2003. On that basis, Teva conjectures, without submitting any conclusive evidence or concrete indicia, about the possibility that information on the subject-matter of the investigation may have been collected during these calls. However, account must be taken of the fact that, the Additional Contacts allegedly being outside the scope of Article 19 of Regulation 1/2003, the Commission would not have created, nor was under a duty to create, contemporaneous records of the content of conversations held during those contacts. It is therefore legitimate for me to look at all evidence available in connection with the Additional Contacts, as DG Competition has done, including, in particular, correspondence around the time of the Additional Contacts and the recollections of other participants (to both of which Teva has had access), as well as DG Competition’s internal notes (which are, by their own nature, not accessible during the administrative proceedings).












107.


In my reading, and consistently with explanations provided by DG Competition to Teva, it clearly emerges from the whole of the above information that during the Additional Contacts the Commission discussed purely technical or procedural aspects, provided procedural updates to the Complainants and/or did not collect information pertaining to the subject-matter of the investigation. The Additional Contacts, therefore, cannot be considered interviews subject to the procedural requirements of Article 19 of Regulation 1/2003, based on the content of each of the contacts as reflected in the file, which I summarize for reference, in chronological order, below:






—


The call of 8 February 2017 happened on the same day as a substantive written submission was made by the Complainants, (76) and appears to have been made to discuss the handling of the submission.










—


The call of 13 February 2017 was made on the same day as a hard copy of a written submission was being delivered to DG Competition and appears to concern procedural or logistical aspects of that submission.










—


Two calls on 6 March 2017
                               (77) were made to confirm a meeting of the Commission with the Complainants taking place on 16 March 2017, of which Ex-Post Minutes have been provided to the Complainants. (78)











—


The call of 13 March 2017 happened on the same day as a substantive written submission was made by the Complainants, and appears to have been made to discuss the handling of the submission.










—


The call of 20 March 2017 was made to discuss the order in which the Complainants should respond to the questions asked by the Commission during the meeting held on 16 March 2017, and how they should be conveyed, in the form of mark-ups, to the Commission, for organisational purposes.










—


The call of 6 April 2017 was made on the same day as a revised substantive written submission to DG Competition, and appears to concern procedural or logistical aspects of that submission.










—


The call of 24 May 2017 was made in connection with a request by the Complainants for an update on the procedural status of the case, which DG Competition provided.










—


The call of 9 June 2017 was made to (a) discuss the date for an in-person meeting between the Commission and the Complainants ([…] and […]) in July 2017, and (b) other matters that were not connected to the Teva Copaxone investigation.










—


The call of 14 September 2018 was an approach by the Complainants to seek updates on the status of the investigation, and announcing a written submission (received by the Commission on 25 September 2018).










—


The alleged call of 28 January 2019, which took place, ultimately, on 30 January 2019 was made by the Complainants to announce the submission of their replies to an outstanding request for information.










—


The call of 26 February 2019 was made to verify the correct submission of an Annex to a previously made written submission of the Complainants.










—


The call of 4 April 2019 was only made to arrange the call of 8 April 2019 (see next indent).










—


The call of 8 April 2019 concerned a status update from the Commission to the Complainants on the ongoing investigation, in particular on the next steps to be taken by the Commission to decide whether the Commission would pursue the investigation.










—


The call of 4 November 2019 concerned a status update from the Commission to the Complainants on the ongoing investigation.










—


The call of 19 December 2019 was for the Commission to provide the Complainants a further update on the status of the investigation, specifically to confirm that the Commission’s investigation had commenced. During the call, the Commission appears to have asked the Complainants to keep the Commission informed of any developments that may be of interest in regard of Teva’s conduct, without any element suggesting that any new information was provided by the Complainants during the call.










—


The call of 10 January 2020 was held to discuss, at the “urgent” initiative of the Complainants, whether the Commission would be willing to impose interim measures with regard to the conduct under investigation. This call followed a written submission made by the Complainants to the Commission the previous day (and available in the file), where the Complainants argued in favour of the imposition of interim measures. The call was therefore for the Commission to reply to the Complainants’ specific question, without any element suggesting that any new information was provided by the Complainants during the call.










—


The call of 24 July 2020 concerned a status update from the Commission to the Complainants on the ongoing investigation.










—


The call of 25 September 2020 enabled the Complainants to confirm with the Commission that there were no sensitivities regarding a proposed publication to which the Complainants would contribute, on the subject of the “divisionals game”, on which the Commission provided feedback to the Complainants.










—


The call of 20 November 2020 was for the Commission to provide the Complainants a further update on the status of the investigation, including on the Commission’s expected opening of formal proceedings and the potential timeline for the upcoming investigative steps.










—


The call of 29 January 2021 concerned a status update from the Commission to the Complainants on the ongoing investigation. The timing of the submission of a formal complaint appears to have been discussed. (79) There is no suggestion that the Commission collected any information on the subject-matter of the investigation.










—


The call of 22 July 2021 concerned a deadline extension request by the Complainants’ external counsels in relation to an outstanding request for information from the Commission.










—


The call of 19 October 2021 was used by the Commission to announce to the Complainants that it would send them new information requests, and outline the subject-matter of the requests.










—


The calls of 4 November 2021, 2 December 2021 and 3 January 2022 were all held to clarify technical aspects of ongoing written requests for information from the Commission, notably the deadlines to respond to those requests due to technical or organisational difficulties encountered by some of the Complainants. Teva’s claims that those difficulties may reveal that there was limited inculpatory evidence available are clearly speculative and unfounded.










—


The call of 10 November 2022 was used by the Commission to announce to the Complainants that they would receive a non-confidential version of the SO, for their comments, and to mention the broad, expected timing of the oral hearing.










—


The two calls of 16 November 2022 were made (first) to inform DG Competition’s case team of a career change affecting one of the Complainants’ external counsel team and (second) to discuss the confidentiality declaration that the Complainants were expected to sign before receiving the non-confidential version of the SO.










—


The calls of 5 January 2023 and 9 January 2023 were used by the Complainants to discuss a possible extension to the deadline to provide written comments on the SO.










—


The call of 26 January 2023 took place at the request of the Complainants to discuss how to proceed with their observations on Teva’s confidentiality claims in the Statement of Objections. Some practicalities of the oral hearing were discussed too. The Commission also indicated that they may reach out at a later point to request an update on patent enforcement by Teva from the Complainants.










—


The call of 17 February 2023 concerned some practicalities of the oral hearing. The Commission also announced that they would soon after the call share the non-confidential version of Teva’s SO Reply with the Complainants.










—


The call of 26 April 2023 was organised to discuss the method to identify the contacts held between the Commission and the Complainants, in the context of the preparation of Ex-Post Minutes and the Supplementary Access to File. Other procedural issues were discussed, including Powers of Attorney, confidentiality claims made by Teva on the SO and whether the Complainants would receive Teva’s written comments concerning the Complainants’ presentation in the oral hearing (which are referred in paragraph 23 above).
















108.


In light of these considerations, I conclude that the Commission was not obliged to record any of the Additional Contacts pursuant to Article 19 of Regulation 1/2003, therefore no procedural error was committed by the Commission by not producing and giving access to those records.












109.


As for the Ex-Post Minutes, and without prejudice to my considerations on the approach followed to recording those minutes expressed below, I confirm that DG Competition followed a cautious approach to the selection of relevant contacts, as it cannot be said with certainty that all of them constituted interviews under Article 19 of Regulation 1/2003. In fact, some of those contacts would very doubtfully constitute, in my opinion, an interview under Article 19 of Regulation 1/2003, as no information on the subject-matter of the investigation appears to have been collected during several of those calls. (80)













110.


In any event, as already mentioned, I do not need to conclude as regards the contacts subject to Ex-Post Minutes.




5.4.3.   Whether the Commission adequately fulfilled its obligation to record calls and meetings presumably falling under Article 19 of Regulation 1/2003









111.


Having concluded that there were no other calls or meetings for which the Commission was obliged to produce and disclose records under Article 19 of Regulation 1/2003, I now turn to whether, in the cases where that obligation existed (or the Commission acted as if it had existed), the Commission adequately fulfilled its duties under Article 19 of Regulation 1/2003. I have therefore assessed compliance with the requirements of Article 19 of Regulation 1/2003 in connection with the Ex-Post Minutes (without necessarily concluding that each and every one of these calls or contacts qualifies as an interview subject to the recording obligations of Article 19).












112.


Teva has claimed that the Ex-Post Minutes did not meet the requirements established in case law for the recording of calls and meetings presumably falling in the scope of Article 19 of Regulation 1/2003, and therefore are not capable of remedying the Commission’s procedural error with regard to the meetings and calls to which they refer.












113.


In particular, as summarized in paragraph 87 above, Teva has claimed that (a) the Ex-Post Minutes were produced too late, and cannot therefore constitute an accurate record of the relevant call or meeting, and (b) they were too vague to serve as complete records of discussions between the Commission and the Complainants, noting in particular that many of them contain a limited amount of text and provide little more than a brief overview of topics discussed.












114.


As regards the concern with brevity and limited detail, I do not consider that any of those constitute a procedural irregularity per se. The essence of the obligation to record interviews under Article 19 of Regulation 1/2003, in conjunction with Article 3 of Regulation 773/2004, is to collect ‘information relating to the subject-matter of an investigation’, by recording ‘the statements made by the persons interviewed’. (81) The length, scope and detail of the information contained in minutes can only be a function of the actual information that is presented or discussed at the call or meeting. In the same way as there is no obligation to produce minutes of every call and meeting attended by the Commission with external parties (some of which may be purely administrative or organizational), so may participants in a call or meeting provide only a limited amount of information regarding the subject-matter of an investigation, to which the duty to take minutes is confined. It is, therefore, perfectly possible that calls and meetings where only a limited amount of information is collected have relatively short minutes.












115.


Amongst the 24 Ex-Post Minutes, there are minutes of varying lengths, including some very detailed ones (such as the minutes of the meeting with all Complainants and their counsel, held on 16 March 2017 at DG Comp premises). There are also minutes which, in spite of being relatively short, appear to have a degree of detail commensurate with the subjects discussed (such as the minutes of the call with […] and […] external counsel on 2 May 2019).












116.


Conversely, as regards the claim that the late production of minutes could affect the accuracy of those minutes, I consider that this is a legitimate concern. While there is no specific deadline for the Commission to prepare minutes of interviews conducted under Article 19 of Regulation 1/2003, I consider that where minutes are put in writing too late after the interview is held, the extent to which the minutes reflect the information that was conveyed orally during the call or meeting may be called into question. When waiting too long to draw up minutes of a call or meeting, it is inevitable that the memories of the individuals attending the meeting fade. There could also be a loss of the recollection of a call or meeting at the level of the Commission when the members of staff or management that participated in the call or meeting leave the organisation. Hence the importance for minutes to be drafted ‘immediately or shortly afterwards’. (82)













117.


There is no exact rule in law for what the good time to write minutes is. This may vary depending on factors such as the complexity of the information received or the quality of the draft notes taken in situ by individual participants contributing to the formal minutes. It is apparent that very long delays may reduce the credibility of minutes as accurate records of what was said, as well as the ability of those in charge of drafting or correcting and approving them to add the necessary detail to the information collected. However, case by case assessment is necessary, as with any issue where the reliability of a piece of evidence is in question. Occasionally, even late minutes drafted years after a conversation may be, in fact, highly accurate (e.g., when prepared on the basis of detailed personal notes taken during the meeting, or confirmed unanimously by several individuals present at the meeting).












118.


In the present case, the dates of the calls (23) and meeting (one) recorded in the Ex-Post Minutes range from 16 March 2017 (the oldest) to 20 September 2022 (the most recent). Since all Ex-Post Minutes were drafted in late June 2023 and approved by the Complainants’ counsel on 13 July 2023, the time span between the actual calls and meeting and the time of the approval of their minutes by all participants ranged between just under 10 months and more than 6 years. This is not dissimilar to the situation in Google Android, where most of the minutes under consideration were drawn up several years after the meeting in question, and were considered ‘too late and too cursory’ to be capable of constituting the record of an interview in the sense prescribed by Article 19(1) of Regulation 1/2003. (83)













119.


The Ex-Post Minutes are an attempt to reflect, non-contemporaneously, the content of what was discussed during each relevant contact with the Complainants. This was done by reviewing all available internal notes (including, amongst others, contemporaneous notes taken by the Commission’s staff or internal emails exchanged between them about what they have heard at each call or meeting), as well as exchanges with the Complainants, including both organisational communications (e.g., emails to arrange for a call, where they existed) and materials submitted in preparation for the relevant calls and meeting or as a follow-up to those contacts. In addition, DG Competition took into account other submissions made by the Complainants around the time of each call and meeting, so as to ascertain the discussions in progress with the Complainants at the time of each contact, hence contextualize any information available as regards the purpose and content of each individual call or meeting. Submissions made more widely during the proceedings are sometimes also cited, for Teva to contrast the contents of each minute with other documents available in the file.












120.


Whereas this exercise is different from the contemporaneous recording and approval of the discussions held with Complainants, and may not therefore always provide the same degree of certainty about what was explicitly said during a call or meeting, (84) it is nevertheless a valuable step towards enabling the effective exercise of Teva’s right of defence, by reducing the scope of uncertainty about what was discussed during each contact, on the basis of all information available to the Commission at the time of the drafting and approval of the Ex-Post Minutes. Therefore, it cannot be ruled out that the Ex-Post Minutes could be sufficiently specific to reflect the ‘content of the discussions’ and in particular the ‘nature of the information provided during the interview on the subjects addressed’. (85)













121.


I have reviewed the process followed by DG Competition to prepare the Ex-Post Minutes and conclude that it has been done thoroughly and utilizing all the information available to DG Competition at the time of drafting the Ex-Post Minutes. Moreover, I consider unfounded Teva’s claims about the excessive reliance of DG Competition on the Complainants’ recollection of the relevant calls and meetings. The Commission effectively reached out to other meeting participants to ask them to complement its own recollection of what was said at those meetings, including by checking their own contemporaneous notes. There is nothing in the law to prevent such effort, which is consistent with the fact that the minutes need to be approved by those other participants. In circumstances where “minutes” are drafted belatedly it is in fact prudent to ask all participants to check their own recollection and notes.












122.


All of the above said, I do not need to conclude on whether the Commission committed a procedural error by not producing the Ex-Post Minutes in a timely and more comprehensive manner. Even if the delay in producing the Ex-Post Minutes, combined with their degree of detail, may have entailed a procedural error as regards certain contacts, it would still be necessary to determine whether Teva has adequately demonstrated, in light of the content of the Ex-Post Minutes and the overall evidence available in the file, that it would have been better able to ensure its defence absent that error. This is addressed in the following section.




5.4.4.   Whether the alleged procedural irregularities resulted in a breach of Teva’s rights of defence









123.


As set out above, for a breach of an undertaking’s rights of defence to be established, it has to be shown not only that an interview falling within the scope of Article 19 of Regulation 1/2003 was not properly recorded, but also that this failure impinged on the party’s ability to defend itself. It generally falls on the undertaking under investigation to prove that it did not have access to incriminating or exculpatory evidence and to explain the inferences to be drawn from that with regard to the exercise of its rights of defence (see paragraphs 93 to 97 above). Where it is, overall, possible to deduce from the notes sent by the Commission the content of the interviews in question, a party must put forward ‘detailed arguments’ in order to establish that it would have been better able to defend itself had it not been for the procedural irregularity identified. (86)













124.


Only one exception to this rule is contemplated in case law, that is, where the ‘content of undisclosed evidence may be neither determined nor be determinable’, as recalled above (see paragraph 94 above and case law cited).












125.


Moreover, the General Court has accepted that in certain instances, upon individual assessment, other documents in the file to which the undertaking concerned had access could allow the parties to ascertain what was discussed during an interview, absent appropriate minutes. This was the case, particularly, in Google Android, where the General Court considered that, in respect of most of the interviews for which Google had received only cursory notes (not capable of constituting a record of an interview), the ‘content of what was discussed during that interview’ was nonetheless ‘fully reflected in specific documents in the file, to which Google […] acknowledged having had access’. (87) The General Court therefore stated that Google was ‘able to obtain information from the Commission about the substance of what was discussed during those interviews, particularly as regards the nature of the information provided on those occasions on the topics discussed’. (88)













126.


The General Court reached the same conclusion in respect of certain notes that contained ‘no reference […] to any document in the file’, as it was ‘nevertheless possible for Google to place it in context with the information provided in relation to two other interviews conducted with the same undertaking […] on the same subject’. These two other interviews, the minutes of which were ‘approved by the undertaking concerned’, referred to ‘documents contained in the investigation file reflecting the content of what was discussed on those occasions’. The General Court therefore concluded that Google was ‘aware of the views of that undertaking in the context of the investigation’. (89)













127.


Taking account of this case law, I have examined, firstly, whether the content of the calls and meetings recorded in the (non-contemporaneous) Ex-Post Minutes can be sufficiently determined a posteriori, (90) either through the basic elements of the call or meeting as set out in the Ex-Post Minutes, through contextual references included in the Ex-Post Minutes or elsewhere in the case file, or through a combination of both. Even where the descriptions of the contents of the conversations in the Ex-Post Minutes may be too brief, or may lack accuracy, the Ex-Post Minutes themselves provide references to other documents in the case file, allowing this assessment by myself and also by Teva.












128.


Secondly, where the Ex-Post Minutes or other information available in the file enable Teva to sufficiently determine the content of the discussions for the meetings under consideration (particularly as regards the nature of the information provided on those occasions), (91) I have considered whether Teva has put forward ‘detailed arguments’ in order to establish that it would have been better able to defend itself had it not been for the procedural irregularity identified. (92)













129.


Based on my own assessment of the Ex-Post Minutes and the connected documents in the file, I consider that Teva could sufficiently determine the content of the discussions which took place during each call and meeting, in particular the nature of the information provided on the subjects addressed, as shown by the elements listed below. This is without prejudice to my opinion, set out in paragraph 109 above, that it is doubtful that all calls constituted an interview under Article 19 of Regulation 1/2003, as no information on the subject-matter of the investigation appears to have been collected during several of the calls to which the Ex-Post Minutes relate.






—


As regards the meeting of 16 March 2017, (93) held in person at DG Competition premises, it was aimed at discussing and clarifying the Complainants’ “Follow-up Submission re Copaxone” of February 2017 (available, with its Annexes, through Document IDs 2706, 2982 and 2007). The Ex-Post Minutes contain a fully detailed list of questions asked by the Commission to the Complainants during the meeting. Initial responses were provided during the meeting, which were not recorded. However, the Complainant’s submitted an updated version of their “Follow-up Submission re Copaxone”, on which the meeting focused, in April 2017. This updated submission, together with relevant Annexes and a marked-up version highlighting the changes made to earlier versions of the document, are available through Document IDs 2644, 2723, 2871 and 2827. It is therefore abundantly clear that Teva could sufficiently determine the content of the discussions that took place during the meeting.










—


As regards the calls of 25 October 2017 and 1 December 2017, (94) which were used by the Complainants to discuss various developments in the market bearing upon their informal request, the respective Ex-Post Minutes reflect the wording of very detailed contemporaneous internal notes made by the DG Competition participants in the meeting, to which I have had access. I therefore confirm that Teva could sufficiently determine the content of the discussions that took place during the calls on the basis of the Ex-Post Minutes.










—


As regards the call of 13 December 2017, (95) it was made by DG Competition to the Complainants to confirm certain information contained in their latest submission (dates of submissions in certain decentralized patent procedures). The information required was not provided during the call but in follow-up written correspondence. The Ex-Post Minutes reflect the content of a contemporaneous internal note that I have had access to. Moreover, both the submission to which the clarification refers and the follow up reply to the question raised in the call have been made available to Teva, as noted in the Ex-Post Minutes. Therefore, I confirm that Teva could sufficiently determine the content of the discussions.










—


As regards the call of 21 December 2017, (96) it was made by one of the Complainants’ lawyers to discuss with DG Competition’s case team an investigation of the French Competition Authority into a disparagement case similar to the conduct to which the “informal complaint” related. The call was followed by an email to the case team member on the call, providing an unofficial translation of the French Competition Authority’s press release, which is available in the file, as noted in the Ex-Post Minutes. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 9 April 2018, (97) it was held to discuss two written submissions made by the Complainants, as cited in the Ex-Post Minutes and accessible to Teva. The Complainants also invited DG Competition to reach out to the Germany’s Federal Institute for Drugs and Medical Devices (BfArM) to obtain their views on Teva’s conduct in the German market (with no indication that this suggestion entailed the provision of any information on the subject-matter of the investigation over and above the discussion of the submissions made by the Complainants). Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 18 July 2018, (98) it was held to discuss an “overview of disparagement examples and additional conduct”, as reflected in a Power Point presentation used during the call and available to Teva, as noted in the Ex-Post Minutes. Other aspects of interest for the investigation were also discussed, namely an “overview of US pricing and reimbursement developments for Copaxone and competing medicinal products”, based on information provided in writing to DG Competition shortly before the meeting and available in the case file, as noted in the Ex-Post Minutes. Finally, the Commission updated the Complainants on the timing and progress of the investigation (which does not in itself amount to collecting information on the subject-matter of the investigation). Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 16 November 2018, (99) it was made by DG Competition to the Complainants’ external counsel, to announce the sending of questions on the subject of vexatious regulatory litigation and to outline the content of those questions. The questions were subsequently sent by email and are available in the file, as noted in the Ex-Post Minutes. Therefore, I consider that Teva could sufficiently determine the content of the discussions.










—


As regards the call of 29 November 2018, (100) it was held to discuss the request for information sent by DG Competition to the Complainants on 16 November 2018. The Complainants sought clarification of some questions. Both the request for information by DG Competition and the Complainants’ response to it were provided in writing and are available in the case file, as noted in the Ex-Post Minutes. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 2 May 2019, (101) it was made by the Complainants’ counsel to request an update on the status of the investigation. The Complainants’ would also appear to have expressed concerns about the resources required by their continued engagement in the investigation, paired with uncertainties as to whether the Commission would ultimately take action against Teva, as mentioned in the Ex-Post Minutes. Finally, DG Competition asked questions on certain aspects of the Complainants’ earlier written submissions, the responses to which were subsequently submitted in writing and are available in the case file, as noted in the Ex-Post Minutes. The Ex-Post Minutes are consistent with the content of a DG Competition contemporaneous internal note on this call, to which I have had access. Therefore, I confirm that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 20 June 2019, (102) it was made by the Complainants’ counsel to draw the attention of the case team to a recent injunction of a Düsseldorf Court against […] further to “a forum shopping battle in Germany on 40 mg”, as noted in the Ex-Post Minutes. DG Competition did not ask for further information on the issue, according to the Ex-Post Minutes. The Ex-Post Minutes are consistent with the content of a DG Competition contemporaneous internal note on this call, to which I have had access. Therefore, I confirm that Teva could sufficiently determine the content of the discussion that took place during the call on the basis of the Ex-Post Minutes.










—


As regards the call of 28 June 2019, (103) DG Competition provided an update on progress of the Commission’s investigation and expected next steps, and asked for additional information regarding Teva’s preliminary injunctions, as set out in the Ex-Post Minutes. The questions asked by DG Competition were answered in a subsequent email, available in the case file and cited in the Ex-Post Minutes. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 23 July 2019, (104) DG Competition essentially requested further information from the Complainants and provided some context on the purpose of the requested information. The requested information was subsequently provided in writing, as cited in the Ex-Post Minutes. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 10 October 2019, (105) it was made by the Complainants to DG Competition to draw attention to and explain certain recent tweets published by Teva Spain, which were said to reinforce the Complainants’ earlier submissions on Teva’s conduct, according the Ex-Post Minutes. The tweets were later sent via email to the Commission (accessible in the file), as cited in the Ex-Post Minutes. The relevant emails make also clear the views and reactions of the Complainants on those tweets. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 9 January 2020, (106) it was made by the Complainants to DG Competition, to draw attention to a particular development concerning Teva’s divisional patents. After the phone call, the Complainants sent to the Commission an email summarizing and complementing the information provided during the call, made available to Teva, as cited in the Ex-Post Minutes. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 27 March 2020, (107) held at the request of the Complainants to discuss the status and focus of the investigation, an update was given by DG Competition and additional information was requested from Teva. The information was provided in writing after the call, and has been made available to Teva, as cited in the Ex-Post Minutes. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 6 April 2020, (108) it was held at the request of the Complainants to clarify the context for DG Competition requests for information concerning certain Member States. These clarifications were provided by DG Competition, as set out in the Ex-Post Minutes. In addition, the participants agreed that they will revert to each other on certain actions (organisation of a workshop and provision of certain documents – added later to the file, as cited in the Ex-Post Minutes-). The Ex-Post Minutes are consistent with the content of a DG Competition contemporaneous internal note on this call, to which I have had access. Therefore, I confirm that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 12 May 2020, (109) it was made by the Complainants’ external counsel to a member of staff at DG Competition, requesting an update on the status of the investigation and next steps. The Commission in turn requested additional examples of Teva’s conduct that were submitted in writing and are available in the case file, as cited in the Ex-Post Minutes. Therefore, I consider that Teva could sufficiently determine the content of the discussion. The Ex-Post Minutes are consistent with the content of a DG Competition contemporaneous internal note on this call, to which I have had access. Therefore, I confirm that Teva could determine the content of the discussion.










—


As regards the call of 10 June 2020, (110) it was made by the Complainants to the Commission to inform them of the postponement of a certain hearing in patent proceedings, and give an updated on the timing of an expected written submission, as noted in the Ex-Post Minutes. The Ex-Post Minutes are consistent with the content of a DG Competition contemporaneous internal note on this call, to which I have had access. Therefore, I confirm that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 20 July 2020, (111) it was made by the Complainants to the Commission, to clarify a question in an outstanding written request for information. The response to that question was subsequently provided in writing and is available in the case file, as cited in the Ex-Post Minutes. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 1 July 2021, (112) it was initiated by the Complainants, to inform the Commission that they had requested a court in Amsterdam to postpone certain proceedings on substance until the potential adoption of a Commission decision. The Commission requested information on proceedings in other jurisdictions, which was later submitted in writing and is available on the case file, as cited in the Ex-Post Minutes. Additionally, the Commission clarified the background of certain questions previously asked to the Complainants, and it announced that it may require non-confidential versions of a number of documents from the Complainants, in anticipation of a possible access of file procedure. In any event, the Ex-Post Minutes are consistent with the content of a DG Competition contemporaneous internal note on this call, to which I have had access. Therefore, I confirm that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 7 February 2022, (113) it was held at the initiative of the Commission to announce and give context to further information to be requested from the Complainants in connection with the Commission’s drafting of the SO. The required information was later specified in writing. The Complainant’ replies were submitted in writing too. Both the written questions and responses are accessible in the case file. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 25 August 2022, (114) it was made by the Commission to the Complainants, to request examples of a certain type of documents (warning letters), as cited in the Ex-Post Minutes. An update was provided by the Complainants’ counsel on the expected time to provide certain outstanding inputs to the Commission. The Complainants also confirmed that they had no concerns with the Commission’s latest reactions to certain confidentiality claims. Therefore, I consider that Teva could sufficiently determine the content of the discussion.










—


As regards the call of 20 September 2022, (115) it was made by the Complainants to the Commission, and touched on three subjects: confirmation that a formal complaint could “still” be filed in the first week of October 2022; urgency of outstanding information requested by the Commission; and a request from the Commission to the Complainants to provide turnover data for […]. All information referred to during the call is available in the case file. Therefore, I consider that Teva could sufficiently determine the content of the discussion.
















130.


Having concluded that Teva could sufficiently determine the content of the discussions that took place, I have considered whether Teva has put detailed arguments to establish (or has otherwise established) that, absent possible procedural errors regarding the minutes in question, it would have been better able to ensure its defence.












131.


Teva claims that ‘it is impossible for Teva to "reconstitute with certainty" the information that was communicated during those meetings […] as the Commission has […] provided vague and presumably inaccurate/incomplete [Ex-Post Minutes]’ below). On that sole basis, Teva submits that it ‘is not able to identify, from the inadequate records of meetings, instances where the Complainants (in their central role in the Commission's investigation) may have provided exculpatory evidence that contradicts the Commission's proposed theory of harm.’ According to Teva, ‘had [it] been able to accurately identify the information provided by the Complainants – and, in particular, the absence of inculpatory evidence capable of supporting the Commission's foreclosure analysis – then Teva could have used this information to substantiate and better ensure its defence.’ (116)













132.


However, Teva does not bring forward any concrete elements to demonstrate that it did not have access to incriminating evidence (and that ‘the outcome of the procedure might have been different, assuming that that incriminating evidence had been disclosed’), nor that it did not have access to exculpatory evidence that it would have been able to invoke and that ‘could have had an influence, in any way at all, on the assessments made by the Commission in its decision’. (117) Yet, as discussed above, the Ex-Post Minutes, even if an imperfect depiction of what was actually discussed at the relevant calls and meeting, allowed Teva to provide a minimum, rational indication of those elements.












133.


For these reasons, I consider that any procedural errors in respect of the records of interviews raised by Teva do not, in the circumstances of the present case, result in an infringement of Teva’s rights of defence.




5.5.   Lack of access to other documents in the file









134.


As discussed in sections 4.5 and 5.3 above, Teva’s two only requests for further access to file in these proceedings were both addressed to DG Competition after the submission of the SO Reply, first with the Observations, and then with the Letter of 19 July 2024. In addition to requesting access to records of Additional Contacts pursuant to Article 19 of Regulation 1/2003, through the Observations, Teva effectively requested access to two classes of documents concerning contacts between the Commission and the Complainants: (i) contemporaneous internal documents of the Commission in connection with those contacts; and (ii) correspondence between the Commission and the Complainants regarding the preparation of the Ex-Post Minutes. (118)













135.


DG Competition rejected access to both classes of documents through the Letter on Further Access.












136.


DG Competition’s grounds to reject access to contemporaneous internal documents of the Commission in connection with contacts held with Complainants were, in essence, that there is no obligation for the Commission to disclose internal documents to Teva. (119)













137.


As for the correspondence between the Commission and the Complainants regarding the preparation of approved minutes, the Commission relied on three arguments.












138.


First, it noted that under Article 3(3) of Regulation 773/2004, on the Commission’s power to take statements in accordance with Article 19 of Regulation 1/2003, “[a] copy of any recording shall be made available to the person interviewed for approval”. Therefore, according to DG Competition, until the statements or minutes are approved, they have no probative value. Moreover, given the voluntary nature of interviews under Article 19 of Regulation 1/2003, there is no legal obligation to disclose provisional recordings or drafts, which have not been approved by the person interviewed, to the undertaking under investigation. DG Competition inferred from these premises that the right of access to file only applies to the final Minutes, as approved by the person interviewed. (120)













139.


Second, in response to Teva’s remark that the General Court in Qualcomm (exclusivity payments) acknowledged a party’s right to access non-approved minutes of interviews, (121) DG Competition noted that the circumstances in the present proceedings where different. Indeed, in Qualcomm (exclusivity payments) corrections of the minutes were made by the interviewees after a final infringement decision had been adopted, thus altering the minutes without providing Qualcomm with the opportunity to comment). (122)













140.


Third, DG Competition noted that the Complainants had been asked to provide corrections on the Ex-Post Minutes as well as confidentiality claims. In this regard, DG Competition stressed that exchanges on confidentiality are by their own nature not accessible to parties (only final non-confidential versions of meeting records, or any documents in the file, are accessible). (123)













141.


Following DG Competition’s rejection, Teva did not submit to me any request for further access pursuant to Article 7 of Decision 2011/695/EU. Therefore, I consider that the effective exercise of Teva’s right to access to the file has been respected with regard to the classes of documents described in this section.




5.6.   Complainants utilizing the SO Reply during the oral hearing









142.


On the eve of the oral hearing, immediately after receiving an advance copy of the presentation to be used by the Complainants during the hearing that was held on 24 March 2023, Teva complained about the fact that the Complainants’ presentation rebutted Teva’s SO Reply. These concerns were reiterated by Teva during the oral hearing and in the further written comments submitted by Teva on 24 April 2023 making use of the possibility afforded by me pursuant to Article 12(4) of Decision 2011/695/EU.












143.


Teva claimed that it would be procedurally unfair for (i) the Complainants to use the oral hearing as a means to respond to the SO Reply, and (ii) Teva to have less than a day to review the Complainants' presentation for the oral hearing, and be unable to amend its own presentation materials accordingly or otherwise address, during the oral hearing, the Complainants' allegations. Teva requested that either (i) the Complainants be prevented from presenting the slides responding to the SO Reply and making arguments in this regard or (ii) the oral hearing be postponed.












144.


In support of its claim, Teva argued that the purpose of an oral hearing is to allow the parties to develop orally observations on the SO which they have already made in writing. Conversely, according to Teva, it is not the purpose of the oral hearing to allow participants to make allegations which have never been made in writing or to discuss new elements. Teva considers that allowing the Complainants, or the Commission for that matter, to make new allegations during the oral hearing, without leaving sufficient time for the defendant to assess these and respond constitutes a breach of the rights of defence. Teva further noted that it cannot credibly be submitted that the Complainants' presentation would not unduly influence each attendee's perception of the case.












145.


By email of 23 March 2023, I refused Teva’s request to prevent the Complainants from presenting their slides or to postpone the oral hearing. When communicating my position to Teva, I noted that the fact that another participant raises at the oral hearing issues and arguments that are not in the SO should not be a matter of concern for Teva. If the Commission were to build on such new issues, investigate them, and subsequently expand the objections (by sending a supplementary SO), the addressee would be able to respond and could request a new oral hearing. I therefore did not see an issue of rights of defence and refused to unduly “police” the contents of any party’s presentation (other than Commission participants, who are bound at the hearing by the terms of the SO adopted by the Commission). Further, I took into account the fact that, over a month before the oral hearing, DG Competition had informed Teva that the SO reply would be shared with the Complainants, and Teva did not raise any concerns at that time.












146.


I stand by this decision and continue to believe that Teva’s rights of defence were not breached by allowing the Complainants to rebut Teva’s arguments contained in the SO Reply. Moreover, to maximise the procedural guarantees offered to Teva, I afforded Teva the possibility to submit further written comments on the presentations made by the Complainants during the oral hearing, making use of my powers under Article 12(4) of Decision 2011/695/EU.




6.   CONCLUSION









147.


Pursuant to Article 16 of Decision 2011/695/EU, I have examined whether the draft decision deals only with objections in respect of which Teva has been afforded the opportunity of making known its views. I conclude that it does so.












148.


In light of the considerations above, I conclude that the effective exercise of the procedural rights of Teva has been respected.






Brussels, 29 October 2024.

Eric GIPPINI FOURNIER
               





(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 (‘Decision 2011/695/EU’).

(2)  Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty, OJ L 1, 4.1.2003, p. 1 (‘Regulation 1/2003’).

(3)  Commission Regulation (EC) No 773/2004 of 7 April 2004 relating to the conduct of proceedings by the Commission pursuant to Articles 81 and 82 of the EC Treaty, OJ L 123, 27.4.2004, p. 18 (‘Regulation 773/2004’).

(*1)  Parts of this text have been edited to ensure that confidential information is not disclosed. Those parts are replaced by a non-confidential summary in square brackets or are shown as […].

(4)  […] and […] submitted “Follow-up submissions” to the Commission on 8 February 2017 and 7 April 2017. In its reply to the SO, Teva refers to the submission made on 7 April 2017 as the “informal complaint”. For simplicity and consistency, this report refers to documents submitted by […] and […] as an “informal complaint” and to 7 April 2017 as the date of the submission of an “informal complaint” by […] and […].

(5)  Section 3 of the SO Reply (‘The Commission’s assessment of Teva’s conduct is biased, and demonstrates a breach of its duty of impartiality’).

(6)  Section 3.2. of the SO Reply (‘The Commission's handling of the […] Complaint has breached Teva's procedural rights’).

(7)  Developed, amongst others, in Section 3.3. of the SO Reply (‘The content of the SO shows a clear bias against Teva’), although the accusation of bias permeates multiple substantive arguments of Teva throughout its defence.

(8)  Paragraph 141 of the SO Reply.

(9)  Section 3.4 of the SO Reply (‘The Commission has failed to respect Teva's rights of defence’).

(10)  SO Reply, paragraphs 142-145. The seven calls or meetings for which minutes had been provided during the initial access to file took place on: 16 December 2016; 18 July 2017; 21 July 2017; 2 October 2020; 6 April 2020; 6 May 2020; and 24 June 2020. The other 16 calls or meetings would have taken place, according to Teva, on: 8 February 2017; 9 April 2018; 29 November 2018; 18 or 19 July 2018; 28 June 2019; 23 July 2019; 4 November 2019; 8 January 2020; 9 January 2020; 10 January 2020; 27 March 2020; 20 July 2020; 24 July 2020; 11 June 2021; 2 December 2021; and 3 January 2022.

(11)  SO Reply, paragraphs 148-150.

(12)  This exercise was undertaken without Teva actually formulating a request for further access to file, either in the context of the SO Reply or, as mentioned in paragraph 13 above, before submitting the SO Reply.

(13)  Letter from the Commission to Teva of 19 July 2023, ‘Case AT.40588 - Teva Copaxone – supplemental access to file’.

(14)  The Ex-Post Minutes correspond to 23 calls and one meeting held on these dates (case file Document ID in brackets): 16 March 2017 (Document ID 4723); 25 October 2017 (Document ID 4724); 1 December 2017 (Document ID 4725); 13 December 2017 (Document ID 4726); 21 December 2017 (Document ID 4727); 9 April 2018 (Document ID 4704); 18 July 2018 (Document ID 4705); 16 November 2018 (Document ID 4706); 29 November 2018 (Document ID 4707); 2 May 2019 (Document ID 4708); 20 June 2019 (Document ID 4709); 28 June 2019 (Document ID 4710); 23 July 2019 (Document ID 4711); 10 October 2019 (Document ID 4712); 9 January 2020 (Document ID 4713); 27 March 2020 (Document ID 4714); 6 April 2020 (Document ID 4715); 12 May 2020 (Document ID 4716); 10 June 2020 (Document ID 4717); 20 July 2020 (Document ID 4718); 1 July 2021 (Document ID 4719); 7 February 2022 (Document ID 4720); 25 August 2022 (Document ID 4721); 20 September 2022 (Document ID 4722). All of those were phone or conference calls, with the exception of the meeting held on 16 March 2017, which took place in person at DG Competition’s premises.

(15)  Observations, paragraphs 153 to 155.

(16)  Paragraph 126 of the Observations and relevant footnote. These would have taken place, according to Teva, on the following dates: 13 March 2017; 24 May 2017; 18 July 2017; 19 December 2019; 25 September 2020; 20 November 2020; 29 January 2021; and 4 November 2021.

(17)  Paragraph 125 of the Observations and footnote 76. These would have taken place, according to Teva, on the following dates: 8 February 2017; 4 November 2019; 8 January 2020; 10 January 2020; 24 July 2020; 11 June 2021; 2 December 2021; and 3 January 2022. Teva later acknowledged that the alleged meeting of 8 January 2020 was likely postponed and took place the following day, for which an Ex-Post Minute was provided (see paragraph 32 of the Letter on Further Access referred to in paragraph 32 below, and paragraph 12 of the Letter of 19 July 2024 referred to in paragraph 33 below).

(18)  To the extent that some of these documents concerned email exchanges between the Commission and the Complainants relating to the Ex-Post Minutes, this additional access to file also responded to Teva’s request for further access to file referred to in paragraph 26 above.

(19)  The initial deadline to reply to the First Letter of Facts was originally 8 March 2024. Upon request by Teva, an extension of this deadline was first granted until 22 March 2024. Teva submitted its comments on 26 March 2024.

(20)  The initial deadline to reply to the Second Letter of Facts was originally 3 June 2024. Upon request by Teva, one extension of this deadline was granted until 10 June 2024.

(21)  Letter of 19 July 2024, paragraphs 57 to 59 and Annex I. These would have taken place, according to Teva, on the following dates: 13 February 2017; 6 March 2017; 7 March 2017; 20 March 2017; 6 April 2017; 9 June 2017; around 16 June 2017; 14 September 2018; 28 January 2019; 26 February 2019; 4 April 2019; 8 April 2019; 9 October 2020; 22 July 2021; 19 October 2021; 10 November 2022; 16 November 2022; 16 November 2022; 5 January 2023; 9 January 2023; 26 January 2023; 17 February 2023; 26 April 2023; and around 11 May 2023.

(22)  See footnote 1 and relevant paragraph of the Submission of 16 September 2024. The dates for which Teva no longer insisted on obtaining records were: 18 July 2017 and 11 June 2021 (for which further access had been requested in the Observations), and 16 June 2017, 9 October 2020 and 11 May 2023 (for which further access had been requested in the Letter of 19 July 2024). With regard to these contacts, Teva noted that it had no means to verify the Commission’s assertion that they had not taken place, and reserved its rights to make submissions on those alleged contacts in any appeal, thus implying that it was no longer insisting on obtaining records for them in the administrative proceedings.

(23)  See footnote 17 above and relevant paragraph. As mentioned in that footnote, Teva acknowledged that no Additional Meeting took place on 8 January 2020.

(24)  See footnote 16 above and relevant paragraph.

(25)  See footnote 21 above and relevant paragraph.

(26)  See footnote 22 above and relevant paragraph.

(27)  Paragraphs 8, 106-135 of the SO Reply.

(28)  Paragraph 106 of the SO Reply, and Document ID 2876.

(29)  Observations, paragraph 93, and Document ID 4547.

(30)  Judgment of 2 February 2022 in Scania and Others v Commission (hereafter, ‘
            Scania
            ’
            ), T-799/17, EU:T:2022:48, paragraph 154.

(31)  Judgment of 16 May 2018 in Lufthansa v Commission, T-712/16, EU:T:2018:269, paragraph 145.

(32)  
            Scania, paragraph 154. This echoes the general rule in EU law that a party alleging a fact normally bears the burden of proving it: see, in this sense, judgment of 30 March 2022, Latam Airlines Group and Lan Cargo v Commission, T-344/17, EU:T:2022:185, paragraph 166 and case law cited; and order of 23 September 2020, Deutsche Telekom v Commission, T-64/20, EU:T:2020:481, paragraph 23 and case law cited.

(33)  SO Reply, paragraphs 7 and 87 to 107. These claims were further expanded as and when Teva had access to further correspondence between the Commission and the Complainants through the Supplemental Access to File and upon adoption of the First Letter of Facts.

(34)  Commission notice on best practices for the conduct of proceedings concerning Articles 101 and 102 TFEU (OJ C 308, 20.10.2011, p. 6) (‘Antitrust Best Practices Notice’), paragraphs 71 to 73.

(35)  Antitrust Best Practices Notice, paragraph 71.

(36)  Antitrust Best Practices Notice, paragraph 71.

(37)  Judgment of 8 July 2008, AC Treuhand v Commission, T-99/04, EU:T:2008:256, paragraph 48.

(38)  Judgment of 18 September 2024, Qualcomm Inc. v. Commission, T-671/19, EU:T:2024:626 (hereafter ‘
            Qualcomm (predation)
            ’), paragraph 118, and case law cited therein.

(39)  Observations, paragraph 11.

(40)  Observations, paragraph 116.

(41)  Observations, paragraph 150.

(42)  Judgment of 7 January 2004 in Aalborg Portland and Others v Commission, C-204/00 P, C-205/00 P, C-211/00 P, C-213/00 P, C-217/00 P and C-219/00 P, EU:C:2004:6, paragraphs 66 and 67. See also Qualcomm (predation), 166.

(43)  
            HeidelbergCement AG and Schwenk Zement KG v Commission, T-380/17, EU:T:2020:471, paragraph 634 and case law cited.

(44)  As mentioned in paragraph 40 above, no request for further access to file has been submitted to me under Article 7(1) of Decision 2011/695/EU in these proceedings.

(45)  See, in particular, judgments of 6 September 2017, Intel v Commission, C-413/14 P, EU:C:2017:632 (hereafter, ‘
            Intel
            ’); of 15 June 2022, Qualcomm v Commission, T-235/18, EU:T:2022:358 (hereafter, ‘
            Qualcomm (exclusivity payments)
            ’); of 14 September 2022, Google and Alphabet v Commission (Google Android), T-604/18, EU:T:2022:541 (hereafter, ‘
            Google Android
            ’); of 9 March 2023, Les Mousquetaires and ITM Entreprises v Commission, C-682/20 P, EU:C:2023:170 (hereafter, ‘
            Les Mousquetaires
            ’); of 9 March 2023, Intermarché Casino Achats v Commission, C-693/20 P, EU:C:2023:172 (hereafter, ‘
            Intermarché Casino Achats
            ’); of 9 March 2023, Casino, Guichard-Perrachon and Achats Merchandises Casino v Commission, C-690/20 P, EU:C:2023:171 (hereafter, ‘
            Casino
            ’); of 25 October 2023, Bulgarian Energy Holding and Others v Commission, T-136/19, EU:T:2023:669 (hereafter, ‘
            Bulgargaz
            ’); and Qualcomm (predation) (cited above).

(46)  SO Reply, paragraphs 136 to 150. See also section 4.3 above.

(47)  See above paragraph 19 and relevant footnotes.

(48)  SO Reply, paragraphs 148-150.

(49)  Letter on Further Access, paragraphs 18 to 23.

(50)  See above footnote 14 and relevant paragraph.

(51)  After the Supplemental Access to File, only the minutes of one additional contact were provided to Teva, together with the First Letter of Facts, corresponding to a call held between DG Competition and the complainants’ external counsel on 18 September 2023, for which minutes were drafted by DG Competition the next day and approved by the complainants’ external counsel on 3 October 2023. These cannot therefore be considered Ex-Post Minutes, as they were prepared in a timely fashion. The minutes of this meeting have not been questioned by Teva as potentially inaccurate, imprecise or non-comprehensive.

(52)  See above paragraphs 26 and 36.

(53)  See above paragraphs 33 and 36.

(54)  Observations, e.g. paragraph 8.

(55)  Observations, e.g. para. 29., and Reply to the First Letter of Facts, paragraphs 23 to 27. Teva also criticized the fact that the complainants were allowed to make corrections and approve the content of the minutes very late after the contacts took place (in some instances several years after), which is, again, in Teva’s view, evidence that the ex-post Minutes cannot be accurate.

(56)  Observations, paragraphs 78 to 48.

(57)  Observations, paragraphs 71 to 77. Reply to the First Letter of Facts, paragraphs 21, 22 and 28 to 30.

(58)  E.g., Observations, para. 10.

(59)  
            Intel, paragraph 91; see also Qualcomm (exclusivity payments), paragraph 190, Google Android, paragraph 912; and Bulgargaz, paragraph 1157 .

(60)  
            Intermarché Casino Achats, paragraph 106; Les Mousquetaires, paragraph 90; Casino, paragraph 86.

(61)  
            Qualcomm (exclusivity payments), paragraph 190; see also Intel, paragraph 92, Google Android, paragraph 912, and Bulgargaz, paragraph 1160.

(62)  
            Qualcomm (exclusivity payments), paragraph 202, and Google Android, paragraph 935.

(63)  
            Google Android, paragraph 934.

(64)  
            Google Android, paragraph 935.

(65)  
            Google Android, paragraph 936. See, in the same sense, Intel, paragraph 96: ‘in so far as Intel argued that [the information provider] had provided exculpatory evidence to the Commission which the latter should have properly recorded and disclosed to Intel, it must be borne in mind that, as regards failure to disclose an exculpatory document, it is for the undertaking concerned to establish that the non-disclosure was able to influence, to its detriment, the course of the procedure and the content of the Commission’s decision’.

(66)  
            Google Android, paragraphs 937 and 938. See, in the same sense, Intel, paragraph 97.

(67)  
            Qualcomm (predation), paragraph 194.

(68)  See paragraph 91 above.

(69)  In one instance, the General Court seems to have considered two meetings with a third party, whereby ‘the purpose of those meetings was, as far as the [third party] was concerned, to obtain information from the Commission’, as falling under Article 19 of Regulation 1/2003 (see Google Android, paragraph 954). However, the General Court also stated in the same paragraph that ‘the very purpose of those meetings and their summary […] serve to rule out any assumption that the Commission withheld evidence’, and therefore concluded that the Commission’s non-compliance with Article 19 with regard to those meetings was not capable to leading to a breach of the applicant’s rights of defence.

(70)  Judgments of 7 January 2004, Aalborg Portland and Others v Commission, C-204/00 P, C-205/00 P, C-211/00 P, C-213/00 P, C-217/00 P and C-219/00 P, EU:C:2004:6, paragraph 126; and of 16 June 2011, FMC Foret v Commission, T-191/06, EU:T:2011:277, paragraph 306. See also Bulgargaz, paragraph 1171.

(71)  In Google Android, the General Court also concluded that the procedural errors regarding recordings of two meetings were not in breach of Google’s rights of defence, given that there was a ‘lack of any obvious link between those interviews and the abuses alleged in the contested decision’ (see Google Android, paragraphs 951 to 953).

(72)  See footnote 80 and relevant paragraph for further details.

(73)  See, in particular, sections 3.1.1, 3.1.2 and 3.1.3 of the Letter on Further Access.

(74)  See, in particular, sections 2 and 3 of the Letter of 2 September 2024.

(75)  Document IDs 4767 and 4773.

(76)  For simplicity, references are generally made to ‘the Complainants’ in this report without specification of specific individuals taking part, where relevant, in a specific procedural step, their number, or whether they are staff or managers of the Complainants’ corporate entities or their external counsel. In the context of the Additional Contacts, while not specified in the report, the vast majority of calls involved only the Complainants external counsel.

(77)  Teva claims that these calls took place on 6 March 2017 and 7 March 2017. However, DG Competition’s internal records indicate that both calls took place on 6 March 2017.

(78)  Document ID 4723.

(79)  That is a question of procedure, discussed in section 5.2 above.

(80)  For instance, there are no indicia suggesting that information on the subject-matter of the investigation was collected during the calls of 13 December 2017, 16 November 2018, 28 June 2019, 27 March 2020, 20 July 2020, 25 August 2022 or 20 September 2022 (inter alia). See, for further reference, the analysis of the Ex-Post Minutes contained in paragraph 129 below.

(81)  Article 19(1) of Regulation 1/2003 and Article 3(3) of Regulation 773/2004.

(82)  
            Google Android, paragraph 928.

(83)  
            Google Android, paragraph 932.

(84)  In fact, the term ‘minutes’ may not correctly describe the retrospective exercise undertaken for the preparation of the ex-post Minutes.

(85)  
            Intel, paragraphs 91 and 92; Qualcomm (exclusivity payments), paragraph 190; Google Android, paragraph 912.

(86)  
            Qualcomm (predation), paragraph 194, as cited in paragraph 97 above.

(87)  
            Google Android, paragraph 944.

(88)  
            Google Android, paragraph 945. See also Intel, paragraph 99, where the Court of Justice considered, among the factors that led it to conclude that Intel’s rights of defence had not been breached despite the fact that the Commission had not properly recorded an interview with Dell, that ‘Intel was provided with […] a follow-up document containing Dell’s written responses to the oral questions put to [Dell] during that interview’.

(89)  
            Google Android, paragraph 949.

(90)  
            Google Android, paragraph 935-936.

(91)  
            Qualcomm (exclusivity payments), paragraph 190; see also Intel, paragraph 92, Google Android, paragraph 912, and Bulgargaz, paragraph 1160.

(92)  
            Qualcomm (predation), paragraph 194.

(93)  Ex-Post Minutes in Document ID 4723.

(94)  Ex-Post Minutes in Documents ID 4724 and 4725.

(95)  Ex-Post Minutes in Document ID 4726.

(96)  Ex-Post Minutes in Document ID 4727.

(97)  Ex-Post Minutes in Document ID 4704.

(98)  Ex-Post Minutes in Document ID 4705.

(99)  Ex-Post Minutes in Document ID 4706.

(100)  Ex-Post Minutes in Document ID 4707.

(101)  Ex-Post Minutes in Document ID 4708.

(102)  Ex-Post Minutes in Document ID 4709.

(103)  Ex-Post Minutes in Document ID 4710.

(104)  Ex-Post Minutes in Document ID 4711.

(105)  Ex-Post Minutes in Document ID 4712.

(106)  Ex-Post Minutes in Document ID 4713.

(107)  Ex-Post Minutes in Document ID 4714.

(108)  Ex-Post Minutes in Document ID 4715.

(109)  Ex-Post Minutes in Document ID 4716.

(110)  Ex-Post Minutes in Document ID 4717.

(111)  Ex-Post Minutes in Document ID 4718.

(112)  Ex-Post Minutes in Document ID 4719.

(113)  Ex-Post Minutes in Document ID 4720.

(114)  Ex-Post Minutes in Document ID 4721.

(115)  Ex-Post Minutes in Document ID 4722.

(116)  E.g., Observations, paragraphs 81 and 82.

(117)  See Google Android, paragraphs 937 and 938.

(118)  These three categories can be inferred from the wording of Teva’s request, in paragraphs 154 and 155 of the Observations:







“154.


First, the Commission should provide the following categories of contemporaneous email exchanges with the Complainants:






—


Any contemporaneous records or 'detailed minutes' of meetings with the Complainants that either (a) were used to prepare the Post-Hearing Notes or (b) record meetings for which no note has been provided (see further Section 3.2.2(a) above).










—


Any email exchanges between the Commission and the Complainants that relate to the Post-Hearing Notes, including the underlying mark-ups to the Post-Hearing Notes (see further Sections 3.2.2(a) and (c) above).














155.


Second, Teva presumes that the Commission will be unable to provide more accurate and comprehensive versions of the Post-Hearing Notes. However, it must provide notes or minutes of those meetings between the Commission and the Complainants which Teva has identified as missing […]”.






(119)  Letter on Further Access, paragraph 64 and Section 1.1.

(120)  Letter on Further Access, paragraph 66.

(121)  
            Qualcomm (exclusivity payments), paragraph 195.

(122)  Letter on Further Access, paragraph 67.

(123)  Letter on Further Access, paragraph 68.


ELI: http://data.europa.eu/eli/C/2025/1679/oj
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