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Document 52025AT40588
Summary of Commission Decision of 31 October 2024 relating to a proceeding under Article 102 of the Treaty on the Functioning of the European Union (Case AT.40588 – Teva Copaxone) (notified under document number C(2024)7448 final)
Summary of Commission Decision of 31 October 2024 relating to a proceeding under Article 102 of the Treaty on the Functioning of the European Union (Case AT.40588 – Teva Copaxone) (notified under document number C(2024)7448 final)
Summary of Commission Decision of 31 October 2024 relating to a proceeding under Article 102 of the Treaty on the Functioning of the European Union (Case AT.40588 – Teva Copaxone) (notified under document number C(2024)7448 final)
C/2024/7448
OJ C, C/2025/1680, 19.3.2025, ELI: http://data.europa.eu/eli/C/2025/1680/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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Official Journal |
EN C series |
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C/2025/1680 |
19.3.2025 |
Summary of Commission Decision
of 31 October 2024
relating to a proceeding under Article 102 of the Treaty on the Functioning of the European Union
(Case AT.40588 – Teva Copaxone)
(notified under document number C(2024)7448 final)
(Only the English text is authentic)
(C/2025/1680)
On 31 October 2024, the Commission adopted a decision relating to a proceeding under Article 102 of the Treaty on the Functioning of the European Union. In accordance with the provisions of Article 30 of Council Regulation (EC) No 1/2003 (1) , the Commission herewith publishes the names of the parties and the main content of the decision having regard to the legitimate interest of undertakings in the protection of their business secrets.
1. INTRODUCTION
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(1) |
This Decision under Article 7 of Council Regulation (EC) No 1/2003 (‘Regulation 1/2003’) imposes a fine on Teva Pharmaceutical Industries Ltd and Teva Pharmaceutical Europe B.V. (together: “Teva”) for infringing Article 102 of the Treaty on the Functioning of the European Union (the ‘Treaty’). It establishes that Teva abused a dominant position in several markets for glatiramer acetate (“GA”) in the European Union. GA is a medicine used in the treatment of the disease multiple sclerosis – a highly debilitating and incurable disease, currently affecting more than a million patients in Europe. |
2. PROCEDURE
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(2) |
Between 24 and 28 October 2019, unannounced inspections pursuant to Article 20(4) of Regulation 1/2003 were carried out at Teva’s premises in the Netherlands, Germany and the United Kingdom. The inspections continued between December 2019 and February 2020, at the Commission’s premises and in the presence of Teva representatives. |
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(3) |
On 4 March 2021, the Commission opened proceedings with a view to adopting a decision pursuant to Chapter III of Regulation 1/2003. |
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(4) |
On 7 October 2022 and on 8 December 2022, the Commission received two formal complaints against Teva. |
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(5) |
The Commission adopted a Statement of Objections on 10 October 2022. |
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(6) |
On 8 February 2023, Teva submitted a written reply to the Statement of Objections, and an Oral Hearing was held on 24 March 2023. |
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(7) |
On 9 February 2024, 17 May 2024 and 23 October 2024 the Commission adopted three Letters of Facts, informing Teva about further evidence relevant to support the preliminary conclusions reached in the Statement of Objections and additional evidence which had been added to the case file as well as clarifying the method for calculating the fine. Teva replied to these Letters of Facts respectively on 26 March 2024, 11 June 2024 and 28 October 2024. |
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(8) |
On 29 October 2024, the Advisory Committee on Restrictive Practices and Dominant Positions was consulted and issued a favourable opinion. |
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(9) |
On 29 October 2024, the Hearing Officer issued his final report. |
3. LEGAL ASSESSMENT
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(10) |
Teva is the originator producer of GA, which it commercialises under the brand name “Copaxone”. When its basic patent for GA approached expiry in 2015 and the competing Dutch manufacturer Synthon was preparing to enter the market with its GA product (“Synthon GA”, marketed under different brands – to date, still the only competing GA medicine authorised in the EU), Teva devised an elaborate, multifaceted strategy to protect Copaxone from competition by prolonging its exclusivity and preventing or delaying the start of significant price competition from other GA medicines. |
3.1 Market definition and dominance
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(11) |
The Decision concludes that in each of the seven investigated Member States (Belgium, Czechia, Germany, Italy, the Netherlands, Poland and Spain – the “Relevant Member States”), the relevant product market is the market for GA. This is because the (approaching) market entry of Synthon GA has changed the nature of competition for Copaxone from non-price competition to price competition. As a result, Copaxone is constrained only by its hybrid (2) (generic-like) rival Synthon GA. The relevant geographic market is national in scope, because the conditions of supply and demand are likely to vary across Member States due to several factors, such as national rules on the supply and pricing of pharmaceuticals. |
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(12) |
The Decision also finds that Teva held a dominant position in each of the seven Relevant Member States, in light of Teva’s (very) large market shares and significant net profits, high barriers to entry and expansion, lack of sufficient countervailing buyer power and Teva’s internal documents referring to its dominance and corroborating the Commission’s analysis. |
3.2 First abuse: Misuse of divisional patents
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(13) |
The Decision concludes that Teva has committed an abuse of its dominant position in breach of Article 102 TFEU by misusing the patent system and patent procedures. Teva’s conduct consisted of two intertwined practices. First, Teva staggered filings of divisional patents in two patent families before the European Patent Office that largely overlapped in content. These patents shared essential features with ingrained legal weaknesses. They therefore shared the same risk of being revoked in validity challenges, which are a key instrument to remove unjustified patent barriers. |
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(14) |
The second leg of Teva’s conduct consisted in the obstruction of effective legal review of these weaknesses through the strategic withdrawals of these patents before the competent appeal instances (i.e. the European Patent Office’s Technical Board of Appeal) could adopt a decision and while one or more patents with similar, overlapping claims were still in place. Teva thus prevented the European Patent Office from issuing a final decision on the validity of overlapping claims, which would likely have created a harmful precedent for Teva’s ability to enforce and defend the remaining divisional patents. As a result of this combined conduct, generic companies had no option but to repeatedly restart their validity challenges against the remaining patents (the ones not yet withdrawn by Teva) from scratch. |
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(15) |
Patent validity challenges are an important expression of competition between originator and generic companies. Teva’s conduct obstructed their effectiveness, artificially prolonged the legal uncertainty concerning the validity of its remaining patents and enabled Teva to assert its remaining divisional patents against Synthon GA and potential future entrants in the GA market. |
3.3 Second abuse: Exclusionary disparagement
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(16) |
The Decision concludes that Teva implemented a disparagement campaign against Synthon GA to hinder and/or delay its market entry and uptake in the Relevant Member States. In particular, the Decision finds (i) that Teva disseminated objectively misleading information on key features of Synthon GA capable of discrediting it (namely questioning its safety, efficacy, and therapeutic equivalence with Copaxone), (ii) that Teva put in place effective mechanisms for the dissemination of the objectively misleading messages to relevant stakeholders (national authorities competent for pricing and reimbursement, health insurance funds and health care professionals) in the seven Relevant Member States, (iii) that this conduct was capable of producing exclusionary effects; and that (iv) it was not objectively justified. |
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(17) |
The objectively misleading information in question concerned three different types of messages which ran against the regulatory findings of the competent medicines agencies in the EU. More precisely, these messages consisted of (i) emphasising clinically irrelevant differences in molecular structures of Copaxone and Synthon GA, (ii) pointing to the risks observed in the use of other glatiramer-related substances, unjustifiably implying that they equally applied to Synthon GA, and (iii) calling into question the scientific validity of the study on which the competent authorities based their finding of therapeutic equivalence between Copaxone and Synthon GA. |
4. DURATION
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(18) |
The Decision finds that the first abuse, Teva’s misuse of divisional patents, started in all the Relevant Member States on 3 February 2015, when Teva withdrew the approval for the text of one of its divisional patents related to Copaxone. The infringement ended (i) in the Netherlands on 4 April 2017, when Teva did not hold anymore any of the relevant divisional patents in the Netherlands; (ii) in Italy on 31 December 2021 and in Poland on 31 December 2022, i.e. on the last day of Teva holding a dominant position on the GA markets in Italy and Poland, respectively; and (iii) in Belgium, Czechia, Germany and Spain on 7 February 2024, when the European Patent Office’s Technical Boards of Appeal revoked the last of Teva’s remaining divisional patents in those Relevant Member States. |
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(19) |
The Decision also finds that the second abuse, Teva’s disparagement campaign against Synthon GA, started in all the Relevant Member States on 12 April 2016, the date on which the successful conclusion of the procedure to approve Synthon GA as a safe and effective medicine, therapeutically equivalent to Copaxone, was publicly announced. As to the end date of the infringement, the Commission’s file includes evidence of Teva referring to its disparaging messages on Synthon GA at least until 2021, and the Commission notes that Teva never implemented any corrective measures with respect to the dissemination of its disparaging messages. However, the Decision takes a conservative approach and finds that Teva’s disparagement campaign in each Relevant Member State ended on the date of the last available evidence of dissemination of disparaging messages in that Member State. Accordingly, the Decision finds that the infringement ended on 8 August 2017 in Poland, on 18 August 2017 in Czechia, on 11 March 2019 in Belgium, on 24 March 2020 in Germany, on 20 September 2020 in Spain, and on 20 October 2020 in Italy. The infringement in the Netherlands ended on 31 December 2018, the last day of Teva holding a dominant position on the GA market in the Netherlands. |
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(20) |
Since these two abuses are complementary and pursue an identical objective, namely to protect or strengthen Teva’s dominant position on the GA markets, they constitute a single and continuous infringement which started in all Relevant Member States on 3 February 2015 and ended (i) on 31 December 2018 in the Netherlands, (ii) on 31 December 2021 in Italy, (iii) on 31 December 2022 in Poland, and (iv) on 7 February 2024 in Belgium, Czechia, Germany and Spain. |
5. FINES
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(21) |
The fine calculation is based on an average annual value of sales calculated over the entire period rather than the value of sales during the last full business year of the infringement. This is because the revenues Teva derived from its anticompetitive conduct were significantly higher at the onset of the infringement and, in most of the Relevant Member States, gradually reduced over time. Therefore, relying on the revenue in the last full business year of the infringement would significantly understate the value of sales to which the infringement related and would not be representative of the economic importance of Teva’s single and continuous infringement. |
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(22) |
When assessing the gravity of the infringement, the Decision takes into account the particularly serious nature of the infringement, the fact that Teva committed the infringement intentionally or at least negligently, that Teva’s abusive conduct has been implemented, that Teva held high market shares in each Relevant Member State and that Teva’s infringement covered approximately two thirds of Teva’s sales of the relevant product in the EEA. |
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(23) |
In addition, the Decision considers that the two abusive practices were highly complementary and reinforced one another by being largely overlapping in time. The Decision therefore sets a higher gravity coefficient for Relevant Member States where the two practices were both ongoing at the same time for more than one third of the total duration of the single and continuous infringement. Finally, for Czechia and Germany, the Decision applies a further increase to the gravity coefficient, to reflect the amount of gains improperly made by Teva as a result of the infringement – namely, as a result of preliminary injunctions obtained on the basis of the divisional patents that were covered with Teva’s abusive conduct. |
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(24) |
In order to contribute to the deterrent effect the fine should have on an undertaking of a size and with resources such as Teva, the Commission applied an additional amount of the relevant values of sales. For each of the seven Relevant Member States, the additional amount was equal to the average value of sales of Copaxone multiplied by the gravity coefficient used in the same Relevant Member State. |
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(25) |
No aggravating or mitigating circumstances were applied. |
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(26) |
The Decision imposes a single fine of EUR 462 578 000 on Teva. Considering that the duration of the single and continuous infringement differed between the Relevant Member States, the fine is calculated separately for each of the Relevant Member States:
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(27) |
The calculated fines do not exceed 10 % of Teva’s worldwide turnover. |
(1) OJ L 1, 4.1.2003, p. 1. Regulation as amended by Regulation (EC) No 411/2004 (OJ L 68, 6.3.2004, p. 1).
(2) Article 10(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67) as amended.
ELI: http://data.europa.eu/eli/C/2025/1680/oj
ISSN 1977-091X (electronic edition)