Commission fines Teva €462.6 million over misuse of the patent system and disparagement to delay rival multiple sclerosis medicine

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The European Commission has fined Teva €462.6 million for abusing its dominant position to delay competition to its blockbuster medicine for the treatment of multiple sclerosis, Copaxone. The Commission found that Teva artificially extended the patent protection of Copaxone and systematically spread misleading information about a competing product to hinder its market entry and uptake.

The infringements

Teva is a global pharmaceutical company operating through several subsidiaries in the European Economic Area. Its blockbuster medicine, Copaxone, is widely used for the treatment of multiple sclerosis and contains the active pharmaceutical ingredient glatiramer acetate, over which Teva held a basic patent until 2015.

The Commission’s investigation found that Teva abused its dominant position in the markets for glatiramer acetate in Belgium, Czechia, Germany, Italy, the Netherlands, Poland and Spain.

Teva’s abusive conduct had the overall objective of delaying competition and artificially prolonging the exclusivity of Copaxone by hindering the market entry and uptake of competing, cheaper glatiramer acetate medicines. In particular, the Commission found that Teva:

• Misused patent procedures. When its patent protecting glatiramer acetate was about to expire, Teva artificially extended Copaxone’s patent protection by misusing the European Patent Office’s (“EPO”) rules and procedures on divisional patents. Divisional patents derive from an earlier ‘parent’ patent application and share similar content, but may focus on different aspects of the invention and are treated independently when it comes to assessing their validity. In this specific case, Teva filed multiple divisional patent applications in a staggered way, creating a web of secondary patents aroundCopaxone focusing on the manufacturing process and the dosing regimen of glatiramer acetate. Rivals challenged these patents to clear the way to the market. Pending review by the EPO, Teva started enforcing these patents against competitors to obtain interim injunctions. When the patents seemed likely to be revoked, Teva strategically withdrew them, to avoid a formal invalidity ruling, which would have set a precedent threating other divisional patents to fall like dominos. By doing so, Teva forced competitors to repeatedly start new lengthy legal challenges. This tactic allowed Teva to artificially prolong legal uncertainty over its patents and, potentially, hinder the entry of competing glatiramer acetate medicines. All Teva’s divisional patents have now been annulled.
• Implemented a systematic disparagement campaign against a competing glatiramer acetate medicine for the treatment of multiple sclerosis, by spreading misleading information about its safety, efficacy and therapeutic equivalence with Copaxone. Teva did so despite the relevant health authorities having approved the competing medicine and confirmed its safety, efficacy and therapeutic equivalence with Copaxone. Teva’s disparagement campaign targeted key stakeholders, including doctors and national decision-makers for pricing and reimbursement of medicines, with the objective of slowing down or blocking the entry of its rival product in several Member States.

Today’s decision concludes that Teva’s abuses were complementary and together amounted to a single and continuous infringement of Article 102 of the Treaty on the Functioning of the European Union (‘TFEU’), which prohibits the abuse of a dominant position. This is the first time the Commission imposes a fine in relation to these two types of practices.

Teva’s conduct, which lasted between 4 and 9 years depending on the Member State, may have prevented list prices to decrease, with a negative impact on public health budgets. This is confirmed by the fact that, once the rival product entered the market, the list prices decreased by up to 80%, leading to significant savings for health systems.

A statement by Executive Vice-President Margrethe Vestager, in charge of competition policy, is available here.

Fine

The fine was set on the basis of the Commission’s 2006 Guidelines on fines (see press release and MEMO).

In setting the level of the fine, the Commission took into account the gravity and duration of the infringements as well as the value of Teva’s sales relating to the latter.

The Commission has concluded that the total amount of the fine of €462.6 million is proportionate and is necessary to achieve deterrence.

Background

Following unannounced inspections at the premises of several Teva subsidiaries in October 2019, the Commission opened proceedings in March 2021 against Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV. In October 2022, the Commission sent the parties a Statement of Objections.

This is the second Commission decision about disparagement campaigns. In July 2024, the Commission accepted commitments by Vifor addressing the Commission’s preliminary concerns that the pharmaceutical company could have engaged in a potentially anticompetitive disparagement campaign.

Article 102 of the TFEU prohibits the abuse of a dominant position that may affect trade within the EU and prevent or restrict competition. The implementation of this provision is defined in Regulation No 1/2003.

Fines imposed on companies found in breach of EU antitrust rules are paid into the general EU budget. These proceeds are not earmarked for particular expenses, but Member States’ contributions to the EU budget for the following year are reduced accordingly. The fines therefore help to finance the EU and reduce the burden for taxpayers.

In the decision, the Commission also relied on documents from Teva’s in-house lawyers who were involved in the design of its abusive strategy to protect Copaxone. In-house lawyer communications are not privileged under EU law.

Action for damages

Any person or company affected by anticompetitive behaviour as described in this case may bring the matter before the courts of the Member States and seek damages. The case law of the Court of Justice of the European Union and Council Regulation No 1/2003 both confirm that in cases before national courts, a Commission decision that has become final constitutes binding proof that the behaviour took place and was illegal. Even though the Commission has fined the company concerned, damages may be awarded by national courts without being reduced on account of the Commission fine.

The Antitrust Damages Directive makes it easier for victims of anticompetitive practices to obtain damages. More information on antitrust damages actions, including a practical guide on how to quantify antitrust harm, is available here.

Whistleblower tool

The Commission has set up by a tool to make it easier for individuals to alert it about anticompetitive behaviour while maintaining their anonymity. The tool protects whistleblowers’ anonymity through a specifically designed encrypted messaging system that allows two-way communications. The tool is accessible via this link.

For More Information

More information on this case will be available under the case number AT.40588 in the public case register on the Commission’s competition website, once confidentiality issues have been dealt with.

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