Disparagement under the microscope: the Vifor and Teva pharma decisions
The pharmaceutical sector has long been a key area for competition enforcement, with enforcement over the past two decades largely having focussed on 'pay-for-delay' arrangements between pharmaceutical firms to delay the market entry of competing generic medicines. Recently, the European Commission (Commission) and the UK Competition and Markets Authority (CMA) have concluded their investigations into two relatively novel types of anticompetitive conduct in the sector – namely, exclusionary disparagement of competing products and the misuse of patent procedures to hinder market access. We briefly consider these below.
Vifor commitments relative to IV iron products
Commission Decision
On 22 July 2024, the Commission accepted commitments from Vifor to resolve competition concerns related to Vifor's potential disparagement of the drug Monofer, which is the closest competitor to Vifor's flagship intravenous iron medicine in Europe, Ferinject (see Case AT.40577).
The Commission's preliminary concern was that Vifor may have restricted competition in the markets for intravenous iron treatment by spreading potentially misleading information about Monofer's safety and efficacy. This conduct, which was primarily targeted at healthcare professionals, may have unduly hindered Monofer's uptake in the EEA and shielded Ferinject from competition.
Following an offer of commitments by Vifor, on 22 July 2024, the Commission made a number of the commitments binding on Vifor, including:
- Corrective communications to rectify the potentially misleading information disseminated about Monofer.
- Restrictions on future communications about Monofer’s safety.
- Internal compliance measures to prevent similar conduct in the future.
The implementation of these commitments will be monitored by a trustee and will remain in place for a 10 year period to ensure compliance.
In this regard, relevant to the Commission’s decision to explore commitments in this case was the fact that Vifor had entered into a settlement agreement with Pharmacosmos, the owner of Monofer, which had filed the initial complaint to the Commission against Vifor.
CMA investigation
The CMA opened an investigation into Vifor's potential anti-competitive disparagement of Monofer in January 2024. On 10 December 2024, the CMA published a notice of intention to accept commitments offered by Vifor. The proposed commitments mirror the commitments accepted by the Commission, with an additional payment of £23 million to the NHS. This payment is intended to address the CMA’s concerns that Vifor's conduct influenced healthcare professionals' prescribing decisions, which negatively impacted the NHS as the ultimate purchaser of high-dose IV iron products given that Monofer was cheaper than Ferinject. This is the third time the CMA has secured a payment to the NHS further to one of its investigations in the pharmaceutical sector, following Fludrocortisone and Nortriptyline.
The CMA has invited third-party representations on the proposed commitments before making a final decision, which is expected imminently.
Teva infringement decision relative to Copaxone
On 31 October 2024, the Commission fined Teva €462.6 million for abusing its dominant position in the market for glatiramer acetate, the active ingredient in its blockbuster multiple sclerosis drug, Copaxone, in Belgium, Czechia, Germany, Italy, Poland, Spain and the Netherlands (see Case AT.40588).[1]
The Commission found that Teva implemented two complementary abusive practices to delay competition and artificially prolong Copaxone's exclusivity by hindering the market entry of competing, cheaper glatiramer acetate medicines: namely, by engaging in a systematic disparagement campaign, and the misuse of patent procedures.
Systematic disparagement campaign
Teva implemented a disparagement campaign against a competing glatiramer acetate medicine, Synthon GA. The Commission found that Teva disseminated misleading information to key stakeholders about Synthon GA's safety, efficacy and therapeutic equivalence with Copaxone, with the aim of hindering and/or delaying Synthon GA's market entry and uptake. The Commission found that Teva’s disparagement campaign commenced on the day of the public announcement that Synthon GA had been approved as therapeutically equivalent to Copaxone.
Misuse of patent procedures
Teva artificially extended Copaxone's patent protection by misusing the European Patent Office’s ("EPO") rules on secondary (or divisional) patents. When its patent protecting glatiramer acetate was about to expire, Teva created and enforced a web of secondary patents around Copaxone focusing on its manufacturing process and dosing regimen. When a patent seemed likely to be revoked, Teva strategically withdrew it before a formal invalidity ruling could be made by the EPO, thereby avoiding a negative precedent that would undermine the validity of its other divisional patents. This forced Teva's rivals to bring repeated lengthy legal challenges, prolonged uncertainty over its patents and hindered market entry by competing medicines.
The Commission concluded that Teva's conduct may have delayed price decreases, negatively impacting public health budgets, with prices falling by up to 80% once rival products entered the market.
Teva has appealed the Commission’s decision to the General Court (Case T-19/25). [2]
Comment
These are the first decisions by the Commission and the CMA to address disparagement campaigns, and the Teva (Copaxone) infringement decision is the first time the Commission has imposed a fine on a pharmaceutical company for engaging in both disparagement and misuse of patent procedures. The cases highlight the increasing focus of competition authorities on new and novel forms of anti-competitive conduct and emerging theories of harm, reflecting significant contemporary issues in the pharmaceutical sector.
Disparagement is a significant concern in this context as spreading misleading or incomplete information about a drug’s safety, efficacy, or therapeutic equivalence can have a substantial impact on market dynamics. Patients, healthcare professionals and health authorities are particularly susceptible to negative statements regarding a medical product’s safety and efficacy. Given this, we may well see more cases as competition authorities scrutinise the impact of such conduct on competition and public healthcare systems, as well as its potential application in other sectors of the economy.
Footnotes
[1] At the date of publication of this article, the Commission's infringement decision in the Teva (Copaxone) case was not made publicly available. The Commission had, however, published a press release announcing its decision on 31 October 2024, and a summary of its infringement decision and the Final Report of the Hearing Officer on 20 January 2025.
[2] https://content.mlex.com/Attachments/2025-02-24_P8H34R51LUF542W0%2FOJ_C_202501126_EN_TXT.pdf