Today's decision to impose an antitrust fine on Teva for disparagement and misuse of the patent system reaffirms the Commission's commitment to competition enforcement in the pharmaceutical sector. With today's decision, the Commission contributes to keeping drugs affordable, preserving choice of treatment and fostering innovation, to the benefit of EU patients and national healthcare systems.
This is the second consecutive decision addressing allegations that a dominant company abusively disparaged a competing drug. In the present case, Teva devised a strategy to delay competition as the patent for its blockbuster multiple sclerosis drug Copaxone was due to expire. Copaxone's active ingredient is called glatiramer acetate. As part of this strategy Teva launched a disparagement campaign against the only other glatiramer acetate medicine authorised in the EU, which is manufactured by Synthon. Teva sought to create doubts about its rival product. It spread information contradicted by health authorities' findings, seeking to sow doubt on the safety, efficacy and therapeutic equivalence of the rival product. Its campaign targeted key stakeholders, such as doctors and organisations involved in drug pricing and reimbursement with the objective of slowing down or blocking its competitor's entry in several Member States.
Last July, in another case, we investigated a similar tactic and accepted commitments by Vifor to undo the effects of its potentially misleading communications on the safety of the closest competing medicine for intravenous iron treatment, marketed by Pharmacosmos. In that case, we preliminarily found that Vifor spread potentially misleading information to healthcare professionals about the safety of its closest and potentially only competing medicine in Europe. These messages may have unduly hindered the uptake of the competing product in Europe.
To address this issue, Vifor committed to launch a comprehensive communication campaign targeting nearly two hundred thousand European healthcare professionals. The aim is to rectify and undo the effects of its disparagement campaign. Vifor also committed not to communicate about Monofer's safety unless the information is based on Monofer's label or valid clinical trials. In addition, Vifor reached a commercial settlement to compensate Pharmacosmos for the potential harm arising from its conduct. The commitments aimed to quickly stop Vifor's potential disparagement and prevent any possible long-term anticompetitive effects.
With these consecutive actions, we send a clear message to dominant pharmaceutical companies that we will not tolerate the use of disparagement campaigns to foreclose competing medicines.
Today's decision also finds that Teva misused the patent system to artificially extend patent protection for Copaxone active ingredient. Patent rights are essential to incentivize innovation and play a crucial role in the competitive process. But we found that Teva disrupted the patent process and delayed a final decision on the validity of its patent claims. By doing so, Teva undermined the objectives of the patent system, which is to provide legal certainty and to protect genuine innovation.
To do so, it engaged in a tactic known as "divisionals game". Divisional patents derive from an earlier "parent" patent application and share similar content. However they may focus on different aspects of the invention, and they are treated independently when it comes to assessing their validity. A divisional patent can in turn be a "parent" to other divisionals, leading to several generations of very similar patents. In view of the expiry of its main patent in 2015, Teva gamed this system by filing multiple divisional patents protecting dosage and manufacturing process with the European Patent Office in a staggered way. It then strategically withdrew these highly contested patents when they seemed likely to be revoked. The legal review of a patent's validity is key for generic companies to enter such markets. By withdrawing its patents when they were challenged, Teva avoided having the European Patent Office rule that one of its patents was invalid. Such a ruling would have set a precedent threatening other divisional patents, which Teva kept enforcing, to fall like dominos. As a result of Teva's withdrawal of contested patents, generic companies had to repeatedly start fresh challenges, prolonging the process. It took more than 9 years for all the divisional patents in question to be eventually annulled.
We found that Teva's conduct contributed to maintaining Teva's quasi-monopoly in several Member States years after the basic patent for Copaxone expired. This may have prevented significant savings for public health budgets, as a result of expected price decreases that could reach 80% in terms of list prices.
Teva will now have to pay a €462.6 million fine and must refrain from similar practices in the future. Antitrust intervention in the Vifor and Teva will lead to tangible and positive results for patients' access to safe, effective, affordable and innovative medicines. Competition policy in this sector also complements the applicable regulatory framework.
Background
