The European Commission informed Teva on Monday 10 October of its preliminary view that the company had breached EU rules on anti-competitive behaviour by engaging in practices designed to delay competition for its medicine Copaxone.
These practices consisted of an artificial extension of the patent protection of Copaxone and the systematic dissemination of misleading information about a competing product in order to hinder its market entry and uptake.
Teva’s blockbuster medicine Copaxone is widely used for the treatment of multiple sclerosis and contains glatiramer acetate, over which Teva held a basic patent until 2015.
According to the Commission, Teva abused its dominant position in the markets for glatiramer acetate in Belgium, the Czech Republic, Germany, Italy, the Netherlands, Poland and Spain.
The Commission is concerned that Teva has engaged in two types of abusive conduct.
Teva allegedly abused patent procedures: after the expiry of the original basic patent, the company artificially extended the protection conferred by the basic patent for glatiramer acetate by filing and withdrawing secondary patent applications, thus forcing its competitors to file new and lengthy legal challenges each time. This technique artificially prolongs legal uncertainty for the benefit of the patent holder and can block or delay the market entry of generic or similar medicines.
In addition, Teva allegedly implemented a systematic disparagement campaign targeting healthcare professionals and casting doubt as to the safety and efficacy of a competing medicine containing glatiramer acetate.
Teva’s behaviour would infringe Article 102 of the Treaty on the Functioning of the EU (abuse of dominant position). It would harm competitors and patients and increase public health spending on certain multiple sclerosis treatments. (Original version in French by Lionel Changeur)