The European Commission has informed Teva of its preliminary view that the company has breached EU antitrust rules by engaging in practices intended to delay competition to its blockbuster medicine, Copaxone.
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These consisted in artificially extending patent protection of Copaxone and by systematically spreading misleading information about a competing product with a view to hinder its market entry and uptake.
The Commission preliminarily finds that Teva abused its dominant position in the markets for glatiramer acetate in Belgium, Czechia, Germany, Italy, the Netherlands, Poland and Spain.
The Commission is concerned that Teva engaged in two types of abusive conduct, with an overall objective of artificially prolonging the exclusivity of Copaxone by hindering the market entry and uptake of competing glatiramer acetate medicines.
In particular, the Commission preliminarily found that since February 2015 until today Teva:
• Misused patent procedures: after the original, basic patent expired, Teva artificially extended glatiramer acetate's basic patent protection by filing and withdrawing secondary patent applications, thereby forcing its competitors to file new lengthy legal challenges each time.
This scheme is sometimes referred to as the “divisionals gameâ€. This is because the strategy implies filing so-called “divisional patents†which are patents derived from an earlier secondary patent and whose subject matter is already contained in the earlier patent.
This artificially prolongs legal uncertainty to the benefit of the patent holder, and can effectively block or delay entry of generic or generic-like medicines.
• Implemented a systematic disparagement campaign targeting healthcare professionals and casting doubts about the safety and efficacy of a competing glatiramer acetate medicine and its therapeutic equivalence with Copaxone.
If the Commission's preliminary views were confirmed, Teva's behaviour would not only harm competitors and patients, but also inflate public health spending on certain multiple sclerosis treatments, which for Copaxone alone amounts to up to €500 million per year in the EU. ■