EU fines Teva $502m for Copaxone practices

The European Commission (EC) has levied a substantial fine of €462.6 million ($502 million) on Teva Pharmaceutical Industries. This penalty arises from an investigation into Teva's conduct concerning Copaxone, a widely used treatment for multiple sclerosis.

The EC's fine addresses Teva's efforts to obstruct competition by artificially prolonging Copaxone's patent protection and spreading false information about competing products. Copaxone's active ingredient, glatiramer acetate, had its primary patent expire in 2015. However, the EC discovered that Teva engaged in practices to extend its market exclusivity improperly.

Teva's misconduct involved exploiting patent procedures to delay competitors' entry into the market. The company filed a series of staggered divisional patent applications, creating a web of secondary patents around Copaxone. This tactic was designed to generate legal uncertainty and hinder the introduction of more affordable alternatives. The affected markets included countries such as Czechia, Belgium, Germany, Italy, the Netherlands, Poland, and Spain.

In addition to patent manipulation, the EC found that Teva initiated a systematic campaign to discredit rival glatiramer acetate treatments. This campaign involved spreading false claims about the efficacy and safety of competitors' products, despite these products having received approval from health authorities. The disparagement was aimed at influencing doctors and national decision-makers, with the goal of delaying or preventing the market entry of these alternatives in various EU Member States.

This decision marks the first instance where the EC has imposed a fine for such combined practices, considering them a continuous infringement of Article 102 of the Treaty on the Functioning of the European Union. The fine was determined based on the EC’s 2006 guidelines on fines.

Following the ruling, Teva expressed significant disappointment, emphasizing its cooperation with the EC since 2019. The company contests the legal theories applied by the EC, arguing that they are untested and not factually supported. Teva stated its intention to appeal the decision and reaffirmed its commitment to supporting the multiple sclerosis community, highlighting its long-standing involvement since 1996.

Despite the legal challenges, Teva assured that its focus on providing access to Copaxone for multiple sclerosis patients would remain undeterred.