Commission Imposes €462.6 Million Teva Fine Over Copaxone Patent Misuse

Copaxone contains the active ingredient glatiramer acetate, over which Teva held a basic patent until 2015. The Commission found that Teva was dominant in the markets for glatiramer acetate in Belgium, Czechia, Germany, Italy, the Netherlands, Poland and Spain.

Misuse of patent procedures

As its basic patent was about to expire, Teva filed multiple divisional patent applications at the European Patent Office in a staggered way, creating a web of secondary patents on the manufacturing process and dosing regimen. It enforced these patents against competitors to obtain interim injunctions and, when the patents seemed likely to be revoked, withdrew them strategically to avoid a formal invalidity ruling. This forced rivals to start new legal challenges repeatedly. All of Teva's divisional patents have now been annulled.

Disparagement campaign

The Commission also found that Teva ran a systematic campaign spreading misleading information about the safety, efficacy and therapeutic equivalence of a competing glatiramer acetate medicine, even though health authorities had approved it. The campaign targeted doctors and national decision-makers on pricing and reimbursement.

A first for these practices

The Commission concluded that the abuses formed a single and continuous infringement of Article 102 TFEU, lasting between four and nine years depending on the Member State. It is the first time the Commission has fined these two types of practice. The Commission said that once the rival product entered the market, list prices fell by up to 80%. In a statement on the decision, the Commission set out its reasons for acting.

What it means

The decision signals that patent filing and enforcement strategies, and communications about rival medicines, can be scrutinised under competition law when a company is dominant. Pharmaceutical companies may wish to review divisional patent practice and medical communications policies in light of the decision.

Sources

• European Commission: Commission fines Teva €462.6 million over misuse of the patent system and disparagement to delay rival multiple sclerosis medicine
• European Commission: Statement by Executive Vice-President Vestager on the adoption of an antitrust decision against Teva