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11 October 2022EuropeSarah Speight

Teva breached antitrust rules over Copaxone, says EU

European Commission says pharma firm blocked generics over blockbuster MS drug| Teva “engaged in abusive conduct” to “artificially prolong the exclusivity” of Copaxone | Teva could be found to have infringed Article 102 of TFEU.

The European Commission believes that pharmaceutical company Teva breached EU antitrust rules over its blockbuster medicine, Copaxone, a widely used treatment for multiple sclerosis (MS).

Eighteen months after initiating an investigation into whether the Israeli company illegally blocked generic versions of the drug, the Commission informed Teva yesterday, October 10, of its preliminary view that the company attempted to delay competition against the medicine.

Teva engaged in practices such as “artificially extending patent protection of Copaxone, and systematically spreading misleading information about a competing product with a view to hinder its market entry and uptake”, the Commission said in a press release.

Copaxone contains the active pharmaceutical ingredient glatiramer acetate, for which Teva held a basic patent until February 2015.

“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,” said the Commission.

The EC’s executive vice-president Margrethe Vestager, in charge of competition policy, said: "Until today, there is not yet a treatment for the chronic illness of multiple sclerosis. So innovative medicines can make a major difference to patients’ quality of life.

“Effective protection of intellectual property is key to this scientific progress. Our concern is that Teva may have misused the patent system to shield itself from competition. It may have spread misleading information to discredit its closest competitor, to the detriment of patients and public health systems across the EU.”

Abuse and misuse

The Commission believes that Teva “abused its dominant position” in the markets for glatiramer acetate in Belgium, Czechia, Germany, Italy, the Netherlands, Poland and Spain.

After the original, basic patent expired, the Commission says Teva misused patent procedures, artificially extending basic patent protection for glatiramer acetate by filing and withdrawing secondary patent applications, forcing its competitors to file new, lengthy legal challenges each time.

This strategy, says the Commission, is also known as the “divisionals game” because it involves filing so-called “divisional patents”—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.

Teva also 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”, it said.

Teva could be found to have infringed Article 102 of the Treaty on the Functioning of the European Union (TFEU), which prohibits the abuse of a dominant position, if the Commission’s view is confirmed. Penalties for such infringement include fines of up to 10% of the guilty company’s turnover from the prior financial year.

“If 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,” said the Commission.

Teva is headquartered in Israel and operates through several subsidiaries in the European Economic Area.

As part of its investigation, the Commission carried out unannounced inspections at the premises of several Teva subsidiaries in October 2019.

In March 2021, the Commission initiated proceedings against Teva Pharmaceutical Industries and Teva Pharmaceuticals Europe BV.

Teva's response

In a statement, Teva said: "We regret that the European Commission (EC) has decided to proceed further with an investigation of Teva. [The] statement of objections is a disappointment for Teva as we have been cooperating intensively with the EC from first learning of this investigation in 2019 (which was first described in our securities filing in 2020).

"Teva will defend itself vigorously and continues to engage with the EC toward a resolution of this matter, which could take several years. While we will first seek to persuade the EC that their preliminary view is incorrect, we are also prepared if needed to contest any allegations resulting from the EC’s investigation using all the legal and other procedural rights at our disposal.

"Teva remains fully committed to the lawful conduct of our business and our mission of providing accessible medicines to millions of people every day. This investigation will not distract us from supporting patients using Copaxone and living with MS, and their families."

Copaxone was worth $4 billion a year at its peak in 2014, but dwindled to around $1 billion last year and is predicted to make approximately $700 million this year, 2022, according to pharmaphorum.

This article was updated later on the day of publication to accommodate the statement from Teva.

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