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Teva's divisional patent strategy under the Commission spotlight

Posted on 19 April 2021

On 4 March 2021, the European Commission announced that it had opened a formal competition investigation to assess whether Teva had illegally delayed the market entry and uptake of medicines that compete with Teva's blockbuster multiple sclerosis drug Copaxone.

The Commission has said that it will investigate whether, following the expiry of Teva's basic patent covering glatiramer acetate in 2015, Teva has artificially extended the market exclusivity of Copaxone by strategically filing and withdrawing divisional patents. Doing so is said to have delayed the entry of its generic competitor, Mylan, to the market, as it was obliged to file a new legal challenge each time.

Teva has used a patent (EP 2,949,335) protecting a specific dosing regimen of Copaxone 40mg/ml to obtain preliminary injunctions against Mylan in several key jurisdictions (but had not always enforced those injunctions). In the UK, the Patents Court invalidated the patent in 2017. However, Teva continued to rely on and enforce the patent in other jurisdictions, whilst the Technical Board of Appeal of the EPO considered Mylan's appeal, until September 2020 when the EPO revoked the '335 patent.

It is interesting that in the 2017 UK litigation, in which Mylan also sought an Arrow declaration, Mylan cited similar concerns to those now being investigated by the Commission in relation to Teva's seeking to "shield the subject-matter of the Patent from scrutiny by the courts of this country and the Netherlands and the Boards of Appeal." This claim was rejected by Mr Justice Arnold.

The Commission has also stated that it will examine whether Teva may have pursued a communication campaign designed to unduly hinder the use of competing glatiramer acetate products. The Commission has referred to indications that Teva's campaign, primarily directed at healthcare institutions and professionals, may have targeted competing products to create a false perception of health risks associated with their use, even following the approval of these medicines by competent public health authorities. If proven, Teva's behaviour may amount to an abuse of a dominant position, and infringe Article 102 of the Treaty on the Functioning of the European Union (TFEU) and Article 54 of the European Economic Area (EEA) Agreement.

These issues are not novel to the Commission. They were first raised during the Commission's Pharmaceutical Sector Inquiry in 2008, and were also raised in the context of some of the Commission's cases that flowed from the inquiry, most notably Servier.

What appears to have changed is the Commission's appetite to assess how divisional patents operate. It is a very interesting development, and one which should be both of concern to all originators and, perhaps, a welcome opportunity for generics and biosimilars. However, it's unlikely that we will have any clarity as to whether these types of life-cycle management tactics amount to abuses of a dominant position for some time.

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