GSK paroxetine generics deals may be anti-competitive in Europe

23 January 2020 (Last Updated January 23rd, 2020 12:39)

A legal adviser to the European Court of Justice (ECJ) said that the deals signed by GlaxoSmithKline (GSK) to delay the market availability of generics of antidepressant drug, paroxetine (Seroxat), may have harmed market competition.

GSK paroxetine generics deals may be anti-competitive in Europe
GSK’s paroxetine is indicated for the treatment of major depressive disorder. Credit: GSK.

A legal adviser to the European Court of Justice (ECJ) said that the deals signed by GlaxoSmithKline (GSK) to delay the market availability of generics of antidepressant drug, paroxetine (Seroxat), may have harmed market competition.

The opinion by Advocate General Juliane Kokott is not legally binding but carries weight. It also upholds a £37.6m fine imposed by the UK Competition and Markets Authority (CMA) in 2016.

The first patent for the drug expired in 1999, paving the way for generic manufacturers to launch cheaper versions of the drug in the UK.

However, GSK entered agreements with the generic drugmakers to settle certain disputes concerning the secondary patents of paroxetine.

As part of these ‘pay-for-delay’ deals, GSK made payments to the generic companies to not launch their product for a certain period, said Kokott.

After the CMA found the agreements anti-competitive and imposed a penalty, GSK appealed to the Competition Appeal Tribunal (UK), which sought guidance from the ECJ.

According to the Advocate General, the court should reply that patent dispute settlements may hinder competition and such deals may be an ‘abuse of a dominant position’.

In a statement, Kokott said: “In today’s opinion, Advocate General Juliane Kokott proposes that the Court should reply to the Competition Appeal Tribunal that, subject to certain matters to be determined by that tribunal, an agreement in settlement of a patent dispute may constitute a restriction of competition by object or by effect and that entering into such an agreement may be  an abuse of a dominant position.”

In 2013, Lundbeck and eight pharmaceutical companies were fined a total of €146m for similar pay-for-delay deals concerning antidepressant drug citalopram.