View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
January 23, 2020

GSK paroxetine generics deals may be anti-competitive in Europe

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.

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology