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British "pay-for-delay" questions are to be decided by the European Court of Justice

One of the questions that will be referred by the UK Competition Appeal Tribunal (CAT) to the European Court of Justice is whether the so-called "pay-for-delay" agreements in the pharmaceutical industry restrict competition in the market by object or by effect.

UK Competition Appeal Tribunal's judgment of 8 March 2018 – GlaxoSmithKline and others v. Competition and Markets Authority

By attorney Line Berg Madsen

The case was brought before CAT after the UK Competition and Markets Authority (CMA) in 2016 in its first "pay-for-delay" case imposed fines on GlaxoSmithKline (GSK) and other pharmaceutical companies totalling more than GBP 45 million (approx. DKK 430 million in 2016) in the case concerning the anti-depressant medicinal product Seroxat.

CAT's questions to be referred to the European Court for a preliminary ruling are currently being finalized, but it appears from the judgment that the following will be the main points:

  • The fundamental issue is whether settlement agreements concerning value transfers from an originator to a generic player constitute a restriction of competition by object in the event of uncertainty as to the strength of the patents on the original product.
  • Just as important, it is expected that CAT will ask whether it makes a difference if the originator allows the other party to distribute a generic version of a medicinal product as a so-called authorised generic product - with the resulting benefits to the consumers in the form of access to the generic product.
  • In summary, it also appears from the judgment that CAT will seek to clarify the definition of the relevant market, which often - and not least in this case - is subject to a thorough analysis of whether the market is to be restricted to the medicinal product in question or whether other medicinal products also belong to the relevant market.

Since the European Court of Justice is already examining the cases concerning Citalopram (under appeal) and Perindopril (judgment will be given soon), which are based substantially on similar "pay-for-delay" issues, CAT found it natural to refer the questions to the Court.

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