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Drug Test: When Are Pay-for-Delay Agreements Illegal?

Irene Fraile, Ankur Kapoor, and Rosa Morales, Global Competition Litigation Review, Issue 4, 2014

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In recent years, so-called “pay-for-delay” agreements between originator pharmaceutical companies and generic drug manufacturers have preoccupied antitrust authorities worldwide. Together with shortcomings in patent and regulatory systems and other factors, these sorts of potentially anticompetitive practices have been found to be one of the causes of a progressive decline in the number of novel medicines reaching the market and of significant delays in the market entry of generic drugs. In 2013 there were two landmark decisions in this area both in the US and in the EU.1 This article will analyse these decisions and developments since, in particular, regarding the standards that are applied by authorities to decide whether there has been an antitrust infringement.

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