The Health Secretary, along with the Department of Health’s 10 Strategic Health Authorities and 151 Primary Care Trusts, are taking this action because they feel they were forced to pay an elevated price for the drug during the period from its patent expiry in 2001 to the introduction of the first perindopril generic equivalent in July 2007.

The reason that generic versions of perindopril did not appear on the market during this period was that Servier issued a number of secondary patents, claiming that different formulations of the drug and specific drug manufacturing processes were subject to separate, newer patents. When a generic version of perindopril did finally appear in 2006, Servier took its manufacturer, Apotex, to UK’s High Court, gaining an injunction to prevent further sales. It was only in 2007, when a further High Court ruling judged the patent to be invalid, that generic equivalents finally became available. In 2008, Servier was also ordered to pay Apotex GBP 17.5 million (Euros 20 million; US$28.7 million) to cover lost revenue and damages.

In 2009, these very public High Court actions prompted the European Commission to launch an antitrust investigation of Servier and several generics manufacturers over what it described as ‘agreements which may have had the effect of hindering market entry of generic perindopril.’ These agreements allegedly included patent litigation and multi-million pound payments to at least one generics manufacturer. The investigation is ongoing.

Earlier this year, Servier was also under fire for allegedly concealing cardiovascular risks associated with its appetite suppressant, Mediator. The drug has since been withdrawn from the European market following the deaths of approximately 2,000 patients.

Commenting on the latest UK lawsuit, a Servier spokesman told UK’s Financial Times: ‘We are aware of this ongoing case, we are contesting the claim and are confident that the right outcome will be achieved.’

Reference

1. Clare Dyer. UK government sues Servier for £220m over alleged blocking of generic substitute. BMJ 2011; 342:d3645.