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Commercial Question

A chemical carry on

updated on 05 July 2011

Question

The perindopril saga: what's the story of Servier's α-polymorph patent and the delay to the availability of generic versions of this high blood pressure drug?

Answer

This ongoing case brings together science, IP law (specifically pharmaceutical patent litigation) and competition law. 

The patent litigation

Les Laboratoires Servier's patent protecting the active pharmaceutical ingredient perindopril expired in 2003. Apotex launched perindopril in 2006, having obtained regulatory approval for its generic version on the basis that it is bioequivalent (ie, when two medicines contain the same amount of an identical active moiety, and when their bioavailability is the same when administered in equal doses under equal conditions) to Servier's original drug. Servier brought patent infringement proceedings against Apotex in relation to a patent protecting a particular form of the perindopril salt (for the scientists among you, the α-crystalline form of the perindopril tert-butylamine salt). Apotex was injuncted and unable to supply any further generic perindopril pending the outcome of its challenge to the validity of Servier's patent.

One year later, Apotex had shown through the evidence of expert chemists and crystallographers that the claimed salt form would be obtained by a process disclosed in an earlier Servier patent. The α-polymorph patent was therefore invalid for lack of novelty. The Court of Appeal upheld the decision of the first instance judge and the patent was revoked.

Damages

As Apotex had been held off the market for a year (by which time its generic competitors had caught up) the court ordered Servier to pay £17.5 million in damages. There was an unusual end to the litigation, however. Apotex manufactured its perindopril in Canada, where the court upheld a relevant national patent; Servier appealed against the award of damages on the basis of ex turpi causa (ie, the rule that an action cannot arise out of an illegal activity), arguing that Apotex should not be able to recover damages when the manufacture of the drug infringed a valid foreign patent. The UK court then ordered Apotex to repay Servier the damages it had received.

UK government sues Servier for £220 million

As reported in the Financial Times on 27 June 2011, the health secretary Andrew Lansley and more than 150 primary care trusts brought a claim against Servier that between July 2001 and July 2007 the company developed a strategy for preventing competitors from bringing generic perindopril to market. Servier's alleged strategy included threatened or actual legal proceedings, as well as concluding agreements with various companies not to supply perindopril in the UK market in return for money. 

As a result of Servier's alleged strategy, the NHS claims to have lost £220 million because it had to pay 'elevated prices' while generics were unavailable.

The government alleges that Servier abused its dominant position contrary to the Competition Act 1998 and that this "had the object and effect of restricting competition in the UK perindopril market and constitutes, for that reason, an abuse of a dominant position".

Servier is contesting the claim. The ongoing European Commission Pharmaceutical Sector Inquiry is also looking at patent settlements relating to this drug.

The life sciences sector and pharmaceutical markets in particular will remain important in the future. In this ever-changing IP landscape, large pharmaceutical companies and generics will have to move with the times and, where necessary, adapt commercial strategies to gain an edge over their competitors. Medicines will remain important, particularly with the United Kingdom's ageing population and the government’s goal to meet demand while cutting costs. This environment requires lawyers advising pharmaceutical companies to have a commercial and flexible outlook when dealing with the challenges thrown up by both the market and the law.

Charlotte Weekes is a senior associate in the life sciences and patent litigation team at Pinsent Masons.