Healthy Skepticism Library item: 13638

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Publication type: news

Servier loses patent appeal
PMLive.com 2008 May 9
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=6702

Full text:

French pharma company Les Laboratoires Servier has been criticised by the UK Court of Appeal after it lost a major patent dispute with Canadian pharma company Apotex.

Servier sued Apotex for infringement of its patent for the alpha crystalline form of its ACE inhibitor drug perindopril, sold under the brand name Coversyl.

According to senior patents judge, Lord Justice Jacob, the Server patent was “invalid… and very plainly so”. He went on to say: “It is the sort of patent that can give a patent system a bad name.”

In addition, the Court of Appeal agreed that Servier’s patent “lacked novelty” and that the appeal was “without merit”.

No chance of success
The case was originally heard in March 2007 and the judge ruled that Servier’s patent was invalid and that Apotex was free to produce and market generic versions of Coversyl.

Servier was given the right to appeal back in July 2007 by the late Lord Justice Pumfrey. Pumfrey stated at the time that he believed there was no real chance of success but felt bound to grant an appeal because of the precedent set by the Court of Appeal in Pozzoli SA vs BDMO which stated: “…unless the case is very clear on the facts and can be understood sufficiently readily in an hour or so, the better course of action is normally for the trial judge to give permission”.

Pumfrey’s decision has since been criticised both by Lord Justice Jacob, who said in his appeal judgment: “Undaunted and doubtless because much money was at stake, Servier persisted in the appeal,” and the Lord Chief Justice of England and Wales , who said: “I do not consider that his case satisfied the test in Pozzoli. Permission to appeal should not have been given.”

Lacking novelty
In July 2007, the judge ruled that the patent was invalid on the grounds of a lack of novelty and obviousness, as the new drug was not any different to the alpha form that the original patent covered.

Despite losing the case, thanks to an injunction imposed in August 2006 (before the initial case hearing), which stopped Apotex producing generic Coversyl, Servier retained its monopoly for 12 months.

“The important point that came out of Servier v Apotex is the possibility that an interim injunction might now be granted pending appeal even when a patent has been held to be invalid at first instance,” explained Matthew Royle, IP associate at Taylor Wessing, following the initial judgement in October 2007.

The perindopril market is an important one: Servier’s turnover in the UK is around £80m per year and Apotex made £4m in sales from its generic equivalent before the injunction was put in place.