EU & Competition news
10 September 2008 Date: 9 May 2008 Court: Court of Appeal - England OVERVIEW In July 2007, the late Lord Justice Pumfrey found Servier's patent EP (UK) 1 296 947 invalid for lack of novelty and obviousness. The Court of Appeal has recently confirmed that decision. THE PATENT Servier's product perindopril is extremely successful, with UK sales alone estimated at £70m per annum. Servier's basic patent for the drug and its tert-butylamine salt was extended by a supplementary protection certificate, but this expired on 21 June 2003. Servier obtained some further protection for perindopril by way of a patent for the process of making it and its tert-butylamine salt. This patent will expire on 16 September 2008. The patent in suit was for a particular crystalline form (known as the α form) of the tert-butylamine salt of Servier's drug perindopril, and for a process for making this form. The patent's priority date was 6 July 2000, so if it had been found valid it would have provided Servier with protection for perindopril for many years to come. At the time of applying for the patent in suit, Servier had also applied for separate patents covering the other two known crystalline forms of the tert-butylamine salt, β and γ. It claimed that each of the known crystalline forms "especially exhibits valuable characteristics for formulation". The judge at first instance found these simultaneous applications "curious". On appeal, Lord Justice Jacob found that to be a kind way of saying that Servier were simply trying to extend the life of their monopoly in the salt. FIRST INSTANCE DECISION At first instance, Servier's own expert acknowledged that the process disclosed in the patent in suit was obvious over the process disclosed in its earlier process patent. Unsurprisingly, the Judge decided that the process claims of the patent in suit were obvious on this basis, and the Court of Appeal upheld this decision, despite some "desperate" arguments from counsel for the patentee. Apotex' expert at trial gave evidence that Apotex' experiments showed that the process disclosed in Servier's earlier process patent inevitably produced the α crystalline form of tert butylamine claimed in the patent in suit. On this evidence, Mr Justice Pumfrey found that the α crystalline form of tert butylamine claimed was not novel. At appeal, minor quibbles over some of the results of the experiments conducted by Apotex did not prevent Lord Justice Jacob from noticing that Servier had not been prepared at trial to challenge the overall conclusion of Apotex' expert. He found, therefore, that Servier could not have been of the opinion that the expert's conclusion could be shown to be wrong or unsafe, and that the judge was right to rely on the expert's evidence to conclude that the patent was invalid for novelty. CONCLUSION The case is probably best summed up with the Lord Chief Justice's observation: "That [X-ray diffraction] evidence gave the case a spurious veneer of technical complexity. It none the less led the judge to a firm and simple conclusion." In other words, both the High Court and the Court of Appeal were quick to see through Servier's attempt to extend its monopoly on perindopril by blinding the Patent Office and Court with science. Lord Justice Jacob observed, however, that the Patent Office was not at fault in letting this patent slip through the net: "You need the technical input of experts…and some experimental evidence in order to see just how specious the application for the patent was. The only solution to this type of undesirable patent is a rapid and efficient method for obtaining revocation." Ominously, Lord Justice Jacob noted that the only real sanction against defending such patents unreasonably in litigation lies in an award of costs on the higher indemnity scale. The costs hearing in this case may yet result in a cautionary tale for pharmaceutical companies that engage in such 'evergreening' activities. However, even a costs award on an indemnity basis will likely pale into insignificance compared to Servier's profits to date made possible by this "undesirable patent".
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