In Les Laboratoires Servier v Apotex Inc [2008] EWCA Civ 445, the English Court of Appeal dismissed an appeal against a finding of invalidity of a patent, finding that it was clearly unpatentable.

BACKGROUND

The appeal was from one of the last decisions of the late Lord Justice Pumfrey, holding that Servier’s patent was invalid for lack of novelty and obviousness, but that if the patent had been valid, Apotex’s product would have infringed. Pumfrey LJ had also refused to continue an interim injunction pending appeal on the grounds that he considered there was no real prospect of success by Servier. A separate application to the Court of Appeal regarding the continuation of the injunction was refused on the grounds of no real prospect of success.

The patent was for a particular crystalline form of the tertbutylamine salt of perindopil, a process for making it and for pharmaceutical compositions containing it. The patent, using its own nomenclature, called this particular crystalline form of salt, the a (alpha) form. It claimed that the a form “especially exhibits valuable characteristics of filtration, drying and ease of formulation”. The patent did not say with what other crystalline form the comparison was being made or why this form was “especially valuable”. When asked about this, Servier’s counsel could provide no answer.

The priority date of the patent was 6 July 2000. The first and basic patent for perindopril and its tert-butylamine salt (without any indication or specification of crystalline form) had a priority date of 2 October 1980. Servier’s pharmaceutical compositions containing the salt have been on the market since the late 1980s (the first, French, marketing authorisation was June 1988). The basic patent was effectively extended by a supplementary protection certificate that expired on 21 June 2003. The market for the product is vast, with sales in the United Kingdom alone at over £70m per year at Servier’s patent protected price.

Servier sought and obtained additional protection for perindopril and the tert-butylamine by way of a patent filed on 16 September 1988, expiring on 16 September 2008. This was for “the industrial synthesis of perindopril” and covered a process for making it and its tert-butylamine salt. Finally, Servier sought yet further protection for the tert-butylamine salt of perindopril by applying for three patents on 6 July 2000, covering the only three crystalline forms (called by Servier , a , ß and ?) which, to date, are known.

The Court of Appeal was shown the patent for the ß form, which claimed that this form (like the a form) also “especially exhibits valuable characteristics for formulation” without saying what these characteristic were supposed to be. Pumfrey LJ described the fact that there were simultaneous patent applications for the other two forms as “curious”, which, according to Jacob LJ, was shorthand for saying that Servier were simply trying to extend their monopoly in the salt.

THE APPEAL

Unusually, it was decided to dismiss the appeal without the need of even hearing Apotex’s arguments as it was immediately clear to the Court of Appeal that Servier’s patent was plainly invalid and there was no need to hear any evidence regarding the infringement issue. Jacob LJ went on to further hold that, like Pumfrey LJ, he believed that the patent was invalid and very plainly so.

The only real piece of prior art cited against the patent was actually one of the earlier Servier patents. Jacob LJ said that he had never seen a patent claim that contained a limitation “for the industrial synthesis” and he was perplexed as to what it added. He said “it is not as though it is suggested that the chemistry is any different in a laboratory or any other scale. The reacting or crystallising molecules do not know about the size of the pot they are in.”

One might have thought that would be an end to the case. After all, if the cooling regime was obvious, its product, the a form would be too. But Servier made a further, valiant attempt to save the product claim. They submitted that, even if you used the cooling conditions specified in the patent, you do not always get the a form. Although generally you would, sometimes you would not. According to Jacob LJ the premise was comp letely wrong, but even if it were not, the process claim would be invalid. The patent taught that this cooling process would produce what the patentee called the a form. If the process did not do so reliably, then the patent would be insufficient. It would not, according to Article 83 of the

European Patent Convention, “disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art”. Jacob LJ did not think it would be a satisfactory answer to the sufficiency objection to say “well it works most times”, and even if it were more likely than not that the a form would be produced, the claim would be obvious. According to the Court of Appeal “it would be a monstrous thing if the law were otherwise. People are entitled to implement old recipes in obvious ways”.

In reviewing the novelty aspects of the invention, particularly for that of Claim 1, a near avalanche of information was provided in an attempt to “blind the Court with science”. However, once the Court dug deeper into the evidence submitted, and with help of some expert witnesses who Servier was simply incapable of contradicting (in one case Servier simply left the expert witness unchallenged), both the Court of First Instance and the Court off Appeal found the patent also to be invalid for lack of novelty.

The appeal was dismissed as according to Lord Justice Jacob it was completely “without merit”.

COMMENT

Never has such a strong and clearly angry rebuke regarding the invalidity of a patent been handed down by the Court of Appeal. This is an interesting case as so many pharmaceutical companies are attempting to secure as many interrelated patents for their products as possible. This case illustrates what can happen when one attempts one “patent too far”.