With its decision n. 4000/15 issued on 1 June in Case 628/2013 [in the original Italian here and in English translation here] between Sandoz and AstraZeneca a Panel of three specialized Judges of the Turin Court has declared the Italian portion of European Patent No. EP 0 907 364, which had as object an extended-release formulation containing a gelling agent and quetiapine as an active principle having an antipsychotic function, to be null and void for lack of inventive step.This decision is perfectly in line with a long and rather straightforward sequence of European decisions that held this same patent EP 364 to be invalid (similar decisions have indeed been issued in UK, Germany and The Netherlands (with final decisions) as well as in Spain and Belgium (with decisions that are currently under appeal by AstraZeneca).The patent at stake is a formulation patent applied for in 1997 that was meant to protect the sustained release version of quetiapine, now a blockbuster drug in the antipsychotic field, already patented as such in 1987 and for which AstraZeneca enjoyed exclusivity until 2012 by virtue of an SPC. In a nutshell the patent holder claimed that at the priority date of EP 364 there was not enough information on quetiapine as such in order for an expert in the field to embark him/herself in the realization of a new formulation for such a compound, given also a series of possible downside of sustained release formulation in antipsychotic field and in particular with respect to the quetiapine molecule. The position of Sandoz was that, since the expert was aware of the need for a reduced posology of medicines in general and especially of antipsychotics (in Italy in particular it was proven that at least three other antipsychotics drugs had been formulated in sustained release before the priority date), it would have been obvious to go for a sustained release formulation of quetiapine, which was the perfect candidate both under a commercial point of view and from a pharmacology point of view.What I consider interesting in the Italian extension of the case is that, when assessing the invalidity the Turin Court has -- rather unusually -- rejected the opinion of the Expert that had been appointed by the same Court to provide technical guidance (the appointment by courts of a technical Expert in patent proceedings is common practice).The Expert appointed by the Court had analyzed all the alleged problems put forward by AstraZeneca (to name a few among a very very long list: occupancy of D2 receptors; PH-dependent solubility; clinical prejudice against once-a-day formulations) and found them not to be actual “prejudices” but simple “obstacles” that an expert in the field could overcome by means of simple routine activities. Still, however, the Expert suggested in his report to the Court that, given that no medicine based on quetiapine had yet been put into the market at the priority date of EP 364 (the studies on quetiapine were in advanced phase III), an expert in the field would not have had sufficient reasons to try and test a sustained release formulation in order to overcome the problem of reducing the number of daily doses. This, in fact, would have implied the necessity to start lengthy and expensive research. The Expert consideretherefore the patent to be valid since the expert in the field did not have sufficient motivation nor pointers towards the then patented solution.The Italian Court completely rejected this point by affirming the following:“the overcoming of those obstacles and the identification of the pharmacokinetics data concerning quetiapine – the latter was not yet marketed at the priority date of the patent – implied an activity, which can be qualified as a mere routine activity for the expert of the field, consisting of clinical trials. The statement of the Court Technical Expert who affirmed that those barriers would have discouraged the expert of the field, who could have reached the invention but would have not found a stimulus to do that, is not shareable. After all, the same Court Technical Expert affirmed that the expert of the field could have identified such elements through clinic research and that the long analysis which were necessary may also be qualified as routine ones in the pharmaceutical field, in the sense that they have in any case to be carried out but require the use of a great number of employees and resources as well as a substantial economic disbursement. Moreover, the necessity to make use of employees and resources and the costs of the analysis is an element which is not enough to state the inventive step of the patented technical solution because the expert of the field was not required to carry out any inventive activity but instead merely usual clinic research and tests” (see lines 276, ff. of the English translation).In the context of such a long and high-value proceeding the aspects scrutinized were many more and a full reading of the decision may provide further valuable insights (almost every aspect such as definition of the technical problem, identification of the expert in the field and so on were discussed). Still, I think this particular aspect is an interesting interpretation of the inventive step requirement in Italy that may come into question in other cases where the patent holder tries to sustain the validity of the patent on the basis of an “economic analysis” of the situation in the prior art, instead than demonstrating the true technical advancement brought by the patented solution (which in this case was held to be minimum or even absent).To what I said above I should add a couple more pieces of information. On the one side two parallel cases on the merits (involving Accord and TEVA v AstraZeneca) have not been decided yet on this same patent, although preliminary injunctions requests have been submitted by AstraZeneca and refused by the same Court on the basis of the same arguments on which the decision at stake is based. I should also add that AstraZeneca can still appeal this decision in favour of Sandoz before the Court of Appeal.
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