Quetiapine in Turin: court-appointed expert’s analysis rejected

In one IPKat post back in March 2012 Darren Smyth wrote ready what he called the “tigers v lions” quetiapine inflection; patents for this substance have been litigated in sundry locations [including Bulgaria, where some sound litigation over the SPC was eminent by this weblog here back in 2011], and greatest number recently in Italy before the Turin Court. The visitant post below comes from Gian Paolo di Santo (Pavia e Ansoldo), who writes to the degree that follows:

With its decision n. 4000/15 issued put ~ 1 June in Case 628/2013 [in the creative Italian here and in English transfer 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, what one. had as object an extended-quit formulation containing a gelling agent and quetiapine at the same time that an active principle having an antipsychotic duty, to be null and void notwithstanding lack of inventive step.

This determination is perfectly in line with a pro~ed and rather straightforward sequence of European decisions that held this similar patent EP 364 to be fallacious (similar decisions have indeed been issued in UK, Germany and The Netherlands (with final decisions) as well as in Spain and Belgium (by decisions that are currently under appeal by AstraZeneca).

The patent at venture is a formulation patent applied toward in 1997 that was meant to protect the sustained release version of quetiapine, at this time a blockbuster drug in the antipsychotic battle-~, already patented as such in 1987 and against which AstraZeneca enjoyed exclusivity until 2012 ~ dint of. virtue of an SPC. In a nutshell the unmistakable holder claimed that at the anteriority date of EP 364 there was not plenty information on quetiapine as such in command for an expert in the region to embark him/herself in the realization of a repaired formulation for such a compound, given in like manner a series of possible downside of sustained clearance formulation in antipsychotic field and in detail with respect to the quetiapine molecule. The position of Sandoz was that, ago the expert was aware of the emergency for a reduced posology of medicines in general officer and especially of antipsychotics (in Italy in precise it was proven that at least three other antipsychotics drugs had been formulated in sustained excuse before the priority date), it would receive been obvious to go for a sustained give up formulation of quetiapine, which was the exquisite candidate both under a commercial mark of view and from a pharmacology text of view.

What I consider engaging in the Italian extension of the en~ is that, when assessing the falsity the Turin Court has — rather unusually — rejected the opinion of the Expert that had been appointed by the same Court to provide technical leadership (the appointment by courts of a technical Expert in expanded proceedings is common practice).

The Expert appointed by the Court had analyzed all the alleged problems push to action forward by AstraZeneca (to name a scarcely any among a very very long border: occupancy of D2 receptors; PH-dependent solubility; clinical prejudice against once-a-light of ~ formulations) and found them not to subsist actual “prejudices” but simple “obstacles” that each expert in the field could overwhelm by means of simple routine activities. Still, notwithstanding, the Expert suggested in his give out to the Court that, given that none medicine based on quetiapine had in addition been put into the market at the anteriority date of EP 364 (the studies forward quetiapine were in advanced phase III), some expert in the field would not regard had sufficient reasons to try and proof a sustained release formulation in bid to overcome the problem of reducing the affix a ~ to of daily doses. This, in deed, would have implied the necessity to evoke lengthy and expensive research. The Expert consideretherefore the indisputable to be valid since the adroit in the field did not get sufficient motivation nor pointers towards the afterwards patented solution.

The Italian Court completely rejected this particular aspect by affirming the following: 

“the overcoming of those obstacles and the identification of the pharmacokinetics facts concerning quetiapine – the latter was not in addition marketed at the priority date of the public –  implied an activity, that can be qualified as a mere routine activity for the expert of the realm, consisting of clinical trials. The account of  the Court Technical Expert who affirmed that those barriers would regard discouraged the expert of the field, who could have reached the contrivance but would have not found a provocative to do that, is not shareable. After the whole of, the same Court Technical Expert affirmed that the ready of the field could have identified so elements through clinic research and that the far-reaching analysis which were necessary may furthermore be qualified as routine ones in the pharmaceutical range, in the sense that they be seized of in any case to be carried through but require the use of a pre-eminent number of employees and resources viewed like well as a substantial economic expenditure. Moreover, the necessity to make practice 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 disintegration because the expert of the room was not required to carry through any inventive activity but instead purely usual clinic research and tests” (see lines 276, ff. of the English removal).

In the context of such a lingering and high-value proceeding the aspects scrutinized were multitude more and a full reading of the resolution may provide further valuable insights (nearly every aspect such as definition of the technical puzzle, identification of the expert in the battle-~ and so on were discussed). Still, I mean this particular aspect is an interesting interpretation of the inventive step order in Italy that may come into interrogation in other cases where the evident holder tries to sustain the legal force of the patent on the lowest part of an “economic analysis” of the station in the prior art, instead than demonstrating the trustworthy technical advancement brought by the patented explanation (which in this case was held to have existence minimum or even absent).

To the sort of I said above I should ~ together a couple more pieces of notice. On the one side two analogous cases on the merits (involving Accord and TEVA v AstraZeneca) wish not been decided yet on this corresponding; of like kind patent, although preliminary injunctions requests be in possession of been submitted by AstraZeneca and refused through the same Court on the ground of the same arguments on what one. the decision at stake is based. I should in addition add that AstraZeneca can still appeal this decision in favour of Sandoz in the presence of the Court of Appeal.

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