Italy: preliminary injunction against a generic sustained release formulation of quetiapine lifted

06 February 2014

Giovanni Galimberti, Evelina Marchesoni

By decision filed on October 4 2013, the Court of Rome lifted the preliminary injunction granted in August 2013 in favour of AstraZeneca AB and AstraZeneca S.p.A. (jointly "AstraZeneca") against Teva Italia S.p.A. ("Teva"), which had launched a generic sustained release formulation of an anti-psychotic drug known as quetiapine in Italy (marketed by AstraZeneca under the trademark "Seroquel").

The Court of Rome examined the requirement of fumus boni iuris (i.e. the likelihood of validity) of the Italian portion of the European patent EP 0 907 364 ("EP '364") asserted by AstraZeneca, and concluded that the patent should be considered invalid for lack of inventive step.

Background

In November 2012 AstraZeneca filed preliminary injunction proceedings aimed at preventing Teva from selling a generic sustained release formulation of quetiapine in Italy until the expiry of EP '364.

Teva appeared in the proceedings and argued, inter alia, the lack of fumus boni iuris of the patent enforced by AstraZeneca.

In particular Teva argued that EP '364 was invalid for obviousness in view of a prior art document referred to as Gefvert[1]

In this regard, the first instance Judge, following the findings of the   appointed Court Technical Expert, pointed out that Gefvert did not disclose a sustained release formulation of any kind. Even if Gefvert concluded that once to twice dosing of immediate release quetiapine may be sufficient for the treatment of schizophrenia, this could not be interpreted as a hint towards development of a sustained release formulation.

In fact, at the date of filing of EP '314 immediate release quetiapine was not available on the market, and was still in phase III clinical trials. It follows that the optimum dosing of the immediate release formulation was not known at that time. Consequently, in the absence of such information, the person skilled in the art would not even have thought about a sustained release formulation.

Furthermore, the Court of Rome highlighted that there was no actual interest in reducing the frequency of administration of the drug. Teva contended that this interest would have existed to improve patient compliance. However, the Court Technical Expert and the Judge granting the injunction held that the compliance of a schizophrenic patient was a very complex issue which was not exclusively affected by the number of daily administrations.

In light of the above, the Judge held that the requirement of fumus boni iuris of the validity of EP '364 was met.

Consequently, after also having ascertained the likelihood of patent infringement by the generic drug commercialized by Teva as well as the requirement of urgency, the Court of Rome granted (by a decision filed on August 5 2013) the preliminary injunction against Teva, and ordered the withdrawal of the generic "Quetiapinea Teva" from the market.

Teva filed an appeal against this interim decision.

The appeal decision

By decision filed on October 4 2013, the Court of Rome lifted the preliminary injunction against "Quetiapina Teva" for lack validity of EP '364.

According to the Panel of Judges, the fact that the prior art documents concerning the treatment of schizophrenia with quetiapine did not specifically and expressly refer to a sustained release formulation was not sufficient to deem that a skilled person would not have addressed the problem by developing a sustained release formulation of quetiapine.

As admitted by AstraZeneca, sustained release drugs were already known in the art at the date of the patent application, and therefore, according to the Court of Rome "the processes, the ingredients and all the necessary elements to obtain the sustained release quetiapine were certainly known by the person skilled in the art since he would simply have to adapt the widely experimented techniques to a new drug".

Furthermore, in the opinion of the Court of Rome, from the documents filed by the parties it was evident that the person skilled in the art was aware of the need to reduce the daily frequency of the administration of drugs for treating schizophrenia, taking into consideration  schizophrenic patients' compliance difficulties .

Finally, according to the Court of Rome, the obviousness of the invention claimed by AstraZeneca was confirmed by the fact that prior to the filing of EP '364, two sustained release antipsychotic drugs had been invented. Even if the experimentation on such drugs did not continue, it was relevant for the Panel of Judges that the person skilled in psychotic diseases had already encountered the application of sustained release formulations to  to drugs in the field.

In light of the above, by decision filed on October 4 2013, the Court of Rome concluded that one of the requirements for the grant of the preliminary injunction, i.e. the fumus boni iuris of the validity of EP '364, was not met and consequently lifted the preliminary injunction against Teva.



[1] Gefvert is an abstract by Gefvert et al. entitled "Time course for dopamine and serotonin receptor occupancy in the brain of schizophrenic patients following dosing with 150mg Seroquel tid" published in European Neuropsychopharmacology, volume 5, issue 3 in September 1995.

 

This article is part of the International Life Sciences Update for February 2014

Authors

Giovanni Galimberti

Giovanni Galimberti

Co-managing partner
Italy

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