On October 22 2013 the Barcelona Court of Appeal revoked AstraZeneca's European Patent EP0907364 ('EP'364') with effects in Spain. This patent concerned a sustained release formulation comprising quetiapine and a gelling agent.
In July 2011 Accord Healthcare SLU and Sandoz Farmacéutica SA filed an action for the revocation of the EP'364 patent due to lack of inventive step.
On July 9 2012 Barcelona Commercial Court No 2 dismissed the action, upholding AstraZeneca's main arguments as follows:
- At the priority date (May 31 1996), the skilled person would not have been motivated to develop a sustained release formulation of quetiapine. At that time, there was no concluding evidence of the therapeutic efficacy of quetiapine, as it had not yet been commercialised as a drug.
- The chemical and physical properties of quetiapine (ie, high water solubility, high first-step metabolism, high adherence to plasmatic proteins, insufficient occupation of D2 receptors) made it an unsuitable compound for sustained release formulation. Hence, the skilled person would have ruled out this solution.
Accord and Sandoz appealed the first instance judgment, alleging the following:
- At the priority date, the skilled person would indeed have been motivated to develop a sustained release formulation of quetiapine, as the specification of EP'364 itself explicitly acknowledged. The advantages of sustained release formulations were well known, including improvement of patient compliance, which was already desirable in the treatment of psychiatric disorders in general, and in particular in the treatment of schizophrenia.
During the court proceedings, AstraZeneca had provided no evidence regarding:
- the alleged chemical and physical properties of quetiapine;
- whether these properties were known to the skilled person at the priority date; and
- the reasons as to why these properties would have dissuaded the skilled person from developing a sustained release formulation of quetiapine. Furthermore, other than high water solubility, these alleged characteristics of quetiapine were not even mentioned in the EP'364 patent.
After examining all of the evidence, the Barcelona Court of Appeal concluded lack of inventive step of all claims of the EP'364 patent and declared its invalidity.
In line with Accord and Sandoz's arguments, the court of appeal considered that at the priority date (May 31 1996), the skilled person would indeed have been motivated to develop a sustained release formulation of quetiapine, as the specification of EP'364 acknowledged.
The court also observed that there was no evidence that some of the chemical and physical properties of quetiapine alleged by AstraZeneca were actually known at the priority date; in any event, the court concluded that these properties would not have dissuaded the skilled person from developing a sustained release formulation of quetiapine with a gelling agent.
Therefore, the court of appeal applied the so-called 'problem and solution approach' and found that the EP'364 patent lacked inventive step.
AstraZeneca has appealed to the Supreme Court, challenging the Barcelona Court of Appeal's decision.
Also noteworthy are the court proceedings taking place in other EU countries concerning the EP'364 patent. For instance, the UK Patent Courts revoked the patent due to lack of inventive step, both at first instance and appeal (2012 and 2013). In addition, the German Federal Patent Court invalidated the patent in its decision dated November 13 2012. To the contrary, in March 2012 the District Court of The Hague dismissed Accord and Sandoz's action in the Netherlands (appeal pending).
For further information on this topic please contact Anna Casanovas at Grau & Angulo by telephone (+34 93 202 34 56), fax (+34 93 240 53 83) or email (email@example.com). The Grau & Angulo website can be accessed at www.gba-ip.com.
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