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Propiedad Industrial e Intelectual

Patents and pharmaceutical products: The Supreme Court revisits its doctrine on TRIPS Agreement

In a recent decision of 21 December 2015, the Spanish Supreme Court dismissed the appeal of AstraZeneca related to the protection of the product claims of a European patent on quetiapine that had not been granted for Spain through the application of the TRIPS Agreement. The Supreme Court revised its previous jurisprudence in the olanzapine, atorvastatin and losartan cases based on the doctrine of the CJUE in the cases C-414/2011 of Daiichi Sankyo vs Demo (judgement of 18 July 2013), C-462/13 Warner Lambert vs Minerva, and C-372/13 Warner Lambert vs Siegerpharma (Rulings of 20 January 2014).

This last judgement concerned a European patent filed on March 1987, with a separate process claims for Spain, granted by the EPO on 1990 and published in Spain (including only the process claims) on 1991. A supplementary protection certificate (SPC) had been obtained based on that patent.

On January 2007, the holder requested the protection of the product claims on quetiapine of the European patent. It alleged the validity of a revised translation according to article 12 of the Spanish Royal Decree 2424/1986 (corresponding to article 70.3 of the EPC) and a wide interpretation of articles 27 and 70 of the TRIPs Agreement. AstraZeneca brought proceedings against several companies that commercialised the generic version of quetiapine in Spain based on the infringement of the SPC granted for quetiapine.

The first instance judgement, handed down by a commercial court of Madrid on 24 January 2011, held that the product claims could not be validly invoked in Spain as the Spanish Patent and Trademark Office had refused to publish the product claims of the patent. The IP specialised appeal court of Madrid upheld the decision of the first instance through its judgement dated on 20 May 2013.

AstraZeneca appealed before the Supreme Court invoking the application of the case law adopted in precedent cases by judgements of 10 May 2011, 26 October 2012, and 5 December 2012 (olanzapine, atorvastatine and losartan cases, respectively).

In spite of its previous case law, the Supreme Court concluded that in the quetiapine case that doctrine could not be applied anymore as this contradicted with the doctrine of the CJEU.

Therefore, revising its previous doctrine, and following the CJEU interpretation, the Supreme Court stated that “the fact that the European product patent was validated in Spain by means of the publication of the process claims on the grounds of the reservation made by Spain (under Article 167(2) (a) of the EPC), the coming into force of TRIPS Agreement does not justify that, since then, by means of its articles 27.1 and 70.2, the patent protects the pharmaceutical product in Spain”.

The Supreme Court comes in line with the interpretation already given by the appeal court of Barcelona in its judgement on the escitalopram case, rendered on 22 October 2014. There the court of Barcelona stated that the product claims that could not have been protected when the patent was applied for cannot be understood as validly protected by the application of the TRIPS Agreement.

This judgement puts an end to the possibilities of the patent holders to invoke the protection of the product claims of the European patent by means of articles 27 and 70 TRIPs of the Agreement.