Ana-Laura Morales March 3 2014 Court upholds sildenafil generics appeal Grau & Angulo | Intellectual Property - Spain Ana-Laura Morales Intellectual Property FactsFirst-instance decisionSecond-instance decisionOn January 8 2014 the Barcelona Court of Appeal issued an order revoking a previous decision of Barcelona Commercial Court 7, which had granted a preliminary injunction requested by Pfizer against sildenafil generics for alleged patent infringement. Sildenafil is the active pharmaceutical ingredient of Pfizer's Viagra drug.FactsPfizer is the holder of European Patent EP0463756-B1 (EP'756), which was filed in June 1991 and granted in April 1995 with three different sets of claims; one of these was exclusive to Spain and contained only six process claims. The Spanish translation of the patent was published in July 1995 with the number ES2071919-T3.In February 2002 Pfizer obtained a supplementary protection certificate (SPC), which entered into force on June 7 2011 when the patent expired and lasted until June 22 2013.In March 2006 Pfizer filed an alleged revised translation of the EP'756 patent with the Spanish Patent and Trade Office (SPTO), which included 14 claims. These were the six initial process claims of the patent as granted by the European Patent Office (EPO) for Spain and the eight product and use claims of the general set of claims of the patent as granted by the EPO for other countries such as Germany, France and the United Kingdom, but not for Spain.In July 2006 the SPTO published a mention that Pfizer had filed a revised translation, but subsequently set this aside, and eventually refused to publish the revised translation, which was never published as such. Pfizer challenged the SPTO's decision before the contentious administrative courts, which dismissed its appeal at first instance. However, in a judgment dated November 4 2010 the Contentious Administrative Chamber of the Supreme Court upheld Pfizer's appeal.The revised translation was finally published on August 30 2011 (ES2071919-T4), after the patent had expired and the SPC had entered into force. Surprisingly, this revised translation has only eight claims (product and use), instead of the original 14 claims that Pfizer filed in 2006.In October 2011 Pfizer sued all the companies that were marketing sildenafil generics in Spain for alleged infringement of its patent and SPC according to the revised translation (product and use claims). Pfizer also requested a preliminary injunction to remove all its generic competitors from the market.First-instance decisionOn February 21 2012 Barcelona Commercial Court 7 granted the preliminary injunction, despite the fact that the generics had already been on the market for a long time (the first generic was launched in late 2009).The defendants appealed the decision.Second-instance decisionThe Barcelona Court of Appeal reversed on January 8 2014. In its decision, the court of appeal concluded that the so-called 'danger in delay' requirement was not met in Pfizer's preliminary injunction motion. In particular, the court considered that – bearing in mind that Viagra still held 61% of the market, despite almost two years of generics competition – Pfizer's allegation that it would lose its market share before its SPC expired in June 2013 was groundless.In this regard, the court also took into account that the Spanish health system does not finance sildenafil medications. Therefore, their price can be freely determined, as they are not subject to prescription by active ingredient or regulated pricing systems.The lack of 'danger in delay' was sufficient to revoke the first-instance decision, so the Barcelona Court of Appeal did not address the substantive grounds of the case in its recent order.The defendants are entitled to claim against Pfizer for the damages that they suffered due to the preliminary injunction, which kept their sildenafil generics off the market from April 2012 (enforcement of the preliminary injunction order) until June 2013 (expiry of Pfizer's SPC).For further information on this topic please contact Ana-Laura Morales at Grau & Angulo by telephone (+34 93 202 34 56), fax (+34 93 240 53 83) or email ([email protected]). The Grau & Angulo website can be accessed at www.gba-ip.com.