Until recently, cases involving “Supplementary Protection Certificates” (so-called “SPCs”) were relatively rare in Spain. This is due to the fact that, as a consequence of the transitional provisions of article 21 of Regulation 1768/1992 (the “SPC Regulation), SPCs became available in Spain later than in other European Union member states. However, over the last few…

On 30 July 2012, Commercial Court number 5 of Barcelona handed down an interesting decision that has brought again to the fore the legality of so-called “preparatory acts” (in particular, obtaining marketing authorisation and price). The facts of the case may be summarised as follows: Merck Sharpe & Dohme (“MSD”) owns a Supplementary Protection Certificate…

On 9 July 2012, Commercial Court number 2 of Barcelona dismissed a revocation action filed by two Spanish companies against patent EP 907,364, which protects a sustained-release formulation of quetiapine. To sum-up, this formulation comprises a gelling agent such as HPMC and quetiapine or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically…

TRIPS has historically been criticized on the grounds that it makes access to medicines in developing countries more difficult. To address this concern, on 30 August 2003 the World Trade Organization (“WTO”)’s General Council approved a Decision aimed at implementing the famous paragraph 6 of the Doha Declaration of 14 November 2001. To sum up,…

One of the most controversial provisions of the Spanish Patents Act is article 137.2, which states “Where the measures requested involve restrictions on the defendant’s industrial or commercial activity, the judge shall, when deciding with respect thereto, fix the amount of the security by which the said defendant may at any time substitute the effectiveness…