Indirect infringement in Spanish courts: a trend reversal and some teachings concerning infringement of second use medical claims

By Manuel Lobato


The specialised Section No. 15 of the Appeal Court of Barcelona has recently clarified what indirect infringement means by its judgment of 13 November 2020 (rapporteur Justice Rodríguez Vega, No. 2410/2020, Ortho.pras kits). This decision departs from the approach in other judgments which minimised the difference between direct and indirect infringement, treating them in a substantially equal manner [like the 24 October 2012 (nº 541/2012) Supreme Court judgment (the mop case) and in 14 July 2016 Appeal Court of Barcelona judgment (Kaba key case)].

Prior to this decision, the Appeal court of Barcelona analysed quite thoroughly indirect infringement in the pregabalin litigation (Preliminary injunction proceedings nº 650/2016, decision of 5 July 2016). The pregabalin 2016 decision aligned with the position in most European countries concerning pregabalin and imposed on the generics MA holders the burden of adopting specific measures to avoid the off-label use of pregabalin for the treatment of neuropathic pain. These measures consisted in the generics informing their clients that pregabalin could not be used for the patented indication and the obligation to reject the supply of the product to clients where there were reasonable indicia of infringement of the patent.

The Ortho.pras kit case judgment casts further light in this vexata quaestio (what constitutes indirect or contributory patent infringement) and also on other matters (like the statute of limitation

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