On 30 June 2010, the Supreme Court held that the ‘Bolar provision’ introduced by Law 29/2006, which implemented Directive 2004/27 into Spanish law, may not be applied retrospectively. In addition, the Supreme Court revoked the view expressed by the Court of Appeal of Pamplona and other provincial Courts, which had considered that the ‘Bolar provision’…

On 3 August 2007 and 5 December 2007, Commercial Court Number 1 of Barcelona ordered a preliminary injunction preventing the launch of all the generics of a well-known medicament used to treat schizophrenia. Also, for the purpose of maintaining the status quo, the Court ordered for the judgment be notified to the Ministry of Health…

Under Spanish law, when the first generic version of a medicament of reference (i.e. original medicament) is authorized, the setting of the price of the generic triggers the inclusion of the medicament of reference in the so-called “price reference system”, even if the generic is not launched onto the market until the patent protecting the…

One of the strategies used by manufacturers of generic drugs to try to capture the market of the “reference product” when the patent protecting the latter expires is to present the generic as a cheap alternative to the “reference product”. This raises several interesting questions, such as whether or not a generics company, for the…

Like other countries, such as Australia or Germany, a “petty” patent or “utility model” can be obtained in Spain for so-called minor inventions. They present a twofold distinction with regard to “full-fledged” patents, when it comes to examining their patentability: (i) only documents disclosed in Spain form part of the state of the art; (ii)…

EC Directive 2004/48 (known as the “Enforcement Directive”) was implemented in Spain through Law 19/2006, which sought to harmonise, among other aspects, the criteria to establish damages in legal proceedings involving the infringement of intellectual property rights. In cases of patent infringement where the complainant claims profits lost or damages caused by the defendant, one…

On 12 July 2010 the Supreme Court handed down a long-waited judgment, dismissing a complaint filed by a manufacturer of generic medicaments against a patent owner that had threatened more than one hundred wholesalers with patent infringement actions. The facts of the case go back to 2003, when a Court of First Instance of Madrid…

One of the most contentious points discussed before Spanish Courts over the last few years is the question of whether or not Courts should examine the validity of the patent when this has been raised as a defence in the context of preliminary injunction proceedings. On 17 June 2010, the Court of Appeal of Barcelona…

In appeal proceedings against a granted ex parte injunction, the Court of Appeal considered that the test whether there is an imminent threat of infringement must be based on objective criteria.. There is an objective threat of infringement if the defendant obtained a marketing authorisation and a price. The Court considered the conditional intention not…