On 10 February 2012 the Spanish Court handed down a judgment where it accepted for the first time the concept of a “springboard” injunction as a remedy aimed at curing acts of infringement carried out before a patent expires. The background to the case may be summarised as follows:
A manufacturer of generic drugs filed an application for a marketing authorisation of a generic of amlodipine besylate some months before the patent relating to this compound expired. The patent owner reacted by filing a patent infringement action seeking several remedies. Apart from the typical remedies (an injunction, damages, etc.), it requested the Court to order an injunction preventing the defendant from launching, after the expiry date of the patent, for a period of time identical to the period of time elapsed between the date when the application for the marketing authorisation was filed, and the date when the marketing authorisation was granted. The rationale was to offset the effects derived from the fact that the applicant had used a period of time while the patent was still in force as a “springboard.” If the applicant had waited until the patent expired before filing the application for a marketing authorisation, this would have been granted several months after the patent expired. This is the “springboard” period discussed in the case. It should be added that when the acts discussed took place the “Bolar” provision had not yet been implemented in Spain.
On 8 April 2005, Court of First Instance number 28 of Barcelona handed down a judgment upholding the complaint, including the “springboard” injunction. However, the judgment was appealed before the Court of Appeal of Barcelona (Section 15), which on 9 May 2008 reversed the “springboard” injunction on the grounds that the use of samples of a product under patent for the purpose of obtaining a marketing authorisation of a generic was exempted by the “Experimental Use” Exception. It should be noted that while the appeal was under way, Spain implemented the “Bolar” provision enshrined in Directive 2004/27/EC. According to the Recitals of the Law that implemented this Directive, the “Bolar” provision was a “clarification” of the scope of application of the “Experimental Use” Exception. This led the Court of Appeal to consider that the acts complained of were exempted by the “Bolar” provision.
In its judgment of 10 February 2012, the Supreme Court reversed this finding of the judgment of 9 May 2008, after highlighting that the “Bolar” Exception and the “Experimental Use” exceptions are two different exceptions with different rationales. Therefore, the remedies ordered by the Court of First Instance were reinstated, including the “springboard” injunction.
As mentioned at the beginning, the most interesting aspect of the case lies in the fact that the Supreme Court has accepted the concept of a “springboard” injunction, which had already been accepted by Courts in Germany and in the United Kingdom. However, it is doubtful whether the judgment will have practical implications in future decisions, as since July 2006 so-called “preparatory” acts are exempted by the “Bolar” clause.
________________________
To make sure you do not miss out on regular updates from the Kluwer Patent Blog, please subscribe here.
