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’ was simply a ‘clarification’ of the Experimental Use Exception. According to the Supreme Court, both exceptions have different rationales. Thus, before the ‘Bolar provision’ came into force on 28 July 2006, the acts carried out by the manufacturers of generic medicines to obtain marketing approval were not covered by the Experimental Use Exception.

A full summary of this case has been published on Kluwer IP Law.


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