European Bolar Provisions in Spain

Bolar in Spain was implemented by means of the Second Final Provision of Law 29/2006, which included an amendment to the 1986 Patent Act, whereby Article 52(1)(b) was reworded to include, among the acts carried out for experimental purposes exempted from the exclusive right conferred by the patent, the studies and trials carried out for obtaining the authorisation of generic medicinal products. 

This amendment to the 1986 Patent Act fulfilled the provisions of Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.

Nowadays, Bolar is implemented in Article 61(1)(b) of the 2015 Patent Act.

Even though at first the Bolar provision was envisaged as an experimental purposes’ exception to the “ius prohibendi” of the patent owner, nowadays it works as a separate exception.
In such sense Article 61(1) of the 2015 Patent Act expressly establishes that the rights conferred by the patent do not extend to:

1. acts carried out for experimental purposes relating to the subject matter of the patented invention.
2. the performance of the studies and tests necessary to obtain marketing authorisation for medicinal products in Spain or outside Spain, and the consequential practical requirements, including the preparation, procurement and use of the active ingredient for these purposes.

No. As already noted, Bolar not only exempts studies to obtain a marketing authorisation from the exclusive right to patent, but also tests and the consequential practical requirements, including the preparation, procurement and use of the active ingredient for these purposes.

The Preamble to Law 29/2006 stated that Bolar provision was introduced merely for clarification purposes given that it was already included in our legislation within the exception of use for experimental purposes. This led to Bolar being litigated for several years after its implementation with regards to its impact, in particular whether or not it was a clarification of the experimental use exception, and if so, whether the Bolar clause applied retroactively.

Both questions were settled by the Supreme Court in its judgement no. 424/2010 of June 30th, 2010 and again in judgement no. 39/2012 of February 10th, 2012, denying the clarifying nature of the added clause (on the grounds that the two exceptions are independent as they respond to different purposes) and the retroactive application of the Bolar provision.

According to the current wording of Bolar provision, the rights conferred by the patent do not extend to the studies and tests necessary to obtain marketing authorisation for medicinal products in Spain or outside Spain so exempted activities shall be covered by this exemption regardless of where regulatory approval is ultimately sought.

Although neither the 2015 Patent Act nor the case law has addressed this specific case, insofar as Article 61(1)(c) generically exempts activities aimed at obtaining a marketing authorisation, it may be interpreted that this exception should also apply to any third party who assist the MAH in carrying out these activities.