The Bolar provision was expressly incorporated into the Patent Act by Law 29/2006. This law amended Article 52.1 and harmonised national law in light of the EU Directive on the Community Code Relating to Medicinal Products for Human Use (2004/27/EC). Before this amendment came into effect, Article 52.1 simply stated that the rights conferred by a patent do not extend to acts carried out by a third party for experimental purposes in relation to the protected invention.

As a result of the amendment introduced by Law 29/2006, Article 52.1 of the Patent Act now expressly extends the experimental use exception to studies and tests carried out for the authorisation of generic medicines in or outside Spain, and the corresponding practical requirements, including preparing, obtaining and using the active ingredient for these purposes.

The question that arose from this amendment was whether the Bolar provision was incorporated into the Patent Law by Law 29/2006 or whether it was implicitly incorporated into the previous version of Article 52.1 under the scope of the experimental use.

Under the old version of Article 52.1, case law (especially the resolutions issued by the Barcelona Court of Appeals) stated that applications to the Spanish health authorities for a marketing authorisation and price approval for a generic medicine before the expiry of the corresponding patent should be considered to be acts of patent infringement, as these acts included: 

  • Providing samples of the infringing product to the Spanish Medicines Agency.
  • Offering to supply the medicine to the National Health System through the pricing authorities.

In fact, the passing of Law 29/2006 and the amendment of Article 52.1 radically changed this scenario, mainly due to the declaration included in Law 29/2006 by the legislature that this amendment was introduced for explanatory purposes.

This declaration was interpreted by the Spanish courts to mean that the Bolar provision was already covered by the experimental purposes exception in the older version of Article 52.1, and that the newer version only further clarified the situation and made an express statement in this regard.

This interpretation was upheld by Section 28 of the Madrid Court of Appeals in its ruling of 16th September 2008, and was finally accepted by Section 15 of the Barcelona Court of Appeals in its ruling of 15th October 2009. Nonetheless, the court pointed out its theoretical objections to the solution given by the legislature. 

However, this conciliatory interpretation of the law has been revolutionised by the Supreme Court's ruling of 30th June 2010. That ruling held that the experimental purposes exception under the old version of Article 52.1 of the Patent Act must be interpreted restrictively, and therefore only those acts whose exclusive purpose is the improvement or consolidation of the technical rule as such can be covered by the experimental use exception. In the Supreme Court’s opinion, these experimental purposes do not apply to the import or manufacture of the active ingredient or final product for the purpose of supplying it to the health authorities in the context of the marketing authorisation process of a generic medicine.

According to the Supreme Court, the legislature's declaration in Law 29/2006 does not hinder this new interpretation. The Supreme Court stated the grounds of its interpretation but, rather surprisingly, did not resolve why the legislature’s declaration should be set aside or why its own case law with regard to indirect retroactivity of law should not apply in this particular case. 

This resolution imposes two different limits:

  • A material limit, since this interpretation affects only those cases where the generic laboratory effectively imported or manufactured the active ingredient, and not those where the laboratory did not have to supply samples to the health authorities in the context of the marketing authorisation process (ie, a decentralised process).
  • A temporal limit, since this interpretation affects only those acts carried out before Law 29/2006 came into effect.

There is no doubt – and the Supreme Court did not question this – that the new version of Article 52.1 of the Patent Act, which has been in force since 28th July 2006, covers all the steps for obtaining a marketing authorisation for a generic medicine.

This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com