In a decision of 30 June 2010, the Spanish Supreme Court ruled that the Bolar provision implemented in Spain in July 2006 did not have a retroactive effect. It also declared that despite the "confusing" new wording of Article 52.1b) of the Spanish Patents Act, the experimental research exemption and the Bolar provision were two different and independent exemptions to the exclusive rights of the patentee.
The Community Directive 2004/27/EC of 31 March 2004 (Directive 2004/27), which includes the Bolar provision, was implemented in Spain in July 2006 and entered into force at the end of that month. Instead of adding a new paragraph under Article 52.1 of the Patents Act (exemptions to the patent's rights), the Spanish legislator decided to amend Article 52.1b) which originally contained the experimental research exemption as follows (addition to the original in bold):
"The rights conferred by a patent do not extend:
(b) to acts carried out for experimental purposes relating to the subject matter of the patented invention, in particular, to studies and trials necessary to obtain an authorization of generic drugs in Spain or abroad and the corresponding practical requirements, including the preparation, obtaining and use of the active substance for such purposes."
The preamble of the implementing act declared that the introduction of the Bolar provision was for clarification purposes.
Before this amendment of the law, innovators could (successfully) enjoin manufacturers of generics in Spain for preparatory acts aimed at the marketing of infringing products or products manufactured according to a patented process (including those necessary to obtain a marketing authorization).
When the new provision entered into force, some proceedings dealing with these issues were still pending. In this context, the Court of Appeal of Barcelona said in its decisions of 17 March and 9 May 2008 that the patentee was no longer entitled to prohibit the generic to apply for a marketing authorization and dismissed the innovators' infringement claims. According to the court, the Bolar was not a new exemption but some kind of experimental research.
Another proceeding before the Courts of Navarra between Laboratorios Cinfa, S.A. (Cinfa), a Spanish generic manufacturer, and Pfizer gave the Spanish Supreme Court the opportunity to clarify this issue. Cinfa had purchased 5,500 grams of besylate amlopine and used parts of it to carry out bioequivalence and stability tests necessary for a marketing authorization. The Court of Appeal of Navarra dismissed Pfizer's claim on the basis of the retroactive effect of the Bolar provision.
On further appeal, the Supreme Court decided in favor of Pfizer and confirmed the non-retroactive character of the Bolar provision. In particular, the court said that the experimental use exemption originally provided in article 52.1b) did not cover activities aimed at obtaining a marketing authorization but only "experimentation with scientific purposes". Therefore, the court found that the Bolar exemption did not exist before 2006 in Spain.
The court then held that the new wording of article 52.1b) ("in particular") and the preamble of the implementing law were confusing and should not be taken into account. The preamble did not have any legal effect. Even more importantly, the experimental research exemption and the Bolar exemption had different purposes and were, therefore, two independent exemptions of the patentee's rights. Since they limited the rights of the patentee, they needed to be interpreted restrictively as a matter of principle.
The impact of the decision of the Spanish Supreme Court is far beyond a mere interpretation of the law. Whether right or wrong, the wording of the law as decided by the legislator did not provide for two independent exemptions to the rights of a patentee. However, those two exemptions exist now. Apart from the "limited" effect in pending proceedings, the decision will have an impact on which activities the pharmaceutical industry can carry out under article 52.1b).
Although there is still room for interpretation (i.e. with regard to the scope of both exemptions, e.g. under which circumstances the innovative industry can rely on article 52.1b)), the decision is a turning point in the Spanish patents law and practice.