EVERGREENING STRATEGIES IN THE PHARMACEUTICAL SECTOR: SPANISH COURTS REJECT THE CLAIM OF BREACH OF THE RULES ON DATA AND MARKETING EXCLUSIVITY AS AN ACT OF UNFAIR COMPETITION

May 22, 2020 | Life Sciences

BY MIGUEL VIDAL-QUADRAS AND RITA REYES

In an Order dated 9 December 2019, the Commercial Court No. 7 of Barcelona rejected the preliminary injunctions requested at the end of November 2019 by the originators of a medicinal product in an attempt to prevent two other laboratories from placing their recently authorised products on the Spanish market. This was a triple combination of active ingredients, olmesartan/amlodipine/hydrochlorothiazide, for which the accused laboratories had obtained a marketing authorisation on the basis of Article 8(3) of Directive 2001/83 of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

The application was based exclusively on the law on unfair competition and was based on the applicants’ understanding that the existing regulations on medicinal products had been infringed. The reproach was twofold: firstly, that the accused laboratories should not have obtained their authorisations under Article 8(3) of Directive 2001/83, but instead under Article 10 thereof; and secondly, that the eight and ten years of data and marketing exclusivity imposed by Article 10 of that directive had not been respected. It was argued that the defendants had used certain bibliographical references that would have been protected by that exclusivity. Consequently, the applicant requested that the marketing of the medicinal products authorised for the defendants be prohibited.

The Court decided to call the parties to a hearing at the beginning of December 2019.

The defence against the petition of preliminary injunctions was based on three main arguments: firstly, the medicinal products had obtained an administrative authorisation after the corresponding evaluation by the health authorities, and therefore the actions of the defendants were covered by the law in force; secondly, the data and marketing exclusivity did not apply to the medicinal products in question since they had been authorised on the basis of Article 8(3) of Directive 2001/83; and thirdly, the data contained in the dossier of the applicants had been respected.

The infringement of rules as an act of unfair competition raised by the plaintiffs in the case requires that it be the defendant who infringes a certain rule. In the circumstances of the case, the accusation of infringement of rules was in fact not addressed to the accused laboratories, but to the Spanish Medicines Agency, the official body that interpreted the applicable rules and authorised the medicines. The claim of the petitioners would thus fall under the so-called evergreening, or strategy aimed at delaying the entry of other medicinal products when the medicament is no longer protected by a patent.

On the other hand, the discussion on whether data exclusivity had been respected had already been raised by the petitioners themselves with the authority that had evaluated and approved the medicinal product. The request to the commercial courts was therefore proposed as a second chance to achieve a result that the plaintiffs had not obtained from the health authorities.

In any event, the rules invoked by the applicants applied to generic medicines and the authorised medicines were not. The data exclusivity allegedly infringed is laid down in Article 10 of Directive 2001/83 for medicinal products authorised as generics and not for those approved on the basis of Article 8(3) thereof. As regards data exclusivity, Article 10 of the Directive provides that ‘By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community’. With respect to marketing exclusivity, the same article then states that ‘A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product‘.

Finally, the defendants claimed that the studies referred to in order to obtain a marketing authorisation for their medicinal products did not correspond to the combination authorised for the applicants, but to medicinal products no longer covered by marketing exclusivity and that this had been the view of the competent authority when it accepted and authorised the applications for medicinal products that had been submitted.

It was enough for the court to find that the drug was not generic to dismiss the injunctions requested. It did not enter into an assessment of other issues as this was considered sufficient to dismiss the application to prevent the marketing of the medicines. The applicants for interim relief sought that the court assumed the premise that the medicinal products should have been authorised under Article 10 of Directive 2001/83 instead of Article 8(3). However, the fact that the medicinal products had been authorised under the latter article was not in dispute, which meant that the premise pursued by the applicants could not be accepted.

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