Dutch Court reminds innovators that their competitive interests against generics can only be protected for ten years

On 9 January 2018, the North-Holland district court dismissed Teva Pharmaceuticals Ltd. and Teva Nederland B.V.’s appeal against a May 2016 decision of the Dutch Medicines Evaluation Board granting Mylan B.V. and Synthon B.V. (third parties) marketing authorisations (MAs). The third parties’ MAs had been granted under Article 10(3) of the Medicinal Products Directive, as implemented into Article 42(6) of the Dutch Medicines Act, which regulates the so-called hybrid MA procedure. The third parties had referred to Teva's product Copaxone®. Teva claimed that granting the MAs to the third parties via the hybrid procedure was unjustified and that their competitive interests were affected by the board’s decision.

The court declared the appeal admissible on grounds that Teva is active in the same market as the third parties, and thus have a directly affected competitive interest in the matter. The court then recalled that Article 10(1) of the Medicinal Product Directive provides MA holders a period of protection of data and market exclusivity of respectively eight and ten years from the initial authorisation of the reference product that should also be taken into account with respect to MAs granted under the hybrid procedure (Article 10(3) of the directive). It was not in dispute between the parties that the ten-year protection period had expired.

According to the court, EU case law (cf. Olainfarm, Case C-104/13) does in principle not exclude the possibility for a MA holder of a reference product to appeal against a decision granting a MA to a third party outside of this ten-year protection period. However, the court then considered that, on the basis of this Olainfarm case law, the protection against competition following from the granting of an MA is limited to the relevant protection period. Consequently, according to the court, once such period lapses, Article 10(3) of the directive does not aim to protect the competitive interest of the MA holder of the reference product but only other interests. As the ten-year protection period had expired and the applicants had not put forward other interests worthy of protection, the court rejected the appeal (without assessing the substantive grounds of the matter).

A prior version of this post was originally published by the same author in Practical Law – Life Sciences, January 2018 issue (Thomson Reuters).

This post was originally co-authored by Elsie Troll.