Case T‑140/12

Teva Pharma BV

and

Teva Pharmaceuticals Europe BV

v

European Medicines Agency (EMA)

(Medicinal products for human use — Orphan medicinal products — Application for marketing authorisation for the generic version of the orphan medicinal product imatinib — EMA decision refusing to validate the application for marketing authorisation — Market exclusivity)

Summary — Judgment of the General Court (Sixth Chamber), 22 January 2015

1.      Judicial proceedings — Introduction of new pleas during the proceedings — Conditions — Plea based on matters revealed during the proceedings

(Rules of Procedure of the General Court, Art. 48(2))

2.      Plea of illegality — Scope — Measures the illegality of which may be pleaded — General measure providing the basis of the contested decision — Need for a legal connection between the contested measure and the contested general act — Objection of illegality directed against measures preparatory to a Commission decision authorising the marketing of an orphan medicinal product — Inadmissibility

(Art. 277 TFEU; European Parliament and Council Regulation No 141/2000, Art. 5)

3.      Approximation of laws — Uniform legislation — Medicinal products for human use — Orphan medicinal products — Medicinal products similar to an orphan medicinal product already authorised and having the same therapeutic indication — Marketing — Market exclusivity — Scope

(European Parliament and Council Regulation No 141/2000, Art. 8(1) and (3); Commission Regulation No 847/2000)

1.      See the text of the decision.

(see paras 35-37)

2.      See the text of the decision.

(see paras 49-51, 53)

3.      As regards the marketing of ‘similar’ medicinal products within the meaning of Regulation No 847/2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’, Article 8(3) of Regulation No 141/2000 on orphan medicinal products has no bearing on the conditions under which marketing authorisation for such a medicinal product may be granted, but provides, by way of derogation from Article 8(1) of Regulation No 141/2000, that such a medicinal product may be granted marketing authorisation in three cases. There is nothing in that provision concerning whether such authorisation confers market exclusivity on a similar medicinal product.

A similar medicinal product may itself be an orphan medicinal product or a non-orphan medicinal product. If it is not an orphan product, the marketing authorisation for that product will not confer on it any sort of market exclusivity under Article 8(1) of Regulation No 141/2000. On the other hand, it if is an orphan medicinal product, the ten-year period of market exclusivity with which it is endowed by virtue of Article 8(1) of the regulation cannot be curtailed as a result of the fact that there exists an orphan medicinal product which has received marketing authorisation for the same therapeutic indications and which benefits from market exclusivity for those indications.

Accordingly, the marketing authorisation granted for an orphan medicinal product in respect of the same therapeutic indications as those for which the original orphan product was authorised, including on one of the grounds laid down in Article 8(3) of Regulation No 141/2000, automatically confers on that product the ten-year period of market exclusivity provided for in Article 8(1) of that regulation. It is precisely in order to ensure attainment of the objective pursued by the regulation — namely to encourage investment in research, development and marketing of orphan medicinal products — that market exclusivity must be granted in all cases in which an orphan product has been given marketing authorisation. In that regard, the ten-year period of market exclusivity provided by Regulation No 141/2000 as an incentive for the development and marketing of orphan medicinal products cannot be regarded as equivalent to the data protection periods enjoyed by any medicinal product which has been granted marketing authorisation, as the effects and scope of each of those mechanisms are different.

(see paras 73, 74, 78, 80, 81)