PTC Therapeutics International Ltd v European Medicines Agency (T-718/15)

Judgment of 5 Feb 2018

law://eu/cjeu/2015/t-718-15/para_91@2026-11-13

91In the third place, it must be held that potential misuse of the report at issue by a competitor is not in itself a ground for considering that information is commercially confidential under Regulation No 1049/2001. In that regard, it should be borne in mind that, according to the EMA’s own policy, the EMA does not disclose commercially confidential information such as detailed information on the quality and manufacturing of medicinal products. In the present case, as was stated in paragraph 90 above, the EMA did not disclose such information. It must be stated that the applicant has not adduced any evidence to explain why the EMA’s redactions are insufficient. Moreover, even if another undertaking were to use most of the information contained in the report at issue in the manner claimed by the applicant, that undertaking would still have to carry out its own relevant studies and trials and successfully develop its own medicinal product. Furthermore, the medicinal product Translarna benefits, under Article 8(1) of Regulation No 141/2000, from a period of market exclusivity preventing a similar medicinal product being marketed for a ten-year period after MA has been issued. Accordingly, the claim that the report at issue must be considered confidential in its entirety on the ground that its disclosure might enable competitors to apply for MA is unfounded in law.

PTC Therapeutics International Ltd v European Medicines Agency (T-718/15)

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