104

The first plea is based on the assertion that several fundamental rights of the applicant have been infringed: – first of all, the EMA adversely affected the applicant’s right to private life, enshrined in Article 7 of the Charter of Fundamental Rights and Article 8 of the ECHR; the disclosure of the reports which contain proprietary or confidential information facilitates, for other pharmaceutical companies, the development and marketing of another inhalation solution to the detriment of the applicant, while, in its submission, the effort that it had to make to obtain the MA for Vantobra notwithstanding the market exclusivity granted to TOBI was considerable; – next, the EMA infringed Article 339 TFEU on the grounds that the content of the reports is not in the public domain and reveals the applicant’s strategy for obtaining MA for Vantobra; – moreover, for the same reasons, the freedom to conduct a business laid down in Article 16 of the Charter of Fundamental Rights has been violated; the premature market entry of other competitors during the period of market exclusivity would lead to a loss of market share and would seriously harm the applicant’s competitive position; – moreover, the disclosure of the reports affects the applicant’s right to intellectual property laid down in Article 17(2) of the Charter of Fundamental Rights; that right also applies to non-registered know-how with an economic value on the basis of proprietary technical or business information; the applicant refers in that regard to Article 39(2) of the TRIPS Agreement and to the definition of ‘trade secrets’ in the Proposal for a Directive of the European Parliament and of the Council on the protection of know-how; it follows from those provisions that non-registered know-how is recognised as a trade-related aspect of intellectual property; the applicant states that the information contained in the CHMP reports — namely raw data generated on its behalf or the compilation and analysis of publicly-accessible data — constitutes a trade secret within the meaning of that provision and is therefore protected by Article 17 of the Charter of Fundamental Rights; the applicant specifies that the combination of new market research data, the compilation of clinical data and of their analysis by various third parties as well as the conclusions drawn by the applicant made it possible to obtain MA for Vantobra; the applicant thus draws attention to the decisive nature of that information and, therefore, to the fact that its disclosure would reveal its strategy to the advantage of its competitors; – lastly, the applicant submits that, contrary to the contention of the EMA, the assessment of whether a piece of information constitutes confidential information within the meaning of Article 4(2) of Regulation No 1049/2001 should not depend on whether or not that piece of information was used for regulatory purposes in administrative procedures; the EMA moreover recognises itself that certain information contained in clinical reports and the combination, compilation and presentation of findings for regulatory purposes may be considered commercially confidential information; in that context, the applicant specifies that it did not receive any detailed guidelines from the CHMP on the additional information and data which it was required to provide to demonstrate that the conditions for derogation from the market exclusivity of TOBI Podhaler were satisfied; the applicant thus states that it spent six months, without any further regulatory guidance, on the development and performance of a market survey as well as evaluating and summarising the results thereof; the applicant states that it has developed its own strategy to prove the non-similarity and clinical superiority, for the purposes of Article 8(3) of Regulation No 141/2000, of Vantobra and submits that that strategy should be protected.