65It is also apparent from Article 3(1)(b) of Regulation No 141/2000 and the spirit underlying the system established by that regulation that the criteria for a finding of a significant benefit are strict. The development of a medicinal product which is of significant benefit in comparison with the medicinal product already authorised for the treatment of the same condition involves, for the undertaking working on it, investment in research and development of the potential improved medicinal product. An undertaking cannot thus merely develop a similar medicinal product in order to obtain its designation as an orphan medicinal product, marketing authorisation, and the concomitant market exclusivity (see, to that effect, judgment of 9 September 2010 in CSL Behring v Commission and EMA, T‑264/07, ECR; EU:T:2010:371, paragraph 94).
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