64Thus, it is clear from the wording of Article 3(1)(b) of Regulation No 141/2000 that a medicinal product may be designated as an orphan product even if a treatment exists for the condition in question, provided that it represents a significant benefit to those affected by the condition. In that regard, it is case-law that establishing significant benefit takes place in the context of a comparison with an existing authorised medicinal product or method and cannot be limited to an assessment of the intrinsic qualities of the product in question without comparing them with the intrinsic qualities of the authorised methods (see, to that effect, judgment of 9 September 2010 in Now Pharm v Commission, T‑74/08, ECR, EU:T:2010:376, paragraph 46).
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.