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Compiled and written by SCP Herald Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies. In the MA application at issue, UAB VVB designated, inter alia, TOBI as the reference medicinal product and therefore relied in part on data relating to that medicinal product, on the EAGER study comparing TOBI and Tobi Podhaler and on ex post analyses comparing the safety profiles of those medicinal products by subgroups (children, adolescents and adults), namely the 2014 Geller study. Tobramycin VVB may therefore present a new alternative solution to Tobi Podhaler, in particular in Estonia, Latvia and Lithuania, where TOBI, which could have been used for patients who are intolerant to Tobi Podhaler, is not authorised, but also to TOBI, which, in any event, as the applicant acknowledges, no longer enjoys any regulatory protection. In that application, Nebcin, a solution for injection for the purpose of data exclusivity, and TOBI, a tobramycin solution for inhalation by nebulizer (300 mg/5 ml), were designated as reference medicinal products for the purposes of the summary of product characteristics and clinical comparison. [Extracted from the article]