PI for Tadalafil Dosage Patent refused in Italy

By Evelina Marchesoni, Giovanni Galimberti


By decisions dated 30 July 2018, then confirmed in the appeal by decisions dated 30 August 2018, the Court of Milan dismissed PI requested by ICOS and its licensee Eli Lilly against Sandoz, ascertaining the prima facie invalidity of the ICOS patent EP 1 173 181 for a Tadalafil dosing regimen.


EP 1 173 181 (“EP ‘181”) relates to a dosage regime for the PDE5 inhibitor Tadalafil for the treatment for erectile dysfunction (ED), claiming doses of 1-5 mg of Tadalafil up to a maximum total dose of 5 mg per day.

Sandoz filed negative PI proceedings in the Court of Milan, seeking an urgent declaration of non-infringement of EP 181 by its generic tadalafil medicinal products at doses of 10 mg and 5 mg.

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