Merck Sharp and Dohme Limited – Principi Attivi (Italian Competition Authority (ICA), Case A364, Decision n° 14388, Bulletin n° 23/2005, 15 June 2005)

Case Description

This case concerned an active ingredient for antibiotics whose patents had expired in most of European markets but not in Italy. The patent holder, Merck & CO. Inc. (Merck Sharp & Dohme; hereinafter “MSD”) refused to grant a license requested by an Italian company, ACS Dobfar S.p.A. (hereinafter “Dobfar”), for the production and export of the active ingredient to countries where there was no patent protection. The Italian Competition Authority (hereinafter “ICA”) held that MSD’s refusal had the effect of creating an exclusive right on products in countries in which the patents had already expired and that this conduct was capable of causing serious and irreparable damage to competition, hindering market entry of generic producers. Consequently, the ICA ordered a compulsory license as an interim measure allowing Dobfar and any other producer in Italy to manufacture and export the active ingredient.

Decision Year