Lifecycle Management im Arzneimittelsektor

In 2009, the European Commission published the findings of a pharmaceutical sector inquiry. The starting point was the assumption that the entry of generic medicines to the market had delayed and the innovation as measured by the number of new medicines coming to the market had declined. The Commission declared a number of instruments – the so-called „Evergreening“ – which Originators use to achieve a delay of generic entry, inter alia patent application strategies (e.g. by buidling so-called patent clusters) and second generation or line extension strategies.
The work „Lifecycle Management in the Pharmaceutical Sector“ analyses and evaluates both strategies on the national and European market in the light of patent law, pharmaceutical law and law of reimbursement, especially against the background of a potential abuse of patent law and the national early benefit assessment of pharmaceuticals, which was introduced in 2011 by the AMNOG.