The European Commission Issues Its Final Report On Competition In The Pharmaceutical Sector

The European Commission (EC) recently issued its Final Report on its inquiry into competition in the pharmaceutical sector. The inquiry, which began in January 2008 under Articles 81 and 82 of the EC Treaty, was mandated to examine why fewer novel medicines were being brought to market and why generic entry was frequently delayed.

The Final Report reiterates many of the findings from the preliminary report, which we discussed in TLQ 4:4. In the preliminary report, the EC identified a "tool box" of methods that originator companies could use to block or delay generic entry or that may explain the difficulties in bringing new medicines to market; these methods include creating multiple patent applications for the same medicine (i.e., patent clusters or patent thickets and evergreening), initiating disputes and litigation, negotiating patent settlements that constrain generic entry (i.e., reverse payment settlements), and intervening during the generic regulatory