The Commission’s report is the culmination of a 18-month sector inquiry into why fewer new medicines are brought to the market and why generic entry can be delayed.
The Commission said it will monitor the industry under EU antitrust law and bring cases against specific abuses “where appropriate”.
In particular, it said that originator companies’ use of instruments to delay generic entry will be scrutinised if used anti-competitively, as will defensive patenting strategies.
The inquiry found that originator companies have changed patent strategies in recent years, and evidence suggested that in some cases they seek to delay or block generics from the market: “Filing numerous patent applications for the same medicine (forming so called ‘patent clusters’ or ‘patent thickets’) is a common practice.”
The Commission said it will also monitor settlements that limit or delay market entry of generics, and that evidence of wrongdoing should be presented to competition authorities.
In a statement, Competition Commissioner Neelie Kroes said: “The inquiry has told us what is wrong with the sector, and now it is time to act. When it comes to generic entry, every week and month of delay costs money to patients and taxpayers. We will not hesitate to apply the antitrust rules where such delays results from anticompetitive practices.”
The inquiry found that there is widespread support in the industry for a Community patent and specialised patent litigation system, to reduce costs and minimise conflicting judgments.
It also “fully confirmed the relevance of the recent initiatives” of the EPO in ensuring a higher quality standard of patents.
The Commission’s preliminary report, published in November 2008, was heavily criticised by the pharmaceutical industry, as it identified originator’s abuse of IP rights as a key reason for the delay in market entry of generics.
The final report is not so critical of the originator industry and is likely to prove less controversial.
