THE AFTERMATH OF THE ASTRA ZENECA CASE

2 ASTRA ZENECA CASE IS A PART OF A WIDER PHARMA SECTOR LANDSCAPE The landscape of competition law enforcement in the EU in the Pharmaceutical Sector consists of: -the Astra Zeneca decision; -the Pharmaceutical Sector Inquiry; -the Preliminary Findings after the Inquiry and the Final Report of the Inquiry in 2009; -The Aftermath of the Pharma Sector Inquiry (Laboratoires Servier, Lundbeck) -Monitoring exercises in patent settlements by the EU Commission; -National Cases (UK, Italy as significant examples)

3

4 PHARMACEUTICAL SECTOR INQUIRY – MAIN POINTS Final report published on 8 July 2009 after 18-month inquiry Contrast between early findings and final conclusions; Further scrutiny announced for three areas: Patent settlements, „defensive” patents and regulatory complaints; No frontal attack on patents

5 PHARMACEUTICAL SECTOR INQUIRY– MAIN POINTS II When generics come into the market… Patent settlements Patent portfolios Patent Settlements and „reverse payments” Complaints to regulators „Defensive Patents” Policy recommendations Further scrutiny announced for three areas: Patent settlements, „defensive” patents and regulatory complaints; No frontal attack on patents

6 PHARMACEUTICAL SECTOR INQUIRY – AFTERMATH Boehringer Ingelheim: misuse of patent system to exclude potential competition (old case); Les Laboratoires Servier: attempts to delay entry of generics; Sanofi-Aventis, Teva, Novartis, Sandoz, Ratiopharm and Ranbaxy – dawn raids in November 2009

7 PHARMACEUTICAL SECTOR INQUIRY – PATENT SETTLEMENT MONITORING EXERCISE Monitoring exercises in patent settlements by the EU Commission: - January 2010 – the Commission requests copies of patent settlement agreements; - 5 July 2010 – First Commission Report on the Monitoring of the Patent Settlements – claims reduction of „problematic settlements” - 17 January 2011 – Second Monitoring Exercise of Patent Settlements in Pharma Sector

8 NATIONAL CASES – UK AND ITALY UK OFFICE OF FAR TRADING – RECKITT BENCKISER (Gaviscon case) – October 2010 early resolution agreement – admission of infringement by selective withdrawal and de-listing from NHS prescription channel; ITALIAN COMPETITION AUTHORITY investigation – Misuse of patent – Ratiopharm/Pfizer – October 2010 alleged abuse through application for a divisional patent and subsequent request for a supplementary patent certificate (SPC)

9 CONCLUSIONS „Snowball” effect across the European Union countries; Good example of new-era competition enforcement in the EU; -policy approach at EU level -sector inquiries as an enforcement tool; -importance of commitments; -follow-UP national cases;

10

Thank you for your attention ! For any questions –