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THE AFTERMATH OF THE ASTRA ZENECA CASE

THE AFTERMATH OF THE ASTRA ZENECA CASE. 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;

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THE AFTERMATH OF THE ASTRA ZENECA CASE

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  1. 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. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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-UPnational cases;

  9. Thank you for your attention !For any questions –tomczak@pl.millercanfield.com

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