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The Pharma Sector: IP Rights and Competition Policy

The Pharma Sector: IP Rights and Competition Policy. Ninette Dodoo Clifford Chance LLP. UOHS Conference, 11 November 2009. Outline. Introduction Recent Developments in IP & Antitrust Current Issues in IP & Antitrust Where Next and Likely Follow up Actions Conclusion. Introduction.

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The Pharma Sector: IP Rights and Competition Policy

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  1. The Pharma Sector: IP Rights and Competition Policy Ninette Dodoo Clifford Chance LLP UOHS Conference, 11 November 2009

  2. Outline • Introduction • Recent Developments in IP & Antitrust • Current Issues in IP & Antitrust • Where Next and Likely Follow up Actions • Conclusion The Pharma Sector: IP Rights and Competition Policy

  3. Introduction • Innovative pharmaceutical companies are entitled to protect valuable IP rights • The key issues for antitrust authorities or courts when faced with IP claims are: • may they intervene to protect competition - Magill, IMS, Microsoft set rules • may they assess the value of an IP right i.e. whether it rewards innovation - side-stepped in Magill, IMS, Microsoft although partially addressed in Microsoft remedies proceedings • Antitrust authorities and courts are grappling with these issues in the pharmaceutical arena The Pharma Sector: IP Rights and Competition Policy

  4. Recent Developments in IP & Antitrust • In the EU: • Astra Zeneca: alleged abuse involved misuse of rules on supplementary patent certificates and marketing authorisations to delay generic entry • Boehringer investigation: alleged abuse involved blocking of competing compounds and combinations • Pharmaceutical sector inquiry: blocking or delaying entry of generics • Servier, Teva, Mylan et al investigation: alleged anticompetive conduct relates to pre-market entry agreements with generic companies The Pharma Sector: IP Rights and Competition Policy

  5. Recent Developments in IP & Antitrust • In the US: • Rambus: alleged anticompetitive conduct concerned participation in a standard setting body and failing to disclose existence of patents related to technology incorporated in the standard • Schering Plough: case related to settlement of IP litigation The Pharma Sector: IP Rights and Competition Policy

  6. Current Issues in IP & Antitrust • Blocking Tactics Against Generics • Patent thickets (e.g. Boehringer) • Defensive patents • Patent settlements (e.g. Schering Plough, Servier investigation) • Vexatious litigation (ITT Promedia) • Pre-entry agreements (e.g. Servier investigation) • Regulatory complaints (e.g. Astra Zeneca) • Agreements between innovators: R&D restrictions, exclusivity, high market shares The Pharma Sector: IP Rights and Competition Policy

  7. Where Next and Likely Follow up Actions • Bad faith regulatory complaints and litigation • Innovator/Generic pre-entry agreements • Agreements between innovators • Patent settlements The Pharma Sector: IP Rights and Competition Policy

  8. Conclusion • Antitrust authorities and courts are reluctant to intervene: strong patent protection stimulates innovation • But, attempts to block or delay generic entry or to limit innovation will be subject to antitrust scrutiny • Policy objective: promote competition by ensuring a wider choice of pharmaceutical products to patients at affordable prices The Pharma Sector: IP Rights and Competition Policy

  9. The Pharma Sector: IP Rights and Competition Policy

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