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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

The Pharma Sector: IP Rights and Competition Policy

Ninette Dodoo

Clifford Chance LLP

UOHS Conference, 11 November 2009

outline
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

introduction
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

recent developments in ip antitrust
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

recent developments in ip antitrust5
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

current issues in ip antitrust
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

where next and likely follow up actions
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

conclusion
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