Reverse payment patent settlements in the pharmaceutical sector – will the European Court of Justice follow the same approach as in the United States?
Mansner, Victor (2017-09-27)
Reverse payment patent settlements in the pharmaceutical sector – will the European Court of Justice follow the same approach as in the United States?
Mansner, Victor
(27.09.2017)
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Turun yliopisto
Tiivistelmä
This thesis focuses on so-called “reverse payment patent settlements” or “pay-for-delay settlements” in the pharmaceutical sector where the patent holder (the originator) is compensating a generic producer while it in return abandon its patent challenge and withhold its product from the market for a specific period of time.
In recent years the lawfulness of settlements involving a reverse payment has raised significant debate in both the EU and the US. Such settlements are complex and take place at the intersection of patent law, competition law, and health care policy. Striking the right balance between protecting the gains from innovation for originator companies and lowering prices through generic entry that reduces health care costs is difficult to adjust.
Research into reverse payment patent settlements is important, since it is still unclear whether such settlements are permissible under EU competition law. The aim of the research is to critically analyse the presumptively illegal (anticompetitive by object) approach taken by the European Commission. At the moment two cases are on appeal at the EU courts, and the main suggestion is that the Court of Justice of the European Union (CJEU) should follow the underlying rationale of the US Supreme Court and consequently reject the Commission’s finding and assess such settlements by their pro- and anticompetitive effects.
This research utilises comparative, descriptive and doctrinal methodologies and is based on the case law of the Court of Justice of the European Union and courts in the US, legislation on EU level, as well as relevant literature.
In recent years the lawfulness of settlements involving a reverse payment has raised significant debate in both the EU and the US. Such settlements are complex and take place at the intersection of patent law, competition law, and health care policy. Striking the right balance between protecting the gains from innovation for originator companies and lowering prices through generic entry that reduces health care costs is difficult to adjust.
Research into reverse payment patent settlements is important, since it is still unclear whether such settlements are permissible under EU competition law. The aim of the research is to critically analyse the presumptively illegal (anticompetitive by object) approach taken by the European Commission. At the moment two cases are on appeal at the EU courts, and the main suggestion is that the Court of Justice of the European Union (CJEU) should follow the underlying rationale of the US Supreme Court and consequently reject the Commission’s finding and assess such settlements by their pro- and anticompetitive effects.
This research utilises comparative, descriptive and doctrinal methodologies and is based on the case law of the Court of Justice of the European Union and courts in the US, legislation on EU level, as well as relevant literature.