In December 2014 the European Commission published its 5th Report on the monitoring of patent settlement agreements in the EEA in respect of the period January to December 2013. The focus of the report was to gather some insight into the types of agreements being entered into between originator and generic companies and to identify the types of agreements that were resulting in a delay to generic entry to the market. While these types of agreements can potentially give rise to competition law issues the Report does clarify that there is no presumption of any legislative breach and that each case would require analysis of the merits and specific circumstances.
There has been much debate during 2014 about the effectiveness of the US Safe Harbour regime. Many EU commentators have queried its effectiveness, pointing in particular to the lack of enforcement over the years by the Federal Trade Commission (FTC), the body which effectively is charged with dealing with complaints that companies are not in compliance with their public representations of adherence to the Safe Harbour principles.
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