Fewer generic-original manufacturer pharma patent settlements in Europe in 2013 than in 2012
Figures have been inflated by Portuguese legislation passed in 2012, says European Commission report
A European Commission report has indicated a fall in patent settlements between researching pharma companies and generic manufacturers in 2013, with 146 such deals struck in the European Economic Area (EEA) that year. This compares with 183 settlements in 2012.
The EEA comprises the European Union (EU), plus Norway, Iceland and Liechtenstein. While the number has fallen, the 2013 figure is large compared with an annual average of 24 patent settlements in the sector between January 2000 and June 2008, when 207 deals were struck overall.
Also, the number of pharmaceutical substances involved in these settlements increased from less than 10 in 2000–2003 to 57 in 2013.
As regards settlements limiting the entry of generics, without compensation from a medicine’s original developer, the report said there were six settlements on average each year from 2000 to July 2008; 21 settlements a year from July 2008 to December 2009; 32 settlements in 2010; 23 in 2011; 93 in 2012; and 69 in 2013.
Settlements which restrict generic entry and involve an original manufacturer compensating a generic company have 'stabilised at a low level', the report said. Such deals made up 22% of all settlements reported between 2000 and 2008, declining to 8% in 2013.
The figures have been inflated by Portuguese legislation passed in 2012, which 'practically mandates arbitration proceedings between originators and [generic] marketing authorisation applicants', said the report, and 'it is not known how many of these settlements would have still taken place absent this law'.
