Paediatric Extensions - A European Initiative To Encourage Research Into Medicines For Children

To sell a medicine in the European Union (EU), a marketing authorisation (MA) is required. Although Du Pont applied for a patent for a medicine called losartan on 9th July 1987, the first MA to place losartan on the market within the EU was granted on 26th September 1994 such that seven years of marketing under patent protection was lost. Consequently Du Pont had been granted a Supplementary Protection Certificate (SPC), effectively an extension to the patent term, in 13 member states. The SPC was due to expire on 1st September 2009.

The Paediatric Regulation was introduced in 2006 to incentivise investigations into whether a particular medicine is suitable for children. As explained by Jacob LJ, giving the judgement of the English Appeal Court in Du Pont v UKIPO [2009] EWCA Civ 966, on 17th September 2009:

"Broadly the scheme is this. The SPC holder agrees a research programme into the treatment of children with...