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 the medicine. The agreement is with a scientific body called the Paediatric Committee, part of the European Medicines Agency. The programme is called a "paediatric investigation plan" (PIP). If you carried that out properly (and the Committee agrees you did), and take proper steps to publish the results including getting an appropriate modification of your MAs (of which more anon) you are entitled to a 6 month extension."

Du Pont applied to the United Kingdom Intellectual Property Office (UKIPO) within the required time period, for a paediatric extension. However, at the time of that application, although the Dutch Reference Authority had stated that the PIP had been complied with, Du Pont had not been granted an MA including a statement indicating compliance.

Jacob LJ agreed with the UKIPO position that the paediatric extension was a reward for obtaining a marketing authorisation containing a statement indicating compliance with an agreed completed paediatric investigation plan. Furthermore, he agreed that the regulations required that the applicant also provide authorisations to place the product on the market of all member states.

Although Du Pont's application to the UKIPO was deficient in failing to meet these requirements when it was filed, all of these defects had been dealt with by the time this case came for consideration at the Court of Appeal and before the expiry of the original SPC.

The basic question for...