First Instance Court of Paris, Decision of 8 June 2012, No. 10/04262

The First Instance Court of Paris rendered one of its very first decisions on the conditions for granting a pediatric extension of a Supplementary Protection Certificate (SPC) under Regulation (EC) No. 1901/2006.

E.I. Du Pont de Nemours & Company (Du Pont) was the owner of European patent EP 0 253 310 for "Angiotensin II receptor blocking imidazoles", which includes antihypertensive Losartan. On the basis of this European patent, Du Pont was also the holder of a French SPC, extended by a six-month "pediatric extension", thus keeping longer market exclusivity.

Laboratoires Merck Sharp & Dohme-Chibret (MSD) was the exclusive licensee of the French designation of the patent and the SPC.

In January 2010, Mylan and Qualimed were about to market a medicinal product containing Losartan and hydrochlorothiazide.

Du Pont and MSD initiated proceedings, first seeking a preliminary injunction (which was granted) and following a decision on the merits.

In the proceedings on the merits, Mylan and Qualimed challenged the validity of the pediatric extension granted within the frame of Regulation No. 1901/2006 (Regulation). Mylan and Qualimed claimed that (1) the extension depended on the grant of the marketing authorisation (MA) specifically for a pediatric use in the Member States of the EU and, (2) this authorisation had to be obtained at the time of filing the application for an extension but not later.

The First Instance Court of Paris dismissed the defense of invalidity of the pediatric extension.

The court noted that Article 36(3) of the Regulation requires that "the product is authorised in all Member States". It does not require that the medicinal product has obtained MAs in the Member State only for a pediatric use. According to No. 28 of the Preamble of the Regulation, the "quid pro quo" for the extension was to "conduct studies in the pediatric population" so that "the reward should be granted even when a pediatric indication was not authorised". Consequently, the pediatric extension should be granted if the product had been authorised in the 27 Member States, regardless of a specific pediatric use.

The court said that Du Pont had provided evidence that, at the time of filing the application for the pediatric extension of its SPC, it had forwarded to the French Intellectual Property Office (INPI) a copy of the 27 MAs of the 27 Member States relating to the initial product Losartan. In light of Article 10.3 of the Regulation, the court held, it was possible for the applicant of a pediatric extension to rectify an irregularity. This showed, so the court, that the situation of the applicant at the time of the filing was not set but may change later during prosecution.

The court concluded that the SPC extended by the pediatric extension was valid and the preliminary injunction ordered earlier was justified.