The Commission's view on paediatric extensions

Recently, the Commission sent the official records of the 3rd meeting of national SPC experts held on 26 September at the EMEA to national patent offices. This meeting was mainly devoted to the implementation of paediatric extensions. The records are particularly interesting to those who are involved with the administrative implementation of Regulation 1901/2006. Some national patent offices, such as the German PTO, have yet started a consultation procedure to discuss with representatives of industrial pharmaceutical associations administrative issues, such as the format of proofs.

As regards the contents of the records it is somewhat disappointing that, by and large, the Commission takes a rather formalistic approach, even when the wording of the provisions seems to be quite clear. This is especially true with respect to Article 36.3 of Regulation 1901/2006 and Article 8.1.d.ii of Regulation 1768/92. When the wording is somewhat ambiguous, as in Article 36.1 of Regulation 1901/2006 and Article 8.1.d.i of Regulation 1768/92, the result is the same. The Commission seems to apply the maxim "in dubio contra paediatric extension".

Consequently, this basic incentive will be devaluated. Of course, such tendencies of strict interpretation undermine the very aims of the Regulation 1901/2006. It remains to be seen if the national patent offices are able and willing to practise the relevant provisions in a more flexible way, e.g., by using the instrument of Article 10.3 of Regulation 1768/92.