Mixed Reaction To ECJ Generics Ruling

Last month, the European Court of Justice ruled on the freedom (underEuropean Union law) of the Dutch Court to take restrictive actions against advanced generic registration and imports which undermine national patent laws in favor of patent holders - as in the case of Generics BV versus SmithKline & French Laboratories (a subsidiary of SmithKline Beecham) - that the submission of samples by a generics company before patent expiry is not allowed.

The case that was judged by the ECJ concerns the Dutch generics company (Generics BV) which, in the early 1990s, submitted samples of a medicine obtained by a process still under patent, in order to benefit from a marketing authorization in the Netherlands before product patent expiry.

According to the European Federation of Pharmaceutical Industries Association, the ECJ "upheld the view of the research-based pharmaceutical industry and has ruled that such a prohibition under national law is allowed according to Article 36 of the Treaty of Rome, insofar as it is justified for the purpose of safeguarding rights constituting the specific subject matter of the patent."