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Sandoz B.V. v. Astrazeneca AB, Court of Appeal The Hague, The Netherlands, 31 October 2017, Case No. 200.200.332/01, with thanks to Willem Hoyng and Theo Blomme, HOYNG ROKH MONEGIER, for submitting the case including an English and German translation thereof

Astrazeneca markets FASLODEX which is used for the treatment of oestrogen hormone dependent breast cancers. Active ingredient fulvestrant attaches to the oestrogen receptors of tumor cells, making it impossible for oestrogen to attach to the tumor cells, which slows down or even stops tumor growth. Astrazeneca holds patent EP 1250138 related to a fulvestrant formulation.

Sandoz obtained a market authorisation in 2015 for its pre-filled syringes containing a fulvestrant formulation. In 2016 Sandoz had their fulvestrant syringes added to the ‘G-standaard’. The G-Standaard is a database comprising ordering information on products that are available with wholesalers and pharmacists in the Netherlands. Subsequently, Astrazeneca started PI proceedings against Sandoz. Sandoz did not place fulvestrant on the Dutch market. The PI judge issued an injunction and orders that the pre-filled fulvestrant syringes are to be removed from the G-standaard. This despite invalidity arguments brought by Sandoz.

On appeal the invalidity arguments fail again. The Court of Appeal rules that the invention is deemed to be novel. Sandoz argues that if the invention is deemed to be novel, there is a squeeze. Either the invention in such case is not sufficiently disclosed to perform the invention or it is not inventive. The Court of Appeal disagrees and states that the standard for assessing sufficient disclosure in order to perform the invention and inventive step differs from the standard for assessing novelty. EP 138 contains enough information for the man skilled in the art to, combined with its general knowlegde, put the invention to effect.

The Court of Appeal also ruled on plausibility. The claimed technical effect was made sufficiently plausible in the application for the man skilled in the art. It is not required to give complete substantiation of experimental data mentioned in the application.

The Court of Appeal concludes that there is no serious chance that EP 138 will be invalidated in proceedings on the merits and confirms the preliminary injunction.

A copy of the judgment (in Dutch) can be read here.
A copy of the judgment (in English) can be read here.
A copy of the judgment (in German) can be read here.