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G.D. Searle LLC. v. Sandoz B.V., PI Judge District Court The Hague, 1 November 2018, Case no. ECLI:NL:RBDHA:2018:13017

Sandoz, without any prior warning, introduced a generic version of Prezista® at risk on the Dutch market. Sandoz included its product in the October version of the ‘G-Standaard’, which is the Dutch database containing information on all remedies (medicines, medical devices and homeopathic medicines) that are or may become available at pharmacies, as published by ‘Z-Index’, a subsidiary of the Dutch professional association for pharmacists. The information was published on October 18, 2018. This is before expiry of G.D. Searle’s SPC (23 February 2019). Also, Sandoz offered its product to wholesalers and intends to actually market the product as of 1 November 2018.

G.D. Searle started PI proceedings and included a provisional claim for an injunction against Sandoz for the duration of the PI proceedings as Sandoz was not willing to postpone the launch until after the outcome of the PI proceedings.

On balancing the interests of both parties, the PI judge ruled that the interest of G.D. Searle to keep the status quo outweigh Sandoz’ interest. G.D. Searle especially argued and Sandoz did not sufficiently refute that price erosion will occur should Sandoz launch its generic version.

Further, the PI judge took into consideration that the English High Court (Arnold J) in the parallel proceedings on the merits rejected Sandoz’ claim to invalidate the SPC as in his opinion the SPC complies with the requirements of Article 3 (a) of the SPC Regulation. The Court of Appeal (Lewison LJ, Kitchen LJ, Floyd LJ) -which appeal is currently awaiting the outcome of prejudicial questions asked at the CJEU- has also not yet ruled in favour of Sandoz, while Sandoz in the current PI proceedings has not brought forward any new invalidity or other arguments.

The provisional injunction for the duration of the PI proceedings is therefore granted.

A copy of the decision (in Dutch) can be read here.