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NL – SPC Trastuzamab emtansine (Kadcyla)

09 Aug 2017

Legal entity [X] v. The Dutch Patent Office, District Court The Hague, 19 July 2017, Case No. ECLI:NL:RBDHA:2017:8031

Court appeal against the decision of the Dutch Patent Office to refuse to grant an SPC for trastuzamab emtansine.

The Court agrees with the Dutch Patent Office that Article 3 first part and under a of SPC Regulation (EC) no. 469/2009 is not complied with. Refusal to let a third party participate in the proceedings since Article 19(2) of the SPC Regulation does not allow a third party to do so.

The Court explicitly does not take into account the fact that plaintiff did not contribute at all to the development of Kadcyla and does not rule on whether there was an insufficient period of effective protection as stated in the fourth preamble of the SPC regulation or not. This, since the lack of contribution to the development of Kadcyla was not part of the grounds of the decision of the Dutch Patent Office. Also, the Court hints that this question could only be answered after referring questions to the CJEU.

A copy of the case can be read here.