Trastuzamab emtansine - Netherlands

On Aug. 02, 2017, the Hague court of Netherlands published its judgment in Trastuzamab emtansine Supplementary Protection Certificate (SPC) case & affirmed the Dutch patent office decision to refuse the SPC.

This is an appeal against the decision (10 March 2016) of the Dutch Patent Office to refuse to grant an SPC for trastuzamab emtansine. The plaintiff challenged the contested decision and requested the defendant (The Netherlands Patent Office) to conclude a direct appeal within the meaning of Article 7.

On 9 May 2014, plaintiff filed an application (registered under number 300665) to issue an SPC for the product trastuzumab emtansine registered under number EU / 1/13/885, on 15 November 2013. Furthermore, plaintiff has applied for its application based on European Patent 0 865 448 B2 entitled "Apoptosis induced by monoclonal antibody anti-her2" (Apoptosis induced by monoclonal antibody anti-Her2). The defendant based on the contested decision that trastuzumab emtansin is not protected by the basic patent so that Article 3, preamble and (a) of the Regulation is not fulfilled. The defendant has summarized in the contested decision that the active substance in the medicament according to claim 1 of EP 448 is a genus characterized by functional characteristics and that one skilled in the art, in the light of the description of The patent, on the priority date, will not have been able to realize that the thus-described antibody also relates to conjugates of antibodies with cytotoxic agents, not to mention the specific trastuzumab emtansin. Plaintiff claims that the term antibody as described in claim 1 of EP 448 does not in any way imply the exclusion of conjugates with other chemical groups, including cytotoxic agents. Furthermore, plaintiff claims that trastuzumab emtansin, although in the form of a conjugate, should be seen as an "antibody" which, as a whole, induces apoptosis. In view of the wording of the conclusion, it is irrelevant which part of this "antibody" leads to apoptosis.

In dispute, whether trastuzumab emtansin is protected by the basic patent within the meaning of Article 3, preamble and (a) of the Regulation, more specifically whether it is protected by claim 1 of that patent. Trastuzumab emtansin is not mentioned (as structural formula) in that conclusion. The question then is whether the active substance trastuzumab emtansin falls under the antibody described in claim 1 of EP 448, and that based on that conclusion, explained in particular in light of the description of the invention as required In Article 69 of the European Patent Convention and the Protocol on its interpretation, it can be concluded that this conclusion implicitly but necessarily and specifically relates to this active substance.

The Court agrees with the Dutch Patent Office that Article 3 first part and under SPC Regulation (EC) no. 469/2009 is not complied with. The anti-Her2 antibody of the invention may also be an anti-Her2 body which induces apoptosis as a result of a cytotoxic agent conjugated thereto, as claimed by the plaintiff, will be understood by one skilled in the art from claim 1 of EP 448 in the light of the foregoing Description, do not distract. In view of the foregoing, it cannot be concluded that conclusion 1 of EP 448 implicitly but necessarily and specifically relates to trastuzumab emtansin.