The NEURIM approach may be restricted or even dismissed. Once again, an advocate general recommends a reversal of jurisprudence. What will the Court’s position ultimately be?

The NEURIM decision opened the possibility to grant SPC for subsequent therapeutic indications of a known active ingredient. This decision, comprising indefinite concepts subject to interpretation, has undermined the objective that Regulation No 469/2009 is uniformly implemented within the European Union. Three requests for a preliminary ruling have since been lodged at the Court of Justice of the European Union leading to the Abraxis judgment delivered on March 21, 2019 and to the Santen case, C-673/18, in progress, in which the Advocate General delivered its opinion on January 23, 2020. The third further pending referral is the Novartis case, C-354/19.

Paris, January 28, 2020 – The NEURIM decision opened the possibility to grant SPC for subsequent therapeutic indications of a known active ingredient. This decision, comprising indefinite concepts subject to interpretation, has undermined the objective that Regulation No 469/2009 is uniformly implemented within the European Union.

Three requests for a preliminary ruling have since been lodged at the Court of Justice of the European Union leading to the Abraxis judgment delivered on March 21, 2019 and to the Santen case, C-673/18, in progress, in which the Advocate General delivered its opinion on January 23, 2020. The third further pending referral is the Novartis case, C-354/19.

“If in the Abraxis judgment the Court did not go so far as to revise the Neurim judgment (…) it must, in my opinion, take this step in its forthcoming judgment”.

In the Abraxis case, the Advocate General had already asked the Court of Justice of the European Union to abandon the test of the scope of the patent introduced in Neurim. Advocate General Pitruzzella, intervening in this Santen case, reiterates this recommendation after having developed his own legal analysis of the case-law of the Court and of the objectives of the regulation.

In particular, he retains that in his view the Neurim decision cannot “be read as an exception and that the inconsistency in the case-law to which it has given rise can be resolved by narrowing its scope to the point of reducing it to a kind of empty shell “. This is how he invites the Court “to make a clear choice”.

If the Court should wish to hold on to Neurim, the Advocate General recommends, as an auxiliary suggestion, to restrict it to cases where “the old active principle exerts its own pharmacological, immunological or metabolic action, different from that previously known” and thus follows the recommendation of the European Commission.

It remains to be seen how the Court decides. Will the Court indeed revise the Neurim decision, as already advised by the Advocate General in Abraxis, or on the contrary confirm in-part the Neurim approach in order to take into consideration an economic reality of investment in “innovation leading to strengthening the therapeutic efficacy of active ingredients already known or to using them in the treatment of new pathologies”?

Response in the coming months

If you want to read the opinion (in French), click here.

Published by

Anne Boutaric

Associée