The question as to whether an SPC can be obtained for a further use or new formulation of a previously approved drug has been the subject of much debate and speculation in recent years. The requirements for the grant of an SPC are specified in Article 3 of the SPC regulation in Europe (Regulation (EC) No 469/2009). According to Article 3(b) a valid marketing authorisation is required, and Article 3(d) further requires this marketing authorisation to be "the first authorisation to place the product on the market as a medicinal product". This wording is in line with a number of decisions such as Pharmacia (C-31/03), Yissum (C-202/05) and MIT (C-431/04).
Going against the wording of the regulation and previous decisions, in the Neurim (C-130/11) ruling, the CJEU opened the way to obtain a further application for a previously approved drug. In the Neurim case, an SPC for human use was granted, despite a previous SPC having been granted for veterinary use. By contradicting the previous decisions, Neurim challenged the SPC regulation by applying a broader interpretation to Article 3(d), in particular the meaning of "the product". But how broad is broad?
A more recent referral, Abraxis (C-443/17), offered an opportunity to clarify the Neurim decision. In the preliminary opinion of this case, the Advocate General pointed out the fundamental incompatibility of the SPC regulation and the CJEU's position in Neurim. The opportunity was presented in Abraxis to restrict the meaning of the Neurim decision to medicinal products for human use that were first approved for a veterinary product – or to depart from the Neurim standpoint altogether. However, the earlier Neurim decision was not overturned in the Abraxis ruling. Instead, the CJEU opted to endorse a narrow interpretation of Neurim, wherein a new formulation of a previously approved drug may not form basis for an SPC.
Another referral, Santen (C-673/18), now provides a further opportunity to gain clarity on how SPCs based on second medical use and formulation patents are expected to be handled in the future in Europe. The opinion of the Advocate General was recently published in this case and provides an in-depth analysis of the Neurim decision and its implications on the legal framework of granting SPCs in Europe. The opinion not only discusses the incompatibility of Neurim with the previous case law and the SPC regulation, but also points out the contradictions between Neurim and Abraxis. According to the Advocate General, the path taken in Abraxis to interpret Neurim narrowly is not at all justified by the Neurim ruling itself. The Advocate General takes the position that Neurim is to be understood more generally as applying to a new therapeutic application, which would also include a new formulation of an already approved drug.
The Advocate General goes on to say that the CJEU should make a clear choice by either rejecting the Neurim approach outright or by adopting a broad interpretation of the concept of the "product". Of these two approaches the Advocate General is in favour of abandoning Neurim altogether. If this suggestion is followed, it would be seen as a negative development for research-based pharmaceutical companies.
Whichever way this case is decided, a move to provide clarification is welcomed. Along with a further pending referral, Novartis (C-354/19), the question of the requirements for obtaining SPCs for new therapeutic applications is receiving attention and the hope is that these issues will be resolved soon. Time will tell whether the CJEU takes these opportunities to settle the uncertainties around these issues once and for all.
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