EU Court of Justice ruling in Santen
Outlooks for availability of SPC protection based on subsequent medical use drug approvals
We revert to the important Santen decision issued on 9 July 2020 by the Court of Justice of the European Union. This ruling constitutes a reversal of the caselaw in Neurim and enshrines a strict approach to the concepts of “product” and “first marketing authorisation”, which are core to the conditions for obtaining a certificate. The analysis of the grounds adopted by the Court lead us to envisage an alternative interpretation of the notion of "first marketing authorisation". (*)
Besides regulatory data exclusivity, supplementary protection certificates play a pivotal role in the pharmaceutical sector in the EU. On 9 July 2020, the Court of Justice of the European Union issued a ruling that is likely to affect the availability of SPC protection in the context of so-called second medical applications.
The SPC Regulation
Regulation (EC) No. 469/2009 is the EU instrument for Supplementary Protection Certificates (SPCs), which were created in 1992. The aim was to provide for a compensation of the time spent by pharmaceutical companies to secure a marketing authorisation (MA). Indeed, the time elapsed between the filing of a patent application and the grant of an MA leads to a drastic shortening of effective patent exclusivity, thus making it difficult if not impossible for companies to recoup the investments made in research and clinical development.
The requirement for ‘first authorisation’ and the Santen referral
One of the requirements for eligibility to SPC protection, is that the SPC application must be based upon an MA which is the ‘first authorisation to place the product [active ingredient] on the market as a medicinal product’. While seemingly this wording is rather clear and simple, it gave rise to a number of referrals before the Court of Justice of European Union. The issue raised by the Paris Court of Appeal in the Santen case (C-673/18) more specifically revolved around the possibility that a previous MA to a medicament comprising a given active ingredient, may not be the ‘first MA’ for the same active ingredient if incorporated in another medicament for a different application than the one formerly approved. In other terms, may an MA be ‘the first’ as long as the active ingredient, even though already previously approved for a first medicament, was provided in a medicament with a different, novel application? The answer to that question has a very significant impact on the availability of SPC protection for so-called second medical use medicaments, including treatments stemming from drug repurposing. Drug repurposing (or drug repositioning) refers to investigating new uses for already approved medications (what could be referred to as an ‘old drug’). As recently illustrated in the context of the covid-19 pandemics, such strategies are increasingly used, as they allow to mitigate some of the clinical uncertainties, for example with respect to drug safety, based upon initial assessments and post-marketing pharmacovigilance data.
The CJEU ruling in Santen
Following the primary recommendation from the Advocate General, the Court in Grand Chamber ruled that the active ingredient (termed ‘product’ in the Regulation) shall be interpreted in a strict, intrinsic and absolute manner: for the purpose of the Regulation, a ‘product’ is not made any different by virtue of the fact that it may be used for a (novel or different) application such as a therapeutic indication or a formulation. Therefore, the Court came to the conclusion that ‘a marketing authorisation cannot be considered to be the first marketing authorisation […], where it covers a new therapeutic application of an active ingredient […], and that active ingredient […] has already been the subject of a marketing authorisation for a different therapeutic application’.
Impact of Santen and outlooks
This ruling may come as a strong disappointment to many innovating companies whose business models included the option for SPC protection following drug repurposing or further approval of additional therapeutic indications. Conversely, based upon Santen, some granted SPCs may stand in a new line of fire and face increased risks of revocation, as some generics companies will doubtlessly consider. Further, companies either licensing-in or licensing-out, may wish to review and possibly re-negotiate certain terms in existing SPC license agreements. As strict and literal as it may be, the approach taken by the Court is designed to promote legal certainty. Indeed, prior to Santen, there had been some hesitation between the decisions in Neurim (C-130/11) and Abraxis (C-443/17), leading to an non-uniform application of the law by national SPC-granting patent offices and national courts over the territory of the EU. From this vantage, Santen seemingly provides clarity.
However, bearing in mind the string of rulings of the CJEU on SPCs, one may wonder whether Santen indeed closes the chapter on ‘second medical use’-type SPCs, including pertaining to new formulations or new indications.
History shows that SPC applicants may attempt to seek CJEU referrals again and again – as was done on SPCs for combinations of active ingredients, or based upon patents claiming functionally defined active ingredients, in connection with the interpretation of Article 3a) of the Regulation – which is also a seemingly clear and simple requirement for SPC protection (‘the product is protected by a basic patent in force’).
The following considerations may provide basis for future challenges and referrals:
- What is, and perhaps more intriguingly what is not, an ‘application’ within the meaning of Santen? The term ‘application’ employed by the Court in Santen stems from the case law in Neurim, and presumably derives from patent law. In particular, since the mid-1980’s, the European Patent Office (EPO) has been granting patents for so-called second medical applications or second medical uses, encompassing a wide range of situations (mode of administration, selection of patient population, formulation, dosage regime, …). It may be possible to argue that the notion of ‘application’ as per Santen somehow differs from that of the EPO practice and/or should be further defined. Indeed, while the Court observed that the notion of ‘application’ under Neurim is not defined in the SPC Regulation, which may lead to complex or diverging interpretation, this very term forms part of the operative part of the judgement in Santen…
- Would it be possible to provide for alternate interpretation of ‘the first MA’? One could imagine attempts at interpreting the Regulation in such a way that, while retaining the (strict) definition of ‘product’ (active ingredient) as per Santen, it would allow to establish alternate criteria for qualifying the ‘firstness’ of an MA. In this respect, the objective of the Regulation always has been to foster pharmaceutical research. On balance, Santen does not encourage all and any types of research, possibly leading up to a differential regime for NCEs (new chemical entities) compared to (even fully) repurposed active ingredients (new ‘applications’). To fully meet this objective, instead of looking to patent law (whence the notion of ‘application’), could one turn to pharmaceutical regulatory law? Could one use the type of dossiers (e.g. full v abridged) or the classification of MA variations (EC Regulation No. 1234/2008) as a framework to delineate research-intensive MA or MA variations, as opposed to more ‘cosmetic’ changes in the MA, and thereby provide a basis for defining ‘firstness’ of an MA – this time from a clinical research perspective?
It may be some time until the first effects of Santen become visible on the SPC landscape. We will be watching the space!