A tout seigneur tout honneur, today’s decision, being about SPCs, was first reported on the SPC blog.
However, I would like to talk about it as well because, unlike British courts, it is not every day that the Paris Cour d’appel refers questions to the CJEU.
The case relates to a European patent owned by Santen, a pharmaceutical company specialized in ophthalmology.
Claim 1 of the patent is directed to a particular type of oil-in-water emulsion. According to a dependent claim, the emulsion may contain an active ingredient. According to another dependent claim, the active ingredient is cyclosporine A. Finally, another claim relates to the use of the emulsion for the preparation of an ophthalmic composition for the treatment of ocular diseases such as notably keratitis.
Santen obtained a Marketing authorization (MA) for the drug Ikervis®, which is an emulsion containing cyclosporine as an active ingredient and is indicated for the treatment of severe keratitis.
On June 3, 2015, Santen filed an SPC application at the French patent office (INPI) for “cyclosporine emulsion eye drops”. The SPC application was later amended to rename the product as “cyclosporine for its use in the treatment of keratitis”.
On October 6, 2017, the SPC application was finally refused by the INPI. The reason for the refusal was the existence of a prior MA dating back to 1983, for the drug Sandimmum®.
This drug is in the form of a drinkable solution, in which the active ingredient is also cyclosporine. The therapeutic indications range from the prevention of transplant rejection, to the treatment of endogenous uveitis (which is another ocular disease).
Santen appealed the refusal in front of the Paris Cour d’appel. Instead of deciding on the merits of the case, the court referred some questions to the CJEU regarding the interpretation of article 3 (d) of regulation (EC) No 469/2009, nicknamed the “SPC regulation”.
Article 3 (d) lays down one of the conditions for obtaining an SPC, namely that the MA referred to in the SPC application should be the first authorization “to place the product on the market as a medicinal product”.
The most important ruling from the CJEU regarding the interpretation of this article is Neurim (C-130/11) of July 11, 2012.
According to this ruling, the existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which the MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.
In Neurim, an SPC application for a formulation of melatonin useful for the treatment of insomnia had been initially refused due to the existence of an earlier MA for melatonin in a veterinary product (more precisely for the regulation of seasonal breeding activity in sheep). The Court of justice clarified that, in such a situation, the SPC application should not have been refused for this reason.
However, with the Luxembourg Court, most clarifications usually raise additional questions.
Case in point, Neurim was widely interpreted as a reversal of earlier case law (in particular Pharmacia Italia C-31/03 and Yissum C-205/05) but the Court of justice did not say a word about this in the judgment. More importantly, people wondered how far the principle set out in Neurim should extend. That is, how should the expression of the Court “a different application of the same product for which [an MA] has been granted” be interpreted?
Does the expression refer to veterinary vs. human use only, like in the facts underlying the Neurim judgment? Or does it extend to the treatment of different human diseases? Or to different formulations or modes of administration?
In the Santen case, the INPI noted that there are various interpretations of Neurim across Europe. The French administration’s current position is that Neurim should be applied in a “measured” manner.
The INPI believes in particular that there are two reasons why Neurim does not apply to Santen’s SPC application:
- First, the scope of the basic patent should correspond to that of the MA which is relied upon, like in the Neurim case (cf. the proviso that “the application is within the limits of the protection conferred by the basic patent” in the order of Neurim). This is not the case here, said the INPI, because the basic patent mainly relates to a particular emulsion. Keratitis is only one of the diseases that can be treated according to the patent. Uveitis (i.e. one of the diseases treated by the former drug Sandimmum®) is also mentioned in the dependent Swiss-type claim of the patent.
- Second, the MA which is relied upon should relate to “a new therapeutic field”, i.e. a new medical specialty, or a drug, the active ingredient of which should have a different mode of action from that exerted in the drug of the previous MA. Again, this is not the case here, the INPI argued, since both MAs relate to the treatment of inflammations of the human eye, by the same mode of action of the same substance (cyclosporine). Thus, a new medical use is not sufficiently demonstrated. The INPI’s position seems to be that a “new medical use” in this context has to be appraised in a stricter manner than in the context of a patentability appraisal.
Santen challenged this position, and stated that the conditions demanded by the INPI cannot be derived from the Neurim judgment. Santen insisted on the fact that Sandimmum® and Ikervis® have different therapeutic indications, and treat different diseases in different parts of the eye. Their respective formulations, dosages and modes of administration also differ.
The court considered both positions and came to the conclusion that “when reading the Neurim judgment it is not possible to interpret this notion of different application, which is essential for deciding the case, with any certainty”.
Thus, the Cour d’appel stayed the proceedings and referred the two following questions to the Court of justice:
1. Should the notion of different application under the CJEU Neurim judgment C-130/11 of July 19, 2012:
– be understood in a strict manner, namely be limited to the sole case of a human application following a veterinary application;
– or relate to an indication pertaining to a new therapeutic field, namely a new medical specialty, relative to the previous MA, or to a drug in which the active ingredient has a different action from the one it has in the drug of the first MA;
– or more generally, in view of the purposes of Regulation (EC) No. 469/2009 aiming at setting up a balanced system taking into account all the interests at stake, including those of public health, be appraised according to more demanding criteria than those applied for appraising patentability of the invention;
– or on the contrary be understood in an extensive manner, i.e. as including not only different therapeutic indications and diseases, but also different formulations, dosages and/or modes of administration.
2. Does the notion of application within the limits of the protection conferred by the basic patent under the CJEU Neurim judgment C-130/11 of July 19, 2012 imply that the scope of the basic patent should correspond to that of the MA relied upon, and consequently be limited to the new medical use corresponding to the therapeutic indication of said MA?
In other words, some very precise and extensive questioning of the scope of article 3 (d) of the SPC Regulation. That said, the likelihood that the Court of justice will clearly answer by yes or no as to whether Neurim applies to different diseases, different formulations, etc. is probably close to zero. It is much more likely that the Luxembourg judges will offer a new general test which will still leave room for interpretation. This is indeed the game that has been played quite extensively in the past few years.
The other thing is that there is also another referral pending on the interpretation of Neurim, namely the Abraxis case (C-443/17).
Unsurprisingly, this is a referral by the High Court in the UK. The question asked is the following:
Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the MA referred to in Article 3(b) is the first authorization within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?
In Abraxis, an SPC application was filed based on an MA for paclitaxel bound to albumin nanoparticles, but the issue was the existence of an earlier MA for solvent-based paclitaxel.
The Advocate General’s opinion in Abraxis is expected to be released on October 25, 2018. Will the Santen referral remain useful or relevant once Abraxis is decided?
As always with the SPC saga, to be continued.
CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, October 9, 2018, SAS Santen v. Directeur Général de l’INPI, RG No. 17/19934.