The Neurim CJEU decision of July 2012 has arguably caused an equal amount of excitement and controversy. On the one hand, it seemed to open the door to supplementary protection certificates (SPCs) for second or further medical uses. On the other, it seemed to go against a number of previous decisions. On a strict literal interpretation of Article 3(d)1 of the SPC Regulation2, it should not be possible to obtain an SPC for new applications of old active ingredients that had already been the subject of a marketing authorisation. In Neurim, based on a teleological interpretation to the SPC Regulation, the CJEU held that such an SPC could be validly granted.
A recent Opinion from Advocate General M. Giovanni Pitruzzella in the Santen SPC preliminary reference3 urges the CJEU to expressly reject the Neurim decision, considering that the mere limitation of its application or marginalisation would not be a satisfactory option.
The facts in Santen
On 3 June 2015, Santen filed an SPC application relying on European Patent No. 057959306 as the basic patent in force (the "basic patent") and on an EMA marketing authorisation granted on 19 March 2015 for the drug Ikervis (an eye drop emulsion containing the active ingredient ciclosporin used to treat severe keratisis). The French National Institute of Industrial Property ("INPI") rejected the application on the ground that a marketing authorisation had been previously issued for the same active ingredient for a medication called Sandimmun (an oral solution with several therapeutic indications including the eye disease uveitis, an inflammation of some or all of the uvea (the middle part of the eye)).
INPI held that the conditions in Neurim had not been satisfied for two reasons:
- the basic patent was not limited to the severe keratisis indication – the claims included product only claims and claims to numerous other eye diseases; and
- Santen had not demonstrated that the marketing authorisation constituted a 'new therapeutic indication' within the meaning of Neurim (for example, where the mode of action of the active ingredient differs or where the medical field differs).
Santen appealed the decision to the Paris Court of Appeal and it, in turn, decided to stay proceedings referring two preliminary questions to the CJEU. The first question has asked the CJEU to consider how the concept of "different application" of an old active substance as understood in Neurim should be interpreted and the question provides a range of possible options from strict to broad interpretations. The second question asks whether, in the context of determining whether the "SPC application is within the limits of the protection conferred by the basic patent" as understood in Neurim, the scope of the basic patent should be the same as the marking authorisation relied upon (i.e. it should be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation).
Less than six months after the preliminary reference was made by the Paris Court of Appeal, the CJEU had the opportunity to consider the scope and relevance of the Neurim decision in the Abraxis SPC case4. In that case the CJEU did not openly criticise the Neurim decision and, instead, limited its ramifications by referring to it as an "exception to the narrow interpretation of Article 3(d)" which "does not, in any event, refer to cases of new formulations of the product at issue".
AG Opinion in Santen
After providing a summary of the Neurim decision, AG Pitruzzella notes in the Santen Opinion that Neurim was not only not in line with previous case law5 which followed a strict interpretation of the definition of 'product' in Article 1(b)6 of the SPC Regulation, but it also led to uncertainty over the meaning of expressions such as 'new therapeutic application', 'new use', 'different application' and 'other therapeutic indication'. National IP offices that have not limited the scope of Neurim to cases concerning the use of a medicinal product previously authorised as a veterinary medicinal product or vice versa, have applied these terms inconsistently and this has led to diverging practices across the EU.
AG Pitruzzella goes on to note that in the recent Abraxis decision, the CJEU treated Neurim as an exception to a strict literal interpretation of Article 3(d), an approach which he strongly disagrees with as it would betray the spirit and wording of Neurim.
The Opinion then provides justification for the adoption of a literal interpretation to Article 3(d) rather than the teleological approach adopted in Neurim including by reference to the Explanatory Memorandum and the recitals to the SPC Regulation and, in particular, the following four main objectives:
- preventing the creation of obstacles to the free movement of medicines in the market;
- encouraging pharmaceutical research;
- creating a uniform system based on simple and transparent rules; and
- achieving a correct balance of the interests at stake.
AG Pitruzzella concludes that the CJEU should follow the approach adopted in Abraxis and adopt a strict interpretation of Article 3(d). Moreover, the AG urges the CJEU to abandon the Neurim test altogether rather than limiting its application to those cases where there is a first veterinary MA and the second MA is for a drug for human use (an unsatisfactory option in his view).
Despite the above conclusion, AG Pitruzzella goes on to consider the alternative scenario in which the CJEU confirms the application of Neurim and clarifies its scope. At one extreme Neurim could be limited in scope to cases where the first MA is for animal use and the second for human use. At the other extreme only minor modifications to the new application (formulations, dosages and/or modes of different administration) would be sufficient to satisfy the condition in Article 3(d). He notes, however, that neither of the two extremes follows the logic underlying the Neurim judgment and the scope of Neurim must lie somewhere in between. In answer to the first preliminary question, he concludes that new therapeutic indications of an old active ingredient would fall within the scope of Neurim, as would a new pharmacological, immunological or metabolic action of an old active ingredient.
As for the second preliminary question, the AG concludes that the term 'product' in Article 4 refers only to that application and does not extend to the active ingredient as such or to other applications thereof.
The CJEU is not in the habit of admitting errors in its previous decisions, at least in the context of SPC cases, instead finding ways to distinguish cases or providing alternative tests or a bolt-on to an existing test. Consequently, it is unlikely that the CJEU will choose to abandon Neurim altogether. If that prediction is correct, and the CJEU affirms Neurim, it may decide to limit its relevance to cases where the first MA is for animal use and the second for human use (or vice versa) even if such limitation would not follow the logic of Neurim. Such an approach would at least provide certainty.
If, however, the CJEU chooses a more lenient path, then we may end up with more unanswered questions. It might confirm that all new therapeutic indications of old active ingredients can fall within the scope of Neurim. That, at least, would be clear. If the decision is not so definitive and merely says that Article 3(d) does not preclude the grant of an SPC in circumstances where the MA is for a different therapeutic indication of an old active ingredient, then it begs the question as to how different that new indication needs to be in order to fall within the scope of Neurim? Unless the CJEU also clarifies this point, the Paris Court of Appeal may not end up with the clear guidance that it was seeking.
1 Article 3(d): "the [marketing authorisation] is the first authorisation to place the product on the market as a medicinal product"
2 Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, now replaced by Regulation 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products
3 Case C-673/18 Santen SAS v Director General of the National Institute of Intellectual Property
4 Case C-443/17, ECLI:EU:C:2019:238 Abraxis; www.arnoldporter.com/-/media/files/perspectives/publications/2019/10/aipla-fall-newsletter–october-23-2019.pdf
5 In particular, the AG specifically referred to the following three previous decisions and orders:
- Case C-31/03, EU: C: 2004: 64 Pharmacia Italia;
- Case C-431/04, EU: C: 2006: 291 MIT; and
- Case C-2002/05, EU: C: 2007: 214, Yissum Order
6 Article 1(b): "'product' means the active ingredient or combination of active ingredients of a medicinal product"
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