The Neurim CJEU decision of
A recent Opinion from Advocate General
The facts in
On
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).
Less than six months after the preliminary reference was made by the
AG Opinion in
After providing a summary of the Neurim decision, AG Pitruzzella notes in the
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.
Conclusion
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
Footnotes
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
3 Case C-673/18 Santen SAS v Director General of the
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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