Will the CJEU restrict SPCs this time?

Referrals to the CJEU to clarify the law on SPCs continue their recent resurgence. The latest development is the opinion by the Advocate General (AG) Pitruzzella in Santen (C-673/18), a referral from the Paris Court of Appeal¹.

This case centres on Article 3(d), the requirement that the authorisation being used as the basis for an SPC application must be the “first”. Like its neighbouring provisions in Article 3, this requirement has tumbled through multiple CJEU referrals, with two key decisions being: Neurim (which set this issue alight in 2012); and, more recently, Abraxis (which almost extinguished it altogether).

Put simply: the issue is whether an authorisation for a “different application” of a drug can be the “first”, notwithstanding an earlier marketing authorisation for the same drug.

The CJEU’s view in Neurim and Abraxis

In Neurim, the CJEU held this principle was possible in a scenario where a product already authorised as a veterinary drug was developed for a different indication in humans.

Last year, the issue came before the CJEU in Abraxis, and following years of debate about the uncertain application of Neurim², the CJEU held that the principle persevered, but not when the “different application” was a new formulation. But this raised questions, in particular as in one respect, Neurim itself was concerned with a new formulation.

The AG in Santen recommends reversing Neurim

Because the CJEU chose to provide only ‘an exception to the exception’ in Abraxis, instead of further guidance on the extent of the Neurim principle, the Santen referral took on a greater significance. The AG did not shy away from the challenge, and, like the AG in Abraxis, adopted a tough stance. And, just like the AG in Abraxis, the AG’s primary recommendation is to reverse Neurim and end the availability of SPCs for all but (more literally) the first authorisation of the product in question. One of reasons given by the AG for his opinion is that Neurim swung the balance of interests underlying SPCs too far in favour of pharmaceutical companies. The AG also considered that it should be the job of the legislators and not the courts, to decide whether the principle is permissible.

What is the alternative?

When the AG in Abraxis recommended reversing Neurim, he offered two alternatives for how could be applied:

• For new therapeutic uses of known active ingredients (but not formulations), if that the authorisation is the first to fall within the scope of protection conferred by the basic patent (this was advanced by the UK Government and European Commission); or
• For the first therapeutic use in humans, i.e. as in Neurim itself where a previous authorisation could only be avoided where it had been for a veterinary medicine, again on if the authorisation is also the first to fall within the scope of protection conferred by the basic patent (this was advanced by the Czech, Dutch and Polish Governments).

The CJEU in Abraxis did not say whether it liked either or neither of these options. This perhaps motivated the AG in Santen to offer only one alternative, albeit this is a complex option which takes into account a number of points, including:

(i) You don’t need a species switch - he rejected that Neurim should only apply to developments that switch species (e.g. animal-to-human), leaving the possibility open for it to apply to any new therapeutic use, implicitly including second medical uses in humans.

(ii) New formulations might be able to benefit - acknowledging the outcome in Abraxis, he said that Neurim cannot apply to new formulations, or “dosages and/or modes of administration” (in line with wording in the preparatory documents underlying the SPC Regulation) – BUT distinguishing the outcome in Neurim from Abraxis, the AG says that a “new formulation” is not an absolute bar, and so new formulations may benefit where there is a new indication.

(iii) New therapeutic use covers two categories - the AG split and extended the concept of “new therapeutic use” into two categories: (a) “new therapeutic indications”; or (b) relating to use of an product, in which the product “exerts a new pharmacological, immunological or metabolic activity”.

(iv) “Product” should be interpreted differently when it comes to scope - lastly, the AG agreed that there needed to be a restriction linking the “new therapeutic use” in (iii) to the scope of protection of the SPC. However, in the AG’s opinion, this did not need to be achieved by having a patent claim precisely aligned with the new therapeutic use. Instead, the AG considered that the term “product” should be interpreted to include this limitation when assessing the SPC’s scope of protection under Article 4.

What will the CJEU decide?

All eyes will now be on the CJEU and to what extent (if at all) it follows this AG opinion in the face of a second recommendation to reverse its previous caselaw; something that the CJEU has been unwilling to do in this field.

If the CJEU continues to develop its caselaw following Neurim, it will be interesting to see how it views AG Pitruzzella’s alternative option. In particular, point (iv) above may be controversial as the CJEU has been reluctant to construe the same term differently in different parts of the SPC Regulation (e.g. in Hassle). Nonetheless, the AG opinion in Santen has added considerably to the debate around Neurim and highlights the questions arising from the contrasting CJEU decision versus the AG opinion in Abraxis. Hopefully the CJEU will address these issues and provide clear guidance on the application of this doctrine.

¹ This article is based on an unofficial translation of the opinion and so any references to it may be subject to variation in any official English version, should one be made available.

² Including in the recent Max Planck Commission-driven legal study into SPCs, which again features in the Santen AG opinion.