Santen Revisited – CJEU asked to think again on “first authorisation” for SPCs

A new referral to the Court of Justice of the EU will once again consider what is meant by the “first marketing authorisation” requirement of Article 3(d) of the EU medicines SPC Regulation. Specifically, the CJEU has been asked to clarify whether a veterinary marketing authorisation (MA) for a medicine can be considered the “first” MA for SPC purposes when there has been a prior MA for the same product as a human medicine. 

Background – SPC Regulation and earlier CJEU decisions on “first” marketing authorisation

Article 3(b) of the EU medicinal products SPC Regulation (469/2009) requires a valid marketing authorisation (MA) for the product for which an SPC is sought, under the relevant EU Directive (2001/83/EC for human medicines or 2001/82/EC for veterinary medicines).

Article 3(d) further requires that MA must be the first MA for that product as a medicine.  Although the wording of this Article would appear clear on the face of it, it has been the subject of litigation in Europe for two decades, and the CJEU has moved back and forth on how to interpret it in previous case law.

• In its early decisions on this matter, the CJEU considered that the term “first MA” meant just that, therefore meaning no SPC is possible for a further approved indication of a product if any prior MA existed for that product. In particular, in C-31/03 (Pharmacia Italia), the CJEU specifically ruled that an SPC could not be granted based on a first human MA for a product if a prior veterinary MA existed for that product – the Court confirming that the definition of “product” in Article 1(b) of the SPC Regulation does not include its intended use.

To the surprise of many, the CJEU then changed its mind in C-130/11 (Neurim).  In this case, an SPC for a product based on a first human MA for a product and a basic patent which encompassed that human indication, despite the existence of an earlier veterinary MA for that product.  This decision was considered favourable for applicants looking to extend second medical use patents by means of SPCs, but also caused significant legal uncertainty regarding whether and how far its principles could be extrapolated.

The CJEU then reverted to its original interpretation of Article 3(d) in C-673/18 (Santen), ruling that an SPC application did not meet the requirements of Article 3(d) if any prior MA exists for that product.  The Court confirmed the earlier case law that the definition of “product” in the SPC Regulation does not include its use, and also deemed the scope of the basic patent irrelevant for the purpose of interpreting Article 3(d).  The CJEU decided similarly in C-443/17 (Abraxis) when confirming an SPC could not be granted for a new formulation of an active ingredient which has previously received an MA.

However, it is notable that the facts of Santen are different from those of Neurim.  In Santen, a human MA for one indication followed another earlier human MA for a different indication of the same product.  Arguably, the decision did not directly address the situation in Neurim where the product received a human MA following an earlier veterinary MA.  This left some practitioners questioning whether Santen overruled the earlier Neurim decision entirely.

“New Active Substance” for EMA = a “first authorisation” for SPCs?

The trials necessary for a veterinary MA differ considerably from those for a human MA, and data from human trials are rarely considered relevant by the regulators for the purpose of a veterinary MA.  In view of this, the European Medicines Agency (EMA) deems a product a “New Active Substance” for regulatory purposes if it receives an MA for the first time under either the human or veterinary EU medicines Directive, even if it has previously been approved under the other Directive.

BI’s Aservo EquiHaler® SPC applications – differing decisions across Europe

Boehringer Ingelheim (BI) obtained a veterinary MA for the product Aservo EquiHaler®, containing the active ingredient ciclesonide, for the treatment of the airway of horses.  Based on this MA and a second medical use patent (EP2934779) covering this indication, they applied for national SPCs across the EU.  These SPCs were filed before the CJEU had decided Santen, and therefore Neurim was considered good law at that time.

The SPCs were granted by Patent Offices in a number of EU countries, although some did so before the CJEU decided Santen.  However, they were rejected by many others on the grounds of non-compliance with Article 3(d) in view of a prior human MA for the active ingredient ciclesonide – the Patent Offices generally following Santen, Abraxis, and Pharmacia when reaching their decision.

BI appealed the rejection decision in Germany, France, and the Netherlands.  In its appeals, BI argued the previous human ciclesonide MA should not be taken into account when deciding on compliance with Article 3(d), on the following grounds:

• The new veterinary MA is based on a different EU Directive and a different regulatory regime, and on entirely separate trials – as confirmed by the EMA when granting it NAS status as a veterinary medicine. BI therefore argued that the same distinction should be made between human and veterinary MAs for SPC purposes.
• As Santen did not consider the situation when a veterinary MA follows a human MA, BI argued Santen should be distinguished on the facts and Neurim should be followed instead. BI also argued that Abraxis should also be disregarded for similar reasons to Santen, and that Pharmacia should not be followed as it was limited to the transitional provisions of the original SPC Regulation.
• Rejection of the SPC applications was contrary to the purpose of the SPC Regulation in view of the additional clinical trials required to obtain the veterinary MA.

The French Court of Appeal dismissed BI’s appeal.  The Court followed the CJEU decisions in Santen and Pharmacia in confirming that the concept of a first MA as a medicine in the SPC Regulation does not distinguish between human and veterinary applications.  The Court noted the lengthy, separate trials required to obtain the veterinary MA, but also followed Santen in ruling that this did not mean all pharmaceutical research should be deserving of SPC protection – only that resulting in a first MA for the product.  The Court also ruled that other objectives, including those of public health, must also be taken into account when deciding on SPC eligibility.

The Dutch Court also dismissed the appeal, for similar reasons.  It specifically commented that, even if a distinction between human and veterinary medicines exists for pharmaceutical regulatory purposes, this is irrelevant as regards the SPC Regulation which does not make such a distinction.  It also deemed irrelevant for SPC purposes the EMA’s decision to grant NAS status for ciclesonide as a first veterinary MA.

Both Courts also refused BI’s request for a preliminary ruling from the CJEU on the question of whether the granting of an NAS request by the EMA meant that the veterinary MA should be considered a “first” MA for SPC purposes.  Both Courts considered the current interpretation of Article 3(d) as decided in Santen and Pharmacia to be clear in its own right.

However, the German court was more receptive to BI’s argument that the purpose of the SPC Regulation supports a distinction between veterinary and human MAs, and that the data obtained from human clinical trials are generally not suitable for supporting an application for a veterinary MA – in contrast to a later granted human MA following an earlier granted human MA.  It also noted the factual differences between Neurim and Santen.

In view of its proposed divergence from the French and Dutch decisions, the German court stayed proceedings to refer the following question to the CJEU:

Is Article 3(d) of [the SPC Regulation] to be interpreted as meaning that the authorisation to place a product on the market as a veterinary medicinal product  is the first authorisation to place that product on the market as a medicinal product, even if an authorisation to place the same active ingredient on the market as a human medicinal product has previously been granted?

The CJEU is likely to reach its decision within the next two years.  Having already changed course twice on the interpretation of Article 3(d), in both Neurim and Santen, it will be significant whether the Court upholds Santen in full by continuing to deem any earlier MA as causing non-compliance with the Article, or whether it is prepared to revive some of its earlier reasoning in Neurim to open the door once again to SPC protection in the case where a first veterinary MA follows an earlier human MA.

UK IPO decision – Santen still binding case law in UK

Although the UK has of course left the EU, the CJEU decided Santen before the end of the Brexit transition period and it is therefore still binding case law in the UK – as confirmed by the UK Court of Appeal in its decision in the Merck Serono SPC case.  In that case, the Court also indicated that, even if it were not bound by Santen, it would still have followed Santen as it resolved the legal uncertainties Neurim had caused.

Following the Merck Serono decision, the UK SPC application for Aservo EquiHaler® was also rejected by the UK IPO for non-compliance with both Article 3(d) and 3(c), in view of the earlier MA for ciclesonide and an earlier SPC based on it.  The UK IPO is also bound by Santen, and followed similar reasoning as the French and Dutch courts in dismissing BI’s arguments that the NAS status granted by the EMA (while the UK was an EU member state) should be taken into account when deciding what is a “first” MA under Article 3(d).  BI did not appeal the UK IPO decision, and it is therefore final.

Practice points

Although the question referred to the CJEU is specifically worded, its eventual decision may have significant consequences for SPCs across the EU.  In particular, the validity of SPCs having a similar fact pattern to Neurim, based on a veterinary MA for products having an earlier human MA (or vice versa), may be called into question – particularly if the CJEU affirms the reasoning from Santen in this new decision.  This may ultimately affect the extent to which repurposing human medicines for veterinary purposes is deemed commercially worthwhile to the industry.

We will keep you informed of developments.  In the meantime, we would advise that applicants request the prosecution of such SPCs to be stayed until the CJEU has reached its decision – some Patent Offices may do so automatically.

This article was prepared by Partner and Patent Attorney Garreth Duncan