The German Federal Patent Court is seeking clarification from the Court of Justice of the European Union (CJEU) regarding whether a marketing authorisation (MA) for a veterinary product can be considered the “first MA” if an earlier MA for use of the same product in humans exists.
The “first MA” – a brief history
A key requirement for obtaining SPC protection is that the MA used to support an SPC application must be the first MA for that product. This is stipulated in Article 3(d) of the SPC Regulation. However, the interpretation of “first” has been the subject of debate for many years.
Pre-2012, “first” was generally interpreted to mean that only the first MA, regardless of the therapeutic indication, could be relied upon to support an SPC application. However, a change occurred in 2012 when the CJEU issued their judgement in Neurim (C-130/11). In Neurim, an SPC was applied for using an MA authorising the use of melatonin to treat insomnia in humans, but melatonin had previously been authorised for use in sheep to regulate reproductive capacity. The crux of the issue was whether this previous MA should be deemed the “first” MA and preclude grant of the SPC. The CJEU decided in the negative and specifically stated that the “first” MA used should be the first MA falling within the scope of the claims of the basic patent. Thus, MAs authorising use of a known product to treat a new therapeutic indication could be used to support an SPC application even if the known product was the subject of an earlier MA for a different therapeutic indication.
Following Neurim, there was an incentive for pharmaceutical companies to develop known active ingredients to treat new therapeutic indications. However, Neurim was thought to be overturned by the CJEU in 2020 by the issuance of Santen (C-673/18). In Santen, an SPC was applied for using a MA authorising the use of ciclosporin to treat severe keratitis (a corneal eye disease) in humans, but ciclosporin had previously been authorised for use in humans for the treatment of various indications, including uveitis (inflammation of part of the eye). In their decision, the CJEU took a strict approach in defining the “first MA” and seemed to firmly close the case on obtaining SPCs for previously authorised active ingredients, even if relying on an MA for a different therapeutic indication.
However, Boehringer Ingelheim Vetmedica GmbH (Boehringer) may have found an exception to the strict approach taken in Santen.
Boehringer’s case
Boehringer obtained a European patent (EP2934479) protecting the use of ciclesonide in treating airway disease in equines, preferably horses. An MA was obtained in 2020 for use of ciclesonide as a veterinary product (Aservo EquiHaler®) for the treatment of severe asthma in horses. Boehringer applied for national SPCs based on national patents stemming from EP2934479 and the veterinary MA.
However, ciclesonide (under the brand name Alvesco®) was previously authorised for asthma treatment in humans in 2005. Thus, a key question was whether the issuance of this earlier human authorisation impacted Article 3(d) of the SPC regulation and precluded grant of an SPC based on the subsequent veterinary authorisation.
As is typical of SPC practice, national patent offices in EU member states have taken a divergent approach. SPCs for ciclesonide have been granted to Boehringer in many countries (inc. Czechia, Austria and Italy), but equivalent SPC applications were refused in France, the Netherlands and Germany for violation of Article 3(d). On appeal, the French and Dutch Courts upheld the decisions of the respective patent offices. However, as outlined below, the German Federal Patent Court felt that clarification from the CJEU was required before it could issue a decision.
German Federal Patent Court – Boehringer’s case
On appeal to the German Federal Patent Court, Boehringer pursued their position that the veterinary MA should be deemed the “first MA” in the context of Article 3(d) of the SPC regulation. Their specific argumentation was, in essence, two-fold:
1. Regulatory frameworks for approval need to be considered
Boehringer argued that the veterinary MA was classified by the European Medicines Agency as a “new active substance”, even considering the pre-existing MA for human use, and that it would be unfair for the SPC regulation to merely deem the veterinary MA as a further use of a known active substance rather than a new active substance per se. To bolster their position, Boehringer referred to the fact that EU human and veterinary medicinal products are governed by different EU directives.
To further support their position, Boehringer argued that they were required to undertake additional clinical trials in equines to obtain the MA (as they could not simply rely on available human data), such that the veterinary MA should be considered a “new active substance”. Boehringer felt that obtaining an SPC for this new active substance would compensate them for having to undertake said new clinical trials and the ultimate delay in bringing their equine product to market – said compensation being consistent with the overall purpose of the SPC procedure.
2. Neurim should take precedence over Santen
In Santen, a pre-existing human authorisation precluded grant of an SPC for use of the same active ingredient to treat a different human disease. Santen did not consider the situation of MAs issued for the same active ingredient for use in different species.
In fact, Boehringer noted that their case more closely followed that of Neurim, where an earlier authorisation for one species (sheep) did not preclude grant of an SPC using an MA authorising use of the same active ingredient for another species (humans). Boehringer thus argued that in their specific case, Santen did not overturn Neurim and that the teachings of Neurim should apply such that the veterinary MA should be deemed the first MA.
German Federal Patent Court – the referral
The German Federal Patent Court tended to agree with Boehringer’s arguments and, factoring in the divergence in national patent office decisions regarding SPC validity, referred the following question to the CJEU:
Is Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 on supplementary protection certificates for medicinal products to be interpreted as meaning that the marketing authorisation for a product as a veterinary medicinal product under Directive 2001/82/EC is the first marketing authorisation for that product as a medicinal product, even if a marketing authorisation for the same active substance has previously been granted for marketing as a medicinal product for human use under Directive 2001/83/EC?
We await the CJEU’s decision. In the interim period, pharmaceutical companies may be wary of going to the expense of obtaining regulatory approval of human actives for veterinary indications if the compensation provided by an SPC may not be awarded.
The situation in the UK
Boehringer’s UK SPC application was refused for at least the same reasons as their German SPC application. The UK SPC register shows the UK SPC as pending, and so it appears that the decision of the UKIPO has been appealed.
Since Brexit, the UK courts are not bound by decisions issued by the CJEU. It will be interesting to see how the UK courts decide on Boehringer’s case and whether they are aligned with their EU counterparts or if this provides an early example of UK SPC practice deviating from EU SPC practice. We will be watching the appeals closely.
If you have any questions regarding the above, or SPCs in general, please contact one of Forresters’ SPC experts.
Image source: Court of Justice of the European Union.
