There has been a new reference made to the CJEU on the correct interpretation of Article 3(d) of the SPC Regulation (Regulation (EC) No 469/2009), this time from the Bundespatentgericht (BPatG), the German Federal Patent Court. The reference concerns what counts as a “first authorisation” to place a product on the market. The CJEU has flip-flopped on this point for many years: taking a strict approach in Pharmacia (C-31/03) by denying an SPC for an active ingredient previously authorised for a different use, then reversing this in its landmark decision in Neurim (C-130/11) which opened the doors to SPCs for new uses of known active ingredients, but then most recently reverting back to its previous, strict case law in Santen (C-673/18). The new reference continues this long running saga.
The fact scenario is as follows. Boehringer Ingelheim Vetmedica GmbH holds a patent which protects the use of ciclesonide for treating asthma in horses, along with a veterinary medicinal product authorisation, in accordance with Directive 2001/82/EC, for the marketing of the product Aservo® Equihaler®. This was the first authorised veterinary medicinal product containing ciclesonide as an active ingredient, as acknowledged by the European Medicines Agency (EMA) during the authorisation procedure. However, ciclesonide had already been approved in 2005 for use as a human medicine, for the treatment of asthma (albeit from another manufacturer). Boehringer applied for an SPC in Germany but this was rejected by the German Patent Office (DPMA) in view of the prior marketing authorisation for the human medicine. The DPMA said that following its decision in Santen (C-673/18), the CJEU “abandoned” its previous case law under Neurim (C-130/11), meaning that the assessment of whether an authorisation is a “first authorisation” within the meaning of Art 3(d) of the SPC Regulation must be examined in relation to the active ingredient and not in relation to the therapeutic use of the product.
In appealing the DPMA’s decision, Boehringer argued that there should be a strict regulatory distinction between an authorisation as a veterinary medicinal product and one for a medicinal product for human use. It also argued (as was contended in Neurim, albeit the other way around) that because clinical studies in humans cannot be used for the initial authorisation of a veterinary product, one of the objectives of the SPC Regulation would be frustrated were no SPC to be available in this case. Santen and Abraxis (C-443/17) were distinguished as relating to scenarios where both earlier and later approvals were for medicinal products for human use. Pharmacia (C-31/03) was said to concern only questions relating to transitional provisions of the original Regulation (EC) 1768/92.
In making the reference, the BPatG observed inconsistencies in the approaches taken across Europe (specifically, in the Czech Republic, France and the Netherlands), such that “the correct application of Community Law is not so obvious that there is no room for reasonable doubt”. It also stated firstly, that it “tends to regard” the veterinary authorisation as the first (so paving the way for a valid SPC grant); second, that it is plausible that the Neurim decision will be upheld (despite Santen, as the underlying facts were “very different”), and third, that a distinction between human and veterinary authorisations could validly be made. In an echo of arguments made by Neurim to the CJEU back in 2011, the BPatG observes that were no SPC to be granted in these circumstances, the pharmaceutical industry could be discouraged from researching the possibility of using certain active substances for humans if corresponding products for animals had already been authorised, and vice versa.
In concluding, I would note an interesting observation in a fairly recent (Jan 2025) judgment from the Court of Appeal of England and Wales, in which Lord Justice Birss credited Santen as bringing “a measure of coherence” to the scheme of the SPC regulation whilst also substantially reducing the “legal uncertainty caused by Neurim”. However, it is clear that uncertainty continues across Europe, and one reason behind the BPatG sending this issue up to the CJEU stems from the apparent inconsistency in the pattern of SPC grants and refusals on this product, from the various Patent Offices where the requirements of Article 3(d) of the SPC Regulation are examined.
Finally, another observation from the Court of Appeal, this one by Lord Justice Jacob all those years ago when he referred Neurim up to the CJEU (Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (EWCA Civ 1064, para 68)):
“In short, if Neurim are wrong, then the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose.”
If “Neurim” is replaced by “Boehringer”, this statement might equally apply to the facts of this case now before the CJEU.
The question referred runs as follows:
“Is Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products to be interpreted as meaning that the marketing authorisation for a product as a veterinary medicinal product in accordance with 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 as a medicinal product for human use has previously been granted in accordance with Directive 2001/83/EC?.”