Originally posted on IPKat.
This case once again highlights what many consider to be a tension between the literal wording of the SPC Regulation and its underlying purpose of rewarding pharmaceutical research, and asks the CJEU to reconsider its previous uncompromising approach.
Legal background: the first marketing authorisation (Article 3(d))
Article 3 of Regulation (EC) No 469/2009 (the SPC Regulation) requires that the marketing authorisation relied upon for an SPC is the “first authorisation to place the product on the market as a medicinal product”. This provision ensures that only the initial market entry of an active ingredient receives the benefit of an extended protection period. Historically, the CJEU in Neurim (C-130/11) allowed for a more flexible interpretation, permitting an SPC for a new therapeutic use even if an earlier authorisation existed for a different use, such as a veterinary one. However, the decision in Santen (C-673/18) rejected this interpretation. In Santen, the CJEU found that the “first authorisation” is the earliest one for the active ingredient, regardless of the indication or patient group.
The issue of what constitutes a “first” marketing authorisation was also recently addressed by the CJEU in Genmab (C-181/24). In that case, Genmab sought an SPC for ofatumumab (KESIMPTA) based on a new marketing authorisation for multiple sclerosis, despite an earlier authorisation for leukaemia (ARZERRA) that had been withdrawn. In this case, the CJEU confirmed that a marketing authorisation cannot be considered the first if an earlier one existed for the same product, even if that earlier MA has been withdrawn. The CJEU reasoned that allowing SPC grants based on latest marketed versions by withdrawing prior marketing authorisations, would undermine the objective of the SPC Regulation to protect only research leading to the first marketing authorisation of an active ingredient as a medicinal product. In the words of the CJEU, the law should not:
“allow pharmaceutical laboratories to choose which version of the product to favour. That would turn the objective criterion laid down by that provision into a subjective criterion that would depend on the choice of laboratories, which clearly does not correspond to the choice of the EU legislature.” (para. 32)
Case background: Ciclesonide for horses
The recent referral on Article 3(d) considers the application of Santen with respect to a human versus veterinary authorisation. The referral arose from an appeal by the Patentee, Boehringer Ingelheim Vetmedica GmbH, concerning its patent EP 2934479. The patent related to the use of ciclesonide for treating respiratory diseases in equines, specifically horses. On the basis of this patent and a 2020 marketing authorisation for the veterinary product Aservo EquiHaler, the Patentee applied for an SPC. However, ciclesonide had already been authorised as a human medicinal product for treating asthma (under the brand name Alvesco) back in 2005. The German Patent and Trade Mark Office (DPMA) rejected the application, reasoning that the 2005 human authorisation constituted the “first” authorisation under Article 3(d), following the restrictive approach in Santen. The Patentee appealed, arguing that the distinct regulatory regimes for human and veterinary medicines necessitated a different conclusion.
Horse versus human
The Patentee submitted that the 2005 human authorisation should not count as the first authorisation for a veterinary SPC. In particular, the Patentee argued that for the 2020 veterinary approval, ciclesonide was classified by the European Medicines Agency (EMA) as a “new active substance”. This classification meant that completely new, independent clinical studies were required, as data from human trials could not be reused for equine patients. The Patentee contended that if the regulatory authority considered a product “new,” the SPC regime should reflect this technical contribution.
The BPatG found that it tended (“neigt dazu”) towards the Patentee’s position, noting that a rigid application of Santen might not be appropriate for the human-veterinary divide. Whilst the DPMA had strictly applied the “product-centred” approach from Santen, the BPatG observed that the factual circumstances of Neurim and Santen were distinct. In particular, the court emphasised that human and veterinary marketing authorisations are governed by entirely different legal frameworks, Directive 2001/83/EC and Directive 2001/82/EC respectively. The court warned that failing to distinguish between these regimes could lead to a significant protection gap (“Schutzlücke”). Because clinical data from human trials typically cannot be reused to effectively shorten the veterinary authorisation process, the pharmaceutical industry might be deterred from researching species-specific uses for known active ingredients if no SPC protection is available. Consequently, the court questioned whether the Santen ruling, which involved two different human therapeutic uses, should truly preclude an SPC for a first-in-species veterinary product.
Furthermore, the BPatG highlighted the lack of a harmonised approach across the EU. Whilst the Patentee successfully obtained a corresponding SPC for ciclesonide in the Czech Republic and several other member states, such as Austria and Italy, the application faced rejections elsewhere. Specifically, the Cour d’appel de Paris in France and the Bezirksgericht Den Haag in the Netherlands both refused the grant, following the restrictive interpretation of Article 3(d). Interestingly, the court further noted that its view was also divergent from previous German BGH case law (Cabergolin II, X ZR 236/01) .
Faced with these conflicting national decisions and the risk of further fragmentation, the court stayed proceedings to refer the following question to the CJEU (machine translated from the German):
Is Article 3(d) of Regulation (EC) No 469/2009 […] to be interpreted as meaning that the authorization to place a product on the market as a veterinary medicinal product […] is the first authorization to place that product on the market as a medicinal product, even if an authorization to place the same active ingredient on the market as a human medicinal product […] has previously been granted?
Analysis
In the majority of cases, obtaining an SPC is a relatively mundane matter. Hopefully, the patent is the composition of matter patent covering the product for which a first marketing authorisation is obtained. Obtaining the SPC is then a simple matter of filling in the necessary form and filing by the deadline. The fact that we see so many CJEU referrals challenging the established case law is a testament to the value of the additional years of protection that SPCs offer, as well as the potential for divergent approaches across Europe. This latest referral once again seeks to challenge the absolute and rigid interpretation of the SPC legislation. However, the German court is effectively asking the CJEU to reconsider its previous decision in Santen. As we know, flip-flops in SPC case law are far from unprecedented given that Santen itself overturned Neurim. It is notable that the stated purpose of the new Veterinary Medicines Regulation (2019/6) is to stimulate innovation in the veterinary sector, potentially providing some context for why Santen should also be revisited. We await to see if the CJEU will continue with its uncompromisingly literal approach or seek to bridge the current gap between literal wording and the raison d’être of the SPC Regulation.
Author: Rose Hughes
Rose is a biotech and pharmaceutical patent specialist with over a decade of experience in intellectual property. Rose is a patent attorney at Evolve, where she leverages our unique fractional in-house model to provide clients with deep patent law expertise combined with the strategic commercial oversight typically associated with senior in-house counsel.
With a PhD in Immunology from UCL, Rose applies her technical background to complex innovations in biologics, cell and gene therapies, and the rapidly emerging field of AI-assisted drug development. Previously, Rose held the role of Director. Patents at AstraZeneca, where she was responsible for global IP portfolios and IP strategy at every stage of the pharmaceutical pipeline, from platform development and on-market commercialization to SPCs and patent term extensions.
A recognized thought leader in the field, Rose has been a regular contributor to IPKat since 2018, offering practical insights into European patent law developments. She is also a frequent speaker on the epi podcast, a guest lecturer for the Brunel University IP law Postgrad Certificate, and a contributing author to published books A User’s Guide to Intellectual Property in Life Sciences (2021) and Developments and Directions in Intellectual Property Law (2023).