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The German Federal Patent Court (BPatG) has recently referred a new question to the CJEU on the application of Article 3(d) of the SPC Regulation, asking whether SPC protection is available based on authorisation of a medicinal product for veterinary use, even if the same product had previously been authorised for human use (see full text of the referring decision).
Article 3(d) requires that an SPC be based on the first authorisation to place a drug on the market as a medicinal product (the earliest marketing authorisation). The question of what constitutes the "first" marketing authorisation for a medicinal product has, however, been the subject of much debate in patent offices and courts across Europe.
The landmark CJEU decision in Neurim (C-130/11) introduced a generous interpretation of Article 3(d), holding that the first marketing authorisation under Article 3(d) was the first such authorisation falling within the limits of the protection conferred by the basic patent. The fact pattern underlying Neurim was that (a) a first marketing authorisation had been obtained for veterinary use and (b) a subsequent marketing authorisation was issued for human use for treating a different condition. That subsequent marketing authorisation was considered by the court in Neurim to constitute the "first" marketing authorisation for the purpose of assessing Article 3(d).
This decision opened the door to SPCs for new uses of known drugs based on any later marketing authorisation, provided the patent claims excluded the product as specified by earlier marketing authorisations. There was much debate over how broadly the principles outlined in Neurim should be applied, with the various national patent offices diverging to a significant extent. Perhaps inevitably, this led to additional referrals in Abraxis (C-443/17) and Santen (C-673/18), with the latter now the leading decision. Santen held that the "first" marketing authorisation is the earliest marketing authorisation for the active ingredient(s), irrespective of the disease indication or any other characteristics such as formulation, dose regime or patient group.
The Santen decision has generally been regarded as effectively overturning Neurim and settling the meaning of Article 3(d). However, the present referral shows that this debate is not over quite yet.
The facts of the case underlying the present referral concern the active ingredient ciclesonide. This was initially authorised for human use in 2005 for the treatment of asthma, under the brand name Alvesco®. In 2020, ciclesonide was then authorised for veterinary use for the treatment of severe asthma in horses, under the brand name Aservo EquiHaler®. Boehringer Ingelheim, who own the basic patent EP2934479 directed to treatment of airway disease in horses, sought to obtain an SPC based on this patent and the 2020 authorisation of the drug for equine use.
This SPC application was rejected by the German Patent and Trademark Office following the reasoning of Santen. The applicant appealed this decision to the BPatG. The applicant argued that Santen did not concern veterinary products at all, and so – whilst Santen ruled that an SPC cannot be obtained based on authorisation of a new disease indication in humans where a previous authorisation in humans for a different use already existed – Santen does not overturn Neurim with respect to the specific question of whether human and veterinary authorisations for the same product can independently be considered a "first" marketing authorisation.
Moreover, the applicant pointed out that authorisation of products for human and veterinary use follow different regulatory procedures. For the purposes of regulatory approval, ciclesonide was classified as a "new active substance" when its veterinary use was approved – despite the earlier authorisation in humans. The applicant contended that the SPC award should reflect the regulatory procedure: if the regulators consider the product to be a "new active substance", it would be unfair for Article 3(d) to be interpreted in such a way that that considers the product to be merely a "new use" of an existing authorised product (and thus, following Santen, not the "first" authorised use of that product).
The BPatG was minded to agree with the applicant, but considered it necessary to refer a question on the matter to the CJEU, given inconsistencies in the application of the case law by different EU member states. The court noted in particular that, following a substantive analysis of the same facts under Article 3(d), a corresponding SPC to ciclesonide had been granted in the Czech Republic, but was refused in France and the Netherlands. Separately, we note that the UK Intellectual Property Office also recently refused the application.
The question referred to the CJEU is as follows:
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 ruling on this matter with interest.
J A Kemp LLP acts for clients in the USA, Europe and globally, advising on UK and European patent practice and representing them before the European Patent Office, UKIPO and Unified Patent Court. We have in-depth expertise in a wide range of technologies, including Biotech and Life Sciences, Pharmaceuticals, Software and IT, Chemistry, Electronics and Engineering and many others. See our website to find out more.
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