CJEU to decide if authorisation for human drug precludes SPC for veterinary use

In December 2013, Boehringer Ingelheim filed EP 2 934 479 for “Ciclesonide for the treatment of airway disease in horses” at the EPO. Following clinical trials, the company received market authorisation for its product Aservo EquiHaler in January 2020. As the first veterinary drug containing ciclesonide, the European Medicines Agency classified it as a new active ingredient under Article 3(2)(a) of Regulation (EC) No 726/2004.

However, Covis Pharma had already received approval for ciclesonide in 2005 for treating human asthma. The Dutch company markets its ciclesonide product under the brand name Alvesco.

In June 2020, Boehringer Ingelheim applied to the German Patent and Trademark Office (DPMA) for an SPC (12 2020 000 027) based on EP 479. Citing the 2005 market authorisation for Covis Pharma’s Alvesco, the patent office rejected the SPC application

The DPMA argued that a ‘first authorisation’ under Article 3(d) of Regulation (EC) No 469/2009 must be examined in relation to the active substance, not the product’s therapeutic use. Therefore, it is irrelevant that the authorisations in question relate to a human medicinal product and a veterinary medicinal product, respectively.

First or not

Boehringer Ingelheim appealed to the German Federal Patent Court, which has stayed proceedings and referred the following question to the CJEU (case ID: 14W(pat)28/23):

“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 constitutes 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?”

Not the first

The German Federal Patent Court is not the first to address this issue. In May 2025, the Dutch Court of Appeal ruled that any prior marketing authorisation for the same active ingredient precludes the grant of an SPC, confirming a previous decision by the Dutch Patent Office (case ID: SGR 24/4927 OCT95).

In its decision, the court in The Hague referred to the CJEU ruling in the Santen eye drop case (C-673/18). This judgment clarified that patent offices and courts cannot grant SPCs for a new medical use of an existing product.

Hoffmann Eitle steps up

Patent attorney Bianca-Lucia Vos of Hoffmann Eitle represented Boehringer Ingelheim at the German Federal Patent Court together with Klemens Stratmann. The mixed firm has a long-standing client relationship to the pharma company. Munich-based partner Vos was also present at the Dutch proceedings, where litigator Ricardo Dijkstra of Vondst pleaded the case.

The external advisors cooperated with a team from Boehringer Ingelheim around Global Head Animal Health Patents Friederike Heckmann. Medical lawyer Christian Stallberg, partner at life sciences boutique Novacos advised on authorisation issues, with assistance from Guram Gobechia.

JUVE Patent does not yet know which litigator will take over the representation of Boehringer Ingelheim at the CJEU alongside Bianca-Lucia Vos. The patent attorney is likely to play a major role at the court. Particularly in referrals concerning SPC case law, it is not unusual for patent attorneys to take the lead at the CJEU, as in the cases of Royalty Pharma (C-650/17), Pharmacia Italia (C-31/03) and MIT (C-431/04).

On behalf of the Dutch Patent Office, Martijn de Lange led the proceedings in the Netherlands. He is a patent and SPC examiner at the office. Legislative lawyer Susanne Kantas joined him in the oral hearing. They had previously represented the patent office in a similar case regarding an SPC application by Dana Faber.