Article 3(d) of the SPC regulation: CJEU referral questions meaning of “first authorisation”
The German Federal Patent Court has referred to the Court of Justice of the European Union (CJEU) a question on the interpretation of Article 3(d) of the SPC Regulation, asking whether a marketing authorisation in respect of a veterinary medicinal product can be considered the “first authorisation” to place that product on the market, even if the same active ingredient has previously been authorised as a human medicinal product. The referral reopens the debate on what constitutes a “first authorisation” under Article 3(d).
Background
The referral arises from an appeal to the German Federal Patent Court by Boehringer Ingelheim following the rejection of its application for a supplementary protection certificate (SPC) by the German Patent and Trade Mark Office (DPMA).
SPCs extend the term of patents for medicinal products in Europe which have been granted a marketing authorisation. However, Article 3(d) of the SPC Regulation requires that the authorisation to place the product on the market as a medicinal product is the first authorisation to place the product on the market.
Boehringer Ingelheim sought to obtain an SPC based on its European patent directed to ciclesonide for the treatment of respiratory diseases in horses. In January 2020, the applicant received veterinary medicinal product authorisation for its Aservo® EquiHaler® product. The active ingredient, ciclesonide, had already been approved as a medicinal product for the treatment of asthma in humans under the brand name Alvesco®.
The DPMA refused the application on the basis that Article 3(d) precluded grant of an SPC due to the earlier marketing authorisation for ciclesonide in humans. In its decision, the DPMA followed the reasoning of the CJEU decision, Santen (C-673/18).
Earlier decisions: Santen and Neurim
In Santen, the French patent office (INPI) had refused an SPC application for a ciclosporin eyedrop for the treatment of keratitis due to the existence of an earlier marketing authorisation for an oral solution of ciclosporin for the treatment of inter alia transplant rejection. The CJEU considered that Article 3(d) must be interpreted as meaning that a marketing authorisation for a new therapeutic application of an active ingredient cannot be considered the first marketing authorisation if that active ingredient has already been the subject of a marketing authorisation for a different therapeutic application. The decision was considered a departure from the earlier CJEU decision, Neurim (C-130/11).
In Neurim, the UKIPO refused grant of an SPC for melatonin for treating sleep disorders in humans on the basis that there was an earlier marketing authorisation for melatonin for regulating reproduction in sheep. Neurim appealed the decision, arguing that the relevant marketing authorisation to consider when applying Article 3(d) should be a marketing authorisation covered by the basic patent. Following a referral by the UK Court of Appeal, the CJEU considered that the existence of an earlier marketing authorisation obtained for a veterinary medicinal product did not preclude the grant of an SPC for a different application of the same product for which a marketing authorisation has also been granted (provided that the application is within the limits of the basic patent).
Key issues
While the Santen decision had generally been regarded as effectively overturning Neurim, the present referral shows that the interpretation of Article 3(d) is not yet settled.
Boehringer Ingelheim argues that the Santen decision does not deviate from Neurim as it only decided that an SPC for a human medicinal product cannot be granted based on an authorisation for a new therapeutic use of an active ingredient if that active ingredient has already been authorised for use in humans. Santen did not consider the situation of an earlier veterinary authorisation.
Boehringer Ingelheim also highlights that authorisation of medicinal products for veterinary and human use follow different regulatory procedures. Active ingredients used for the first time in veterinary products are classified as “new active substances”, requiring new, comprehensive and independent clinical studies, even if the same substance has been approved for use in humans. In contrast, approval of a known human medicinal product for a new indication in humans can make use of data and findings from the earlier approval, thus shortening the authorisation procedure.
The German Federal Patent court was inclined to agree with Boehringer Ingelheim’s arguments, nevertheless it considered it necessary to refer the question to the CJEU. We await the CJEU’s decision on the matter.
Useful links
Referral: dycip.com/ep2934479-referral
EP2934479: dycip.com/epo-register-ep2934479
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