BL number

Concerning rights in

Hearing Officer
Dr L Cullen

Decision date
4 December 2020

Person(s) or Company(s) involved
Erber Aktiengesellschaf

Provisions discussed
Regulation (EC) 469/2009, Articles 2; 3(b); 7 Directive 2001/82/EC (Veterinary Medicinal Products Directive) Regulation (EC) 1831/2003 (Animal Nutrition Additives Regulation)

Supplementary Protection Certificates

Related Decisions


This application is the first of two applications for an SPC for the active substance “microorganism DSM 11798 of the Coriobacteriaceae family”. The authorisation provided in support of the application comprises two Commission Implementing Regulations which approve the use of this microorganism as an additive in animal feed. The microorganism reduces the contamination of animal field by mycotoxins, particularly trichothecenes, in feed for pigs (dating from 2013) and in feed for all avian species (from 2017). These approvals were granted by the European Commission under Regulation (EC) 1831/2003 which relates to additives for use in animal nutrition. The applicant argued that the approval granted under Regulation (EC)1831/2003 is equivalent to an authorisation granted under the Veterinary Medicinal Products Directive (Directive 2001/82/EC) and as such it can be used in support of an SPC application.

The hearing officer (HO), adopting a suitable teleological approach and taking account of earlier IPO decisions (O/141/14 (Cerus); O/328/14 (Liebniz) and O/466/15 (Angiotech), considered both the wording and the overall scheme and objectives of the three European legislative instruments involved (the SPC Regulation, the Animal Nutrition Additives Regulation and the Veterinary Medicinal Products Directive). Finding support from CJEU decision C-527/17, Boston Scientific, the HO concluded that the approvals provided in support of this SPC application did not meet the requirement under Article 2 of the SPC regulation that the product has been subject of an “administrative procedure as laid down in Directive 2001/82/EC.” Accordingly, the application did not fulfil the requirement under Article 3(b) to furnish a valid authorisation “to place the product on the market as a medicinal product granted in accordance with Directive 2001/82/EC” in support of this SPC application.

As the application failed to meet the requirements for grant laid down in the SPC Regulation, it was rejected under Article 10(2).

Full decision O/610/20 PDF document672Kb
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