Patent decision

BL number

O/732/21

Concerning rights in

SPC/GB17/076, EP1042449B

Hearing Officer

Dr L Cullen

Decision date

5 October 2021

Person(s) or Company(s) involved

Erber Aktiengesellschaft

Provisions discussed

a) Regulation (EC) No. 1610/96 (Plant Protection Products SPC Regulation) - Articles 2; 3(1)(b) & 7; b) Regulation (EC) No. 1107/2009 (Plant Protection Products to Market Regulation); c) Regulation (EC) No. 1831/2003 (Animal Nutrition Additives Regulation)

Keywords

Supplementary Protection Certificates

Related Decisions

O/610/20

Summary

This application is the second of two SPC applications for the active substance -�microorganism DSM 11798 of the Coriobacteriaceae family-�. The application, filed in 2017, relates to an application for a plant protection product SPC. The authorisation under Article 3(1)(b) provided in support of the application is European Commission Implementing Regulation 2017/930 approving the use of DSM11798 as an additive in animal feed. This additive will consume mycotoxins, particularly trichothecenes, which contaminate feed for avian species and feed for pigs. This approval was granted by the European Commission under Regulation (EC) 1831/2003 on additives for use in animal nutrition. The applicant argued that an approval granted under this regulation is equivalent to an authorisation granted under the Plant Protection Products to Market Regulation and, as such, it can be used to support an SPC application.

The hearing officer (HO), referred to paragraph 69 of the explanatory memorandum of the Plant Protection Product SPC regulation to show that the authors of this regulation were satisfied that it should not apply to animal nutrition additives. Considering both the wording and the overall scheme and objectives of the three European legislative instruments involved and, finding support from the CJEU decision inC-527/17, Boston Scientific, , the HO concluded that the approval provided in support of the application did not meet the requirement under Article 2 of the SPC regulation that the product had been the subject of an -�administrative procedure as laid down in Article 4 of Directive 91/414/EEC (which has been superseded and replaced by the Plant Protection Products to Market Regulation)-�. Accordingly, an approval under Regulation (EC) 1831/2003 does not fulfil the requirement under Article 3(1)(b) for a valid authorisation to place the product, that is the subject of the SPC application, on the market as a plant protection product-�.

As the application failed to meet the requirements of Articles 2 and 3(1)(b) of the Plant Protection Products SPC Regulation, it was rejected under Article 10(2) of this regulation.

Full decisionO/732/21  710Kb