Decision Nº O/610/20 from Intellectual Property Office - (Patent decisions), 4 December 2020
| Judge | Dr L Cullen |
| Parties | Erber Aktiengesellschaft |
| Date | 04 December 2020 |
| Patent Number | SPC/GB17/075 |
| Court | Intellectual Property Office (United Kingdom) |
| Administrative Decision Number | O/610/20 |
1
BL O/610/20
04 December 2020
COUNCIL REGULATION (EC) No. 469/2009
CONCERNING THE SUPPLEMENTARY
PROTECTION CERTIFICATE
FOR MEDICINAL PRODUCTS
APPLICANT
Erber Aktiengesellschaft
ISSUE
Whether application for supplementary protection
certificate SPC/GB17/075 meets the requirements of
Article 2 and Article 3(b) of the Regulation
HEARING OFFICER
DECISION
Introduction
1 This decision relates to supplementary protection certificate (SPC) application
SPC/BG17/075 (“the application”) for a veterinary medicinal product filed in the name
of Erber Aktiengesellschaft (“the applicant”) on 30 November 20171. The product the
applicant is seeking to protect is “microorganism DSM 11798 of the Coriobacteriaceae
family”.
2 The basic patent on which the application relies is EP(UK) 1042449 (“the patent”)
entitled “Microorganism, method for obtaining same and feed additive”. The patent
was filed on 21 December 1998 with an earlier priority date of 30 December 1997 and
was granted by the European Patent Office (EPO) on 4 May 2005. The patent expired
on 20 December 2018.
3 The patent relates to a microorganism of the genus Eubacterium and its use as an
animal feedstuff additive. The microorganism is effective in destroying trichothecenes
(which belong to the mycotoxins class of compounds). Trichothecenes are naturally
produced by mould fungi which grow on animal feedstuffs such as cereals and
grasses. Exposure to trichothecenes can result in inhibited productivity and growth of
the animal. The patent describes how the microorganism converts trichothecenes by
biochemical degradation in a controlled manner into substances which are
1 This decision relates to an SPC applic ation that was applied for in 2017 an d as such it is necessary
to apply the relevant law that was in f orce at that time in the UK. This is set o ut in the decision below.
Dr L Cullen
2
physiologically harmless to the animal. The examples given in the patent all relate to
feeds for pigs and chickens.
4 The authorisation provided in support of the application is Commission Implementing
Regulation EU2017/930 of 31 May 2017 concerning the authorisation of a preparation
of a micro-organism strain DSM 11798 of the Coriobacteriaceae family as a feed
additive for all avian species and amending earlier Commission Implementing
Regulation (EU) No 1016/2013 of 23 October 2013.
5 Commission Implementing Regulation (EU) No 1016/2013 concerns the authorisation
of a preparation of a micro-organism strain DSM 11798 of the Coriobacteriaceae
family as a feed additive for pigs.
6 Both Commission Implementing Regulation EU2017/930 of 31 May 2017 and
Commission Implementing Regulation (EU) No 1016/2013 of 23 October 2013 were
granted in accordance with Regulation (EC) No. 1831/2003 of the European
Parliament and of the Council of 22 September 2003 on additives for use in animal
nutrition (hereafter the ‘Animal Nutrition Additives Regulation’). A summary of the
marketing authorisation documents filed in support of this SPC application, their
relevant dates and the animal species they relate to is provided in Table 1 below.
7 As noted above, the SPC application in question was filed on 30 November 2017. I
note that Commission Implementing Regulation EU2017/930 was adopted by the
European Commission on 31 May 2017 and came into force on 20 June 2017 (i.e., on
the 20th day following its publication in the Official journal of the European Union on 1
June 20172).
8 The examiner objected to the registration of an SPC under Regulation (EC) 469/20093
(‘the SPC regulation’) on the grounds that the application did not comply with Articles
2 or 3(b) of that regulation. With regards to Article 2, the examiner objected on the
grounds that the authorisation provided had not been subject to administrative
authorisation as laid down in Directive 2001/82/EC (the ‘veterinary medicinal products’
directive)4. Therefore, as the application was not within the scope of Article 2, the
requirement of Article 3(b) of the SPC regulation that a valid authorisation to place the
product on the market as a medicinal product in accordance with Directive 2001/82/EC
also was not fulfilled. The examiner was of the view that the authorisation process
under the Animal Nutrition Additives Regulation (Regulation EC 1831/2003) was not
the same as the authorisation process under Directive 2001/82/EC for a veterinary
medicinal product. The examiner did not find any indication in either the Veterinary
Medicinal Products Directive or the Animal Nutrition Additives Regulation that the
2 Commission Implementing Regulation (EU) 2017/930 of 31 May 2017 concerning the authorisation of
a preparation of a microorganism stra in DSM 11798 of the Coriobacteriac eae family as a feed additive
for all avian species and amending Impleme nting Regulation (EU) No 1016/2013 (Tex t with EEA
relevance. ) C/2017/3485. CELEX Document number: 32017R0930; published in Official Journal of the
European Union L 141/6 on 1.6.2017.
3 Council Regulation (EC) 469/2009 concerning the creation of a supplementary protection cert ificate
for medicinal products.
4 Directive 2001/82/EC of the Europe an Parliament and of the Council of 6 November 2 001 on the
Community code relating to veterinary medicinal products
3
Table 1: A comparison of the documents filed in support of SPC application
SPC/GB17/075 and the relevant date is shown in Table 1 for ease of reference.
SPC Application
Application No.
SPC/GB17/075
Proposed product
definition
Microorganism DSM 11798 of the Coriobacteriaceae family
Filing date
30 November 2017
Legal basis
Regulation (EU) No. 469/2009
Marketing Authorisations
MA
Implementing Regulation
(EU) 2017/930
Implementing Regulation
(EU) No 1016/2013
Title
Preparation of a
microorganism strain DSM
11798 of the
Coriobacteriaceae family as a
feed additive for all avian
species and amending
Implementing Regulation
(EU) No 1016/2013
Preparation of a
microorganism strain DSM
11798 of the
Coriobacteriaceae family as
a feed additive for pigs
Additive
Preparation of a
microorganism strain DSM
11798 of the
Coriobacteriaceae family
Preparation of a
microorganism strain DSM
11798 of the
Coriobacteriaceae family
Contaminant treated
For the reduction of
contamination of feed by
trichothecenes
For the reduction of
contamination of feed by
deoxynivalenol (DON)
Animal(s) affected
All avian species;
Pigs
Pigs
Date of MA
31 May 2017
23 October 2013
Legal Basis
Regulation (EC) No. 1831/2003 on additives for use in animal
nutrition as amended by Regulation (EC) No. 386/2009
regarding the establishment of a new functional group of feed
additives
Basic Patent
Patent No.
EP(UK) 1042449
Title
Microorganism, method for obtaining same and feed additive
Filing date
21 December 1998
Priority date
30 December 1997
Date of grant
04 May 2005
Date of expiry
December 2018
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