A guide to the UPC and the UP - Flipbook - Page 60
Introduction
4-01
Before commercialisation, pharmaceutical and agrochemical products must undergo lengthy
and costly clinical and field trials respectively to comply with regulatory requirements related to
safety and efficacy. Typically, marketing authorisations are therefore granted many years after
the relevant patent or patents are filed, leading to a significant reduction in the length of
effective patent protection. To compensate patent holders in the pharmaceutical industry for
this lost time to market, supplementary protection certificates (SPCs) for medicinal products
were first introduced in the EU in the 1990s by way of the Medicinal Products SPC Regulation
(the “MP SPC Regulation”). 1
4-02
The MP SPC Regulation which came into force on 2 January 1993 applies in all EU Member
States. SPCs for agrochemical products were then introduced by way of the Plant Protection
Products SPC Regulation (the “PPP SPC Regulation”), 2 which came into force on 8 February 1997.
It is in similar terms to the MP SPC Regulation Despite one regulation relating to
medicinal products and the other plant products, the latter provides that the former is to be
read in association with it. This is because, whilst the PPP SPC does not amend the MP SPC
Regulation as such, it clarifies certain problems of interpretation that have arisen with
respect to the SPC Regulation. 3
4-03
The MP SPC Regulation has subsequently been amended on two occasions. Firstly to provide
scope for a six-month extension of the up to five year term of an SPC where studies have been
conducted in compliance with an agreed paediatric investigation plan. 4 Secondly to provide a
mechanism (referred to as “the manufacturing waiver”) by which manufacturers established in
the EU (“makers”) can, despite the existence of an SPC, manufacture medicinal products, or the
active ingredients for such medicinal products, which are protected by an SPC, for export to
markets outside the EEA where protection does not exist or has expired. 5 The latter measure
also enables such manufacturers to make and stockpile medicinal products or active
ingredients that are protected by an SPC during the six months before its expiry, thus allowing
them to launch the product in the EU (and the rest of the EEA) on the day after expiry of the
SPC. In April 2023 the European Commission proposed revising both the MP and the PPP SPC
Regulations to introduce a centralised procedure for granting and opposing national SPCs,
for both European patents and Unitary patents, to be managed by the EU Intellectual Property
Office (EUIPO). 6 The centralised procedure would be mandatory when seeking an SPC for those
medicinal products that had received a centralised marketing authorisation and optional for
those plant protection products that had received an authorisation in respect of more than one
Member State. These measures would also amend substantive SPC law in certain respects,
such as providing that where a basic patent has been granted in respect of a product that is the
subject of an authorisation held by a third party, an SPC for that product shall not be granted to
the holder of such basic patent without the consent of that third party.
1
2
3
4
5
6
Regulation (EEC) No. 1768/92 of 18 June, 1992 concerning the creation of a supplementary protection certificate for medicinal
products (OJ No. L 182, 2.7.1992, p.1) which was codified and repealed by Regulation (EC) 469/2009 (OJ No. L 152, 16.6.2009,
p.1). It also applies, with modifications, to Iceland and Norway (but not Liechtenstein because of its patent union with
Switzerland) by virtue of the EEA Agreement.
Regulation (EC) No. 1610/96 of 23 July, 1996 concerning the creation of a supplementary protection certificate for plant
protection products (OJ No. L 198, 8.8.96, p.30). It also applies, with modifications, to Iceland and Norway (but not
Liechtenstein because of its patent union with Switzerland) by virtue of the EEA Agreement.
Recital 17 of the Plant Products SPC Regulation reads: “Whereas the detailed rules in recitals 12, 13 and 14 and in arts 3(2), 4,
9(1)(c) and 17(2) of this Regulation are also valid, mutatis mutandis, for the interpretation in particular of recital 9 and arts 3,
4, 8(1)(c) and 17 of Council Regulation (EEC) No. 1768/92”.
Regulation (EC) No 1901/2006 of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC)
No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ No. L 378, 27.12.2006, p.1).
Regulation (EU) 2019/933 of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection
certificate for medicinal products (OJ No. L 153, 11.6.2019, p.1).
Proposal for a Regulation on the supplementary protection certificate for plant protection products (recast) (COM(2023) 223
final 2023/0128 (COD) 27.4.2023) and Proposal for a Regulation on the supplementary protection certificate for medicinal
products (recast) (COM(2023) 231 final 2023/0130 (COD) 27.4.2023).
© Bird & Bird LLP | May 2023
A Guide to the UPC and the UP 50
