A guide to the UPC and the UP - Flipbook - Page 61
4-04
The MP SPC Regulation and the PPP SPC Regulation referred to in paragraphs 4-01 and 4-02
above provided for the introduction of SPCs as national rights, to be granted by Member States
through national grant procedures. Although the SPC Regulations go some way to harmonise
such SPC rights across the EU (in that the SPC Regulations have direct effect and therefore
theoretically should be applied in the same manner by all Member States), there is no unitary
European SPC title currently available, although the European Commission proposed such
legislation in April 2023. As with the new centralised procedure proposed for national SPCs in
respect of both European patents and Unitary patents outlined in paragraph 4-03 above, the
procedure for securing a unitary SPC in respect of a Unitary patent would be managed by the
EUIPO. 7 In anticipation of such a measure the UPCA provides that the competence of the UPC
would extend to a “Unitary SPC” were it to be created.
4-05
Therefore, if and when the Unitary SPC is introduced it will be some time after the Court opens
its doors, so in the meantime the only SPCs with which the Court will have to deal will be those
granted by national IP offices which have applied national implementations of the MP SPC
Regulation and the PPP SPC Regulation.
Current Medicinal Product SPC Legislation
Requirements for Obtaining an SPC for a Medicinal Product
4-06
As the MP SPC Regulation has direct effect (and is therefore harmonised law as between all
Member States) and a European patent once granted becomes a bundle of national patents,
it is each national IP Office that interprets the MP SPC Regulation and grants national SPCs
with effect in that Member State only.
4-07
The MP SPC Regulation distinguishes between “medicinal product” 8 (or pharmaceutical)
and “product”, the product being the “active ingredient” or “combination of active ingredients”
within the medicinal product. 9 The grant of the SPC is linked to the “product”, in that before
an SPC is granted, the “product” must be the subject of a marketing authorisation and must
be “protected by a basic patent” in force in the Member State in which the SPC is sought.
Although the medicinal product that is the subject of the marketing authorisation may
encompass active ingredients other than the “product”, 10 the marketing authorisation must
be the first for the “product” in the EU and the SPC application must be the first for that
“product” within that Member State. 11
4-08
Although this appears to be a circuitous route to grant, because SPCs are national rights this
ensures that only one SPC per “product” is granted in each national jurisdiction and that
national SPCs granted for the same “product” expire on the same day throughout the EU.
7
8
9
10
11
Proposal for a Regulation on the unitary supplementary protection certificate for plant protection products (COM(2023) 221
final 2023/0126 (COD) 27.4.2023) and Proposal for a Regulation on the unitary supplementary certificate for medicinal
products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
(COM(2023) 222 final 2023/0127 (COD) 27.4.2023).
For the definition of “medicinal product” see art.1(a) MP SPC Regulation.
art.3 MP SPC Regulation.
Medeva BV v. Comptroller General of Patents, Designs and Trade Marks (C-322/10) [2011] ECR I-12051.
For grant in one Member State, it is not relevant if the product has been the subject of a certificate in another Member State.
© Bird & Bird LLP | May 2023
A Guide to the UPC and the UP 51
