A guide to the UPC and the UP - Flipbook - Page 63
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The term of the SPC is calculated as per art.13 MP SPC Regulation:
“13(1) The certificate shall take effect at the end of the lawful term of the basic patent for a
period equal to the period which elapsed between the date on which the application for a basic
patent was lodged and the date of the first authorisation to place the product on the market in
the Community reduced by a period of five years.
13(2) Notwithstanding paragraph 1, the duration of the certificate may not exceed five years
from the date on which it takes effect.”
4-14
Therefore, SPC protection will only be conferred if it took the applicant more than
five years from filing the patent to obtain the first marketing authorisation in the EU.
Although it seems sensible that no SPC would be applied for if the marketing authorisation
is granted within five years from the filing of the basic patent, because of the paediatric
extension of six months, the effective protection of an SPC can be up to five and a half years.
Therefore, an applicant may apply for an SPC from four and a half years from the filing date of
the basic patent, such that the SPC has a zero or negative term, which can then be extended by
the six month paediatric extension. 17
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Accordingly, subject to the paediatric extension, the SPC cannot last for more than five years
from the date it takes effect (patent expiry) or for more than fifteen years after the first
marketing authorisation in the EEA, if earlier.
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A further six-month paediatric extension in the context of a 20-year patent term may not
appear significant but given that the profitability of a pharmaceutical is almost always at its
highest at the end of the patent term, a six-month extension to an SPC can be very valuable.
Application Procedure
4-17
The SPC application is made to the national IP Offices. It must be applied for by the holder
of0the patent or its successor in title 18 within six months of the grant of the first marketing
authorisation for the medicinal product effective in that Member State 19 or, where the
authorisation has been granted before grant of the basic patent, six months from grant of
the patent.
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Therefore, in order to apply for an SPC a patentee must choose, in each Member State in
which a marketing authorisation for a medicinal product is granted, a suitable national patent
in force that protects the product of the authorised medicinal product. This patent becomes
the “basic patent”.
Effect of an SPC
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17
18
19
Art.5 MP SPC Regulation provides that an SPC confers the same rights as the basic patent and
is subject to the same limitations and obligations. So, although the scope of protection of an
SPC is limited to the “product”, it can be enforced against infringers in the same way as the
basic patent.
Merck Sharp & Dohme Corp v Deutsches Patent- und Markenamt (C-125/10) [2011] ECR I-12987.
art.6 MP SPC Regulation.
art.7(1) SPC Regulation.
© Bird & Bird LLP | May 2023
A Guide to the UPC and the UP 53
