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A Supplementary Protection
Certificate is not a patent extension... in fact, it cannot
come into force until the relevant patent has expired.
SPCs were formed by a new regulation that came into effect
on January 2 1993 in nine of the European Union countries
- Belgium, Denmark, France, Germany, Ireland, Italy, Luxembourg,
the Netherlands and the UK. SPCs were not allowed in Spain,
Greece or Portugal until January 1998.
From 1994 onwards, those EFTA (European Free Trade Association)
countries which were party to the European Economic Area Agreement
(Austria, Finland, Iceland, Norway and Sweden) adopted the
EC regulations. Liechtenstein came into the ring under the
EFTA agreement.
An SPC lasts for up to a maximum of five years and was designed
to provide for up to a maximum of 15 years monopoly on marketed
drugs. The SPC is not an automatic right and has to be applied
for in each individual state. The SPC duration allowed cannot
exceed five years.
To
calculate the SPC period allowable you take the time difference
between the patent application date and the date of the
first marketing approval in the first EU State and subtract
five years. If this is greater than five years the SPC period
is restricted to the maximum five-year term. If a patent
was applied for five years or less before the first marketing
approval then the SPC period is zero
The SPC covers a combination of what was claimed in the patent
in relation to the marketed drug and what is covered by the
marketing authorisation.
Switzerland is excluded from the European consortium, but
has set up its own SPC legislation - its certificates are
governed only by marketing authorisation in Switzerland and
not by the first authorisation in the EU. Although Switzerland
is not actually a member of EFTA or the EU, Swiss marketing
authorizations are valid in Liechtenstein and as such may
count towards assessing SPC duration in the community.
According to IMS Health's Patents
International LifeCycle service, which has been monitoring
the filing and granting of SPCs in all markets since the regulation
came into force, the UK and Switzerland have the highest
number of SPCs granted (at 268 and 272 respectively),
whilst Belgium and the Netherlands are only slightly behind
(with about 240 and 242).
Granted SPCs are low in France and Italy as both countries
introduced their own procedures in 1992 ahead of the EU
regulation (as the EU was taking so long to agree on implementation).
The regulations in each country were different, and both differed
from the final EU SPCs.
France introduced the Certificat Complementaire de Protection
(CCP) in 1992. The CCP provided for a maximum of 17 years
protection from the relevant marketing approval in France.
CCPs are valid from the expiry of the cited patent and last
for a maximum of seven years.
In 1992 Italy brought in the Certificato Complementare di
Protezione (CCP). The duration of the certificates was equal
to the period between filing of the patent application and
the date of the first marketing authorisation in Italy, provided
the term does not exceed 18 years from expiry of the cited
patent.
In both France and Italy, CCPs granted under the 1992 regulations
are still valid, but the regulations have been supplanted
by the EU SPC ruling.
SPCs have only been allowed in Spain, Portugal and Greece
since January 1998, and numbers are still relatively low
with approximately 38 granted in Portugal and 11 in Greece
(31 filed), while granted SPCs in Spain number eight at present
(four filed).
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