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With marked improvements in the approval times through the
EMEA centralised procedure for new drugs, and the mutual
recognition of clinical trials between the US, Europe and
other markets helping to speed up the R&D process, one might
be forgiven for thinking that the number of Supplementary
Protection Certificates (SPCs) granted in Europe would be
declining but this is not borne out in the figures for 1999.
According to IMS Health's Patents
International LifeCycle service... Over 50 SPCs were
granted in Switzerland in 1999, whilst over 40 SPCs were
granted in Italy, and the Netherlands.
The UK saw more than 30 granted. Although the number of
SPCs granted in Germany was relatively low, over 50 SPCs
were filed. Similarly, in Ireland and Sweden SPCs filed
topped 30 in each country. Many drugs are also getting the
full five-year SPC time allowed.
R&D companies are aiming to reduce the time from discovery
to launch by several years as a bid to be first to market
in order to leverage maximum sales. The introduction of
faster drug testing procedures and rapid screening techniques
means that early stage drug development is predicted to
be shorter.
Megamerger companies plan to run parallel clinical trials
to reduce the late phase drug development times. The question
is - will we see a slowing down in SPC applications as "effective
patent life" is restored to the 15 years envisaged when
the EU SPC regulations were brought in? Only time will tell...
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