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Why are Supplementary Protection Certificates (SPC) so important
to the innovative pharmaceutical companies in Europe? In
short they provide up to five years marketing exclusivity
after expiry of the patent - at a time when sales are at
their highest.
For many high selling drugs, SPCs have played a major role
in securing high sales after patent expiry. One notable
example is Eli
Lilly's Prozac (fluoxetine), which achieved a high percentage
of its sales over the last 10 years due to the marketing
exclusivity afforded by SPCs.
According to IMS Health's Patents
International LifeCycle service, which monitors SPC
filings and approvals, Lilly has SPCs in nine EU countries,
affording marketing exclusivity of five years in each market.
In the UK, Prozac was introduced in 1986 and its patent
expired in early 1995. Almost 80% of Prozac's sales over
the last 10 years were accrued in the five years covered
by the SPC.
The old Certificat Complementaire de Protection (CCP) law
in France has been even more generous. In France (under the
1992 CCP provisions), Prozac has seven years marketing exclusivity
afforded by the CCP, which expires in January 2002.
Sales of Prozac in the SPC period represent 60% of total
10-year sales, and the CCP has a further two years to run,
with sales in France only now beginning to plateau.
In contrast, the patent for fluoxetine expired in Germany
in March 1993, and sales of Prozac began to decline from 1995
in the absence of SPC protection.
By 1998 there were 11 generic versions of fluoxetine on the
German market.
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