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Despite much discussion and
concern raised at the European Generics Medicines Association
(EGA) meeting held in Brussels, 20-21 November 2001, very
few high-selling drugs gain further marketing monopoly from
the provision afforded by data exclusivity post European
approval.
A study carried out by the editors
of IMS HEALTH's Patents International and Generic
Planning shows that very few drugs afford any additional
monopoly period due to data exclusivity if the drug has
already had a supplementary
protection certificate (SPC) granted in that country.
Indeed, most leading drugs are covered by SPCs far beyond
the period of data exclusivity.
Notable exception protects
true innovation
Only drugs that do not have granted
SPCs or took an exceptionally long time to traverse the
R&D process gain significantly from the data exclusivity
provisions. There are, however, a few notable exceptions.
Aventis' innovative drug leflunomide (Arava, for
rheumatoid arthritis) took years to develop and thus had
limited effective patent life left at launch; even with
the additional protection afforded by a granted SPC it did
not have the usual level of marketing monopoly. Data exclusivity
has provided a further five years protection in the EU market
following SPC expiry. Without this data exclusivity period,
on commercial grounds this innovative drug may never have
reached the market.
The analysis highlighted the
marketed drugs that do not have SPCs, and in these cases
the data exclusivity provisions can afford a significant
marketing monopoly far beyond patent expiry.
Emergence of Czech SPCs
The
survey revealed that in general, the data exclusivity period
at best restored only a few years in those countries where
SPCs had not been granted or were refused. Patents
International monitors SPC filing and granting across
all EU and EFTA countries, as well as Switzerland and the
Czech Republic. Patents International has also been monitoring
the emergence of SPCs in the Eastern European countries,
but as yet only the Czech Republic has filed SPCs. Patents
International has recorded 23 filings of SPCs in the Czech
Republic to date, and none of these have so far been granted.
Other countries like Hungary and Poland are set to introduce
SPCs when they accede
to the EU .
Data exclusivity - what is
it?
Data exclusivity runs from the
date of first approval in the European Community, and conveys
10 years exclusivity from this date if the drug has been
approved via the Centralised procedure through the EMEA.
This is referred to as an EU
approval.
Through the decentralised procedure or national procedure,
the data exclusivity period is 10 years in certain EU countries
(Belgium, Germany, France, Italy, the Netherlands, Sweden,
the UK and Luxembourg) and six years in others (Austria,
Denmark, Finland, Ireland, Portugal, Spain, Greece, Norway
and Iceland). If the patent has already expired, there may
be 0-6 years data exclusivity in Spain, Portugal and Greece.
In order for a generic drug to
be approved in the EU, it goes through what is called an
abridged product licence registration process. Generics
companies have to prove bioequivalence to the original innovator’s
reference product, but do not have to conduct the clinical
trials that proved efficacy and safety of the drug. They
are allowed to use the dossier presented by the originator
to gain the product licence in a country. However, the generics
company is not allowed access to this data until the drug
has been approved in the EU for six or 10 years - this is
referred to as the data exclusivity period.
An even higher hurdle
The areas of concern for many
generics companies are the provisions before the European
Parliament in the Volume 2A Procedures for marketing authorisation
(Chapter 1 Marketing Authorisation May 2001 proposal), whereby
the 6-10-year data exclusivity period would be extended
to a 10-year period across all EC countries. Furthermore,
the provision would also allow innovative companies to gain
a further year's data exclusivity on an additional therapeutic
indication, providing 10 + 1 years data exclusivity.
Even more concerning for generics
manufacturers is the provision for certain innovative drugs
to gain a further 10 years on top of the original 10 years
if the reformulation provided a significant advantage to
the community in general - a somewhat loosely worded part
of the proposal.
Thus Dr Gordon Wright's quote
"that it is not patent expiry that you need to be concerned
about but when does marketing exclusivity expire" is an
even more apt remark in view of these new proposals. Dr
Wright, European Patent Attorney with Elkington and Fife,
was speaking on 'Recent Developments in the Use of Supplementary
Protection Certificates' at Euro Legal's 8th Annual International
Conference on Patent Protection for the Pharmaceutical and
Biotechnology Industries in November 2001.
Unlike the situation with SPCs
where there is a register of all those filed and granted
in an EU country, the same is not true for data exclusivity
and there appears to be more scope for interpretation. Issues
that arise are very complex - but vital to generics companies.
Unfortunately, they often take a lot of time and perseverance
to resolve.
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