GMiA strikes out at patents
March 7, 2013

THE Generic Medicines Industry
Association has expressed it’s
concern over “regular misuses of
pharmaceutical patent
and regulatory systems” saying the
result is “unfortunate and
inappropriate barriers to generic
medicine market entry in Australia”.
The comments follow the
decision brought down by the
Federal Court earlier this week to
revoke patents on AstraZeneca’s
Crestor (rosuvastatin), leading
suppliers of generic medicines a
step closer to launching a generic
version of the drug.
According to GMiA, misuses of
patent and regulatory systems
mean that the supply of generic
medicines in Australia is being
inappropriately delayed, together
with the resulting significant cost
savings to the government
and the public.
“GMiA members believe the
Australian legal framework should
be changed to appropriately
balance the protection of truly
innovative medicines together with
processes which enable
stakeholders to challenge patents
of questionable validity,” GMiA said
in a statement.
“While sponsors of generic
medicines have been successfully
able to overturn these three
rosuvastatin patents in the Federal
Court, the cost and time associated
with such legal action are
substantial.
“Given the existing legal
framework and the size of the
Australian market, only weak
patents related to the most
profitable pharmaceuticals are
likely be challenged,” GMiA added.
According to GMiA the cost of
these ‘bad patents’ to the public
and to government is “too
significant to ignore”.
“GMiA strongly recommends
reform to redress this balance,”
GMiA said.
“Reforms are required to avoid
delays in generic medicine market
entry and thereby reduce the costs
of pharmaceuticals to
the government,” GMiA added.
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