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The
bio-innovation conference: where biotechnology and intellectual
property meet
Maine Science and Technology Foundation
June 27, 2002
DAY
ONE
"A
Life in the Day"
Kathy
Biberstein, Esq., Biotechnology Adviser, Crowell & Moring
Despite
the importance placed on biotechnology patents and international
patent protection, Kathy Biberstein believes that "in
the complex world of biotechnology, patents are rarely
a barrier to entry. They're more likely a seat at the
table."
Still,
said Biberstein, even when small biotech and pharmaceutical
companies have patents, if they can't cultivate a pipeline
of products to develop and ensure constant revenues,
they may not survive.
Biberstein
said trends toward global convergence of patents do
not mean they are equally enforceable in courts around
the world: even within Europe, different court systems
make different rulings based on identical information.
She said that the U.S. and Europe may also evaluate
data from clinical trials differently, and "differing
forms for clinical data may require additional testing
and always necessitate months of reformatting" even
though Biberstein said she believes research is just
as good in Europe as in the U.S.
Civil
society is another factor that global pharmaceutical
and biotech companies must pay attention to, warned
Biberstein. She said she hopes to see companies develop
"trustworthy relationships with foreign governments,
the World Health Organization, and NGOs like Doctors
Without Borders" to develop drugs together and help
treat diseases like tuberculosis and malaria.
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