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My name is Dr. Wayne Carter.
Welcome to this lecture entitled
Intellectual property and
patents. Drug pipeline costs.
0:09
There's enormous cost associated
with drug discovery
and development.
This has been estimated
at one to $2 billion for
the generation of
a new drug entity
and bringing that
drug to market.
These costs need
to be recouped so
drug companies need to make
a profit on the sales
of their drugs.
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Intellectual
property protection.
The intellectual property,
the IP, associated with
the drug needs to be protected
by registered patent.
This patterning
could protect parts
of the drug pipeline
process including
the new chemical
entity or it could be
a new chemical process or
an improvement to an
existing process.
These patents can be filed
in multiple countries to
provide a more global protection
of the intellectual property.
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What is patentable?
Some things are exempt
from patterning
including the laws of nature
and natural phenomena.
The new drug or process or
improvement in the process
needs to be suitably
novel for a patent
to be accepted and
not an obvious change
in either the molecule
or the procedure.
The new use of a
previously patenable drug
may require an agreement
for its usage.
1:36
Patent limitations and expiry.
In order for the drug or
the process to be patented,
the agent or process needs
to be suitably novel and not
known by others and not in
the public domain, hence,
drugs or processes that have
already been in the public
domain such as from
academic publishing or
conference presentations
are not patentable.
The patent has an expiry date.
This is typically 20
years in the UK or USA,
after which other generic
drugs can compete in
the marketplace that
demonstrate bioequivalence
of function.
These can be produced without
the extensive drug
development costs.
