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To find out more
contact Bruce Dean
or Nicholas Jones
This is a view which is likely
to gain more and more traction
as medical devices become
smaller and more sophisticated
to meet the demands of
21st century healthcare.
At present, patents relating
to drugs or agrochemicals
are eligible for patent term
extensions of up to five
and a half years under the
supplementary protection
certificate (SPC) system.
This is to compensate
developers for the delays
suffered in reaching market
due to extensive marketing
authorisation procedures.
Without such extensions, it
would be extremely difficult for
organisations in these fields to
recoup the large research and
development costs required to
create such products.
However, despite the fact
that many medical devices
also take a long time to develop
and also must acquire strict
marketing approval in order
Medical device manufacturers ought to be compensated
for the effective reduction in their patent monopolies
resulting from the lengthy delays involved in obtaining
marketing authorisation for their products.
to be sold, medical devices
are currently deemed ineligible
for SPC protection.
The boundary between
conventional pharmaceuticals
and medical devices is
becoming increasingly blurred
as the industry looks for novel
solutions to treat and manage
disease, rather than relying
on the diminishing number of
“blockbuster” drugs. Advances
in materials, fabrication and
miniaturisation have allowed
smaller and more complex
devices to be manufactured
which require substantial testing
before authorisation for use
in humans may be granted.
This makes the exclusion of
medical devices from SPC
protection increasingly arbitrary
and fails to incentivise research
in this valuable field.
This problem was exemplified
recently in a decision of the
UK Intellectual Property Office
against Leibniz-Institute for
New Materials. The institute
was refused SPC protection for
its novel iron-containing anti-
cancer nanoparticles because,
among other reasons, these
nanoparticles attacked cancer
cells by physical means (heating
up when exposed to a magnetic
field) rather than chemical means.
The UK government is
championing the life sciences
sector, setting up the dedicated
Office for Life Sciences, and has
appointed George Freeman MP
to the new position of Minister
for Life Sciences. If the UK is
to lead the way in this sector, it
seems sensible for legislation to
adapt to properly compensate
innovators, not just in the
conventional pharmaceutical
sector but in the growing field
of modern medical devices.
Supplementary protection
certificate system
Short-changing medical device manufacturers
Medical
