Opinion: Supplementary Protection Certificates urgently needed to
compensate medical device developers for lost patent time
Dr Nicholas Jones, partner and patent attorney at Withers &
3 September 2014
Medical device manufacturers should be compensated for the
lengthy delays involved in obtaining the necessary marketing
authorisation to bring new products to market.
At present, patents relating to drugs or agrochemicals are
eligible for patent term extensions of up to five and a half years.
This is to compensate them for delays experienced in bringing
products to market due to extensive marketing authorisation
Without such time extensions, which allow them more time to
leverage their patent monopolies, it would be extremely difficult
for organisations in these fields to recoup the significant R&D
investment required to create such products.
Despite the fact that many medical devices also take a long time
to develop and must acquire strict marketing approval in order to be
sold, they are currently deemed ineligible for such SPC protection.
This leaves developers of medical devices at an unfair disadvantage.
The boundary between conventional pharmaceuticals and medical
devices is becoming increasingly blurred as the industry looks for
novel solutions to treat 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. This
requires substantial testing before authorisation for use in humans
can be granted. This makes the exclusion of medical devices from
SPCs 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
This ruling seems out of step with current thinking about the
important role played in modern medicine by medical devices.
Legislation concerning the use of SPCs needs to be changed.
The UK government is championing the life sciences sector and
earlier this year, it announced the expansion of its Office for Life
Sciences, in a bid to make the UK the best place to invest in life
sciences research. George Freeman has also been appointed to the new
position of Minister for Life Sciences.
If the UK is serious about leading 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 too.
Dr Nicholas Jones, partner and patent attorney at Withers