Supplementary Protection Certificates (SPCs) are urgently needed to compensate developers of medical devices for lost patent time

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 procedures. 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 means. 

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 & Rogers

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