Thursday - 25 October 2018

CJEU Delivers a Medical Device Decision

On Thursday 25th October, the CJEU delivered a decision that puts beyond doubt, for the foreseeable future, that the duration of patent protection for medical devices cannot be extended by use of a Supplementary Protection Certificate (SPC).

The SPC system was introduced across Europe in the 1990s to enable the term of protection for pharmaceutical products to be extended by up to 5 years if there has been a delay in getting the product to market due to the marketing authorisation process. While the regulations were originally intended to cover only pharmaceutical products, there has been pressure over recent years to extend the scope of SPCs to medical devices, which can also face significant delays in CE approval, particularly when the device is provided in combination with a drug product.

However, this decision from the CJEU now puts beyond doubt any question of medical devices enjoying the same extended protection as pharmaceutical products under the current regulations.

While it seems unlikely that there will be any change in European regulations in the near future, this is one area where there is expected to be pressure on the UK after Brexit to provide more favourable extended protection provisions, so there may be further developments around the corner.

To learn more about SPCs, Brexit affecting your intellectual property or protecting your innovation, please contact Caroline Warren. 

 

 

 

About the author

Caroline Warren

Partner

Caroline manages large portfolios of applications for multinational organisations, including representing clients at hearings before the European Patent Office. Caroline also enjoys advising smaller businesses on their IP strategy, both in the UK and internationally.