Supplementary protection certificates are very important to the pharmaceutical industry because they provide an extended period of monopoly protection which can be of particular importance in relation to sales of blockbuster drugs. There has been a debate for a number of years about whether medical devices should be eligible for SPC protection especially where they incorporate drugs which are to be delivered by that device.
Boston Scientific is the owner of a German patent relating to the use of the drug Paclitaxel to reduce restenosis following angioplasty. It obtained a CE conformity certificate in relation to a medical device called the Taxus Express 2 Coronary Stent System that consisted of a Paclitaxel coated stent. It subsequently applied for a supplementary protection certificate extending the period of protection of its German patent on the basis of the CE conformity certificate.
The German patent office refused to grant the SPC and held that the CE conformity certificate was not a marketing authorisation within the meaning of the SPC legislation. That decision was appealed to the Bundespatentgericht (Federal Patents Court) which referred the case to the CJEU suggesting in its reference that the medical device certification procedure should be treated as equivalent to the marketing authorisation.
The Court of Justice (K. Jürimäe, C. Lycourgos and C. Vajda) handed down judgment on the reference last week in which it held that ‘medicinal product’ within the SPC legislation must be distinguished from ‘medical devices’ and that those two categories are mutually exclusive. This meant that a device incorporating Paclitaxel could not qualify under the SPC legislation even if Paclitaxel could constitute a ‘medicinal product’ if marketed separately.
This is an important judgment on the scope of the SPC regime which will be continued in the UK following its departure from the EU on 29 March 2019.
The judgment can be found here.
Nicholas Saunders QC appeared for the United Kingdom instructed by the Cabinet Office