Device hybrid approval not the same as substance authorisation, rules CJEU
In a decision that will disappoint medical device manufacturers, the CJEU in the Boston Scientific case has addressed the authorisation that must form the basis of an SPC. This is in contrast to recent referrals that address what products can be protected
In a new supplementary protection
certificate (SPC) development, the CJEU has ruled that the
authorisation procedure for a pharmaceutical medical-device
hybrid cannot be treated as an authorisation procedure for the
In its judgment on the Boston Scientific case
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