Post by Gareth Williams

New CJEU referral on SPCs - this time on "loose combinations", and whether a) these are eligible for SPCs at all; and b) a Type II variation to the marketing authorisation can serve as basis for an SPC. The referral comes from the Danish Maritime and Commercial Court (Sø- og Handelsretten) and revolves around Genmab's SPC application for Darzalex(R) (daratumumab) in combination with bortezomib, thalidomide and dexamethasone. Very important questions for pharma and biotech companies. Read all (well, a little) about the referral in my article. https://lnkd.in/dS6ngCyx