Article
CJEU Asked Whether SPCs Can Protect “Loose Combinations” Of Active Ingredients
The Court of Justice of the European Union faces a novel question in a pending referral from Denmark: whether supplementary protection certificates can extend to "loose combinations" of active ingredients that are formulated and administered separately, rather than as a single fixed-dose product. The case involves Genmab's application for SPC protection covering daratumumab in combination with three other cancer drugs, where the marketing authorization was granted through a Type II variation allowing combin
J A Kemp LLP