On 11 September 2019 Advocate General Hogan issued his Opinion in connection with the combined referrals to the CJEU in Royalty Pharma C-650/17 and Sandoz C-114/18. Both referrals concern the interpretation of Article 3(a) of the SPC Regulation, which requires that:
"A[n SPC] shall be granted if... the product is protected by a basic patent in force"
If the CJEU adopt the Advocate General's advice it would represent a further tightening of the interpretation of Article 3(a), with a trend towards excluding SPC protection based on a patent which does not individually disclose the active ingredient(s) of an authorised product. This would arguably introduce a bar on grant of an SPC from a basic patent relating to early-stage fundamental research, as opposed to later-stage clinical development work.
Read our analysis of the Opinion here.
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