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Advocate General Opinion on Approach to Article 3(a) of the SPC Regulation

20 September 2019

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.

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