Life Science analysis: The Advocate General has opined that, for the purposes of Regulation (EC) No 469/2009(the EU SPC Regulation), the classification of a substance in a marketing authorisation (MA) is determinative of whether it constitutes an ‘active ingredient’. In proceedings concerning Halozyme’s application for an supplementary protection certificate (SPC) relating to a combination of trastuzumab and recombinant human hyaluronidase PH20 (rHuPH20), the Advocate General concluded that a substance expressly classified as an excipient cannot form part of a protected ‘product’ under the SPC regime. The Opinion reinforces the link between SPC protection and regulatory classifications, promotes legal certainty and uniformity across Member States, and may significantly limit attempts to obtain SPC protection for substances whose therapeutic contribution is not recognised in the MA. Produced in partnership with Daniel Byrne, partner (barrister) of Venner Shipley LLP.