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Advocate General in C 456/24 Halozyme: The MA has the final say on what constitutes an “active ingredient”
Following widespread litigation over Halozyme's SPC families for Herceptin Hylecta and MabThera, Europe's highest court received a critical referral addressing whether recombinant human hyaluronidase can be considered an "active ingredient" despite its classification as an excipient in marketing authorisation documents. Advocate General Emiliou has now published a significant legal opinion proposing that substances expressly designated as excipients cannot be regarded as active ingredients for SPC purposes.
United Kingdom IP
CR
Carpmaels & Ransford LLP
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