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United Kingdom

SPC ‘active ingredient’: High Court upholds UK IPO’s SmPC-led approach; hyaluronidase deemed excipient, not within therapeutic indications (Halozyme v Comptroller)

Published on: 16 January 2025

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Article summary

Halozyme Inc v Comptroller-General of Patents, Designs and Trade Marks [2024] EWHC 3202 (Pat)

What are the practical implications of this case?

In practical terms, little has shifted. The decision will not deter the UK IPO from continuing its SmPC/EPAR-led approach when identifying what constitutes an active ingredient. The court did not determine whether there are situations where other materials should be taken into account; it simply concluded that, on these facts, the Hearing Officer was entitled to ignore them because they were of no assistance. It remains worth watching how future cases develop on this point, particularly in contrasting contexts yet to be tested, such as pro-drugs, where the UK IPO’s practice is to grant SPCs on the basis that pro-drugs are different chemical entities from the parent drugs even if the pro-moiety would not meet the Forsgren (C-631/13) criteria...

What was the background?

Halozyme applied for an SPC for each of two medicinal products it viewed as combinations of active ingredients. The products combined Trastuzumab with recombinant human hyaluronidase, and...

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