Jurisdiction(s):
United Kingdom

Merck Serono v Comptroller: High Court (England and Wales) confirms ex tunc effect of CJEU judgments; Santen supersedes Neurim for SPC Article 3(d); legitimate expectation no defence

Published on: 11 January 2024

Published by a LexisNexis Life Sciences expert

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Article summary

Merck Serono SA v The Comptroller-General of Patents, Designs and Trade Marks [2023] EWHC 3240 (Ch)

What are the practical implications of this case?

The judgment affirms the settled principle from Court of Justice Case C-61/79, Denkavit Italiana: the default position is that Court of Justice judgments take effect ex tunc, and only in rare, exceptional situations will a deviation from that rule be warranted. The Court further indicated that it will generally be insufficient for a party to contend that its conduct, or the steps it adopted, rested on a legitimate expectation that a particular course would be followed (here, the grant of Merck’s SPC application) under the law as it then stood.

In practical terms, parties—most notably originator pharmaceutical companies—should recognise that CJEU rulings issued after an SPC filing can still influence whether the SPC is ultimately granted, even where the application was lodged in line with the applicant’s understanding of earlier authorities and prevailing case law. Accordingly, reliance on the law at the filing date will not shield an application from the effects of later jurisprudence...

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