Key Facts
- •Merck applied for a Supplementary Protection Certificate (SPC) for cladribine, relying on EP 1827461 B1 and MA EU/1/17/1212 for MAVENCLAD.
- •Prior marketing authorisations (MAs) existed for cladribine in LEUSTAT and LITAK for treating hairy cell leukaemia.
- •The UKIPO Hearing Officer rejected Merck's application, citing Article 3(d) of Regulation (EC) 469/2009 as interpreted by the CJEU in Santen.
- •Merck appealed, arguing that Santen should apply ex nunc, not ex tunc, due to legitimate expectations based on the earlier Neurim judgment and industry practice.
- •Merck also argued that the facts of its case could be distinguished from Santen because it involved a completely new therapeutic use.
Legal Principles
Interpretation of Article 3(d) of Regulation (EC) 469/2009 regarding the 'first authorisation' for placing a product on the market as a medicinal product.
Regulation (EC) 469/2009, CJEU case law (Pharmacia Italia, Massachusetts Institute of Technology, Yissum, Neurim, Abraxis, Santen)
Temporal effect of CJEU judgments (ex nunc vs. ex tunc), considering legitimate expectations and legal certainty.
CJEU case law (Defrenne, Denkavit Italiana, Dansk Industrie, Elmeka)
Standard of review for appeals from the UKIPO: the decision is 'wrong' if there is an error of law.
Axogen Corp v Aviv Scientific Ltd [2022] EWHC 95
Outcomes
Merck's appeal was dismissed.
The Court held that the CJEU's judgment in Santen applies ex tunc, meaning retrospectively. Merck's legitimate expectations based on the Neurim judgment were not sufficient to override the ex tunc effect of Santen. The Court found no basis to distinguish Merck's case from Santen on its facts.