Merck properly denied extra period of exclusivity for cladribine, UK panel says
( January 28, 2025, 21:38 GMT | Official Statement) -- MLex Summary: The UK Court of Appeal turned down calls by Merck Serono to undo their endorsement last year in Newron Pharmaceuticals v. Comptroller of the European Court of Justice 2020 holding in Santen SAS v. Directeur that supplemental protection certificates, or SPCs, based on marketing authorizations, or MAs, for a new use of a previously authorized product are unavailable. Their ruling puts to an end efforts by Merck to secure an SPC for cladribine, the active ingredient in the blockbuster multiple sclerosis drug Mavenclad. Judge Colin Birss said his court cannot depart from retained EU case law under the 2018 Withdrawal Act but that even if it could, he would reject Merck’s claim that a return to Neurim Pharmaceuticals v. Comptroller — which Santen overruled — is warranted. Two earlier marketing authorizations for leukemia treatments, one for “Leustat” in 1995 and one for “Letak” in 2004, also recited the use of cladribine, dooming the extra five years of exclusivity SPC protection for Merck’s new therapeutic use of the ingredient. Mavenclad was touted by Merck as experiencing double digit growth and earnings in excess of $1 billion in 2023.See attached document....
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