Kluwer Patent Blog Article: „Cladribine SPC – a Potential Dilemma for the English Court of Appeal?“ (Feb. 12, 2024) – The blog article discusses the potential for the English court to deviate from the jurisprudence of the Court of Justice of the European Union (Court of Justice of the European Union), particularly regarding the interpretation of the Supplementary Protection Certificate (SPC) Regulation.It refers to a case where the UK Intellectual Property Office (UKIPO) rejected an application by Merck for an SPC for the drug Cladribine because Merck could not demonstrate the first market authorization (MA) for the drug, as required by Article 3(d) of the SPC Regulation.
Merck appealed to the High Court, which rejected Merck’s arguments. Merck has now been granted permission to appeal to the Court of Appeal, which has the authority to depart from CJEU jurisprudence. The outcome of this case is anticipated and could impact the possibility of SPCs for second medical uses of drugs.
Maiwald acts as legal advisors to Merck. This text is a blog article from the Kluwer Patent Blog of Wolters Kluwer. The full text version of the article can be found here: Cladribine SPC – a Potential Dilemma for the English Court of Appeal? – Kluwer Patent Blog (kluweriplaw.com)