The Supreme Court has referred Merck Sharp & Dohme Limited’s dispute with Clonmel Healthcare Limited over a patent extension for the cholesterol medicine Inegy to the Court of Justice of the European Union (CJEU). The court said the interpretation of EU rules on supplementary protection certificates (SPCs) was not clear enough to decide the appeal without guidance.
The case concerns an SPC granted in Ireland in 2005 for Inegy, a combination of ezetimibe and simvastatin. Merck also holds an earlier SPC, granted in 2003, for Ezetrol, which contains ezetimibe alone. Clonmel challenged the later certificate after launching a competing product, arguing that it was invalid under the EU regulation governing SPCs.
The High Court ruled in 2019 that the Inegy certificate was invalid, and the Court of Appeal upheld that decision in 2021. Merck appealed to the Supreme Court. The lower courts concluded that the combination was not covered by the relevant EU rule and that the earlier certificate for ezetimibe also created a problem under a separate provision. Merck disputed those interpretations.
The Supreme Court described the central disagreement as whether a product’s express identification in patent claims is enough for an SPC, or whether a court must also consider whether the product falls within a narrower understanding of the invention covered by the patent. The patent specifically claimed ezetimibe in combination with simvastatin. The court said the answer could affect whether the combination certificate satisfies the regulation’s requirements and how the earlier Ezetrol certificate bears on the later one.
The Supreme Court sent four questions to the CJEU. They ask what must be shown under the regulation when a product is expressly identified in patent claims; whether certificates can cover combinations named in those claims as well as a single drug; and how the rule against a product having already been the subject of a certificate applies when a single drug and a combination are involved.
The referral is a request for an interpretation of EU law. The Supreme Court did not determine the validity of the Inegy certificate or resolve the appeal in this judgment. The source describes the attached questions as a draft reference for circulation to the parties and possible amendment; the final form was to appear with the judgment’s approval.