The High Court held that a 2005 supplementary protection certificate (SPC) for a combination of ezetimibe and simvastatin was invalid because the combination was not an invention covered by the underlying patent. The court said the certificate must be revoked. It rejected the defendant’s separate challenge under Article 3(d) of the SPC Regulation, finding that an earlier authorisation for ezetimibe did not authorise the combination as a product.
Merck Sharp & Dohme Corp brought proceedings against Clonmel Healthcare Limited alleging infringement of its rights under the certificate. Clonmel counterclaimed that the certificate was invalid under Articles 3(a), 3(c) and 3(d) of the Regulation. The judgment, delivered by Mr Justice Denis McDonald on 29 November 2019, addressed the counterclaim. The judge said he would hear counsel on the form of the order and on costs or other issues.
The certificate covered ezetimibe, or a pharmaceutically acceptable salt of it, in combination with a cholesterol-biosynthesis inhibitor such as simvastatin. The underlying Irish patent covered azetidinone compounds including ezetimibe and expressly referred to combinations with inhibitors, including simvastatin. Applying the Court of Justice’s test in Teva v Gilead, the judge concluded that a claim to a combination did not, by itself, establish that the combination fell within the invention covered by the patent.
The judge found that the patent gave detailed information and testing results for its Formula 1 compounds, but little detail about combinations and no experimental data showing that a combination was useful. He considered the patent in light of knowledge at its 1993 priority date, when combination treatment for cholesterol was already known. He concluded that the patent’s invention related to the Formula 1 compounds, not the ezetimibe–simvastatin combination. On that basis, he held that the combination was not protected by the patent for Article 3(a), and that Clonmel was entitled to a declaration that the certificate was invalid and must be revoked.
The judge also considered the other grounds. He said Article 3(c) would apply to ezetimibe alone because it had already been the subject of an SPC granted in 2003, but found it unnecessary to make an order on Clonmel’s pleaded Article 3(c) counterclaim. Clonmel’s alternative argument that the 2003 SPC had already covered the combination failed. The judge rejected the Article 3(d) argument too: the Ezetrol authorisation required ezetimibe to be used with a statin for a specified patient group, but authorised ezetimibe itself, not a product combining it with simvastatin. The judge also noted that the alternative Article 3(c) argument about the combination had not been pleaded.