Summary
This SPC application concernsgolimumab, the active ingredient in the medicinal product, Simponi (RTM), used in the treatment of ulcerative colitis (UC). Commission implementing decision C(2013)6224, dated 19 September 2013, approved the use of golimumab in the treatment of UC, as a Type II variation to the centrally granted EU marketing authorisation (MA, EU/1/09/456) granted by Commission implementing decision C(2009)7653. The examiner-˜s view was that the application for an SPC based on this type II variation fails to meet the requirements of Article 3(c) and 3(d) of the SPC Regulation.
The applicant considers that, in accordance with the purpose of the SPC Regulation and the judgment of the Court of Justice of the European Union (CJEU) inNeurim (C-130/11), this Type II variation is the first relevant MA to place the medicinal product (Simponi) on the market in the UK for the treatment of UC. As a result, this is the first relevant MA relating to the product and so meets the requirement of Article 3(d) of the SPC Regulation. In addition, as no SPC has been granted for the product golimumab for use in treating UC, the requirements of Article 3(c) are also met.
Having considered the relevant law and caselaw, in particular, the impact of the EU Withdrawal Act on the decision of the CJEU inSanten, C-673/18, the HO found that the applicant-™s arguments based onNeurim, C-130/11 were not persuasive.Santenhad, in effect, overturned the CJEU-™s previous judgment inNeurim, and was binding on the IPO. Taking account ofSantenand the Explanatory Memorandum to the SPC Regulation, the hearing officer (HO) found that this Type II variation could not be considered to be the first marketing authorisation to place golimumab on the market, and therefore did not meet the requirement of Article 3(d). The HO also found that, as the applicant had already gained an SPC for the product golimumab, albeit for use to treat other conditions, then this SPC application also did not meet the requirement of Article 3(c) of the SPC Regulation.
The application was refused under Article 10(2) of the SPC Regulation
Full decisionO/242/22 525Kb