Summary
The decision in Newron provides a useful review of the SPC Regulation Article 3 and the debate over the meaning of ‘product’ in pharmaceutical marketing authorisations. The UK Patents Court has restricted the use of supplementary protection certificates (‘SPCs’) for combination products in Newron v Comptroller-General of Patents,[1] where the SPC-applicant challenged the Comptroller-General’s refusal to grant an SPC for a patent related to Parkinson’s Disease treatment, arguing that the marketing authorisation for the medicinal product XADAGO should be considered as an authorisation for the combination of three active ingredients. The Respondent maintained that the marketing authorisation was for the active ingredient safinamide alone, not the combination. The judge dismissed the appeal, upholding the Hearing Officer’s decision that the marketing authorisation was for safinamide alone and not for the combination. Read more