To obtain a Supplementary Protection Certificate (SPC), enabling patent protection beyond 20 years from filing, for up to five additional years, a drug has to have received regulatory approval for marketing.
Yeda, the technology transfer arm of the Weizmann Institute in Rehovot, Israel, applied for such a Supplementary Protection Certificate in the UK for a combination of a novel monoclonal antibody with anti-neoplastic drugs.
However, the Intellectual Property Office (UK Patent Office) refused the request and the British High Court has upheld the decision that the patent was not entitled to a supplementary protection certificate (SPC) under the SPC Regulation (469/2009/EC) because the relevant marketing authorisation was for the monoclonal antibody alone.
However the court also rejected a second application for an SPC for the monoclonal antibody alone, because even though the two components could be separately administered, it was clear that the claimed invention was for the combination, so that the application for an SPC for the monoclonal antibody was also rejected as failing the current UK case-law governing the interpretation of the SPC Regulation in relation to combination drugs.
Case: Yeda Research and Development Company Ltd v Comptroller General of Patents [2010] EWHC 1733 (Pat), 12 July 2010.
