Negative Term Supplementary Protection Certificates Granted by UK Intellectual Property Office

The UK Intellectual Property Office (UKIPO) decided that negative term supplementary protection certificates (SPCs) could be granted under EC Regulation 1768/92, which was a first precedent in the UK. This decision was made in the context of Merck's application for an SPC for sitagliptin phosphate monohydrate, which would have had a negative term of minus 3 months and 14 days according to the SPC Regulation's formula. Merck applied for the SPC to potentially extend it by 6 months under the Paediatric Regulation. The UKIPO initially refused the SPC due to its zero term, but upon appeal, the hearing officer found no harm in granting it, as it would not deceive third parties. The case was settled before going to court, and the practical significance of this decision is that companies may still find it worthwhile to apply for an SPC even with a negative term, in hopes of obtaining a paediatric extension.