A recent UKIPO decision will extend the term of SPCs by a few days. The decision concerned Genzyme Corporation's product colesevelam hydrochloride, which was the subject of an SPC. Genzyme disputed the term of the SPC on two grounds.
First, Genzyme argued that the term of the SPC should be calculated using the date of notification of the relevant marketing authorisation, rather than the date of the decision itself. The term of an SPC is calculated as the duration between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years. However, every marketing authorisation has two dates, namely the date of the decision and the date of notification (which can be up to four days later).
The UKIPO decided that it is indeed the date of notification and not the date of the decision that should be used to calculate the term of an SPC, mainly based on the wording in the TFEU that specifies that decisions (including the decision of the authorisation) take effect upon notification. Further, the applicant is not aware of the grant until the date of notification and a copy of the granted marketing authorisation is required to apply for an SPC. The earliest date an applicant can apply for an SPC is therefore the date of notification.
Secondly, Genzyme argued that the "Euratom Regulation" should be applied to the term of an SPC. This regulation determines the rules applicable to periods, dates and time limits and states that, where a period of time is calculated from the occurrence of an event, the day on which the event falls should not be part of the period itself. This would extend the term of an SPC by an additional day. However, it was held that this is not relevant as the period at issue is a period which can only be calculated after a specific event occurs, rather than a period expressed as so many hours, days, weeks, months and/or years after the occurrence of an event. In other words, the period at issue is a period between two specific events and so the regulation does not apply.
The duration of an SPC should therefore be calculated using the date of notification of the marketing authorisation, rather than the date of the decision itself. This can increase the term of the SPC by up to four days, which can be important for commercially valuable products. However, the calculation of the term should remain the same, as the Euratom Regulation does not apply.
This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK. Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.