25/11/2013
The UKIPO has changed the way it calculates the expiry date of supplementary protection certificates (SPCs) that are based on a European marketing authorisation. This change may, in some cases, lead to a modest increase in the SPC term, which could be highly significant for both innovative and generic pharmaceutical companies.
Background
A supplementary protection certificate (SPC) extends the duration of protection for a patented active ingredient or combination of active ingredients, which are present in a medicinal or plant protection product, after the patent has expired.
An SPC takes effect at the end of the term of the basic patent, and the duration of the SPC is calculated pursuant to Article 13 of the Regulation EC 469/2009. Article 13 defines the duration of the SPC as being equal to the period that has elapsed between the date on which the application for the basic patent was lodged and the date of the first authorisation to place the product on the market in the community, reduced by 5 years.
Article 13 also specifies that the duration of the SPC must not exceed 5 years, unless a 6 month extension has been granted. An extension can be obtained if the marketing authorisation includes a statement of compliance with an agreed paediatric investigation plan and that the medicinal product is authorized in all Member States, as set out in Article 36 of Regulation No 1901/2006.
What Has Changed?
Decision BLO/4018/13 concerns the calculation of the SPC term for SPCs based on a European marketing authorisation, which has been granted for a medicinal product in accordance with the centralised authorisation procedure. The grant of a European marketing authorisation has two associated dates: the date of the European commission’s decision to grant; and the date that the applicant is notified of the decision to grant. It was the practice of the UKIPO and indeed other national patent offices to use the date of the decision to grant a European marketing authorisation to calculate the SPC term.
In decision BLO/418/13, the hearing officer concluded that the term of an SPC should be calculated from the date of notification of grant of the European marketing authorisation. This means that in certain situations an SPC may now have a slightly longer term. The difference between the date of the decision to grant and the date of notification is often between 1 to 4 days and sometimes longer, so for particularly valuable medicinal products, this decision may have a significant impact.
This change is highly relevant to both innovative pharmaceutical companies wishing to obtain the maximum duration of protection for their product, as well as generic companies seeking to enter the market after SPC protection has expired.
It must be noted that the above decision only relates to SPCs based on European marketing authorisations and does not affect the practice in relation to SPCs based on UK national marketing authorisations granted by the Medicines and Healthcare Products Regulations Agency. Furthermore, the SPC term still cannot exceed five years or five and a half years in the case where a paediatric extension has been granted.
The UKIPO has now released a practice note (found here) confirming that they will change how SPC terms are calculated in light of BLO/418/13. Furthermore, the UKIPO confirms that it is possible to apply for rectification of the SPC term for pending SPC applications and granted SPCs.
If you would like advice on any aspect of SPC protection, or you are aware that the above decision may affect your granted or pending SPCs, please contact a patent attorney in our Biotechnology, Chemistry and Pharmaceuticals team.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.
