In a string of decisions issued 4 October 2017, the Patent and Market High Court has overruled decisions from the lower instances and found that under certain circumstances, a decision to grant a Supplementary Protection Certificate* (SPC) can be revised to correct an erroneously calculated duration of the SPC. Most importantly, a request for correction must be filed before the expiry of the basic patent.
The decisions came in a number of appeal cases all requesting that the grant decision by the Swedish Patent Office should be revised with regard to the duration of an SPC granted before the CJEU’s decision in the case Seattle Genetics (C-471/14). These SPCs all had a duration less than the maximal five years and was calculated based on the date of the decision to grant a marketing authorisation for the relevant medicinal product, rather than the date of the notification of the marketing authorisation. The marketing authorisation enters into force on the date of notification, which is typically a few days after the decision date. It was previously the practice of the Swedish Patent Office to calculate the duration of the SPC based on the decision date. In Seattle Genetics, the CJEU however found that the duration should be calculated based on the later notification date.
A number of SPC holders, represented by Hampus Rystedt and Michael Byström of Zacco, thus requested revision and correction of their SPCs granted under the old practice. This was consistently denied by the Patent Office, which found that it was not possible under Swedish law to revise a grant decision after the expiry of the two month appeal period. The Patent and Market Court agreed with the Patent Office.
One important aspect of the reasoning by the Patent Office and the first instance court was that third parties, e.g. producers of generic medicinal products, had a legitimate interest in being able to rely on a decided and published expiration date for an SPC, in order to prepare market introduction of generic products.
The Patent and Market High Court recognized this third party interest, but also found that the holder of the SPC has a legitimate right to the full term of the SPC, as it is established by the SPC regulations and the CJEU’s decision in Seattle Genetics.
The Patent and Market High Court strikes a balance between these competing interests and finds that an SPC granted with a duration calculated based on the decision date can be revised and have its duration corrected if the request for revision is filed before the expiry of the basic patent, i.e. before the SPC enters into force. After this date, the legitimate interests of third parties to know when an SPC is set to expire take precedence and revision should no longer be possible according to the Court.
The decision is subject to appeal by the Patent Office.
Zacco provides services in relation to SPCs in Sweden, Denmark, Norway, and Germany. Please contact Hampus Rystedt or Michael Byström if you have any SPC-related queries.
*A Supplementary Protection Certificate is a stand-alone right available for medicinal and plant protection products. It is based on a basic patent protecting the product and enters into force at the expiry of the basic patent. It can be kept in force for a maximum of five years.