On 20 December 2017, the Court of Justice of the European Union (CJEU) confirmed that the term of a supplementary protection certificate (SPC) can be corrected to bring it into line with CJEU case law at any time before expiry of the SPC.
Following on from the decision in Seattle Genetics (C 471/14) in 2015, which provided welcome clarity on which date should be used as the date of the first marketing authorisation (MA) for the purposes of calculating the duration of an SPC, this week's decision should drive consistency in the application of Seattle Genetics by national patent offices across the EU. In Incyte (C 492/16), the CJEU has ruled that an SPC holder can apply to rectify the duration of an SPC to bring it into line with Seattle Genetics at any time before expiry of the SPC, even if the period for appealing the decision under national legislation has passed.
This case arose out of a set of circumstances which will not be unusual in the aftermath of the Seattle Genetics decision. Incyte was granted an MA for its myelofibrosis product Jakavi in August 2012, and applied for an SPC in (among other countries) Hungary in January 2013. In its SPC application, in line with prevailing practice at the time, Incyte provided the date of the decision granting the MA—23 August 2012. The SPC was granted by the Hungarian patent office in October 2014 with an expiry date of 24 August 2027.
In October 2015, the CJEU ruled in Seattle Genetics (C 471/14) that the duration of an SPC should be calculated by reference to the date on which the MA holder was notified of grant, usually a few days after the formal decision. In this case, Incyte were notified on 27 August 2012, meaning that when calculated using the new correct date, the expiry date of Incyte's SPC would also move four days later, to 28 August 2027.
Some national patent offices—for example, the UKIPO—permitted Incyte to amend the date of the Jakavi MA, and therefore the expiry date of its SPC, in light of the Seattle Genetics decision. However, the Hungarian patent office refused, on the basis that its decision did not contain any "miscalculations or clerical errors": Incyte's SPC application in 2012 listed the earlier MA date, and the Hungarian patent office had used this date to calculate the SPC term. The Hungarian court referred the case to the CJEU, which has ruled that:
- the 2015 decision in Seattle Genetics had retrospective effect, which meant that the date of the first MA for Jakavi given in Incyte's 2012 SPC application was incorrect; and
- where the date of the first MA (and therefore the duration of the SPC) is incorrect, the SPC holder is entitled to bring an appeal for rectification directly with the authority that granted the certificate, at any time before the SPC expires.
The CJEU's decision was expressly driven by the twin objectives of providing sufficient compensation for the delay in bringing pharmaceutical products to market, and preventing the development of conflicting national practice across the EU. The CJEU took a pragmatic view of the effect of its decision, holding that reopening the Hungarian patent office's decision in order to rectify the term of an SPC by a few days did not affect legal certainty.
This view conflicts with decisions of the Swedish patent court earlier this year, which held that the term of an SPC should not be capable of correction once the SPC has come into effect because of the interest of generic companies in having a predictable date for market entry, which demonstrates the need for today's ruling to assist consistency in patent office practice across Europe.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.