Check Your Dates! – Your SPC Could Be Extended…
DECISION C 492/96 (Incyte)
The Courts of Justice of the European Union (CJEU) previously decided in decision C 471/14 (Seattle Genetics) that the date of notification of first marketing authorisation (MA) to an applicant and not the date of the decision itself sets the duration of a supplementary protection certificate (SPC). Accordingly, the term of some SPCs is incorrect. However, the CJEU found in decision C 492/96 (Incyte) that the SPC holder can apply for correction of the SPC term as long as the SPC has not expired.
Extending the patent term for such high value patented products can be particularly significant for rights holders even when the additional term is mere days.
A supplementary protection certificate is intended to partially compensate a patent holder for the patent term that is 'lost' while awaiting regulatory approval for sale of the patented product. The length of an SPC in Europe is capped at five years. Shorter SPCs are possible and are calculated as being the period elapsed between the filing of the patent application and grant of the first EU marketing authorisation for an eligible product protected by that patent, less five years.
The calculation of the term of an SPC is based on the date of the first EU marketing authorisation. As mere days matter when calculating the duration of an SPC, the question arose as to whether the date of the first marketing authorisation was: (1) the date that the decision to issue the first marketing authorisation was reached; or (2) the date the act the decision was communicated to the applicant. In C 471/14 (Seattle Genetics) the CJEU ruled in favour of option (2).
However, SPC have been granted in member states of the European Union before the Seattle Genetics decision, i.e. based on (incorrect) option (1). Thus the question arose as to whether it was possible to retrospectively correct, i.e. extend, the term of an already granted SPC.
In particular this question arose in Hungary in relation to the pharmaceutical product 'Jakavi', used in the treatment of myelofibrosis. The first marketing authorisation was granted on 23 August 2012 and communicated to the applicant on 27 August 2012. Following the Seattle genetics decision, Incyte requested a revision of the administrative decision granting the SPC such that the SPC would expire on 28 August 2027 rather than 24 August 2027.
However, the Hungarian Intellectual Property Office declined to revise the SPC as the requested change was not due to a clerical mistake or miscalculation and, furthermore, the deadline for appealing such an administrative decision had already expired. Incyte appealed to the Budapest High Court, which decided to stay the proceedings and refer the following questions to the CJEU:
"(1) Must Article 17(2) of Regulation … No 1610/96 … be interpreted as meaning that "the date of the first [MA] in the [European Union]" is incorrect in an application for a[n] [SPC], within the meaning of that regulation and of Regulation … No 469/2009, where that date was determined without taking account of the Court of Justice's interpretation of the law in the judgment of 6 October 2015, Seattle Genetics (C‑471/14, EU:C:2015:659), with the result that it is appropriate to rectify the date of expiry of the [SPC] even if the decision to grant that certificate was made prior to that judgment and the time limit for appealing against that decision has already expired?
(2) Is the industrial property authority of a Member State which is entitled to grant a[n] [SPC] required to rectify, of its own motion, the date of expiry of that [SPC] in order to ensure that that certificate complies with the interpretation of the law set out in the judgment of 6 October 2015, Seattle Genetics (C‑471/14, EU:C:2015:659)?"
In answer to the first question the court stated that:
"As regards its scheme, it is clear from Article 13(1) of Regulation No 469/2009 that the certificate is to take effect for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first MA in the European Union, reduced by a period of five years. It therefore follows from that provision that the duration during which the SPC granted 'shall take effect' is wholly determined by the application of the detailed criteria laid down by that provision and the authority responsible for granting the SPC enjoys no degree of discretion in that regard ."
C 492/16, paragraph 53 (our emphasis)
"In the light of the foregoing, the answer to the second question is that Article 18 of Regulation No 469/2009, read in the light of recital 17 and of Article 17(2) of Regulation No 1610/96, must be interpreted as meaning that, in a situation such as that set out in paragraph 44 above, the holder of an SPC may, under Article 18 of Regulation No 469/2009, bring an appeal for rectification of the duration stated in the SPC, provided that the SPC has not expired ."
C 492/16, paragraph 60 (our emphasis)
As Incyte initiated proceedings rectification of the term of the SPC, the CJEU declined to answer the second question as to whether an SPC granting authority should automatically reopen and review the administrative proceedings concerning the terms of the SPCs it has granted with a view to rectifying SPC term.
In the Seattle Genetics decision the court stated that the date given in the application should have been the notification date for first marketing authorisation and any different data is incorrect. In the case of Incyte the court relied on the ex tunc effect of the Seattle genetics decision. In reaching the present decision the CJEU has extended the scope of 'incorrect' in the sense of Article 17(2) beyond correcting clerical and formal errors.
However, the onus is on the rights holder to apply for correction of the SPC term - national SPC granting authorities do not have to investigate and correct eligible SPC of their own motion. Accordingly, we recommend that holders of unexpired SPCs verify the date of notification of their first marketing authorisation and whether there has been any miscalculation of SPC term.