Update from Finland - rectifying the term of an SPC

Kirsikka Etuaho, Jukka Taskinen and Janina Hakanpää of Espatent have sent us the following update on the rectification of an SPC term in Finland:

The Finnish Patent Office recently published two announcements, one in January and one in April 2018, regarding the relevant dates for the term of supplementary protection certificates. 

According to a judgement of the Court of Justice of the European Union given on 20 December 2017 in case C-492/16 (Incyte Corporation), the authority that has granted a SPC must rectify the term of valid SPCs at the request of the holder. The Finnish Patent Office has individually contacted by letter all SPC holders in position to make such a request. Since January, many of the requests have already been processed and requestors informed accordingly. 

The rectification possibility applies to SPCs granted on the grounds of both a centralized marketing authorization and a national marketing authorisation. The date of the relevant marketing authorisation is set to be the date on which notification was given of the marketing authorisation decision (case C-471/14 (Seattle Genetics)). 

In their announcements, the Finnish Patent Office further gave some practical advice to the requestors on the information and enclosures needed.

Many thanks!

Belgian Office for Intellectual Property issues practice note on the calculation of the duration of SPCs

The Belgian Office for Intellectual Property recently issued a circular letter (here in Dutch and here in French) providing details on the calculation of the duration of SPCs in view of the CJEU Seattle Genetics (C-471/14) and Incyte (C-492/16) decisions.  Stijn Lagaert of Gevers provides below an overview of the practice at the Belgian office.

Background
In 2015, the Court of Justice of the European Union (CJEU) issued a decision in C-471/14 (Seattle Genetics). As discussed in more detail here, it ruled that the date for calculating the SPC duration is the date of notification of the decision granting Marketing Authorization (MA), rather than the decision date itself. While Belgium previously already calculated the duration based on the notification date of EU marketing authorizations, it issued a 2016 circular letter to detail its practice. More recently, the CJEU provided more details about the correction of SPC durations that were granted based on the decision date (C-492/16 – Incyte). 

Circular letter of March 2018
The Belgian Office for Intellectual Property has recently issued a circular letter providing further details about the practice in Belgium in relation to the date of the MA. While the practice remains the same for an MA granted by the European Commission (i.e. the notification date published in the Official Journal), the circular letter is perhaps more interesting in relation to the notification date of a national MA. The Belgian Office states that it will consider the date of the decision to be the date of the MA if there is no official publication of the notification date. The applicant has the option to provide proof that it was only notified at a later date in order to use that notification date as the date of the MA. 

Fellow practitioners will appreciate that the circular letter links its practice for the ‘date of the MA’ to both Art. 7 and Art. 13 of the SPC Regulations. Thus, the Belgian Office will use the notification date both for the calculation of the SPC duration and for calculating the deadline for filing the SPC application.  

After Seattle Genetics, some SPC specialists cautioned that the CJEU decision only ruled in relation to the date used for determining the duration of the SPC (Art. 13), but did not necessarily read on the grant date of the MA for the calculation of the deadline for filing the SPC application (Art. 7). In addition, it did not provide guidelines for determining the notification date of national MAs, beyond referring to national law. These issues were e.g. raised by Mike Snodin and Michael Pears. The circular letter provides some welcome clarifications about both aspects, at least under Belgian practice. 

Advice
As the notification date of a national MA will likely be a few days after its decision date, we suggest saving and filing proof of the date of notification in these instances to enjoy the longer SPC duration in Belgium. The proof can be an official publication of the notification date or any other proof. This is of course only relevant in those cases were the national MA is the first to place the product on the European market.

Sweden, Incyte and the correction of the duration of SPCs

Many thanks to Hampus Rystedt (Zacco) for providing the following summary of interesting developments in Sweden on the correction of the duration of SPCs.

Correction of the duration of an SPC in view of the CJEU’s decision in Seattle (C-471/14) was dealt with in the CJEU’s decision in Incyte (C-492/16, here). The CJEU found that the term of an SPC is set by the rules of the Regulation 469/2009 and the factual circumstances of the application, and cannot be set by a national patent office. Also, if the national patent office has anyway decided on a different duration, such an erroneous decision can be corrected at any time before the expiry of the SPC term.
While the CJEU was preparing its decision in Incyte, the Swedish courts were also busy considering the question on whether it is possible to correct the duration of an SPC. Eight separate cases were considered, with slightly different factual circumstances.

Correction of decisions by Swedish government agencies (such as the Patent Office) may be corrected under certain circumstances. These circumstances are partly codified, but are also developed in case law. The first instance court (Patent and Market Court) found that SEPTO was competent to decide on the duration of an SPC and that a correction was not possible due to the need for legal certainty for third parties (i.e. generic pharma companies). The second instance court (Patent and Market Court of Appeal) also found that SEPTO was competent to decide on the duration of an SPC and also that there was no need to refer this question to the CJEU, or even stay the proceedings until the CJEU decided in Incyte. The PMCA then decided that an SPC can be corrected, but only if the request for correction was filed prior to the expiry of the basic patent.

The decision of the PMCA was appealed to the Supreme Court by the SEPTO in all eight cases and by one proprietor who had filed a request for correction only after the expiry of the basic patent. The appeals were filed on 23 October 2017. The CJEU then issued its decision in Incyte on 20 December 2017. On 19 February 2018, the Supreme Court decided to not hear the cases and the decision of the PMCA is thereby final.
There is thus prima facie a not insignificant conflict in Sweden between the decisions of the PMCA and the CJEU. While the CJEU of course is the top instance in these matters, it must be borne in mind that the PMCA did consider the question pending in Incyte and obviously found them not relevant to the situation in the pending cases, as it was decided to not stay the proceedings in view of Incyte.

New cases requesting correction, where the request was filed after the expiry of the basic patent but before the expiry of the SPC are now making their way through the system and it will be interesting to see if the Swedish office or courts will find a way to reconcile the decisions of the PMCA and the CJEU, or if the CJEU decision is considered to simply overrule the PMCA.

This will also be relevant for future cases dealing with other issues with SPCs in Sweden. The PMC and PMCA are developing a body of national case law on SPCs and have not yet referred any SPC case to the CJEU. It is no bold guess that this will create further small discrepancies between national Swedish and European case law that have to be handled in various decisions. One such issue is the interpretation of Article 3(d) in view of Neurim (C-130/11), where the PMC has refused to stay cases pending the outcome in Abraxis (C-442/17). The present matters will probably give some hints on how the Swedish courts will try to handle this.

Swedish Patent and Registration Office appeals to the Swedish Supreme Court on the correction of SPC terms

As previously reported on this blog (here), the Swedish Patent and Market Court of Appeal (PMCA) found that SPCs granted pre-Seattle could be corrected to have the duration calculated based on the notification date rather than the decision date, if applicable. The PMCA found that the Regulation 469/2009 itself did not provide for any legal remedies to correct the term (i.e. Article 17.2 of 1610/96 is not applicable), but that correction could be made under general principles of Swedish national administrative law.

This decision has now been appealed to the Supreme Court by the Swedish Patent and Registration Office. The questions discussed in the appeal relate only to Swedish administrative law and not to the Regulation or other EU law.

The Supreme Court must grant leave to appeal in order to hear the case on the merits. If they do, it will be most interesting to see how they deal with the pending referral in C-492/16 (Incyte).

Many thanks to Hampus Rystedt at Zacco for providing these new developments.