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.

Repercussions of Seattle additional duration: an article

It is no secret that our good friend Mike Snodin (Park Grove IP) has taken a keen interest in the Seattle Genetics reference to the Court of Justice of the European Union (Case C-471/14), so no readers of this weblog will be surprised that he has some further thoughts about this ruling which he is happy to share with us.  As Mike explains: 

I have a particular reason to welcome the judgement in Seattle Genetics.  This is because it validates an argument that I first proposed in an article published in Scrip Regulatory Affairs in October 2011 (discussed on the SPC Blog here), namely that the duration of SPC protection should (where relevant) be calculated upon the basis of the notification date of a "centralised" Marketing Authorisation -- and not the (earlier) date of the European Commission's decision to issue the MA.

 It is gratifying that the CJEU has validated another novel concept that I devised (the first being zero / negative term SPCs -– see this RAJ Pharma article from July 2007 and this SPC Blog post from 2011). However, it is disappointing to note that the CJEU's judgement in Seattle Genetics solely addresses the issue of SPC duration but does not comment upon the interpretation of other provisions of the SPC legislation that also rely upon the precise date ascribed to a MA.
With this in mind, I have published an article that, while noting the additional duration that should be awarded to certain SPCs (perhaps up to about 40% of all SPC applications for medicinal products), also discusses some potentially broader implications with respect to:-       the deadline for filing some SPCs;-       determining the date of certain national MAs; and-       determining the MA date for the purposes of Articles 3(b) and 3(d) (which are two of the four key provisions that determine entitlement to SPC protection).  Finally, the article mentions the battles that companies may face when trying to persuade certain national patent offices and courts to correct (by lengthening) the duration of SPCs already granted -- and points to a recent decision (discussed on the SPC Blog here) that may help to win those battles. My latest article may be viewed by clicking here. With two validated concepts under my belt, I am now keen to complete my hat-trick.  Indeed, there may already be an opportunity for this.  This is because another concept that I proposed (again relating to SPC duration, but this time based upon the Euratom treaty), although rejected by the UK IPO in the Genzyme case, would appear to be eminently arguable in the light of the CJEU’s decision in Merck Canada (C-555/13, see this Scrip Regulatory Affairs article from June 2014, as discussed on the SPC Blog here).  However, with only one additional day at stake for less than half of all SPCs in a handful of countries, I doubt that there will be sufficient commercial incentive for any applicant to vigorously pursue the relevant arguments.  Having said that, this is one occasion on which I would be delighted to be proved wrong!