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.

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.

Swedish Appeal Court opens towards re-examination of Swedish SPC terms

Many thanks to Louise Jonshammar (Awapatent) for providing the following summary of recent decisions of the Swedish Patent and Market Appeal Court on SPC terms following the CJEU's Seattle Genetics case:

"On 4 October, 2017, the Swedish Patent and Market Appeal Court handed down eight decisions in appeal cases regarding re-examination of SPC term decisions. 

The background relates to the famous Seattle Genetics case (C-471/14) in which the CJEU gave a preliminary ruling on the interpretation of Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products. In the judgement, the CJEU held that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of Article 13(1) is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision. As many patent offices around the EU, if not most, calculated the SPC term on the date of grant of the marketing authorisation, the judgement started an avalanche of requests for changes to the already issued SPCs. The different EU countries have handled these requests differently, as re-examination is not provided for in the regulation. 

The Swedish Patent and Registration Office refused to change the term of already issued SPCs unless there was still time within the two months’ appeal limit to appeal the grant decisions – in which case the patentee was urged to file such appeal. The reason for refusal was mainly that new practice is not a basis for re-examination under the Swedish Administrative Law. 

The Patent and Market Court agreed with the patent office and did not change the decisions. Further, the court said that decisions to grant SPC effect not only the applicant but also an unknown number of other actors on the market, having contradictory interests. Therefore, decisions on grant of SPCs shall be considered similar to civil actions, despite the fact that third parties are not parties to these decisions. 

The Patent and Market Appeal Court decisions are long and include a lot of very useful reasoning for understanding the decision. The grand finale of the decisions is a reasoning on the balance of interest between the patentee and third parties. The Patent and Market Appeal Court finds that where the patent protection has ceased and the SPC has come into effect, companies marketing generic drugs may have customised their efforts on the market to fit the decision and prepared according to the final date of the SPC in the decision. If the SPC term has begun, the interest of foreseeability speaks against a change of the SPC term in such cases. Before the beginning of the SPC term, however, the patentees’ interest in a longer term shall prevail. Therefore, as a general rule, decisions on SPC term shall be changed in accordance with the principles set out in the Seattle Genetics judgement, provided that a request for changes has been filed before the beginning of the SPC term. 

The decisions then differ depending on when the patentee filed its request - in some cases the term is extended and the patent office is asked to put that decision into practice, in other cases the request for change of the term is denied because the SPC term has already begun. 

Also, as a point of interest, one may note that the Patent and Market Appeal Court disagrees with the Patent and Market Court with respect to SPC applications being considered similar to civil actions. The fact that a re-examination may have economic consequences for third parties is not a special circumstance which motivates a deviation from the general rule of administrative law. The third party interest shall therefore be considered within the re-examination, which is then what the Patent and Market Appeal Court does in its balancing of interests, as described above. 

Another interesting note is that the Patent and Market Appeal Court has allowed for the decisions to be appealed to the Supreme Court."

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!

Seattle Genetics and an alternative question -- but will the CJEU answer it?

The SPC Blog has received further news from our friend Mike Snodin (Park Grove IP) that he has published another article in Scrip Regulatory Affairs. This latest article, entitled “Supplementary Protection Certificates: the Court of Justice of the EU will have its day after all” (a copy of which can be obtained here), relates to the questions referred to the Court of Justice of the European Union (CJEU) in Case C-471/14 Seattle Genetics [on which see earlier SPC Blogpost here].

As regular readers of this blog will know, the questions referred by the Oberlandesgericht Wien in Seattle Genetics relate to the issue of whether longer term should be awarded to certain SPCs by relying upon the date of notification of a “centralised” Marketing Authorisation instead of the (earlier) date of the European Commission’s decision to issue the Authorisation.

Mike’s article discusses and analyses the questions referred to the CJEU and highlights potential problems with regard to the framing of those questions. In an attempt to clear away any confusion that could be caused by the manner in which the questions referred have been framed, Mike presents an alternative question that is more precisely adapted to the facts underlying Seattle Genetics. He concludes by expressing the hope that the CJEU decides to answer such an alternative question, and by outlining reasons why, in his view, that alternative question should be answered in favour of using the date of notification for “centralised” MAs.