The Forsgren reference: now in English too!

Having first brought you news of the Austrian reference to the Court of Justice of the European Union of some further questions in Case C-631/13 Forsgren, we were delighted to be able to furnish you this morning with the original German-language text of the reference, here. Now, thanks to Alastair Sayce (GSK) and John Miles (Potter Clarkson) comes an English translation, which you can read here or download here.

The SPC Blog thanks Alastair, John and indeed all the kind folk who send us materials which we can make available to a wider community.

Case C-631/13 Forsgren: text of reference now available

Last Tuesday The SPC Blog posted this item, entitled "Austrian Forsgren reference heads for CJEU", on the latest set of questions on which national courts seek guidance from the Court of Justice of the European Union on some of the persistent mysteries that surround the supposedly simple regime for supplementary protection certificates for pharma patents.

The Blog has just received from our reader Arno Markgraf, via the kindness of the Obersten Patent- und Markensenates (the Austrian Patent Office), a copy of the decision in which the questions were referred to the CJEU and which we can bring to you now, in the original German.

You can access the decision here or download it here

Austrian Forsgren reference heads for CJEU

The following has been received from our reader Alexander Robinson (Dehns): 

In the ongoing saga of referrals to the CJEU on matters SPC-related, the UKIPO has just (last Friday) sent out a notification regarding yet another set of questions which have been referred as Case C-631/13 "FORSGREN" [I'm surprised not have received the notification myself and hope I've not been struck off the IPO mailing list for conduct unbecoming ...].  The deadline for submitting comments at the UKIPO is 24 January 2014. 

At issue appears to be the question of whether an SPC is available for a substance which is protected by a basic patent but which is not per se the authorised medicinal product, instead being covalently bound to other actives. 

According to the IPO website the case concerns:

"A request for a preliminary ruling concerning an application for a patent protection certificate [surely they mean Supplementary Protection Certificate...] with respect to a substance (Protein D) which is present in an authorised medicinal product.

Protein D is covalently bound to some pneumococcal polysaccharides in medicinal product Synflorix, which is authorized as a pneumococcal vaccine. Protein D is acting as a carrier in Synflorix but is an active ingredient in vaccines against Haemophilus influenza bacteria. The question arises whether an SPC for protein D may be granted based on the authorisation for Synflorix which does not specify the therapeutic effect of protein D but refers to it as a carrier protein."

Protein D is covalently bound to some pneumococcal polysaccharides in medicinal product Synflorix, which is authorized as a pneumococcal vaccine. Protein D is acting as a carrier in Synflorix but is an active ingredient in vaccines against Haemophilus influenza bacteria. The question arises whether an SPC for protein D may be granted based on the authorisation for Synflorix which does not specify the therapeutic effect of protein D but refers to it as a carrier protein."

The questions referred are as follows:

1. Under Article 1(b) and Article 3(a) and (b) 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 product, provided that the other conditions are met, may a protection certificate be granted for an active ingredient protected by a basic patent (in this case, Protein D) where that active ingredient is contained in the medicinal product (in this case, Synflorix) as part of a covalent (molecular) bond with other active ingredients but none the less retains its own effect? 

2. If Question 1 is answered in the affirmative: 

2.1. Under Article 3(a) and (b) of Regulation (EC) No 469/2009, may a protection certificate be granted for the substance protected by the basic patent (in this case, Protein D) where that substance has a therapeutic effect of its own (in this case, as a vaccine against Haemophilus influenzae bacteria) but the authorisation of the medicinal product does not relate to that effect? 

2.2. Under Article 3(a) and (b) of Regulation (EC) No 469/2009, may a protection certificate be granted for the substance protected by the basic patent (in this case, Protein D) where the authorisation describes that substance as a 'carrier' for the actual active ingredients (in this case, Pneumococcal polysaccharides), the carrier, as an adjuvant, enhances the effect of those substances, but that effect is not expressly mentioned in the authorisation of the medicinal product?

Thanks so much, Alexander, for letting us know. The referring court, incidentally, is the Oberster Patent- und Markensenat - Austria.
Pneumococcal Polysaccharides here