A mystery reference from Portugal: can anyone help?

Our friend and long-time reader and contributor John Miles (Potter Clarkson) has written to ask whether any readers of The SPC Blog might be able to shed any light on another reference to the Court of Justice of the European Union for a preliminary ruling, Case C-555/13.  As John mentions,

The question has now been published but no background to it. It is a reference from the Tribunal Arbitral (Portugal).  I am updating the European Patents Handbook chapter on SPCs and would like to be able to include some more details of it.

The information about this case, as it appears on Curia, looks like this:

Request for a preliminary ruling from the Tribunal Arbitral (Portugal) lodged on 28 October 2013 – Merck Canada Inc. v Accord Healthcare Limited and Others 

(Case C-555/13) 

Language of the case: Portuguese 

Referring court 

Tribunal Arbitral 

Parties to the main proceedings 

Applicant: Merck Canada Inc. 

Defendants: Accord Healthcare Limited, Alter SA, Labochem Ltd, Synthon BV, Ranbaxy Portugal – Comércio e Desenvolvimento de Produtos Farmacêuticos, Unipessoal Lda 

Question referred 

May Article 13 of Regulation No 469/2009 ¹ be interpreted as permitting, by means of a supplementary protection certificate for medicinal products, the period for exclusive exploitation of the patented invention to be more than fifteen years from the date of the first authorisation to place the medicinal product in question on the market within the Community (not including the extension provided for in Article 13(3) of that regulation)?

____________

¹ 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 (Codified version) (OJ 2009 L 152, p. 1).

If anyone can help, that would be great!

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

Israel's Amendment No. 11 now imminent

From Liad Whatstein (Shlomo Cohen & Co) comes news of Amendment No. 11 of the Israeli Patents Act which, Liad tells us, is expected to be enacted shortly --as soon as next week, unless there is an unexpected delay.  The Amendment introduces several important revisions in the Israeli Patent Term Extension (PTE) system. Here's the firm's overview, from which the following is extracted for your interest:

The unique Israeli PTE system is based on “external” linkages to PTEs or SPCs granted in 21 “Recognized Countries” (US, EU-15 (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom), Australia, Iceland, Japan, Norway, and Switzerland). 

Eligibility to PTE and the calculation of the PTE period is based on multiple linkages: 

* The extension will be equal to the shortest extension granted to a Reference Patent in any of the Recognized Countries; 

* The PTE will expire no later than the first expiry date of a PTE of a Reference Patent in any of the Recognized Countries; 

* The extension must end no later than 14 years from the earliest date in which a regulatory approval was obtained in any of the Recognized Countries. 

* PTE in Israel will only be available if PTE/SPC was granted in the US and in at least one EU-15 country;

The result of these multiple linkages is that in most cases the de-facto extension period does not exceed two to three years. 

Amendment No. 11 of the Patents Act is the result of a bilateral agreement between Israel and the US. It has recently been approved by the Knesset (Israeli Parliament) Judiciary Committee and will be enacted shortly. 

Amendment No. 11 reduces the number of Recognized Countries to include only the US and the top five European markets (UK, France, Germany, Spain and Italy). It remains to be seen whether this reduction in the number of Recognized Countries will meaningfully extend in average Israeli PTEs.

Unfortunately, Amendment No. 11 also includes several provisions which further curtail the scope of PTE protection under Israeli law:

* An Israeli PTE will automatically expire when a Reference Patent is revoked or a PTE/SPC of a Reference Patent is revoked or withdrawn in any of the Recognized Countries; 

* If the basic term of the patent is about to expire and US/EU PTEs/SPCs have not yet been granted (i.e. no eligibility for PTE under the linkage mechanism), interim PTE orders will no longer be available; 

* Extensions of the deadline for filing the PTE petition (90 days after the date of regulatory approval in Israel) will not be granted; 

* Only one extension will be allowed during prosecution of the PTE petition; 

* A PTE petition must now be filed within 90 days of regulatory approval in Israel also if the patent application is still pending (previously, the deadline to file a PTE petition was extended until 90 days after patent grant); applicants will have a 90 days grace period from the date of the Amendment to file PTE petitions for pending patent applications. 

The pdf can also be downloaded here.

Thanks so much, Liad!

Correction: Gilding the Lilly: a rapid response event

There's an interesting event coming up next Monday, 20 January [and NOT 13 January, which is of course today], in London. It's called "Rapid Response - Gilding the Lilly: Making Sense of the CJEU’s recent SPC decisions". According to Sara Ashby (Redd), who is the AIPPI UK's Hon Sec)

Registration is now open for this rapid response event which will review the CJEU’s recent decisions in Lilly, Actavis and Georgetown II, which have been eagerly awaited by the SPC community. Speakers from industry and private practice will discuss whether the CJEU has cleared up the confusion left by Medeva, and where the law might go next in this rapidly moving field. 

Carpmaels & Ransford has kindly agreed to host this event (One Southampton Row, London WC1B 5HA) and to provide drinks afterwards. 

Attendance is free for members and new applicants for membership, and £25 for non-members. CPD 1.5hrs.

If you would like to attend this event (open to members and non-members) please register at http://aippiukspcsagain2014.eventbrite.co.uk. At the time of registering if someone else (eg: your secretary or P.A.) registers on your behalf, please make sure that they book in your name, so that the name of the person who is attending - and wants the CPDs – is the name which makes it onto the attendee list.

Shakespeare scholars will be itching to tell everyone that the expression "gild the lily" isn't quite what the Bard actually said: in King John he wrote "to gild refined gold, to paint the lily". but that's beside the point!