Curia Fairies busy last night, posting reasoned orders

Luxembourg night-workers ...

Yesterday the SPC Blog posted that it had been asked by a correspondent if we had a text for another reasoned order of the Court of Justice of the European Union of 14 November, Case C-617/12 AstraZeneca AB v Comptroller-General of Patents. This reasoned order was not accessible via the Curia website.

Good news!  The reasoned order must have been uploaded by the Curia Fairies overnight, since it's now available online here. For the record, the CJEU ruled in that order as follows:

"In the context of the European Economic Area (EEA), Article 13(1) of Regulation ... 469/2009 [on SPCs] must be interpreted as meaning that an administrative authorisation issued for a medicinal product by the Swiss Institute for Medicinal Products (SwissMedic), which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place that medicinal product on the market within the meaning of that provision in the European Economic Area where that authorisation predates marketing authorisations issued for the same medicinal product, either by the European Medicines Agency (EMA), or by the competent authorities of European Union Member States in accordance with the requirements laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and with the requirements of the Republic of Iceland and the Kingdom of Norway. The fact that, on the basis of similar clinical data, the European Medicines Agency, unlike the Swiss authority, refused to grant a marketing authorisation for that medicinal product at the conclusion of its examination of those data, or the fact that the Swiss authorisation to place the product on the market was suspended by the Swiss Institute for Medicinal Products and subsequently reinstated by the latter only when the holder of the authorisation submitted additional data to it are irrelevant".

Further good news is that the reasoned order in Case C-210/13 Glaxosmithkline is now also miraculously available online. A big thank-you to the Curia Fairies for working their magic spells last night ...

Switzerland, Liechtenstein and the AstraZeneca reference: your chance to comment

Readers of The SPC Blog will be familiar with the UK litigation between AstraZeneca AB and the Comptroller of Patents, Designs and Trade Marks since this blog posted a note on it back in October of last year.  This case has now resurfaced as a reference to the Court of Justice of the European Union with the new designation of Case C-617/12  AstraZeneca.

The UK's Intellectual Property Office reminds us that the referring court has asked the following questions:

"1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC?

2. Does it make a difference to the answer to the first question if:

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?

3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?".

If you would like to comment on this case and, by doing so, encourage the UK government to take a position on whether to make observations to the CJEU, please email policy@ipo.gsi.gov.uk by 28 February 2013.  We know there's not much time, but ...

SPCs and Directive 2001/83-compliant authorisations: a comment on AstraZeneca

AstraZeneca AB v Comptroller-General of Patents, Designs and Trade Marks [2012] EWHC 2840 (Pat), decided by Mr Justice Arnold last week, was briefly recorded by this weblog as breaking news.  The SPC Blog is now pleased to host a more substantial comment by Andrew Hutchinson and Marjan Noor (Simmons & Simmons LLP)

AstraZeneca: SPCs, marketing authorisations and Directive 2001/83 -- what's the safest bet?

The latest decision of the Patents Court for England and Wales refers another series of questions (three in total) on SPCs to the CJEU: AstraZeneca AB v Comptroller-General. This time the Court is revisiting the position where a "first authorisation" may be deemed to be a Swiss MA by virtue of its automatic recognition in Liechtenstein, following the CJEU's decision in Novartis (Cases C-207/03 and C-252/03).

It is important to note that the facts occurred before the introduction of the negative-list in Liechtenstein in 2006, which sought to prevent the automatic recognition of Swiss authorisations in Lichtenstein, but that is not to say the case is not relevant to products with SPCs where the first authorisation was in Switzerland and the negative-list was used.

In this case, AZ obtained a Swiss MA for gefitinib in March 2004 (when every Swiss MA was automatically recognised in Liechtenstein), which was suspended in October 2005 and not reinstated until December 2010. By December 2010, AZ had (in June 2009) obtained an MA via the centralised procedure and claimed that this should be the "first authorisation" from which to calculate its SPC term. To achieve this outcome, AZ argued that Novartis should be overturned or confined to its own facts.

Arnold J agreed that the law was not acte clair and referred two questions to the CJEU (which both AZ and the UK's Intellectual Property Office agreed were necessary):

1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83, but automatically recognised by Liechtenstein, capable of constituting the ‘first authorisation to place the product on the market’ for the purposes of Article 13(1) of Regulation 469/2009?

2. Does it make a difference to the answer to the first question if:

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004 and/or

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?

The Court also addressed the more fundamental issue raised by the CJEU in Merz v Synthon and Generics v Synaptech (Joined Cases C-195/09 and C-427/09), whereby products authorised not in accordance with Directive 2001/83 were deemed outside the scope of the SPC regime altogether under Article 2.

Arnold J's third question deals with the consequences of the Swiss authorisation not counting as the "first authorisation" for the purposes of calculating duration (i.e. a 'no' to the first question) because it is deemed not to be compliant with Directive 2001/83:

3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83 render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?

Arnold J offers his thoughts on the answers to both issues. He considers that the earlier Swiss/Liechtenstein MA should be the "first authorisation" for the purposes of Article 13 because the factual scenarios set out in question 2 do not provide a cogent basis for distinguishing Novartis. However, Arnold J considers that, if the Liechtenstein MA does not count as the first authorisation because it is not Directive 2001/83-compliant, for the same reasons the product should fall outside the scope of the SPC regime and not be entitled to an SPC at all as it would have been placed on the market in Europe before the grant of a Directive 2001/83 complaint MA (i.e. following Merz and Generics).

If the CJEU's answer does not maintain the Novartis position as proposed by Arnold J, then the impact of a knock on affirmative answer to Q3 (following Merz) would be significant. SPCs granted before the negative-list would be vulnerable to revocation. Since 2006, although the negative-list procedure in Liechtenstein has provided a mechanism for companies to delay the automatic recognition of MAs between Switzerland and Liechtenstein, this procedure will need to be carefully assessed and managed pending CJEU clarification on this issue. At the very least companies will need to ensure their products remain on the negative-list pending a Directive 2001/83-compliant authorisation. The safest bet would be to ensure that the Swiss MA is delayed until after a Directive 2001/83-compliant European authorisation but this may not be commercially desirable or practical.