A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Showing posts with label reasoned order. Show all posts
Showing posts with label reasoned order. Show all posts

Friday, 22 November 2013

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 ...

Thursday, 21 November 2013

AstraZeneca: another reasoned order. Can you help?

Following today's earlier post with news of Case C-210/13 Glaxosmithline Biologicals SA, Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma GmbH & Co. KG v Comptroller-General of Patents, Designs and Trade Marks, The SPC Blog has been asked by a correspondent if we have a text for what appears to be another reasoned order of the Court of Justice of the European Union that was delivered on the same date in Case C-617/12 AstraZeneca AB v Comptroller-General of Patents. Again, the reasoned order does not appear to be accessible via the Curia website.

If any kind reader has a copy of this reasoned order which he or she is willing to share, do please get in touch!

The end of a dream: reasoned order puts paid to SPC hopes for adjuvants

Back in March, Mr Justice Arnold referred two short, succinct questions to the Court of Justice of the European Union for a preliminary ruling. Just eight months later we now have, in place of the Advocate General's Opinion and CJEU ruling, what the CJEU calls a "reasoned order". The case in question is Case C-210/13 Glaxosmithline Biologicals SA, Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma GmbH & Co. KG v Comptroller-General of Patents, Designs and Trade Marks and the questions referred were these:
Is an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, an 'active ingredient' within the meaning of Article 1(b) of Regulation 469/2009/EC ?

2. If the answer to question 1 is no, can the combination of such an adjuvant with an antigen nevertheless be regarded as a 'combination of active ingredients' within the meaning of Article 1(b) of Regulation 469/2009/EC?
The answer given in the reasoned order is as follows:
"Article 1(b) ... must be interpreted as meaning that, just as an adjuvant does not fall within the definition of 'active ingredient' within the meaning of that provision, so a combination of two substances, namely an active ingredient having therapeutic effects on its own, and an adjuvant which, while enhancing those therapeutic effects, has no therapeutic effect on its own, does not fall within the definition of 'combination of active ingredients' within the meaning of that provision".
You can read the reasoned order (which is not currently on the Curia website) here or download it here.