From the French text, here, it is apparent that the Order is just 35 paragraphs in length. Thanks to Google Translate, the CJEU's reasoning appears to be as follows:
"On the bottom [this appears to be a literal translation of 'Sur le fond']So now you know!
26 Pursuant to Rule 99 of its Rules of Procedure, where the answer to a question for a preliminary ruling admits of no reasonable doubt or it can be clearly deduced from the case law, the Court may at any time on a proposal from the Judge-Advocate General, decide to give its decision by reasoned order.
27 The Court considers that this is the case in the present case and that, given the adoption of this Ordinance, there is no need to adjudicate on the application for an expedited procedure set forth by the court (see in this sense, Order of 8 April 2008, Saint-Gobain Glass Deutschland v Commission, C-503/07 P, p. I-2217, paragraph Rec. 45). Indeed, the answer to the question posed by the Court of Arbitration Necessario leaves no room for reasonable doubt and can also be clearly deduced from the case law of the Court, including the Order of 14 November 2013, AstraZeneca (C -617 / 12, not yet published in the ECR).
28 By its question, the Arbitral Tribunal Necessario asks, essentially, whether Article 13 of Regulation No 469/2009, read in conjunction with recital 9 of the Regulation must be interpreted as precluding that the holder of both a patent and a certificate can claim the entire period of validity thereof calculated in accordance with this Article 13 in a situation where, under such time, he would be given a period of exclusivity for an active ingredient, more than fifteen years from the first marketing authorization in the EU, drug consisting of the active ingredient or containing it.
29 An affirmative answer to this question follows from a literal interpretation of Article 13 of Regulation No 469/2009, read in conjunction with recital 9 thereof.
30 This interpretation was further confirmed recently by the order in Astrazeneca, supra, paragraph 42 which states that the holder of both a patent and a certificate should not be eligible for more than fifteen years exclusive from the first marketing authorization issued in the Union, the medicinal product concerned.
31 In addition, it should be remembered that the words "first authorization for placing on the market in the [European Union]" within the meaning of Article 13, paragraph 1 of Regulation No 469/2009, refer the first marketing authorization issued in any of the Member States and not to the first authorization in the Member State's request. Only this interpretation ensures that the extension of the protection provided by the patent, regarding the product covered by the certificate will expire at the same time in all Member States where this certificate has been granted (see, to that sense, judgment of 11 December 2003, Hassle, C-127/00, Rec. p. I-14781, paragraphs 74, 77 and 78).
32 In the main proceedings, it is undisputed that the first marketing authorization in the EU, medicines containing the active ingredient protected by a basic patent which holds Merck Canada was granted August 25, 1997 in Finland.
33 Therefore, regardless of the date of grant of the basic patent in Portugal and duration of theoretical validity of the certificate resulting from the application of Article 13 of Regulation No 469/2009, the maximum period of exclusivity conferred by both patent No. 99213 and Certificate No. 35 shall not exceed a total of fifteen years computed from 25 August 1997.
34 Having regard to all the foregoing considerations, the answer to the question referred is that Article 13 of Regulation No 469/2009, read in conjunction with recital 9 of the Regulation must be interpreted as meaning it precludes the holder of both a patent and a certificate can claim the entire period of validity of such a certificate determined under this Article 13 in a situation where Under such a period, it would benefit from a period of exclusivity for an active ingredient, more than fifteen years from the first marketing authorization in the EU, drug consisting of, or containing the same active ingredient thereof".
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Thank you, Arno Martin, for your assistance in leading us to the truth.
4 comments:
Quite a shocking little case.
Not because of the result (although that is probably wrong too, it is at least one of the two plausible answers between which the referring court needed help to choose).
Paragraph 29 suggests the Court has forgotten what literal means. Article 13 literally says one thing; recital 9 literally says something else. The Astra Zeneca case doesn't give the answer; it just tells you where the (now undisputed) starting point is for each of the alternative calculations. The relevant parts of the Hässle case are really paragraphs 38-40, where the court said that you can have different protection in different countries, at least under transitional provisions (which are in essence what Merck were invoking here). Hässle was of course the case about the famous "abusive" SPCs, and if you look at the Commission's Article 82 decision you can see (at paragraphs 233, 306 and 761) that the Austrian SPC was just like the Portuguese one here; it expired in August 2005, about a year later (in the Commission's view) than it should have; but August 2004 was already more than 17 years from the first authorisation.
The court seems to have made its mind up before giving the parties, the member states and the Commission their chance to make submissions, as promised by Article 23 of the Statute. This is a pity, as there are policy arguments on both sides which have never come up on any of the previous references. It is true that read literally Rule 99 allows the court to make a reasoned order "at any time", but it seems a little strange to use a provision of the Rules of Procedure to deprive parties of the right to make arguments that is given to them by the Statute, given that the Statute is formally law of a higher order.
The order is still not available in EN. However, there is a press release in EN of that case:
http://curia.europa.eu/jcms/upload/docs/application/pdf/2014-02/cp140021en.pdf
Par. 32 is particularly interesting in view of the new UKIPO practice of not calculating on the basis of the grant date but the date of notification instead (http://thespcblog.blogspot.nl/2013/11/calculating-duration-new-ukipo-practice.html).
What has para 32 got to do with the notification dates of EMA / EC MAs? It talks about an MA in Finland.
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