Forget Holmes, Maigret and Poirot: SPC Blog solves problem of "mystery case"

Case C-555/13 Merck Canada -- The SPC Blog's celebrated "mystery case" (see earlier posts here and here) -- is a mystery no longer. The request for a ruling was made on 28 October 2013, and the CJEU gave an Order on 13 February 2014 which appears to have been posted on Curia today. The Order is available in Bulgarian,  Spanish,  Czech,  German,  Estonian,  Greek,  French,  Italian,  Latvian,  Lithuanian,  Hungarian,  Maltese,  Dutch,  Polish,  Portuguese,  Romanian,  Finnish and Swedish -- but not in English.

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']

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".

So now you know!

Thank you, Arno Martin, for your assistance in leading us to the truth.

"Mystery case" C-555/13: Singulair and generic montelukast

The SPC Blog thanks Manuel Durães Rocha (Trocado, Durães Rocha & Associados, Lisbon) for some further information concerning the "mystery case" from the Court of Justice of the European Union, Case C-555/13 Merck Canada (see earlier SPC Blog posts here and here).  Manuel explains:

This referral was requested by an arbitral court formed in Portugal on the basis of Portuguese Law nº 62/2011 to decide whether Merck´s Portuguese patent 92213 and its SPC 35 covering Singulair was or not infringed by generic medicines of montelukast put on the market by companies manufacturing montelukast generic medicines such as Alter, Accord Healthcare and Synthon. 

Although Merck´s patent elapsed on October 2, 2013, Merck owns SPC35 covering Singulair until August 18, 2014. Alter raised the question, arguing that SPC35 could not be effective until 18 August 2014 taking into consideration that Merck had already benefited from a 15 year market exclusivity counted from the date of the first MA granted for the European Community in August 25, 1997. Alter invoked recital 9 of EU Regulation 469/2009 to defend the proposition that the dates calculated through Article 13 of that regulation should match the objective of granting a 15 year market exclusivity and thus such SPC35 could not enter in force until August 18, 2014 because, if so, it would grant a market exclusivity to Merck of more than 15 years counted from the date of the first MA in the EU despite such SPC is valid until August 18, 2014.

The mystery of the Merck Canada reference: can anyone explain?

On 28 January 2014 The SPC Blog posted an item, "A mystery reference from Portugal: can anyone help?", here, on a reference to the Court of Justice of the European Union which most of us knew nothing about. The plot thickens, in that there has now been a mystery ruling. According to a newsflash from the Lisbon, Portugal law firm of Baptista, Monteverde & Associados, the case is C-555/13 Merck Canada and the question referred to the CJEU is this:

“May Article 13 of Regulation 469/2009 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 authorization 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)?".

Last Thursday, 13 February, the CJEU apparently ruled as follows, according to Baptista, Monteverde & Associados:

“Article 13 of Regulation 469/2009 ..., read in conjunction with recital 9 of that regulation, must be interpreted as meaning that it opposes that the holder of a patent and of a supplementary protection certificate may invoke the whole duration of the said certificate, applying Article 13 in a situation where, due to the said duration, the said holder would benefit from a period of exclusive exploitation of an active ingredient of more than fifteen years from the date of the first marketing authorization within the Community, of the medicinal product consisting of the said active ingredient or containing it.”

This by no means clears up the mystery of this case.  Can anyone explain the following?

First, if you look at the Curia diary for 13 February, you will find lots of cases that received the attention of the CJEU -- but Case C-555/13 is not among those listed.

Secondly, if you conduct a case search for Case C-555/13 you will find it marked "Case in Progress", there being no sign of a judgment.

Thirdly, the case -- according to Curia -- was only filed in October of last year, and notice of it having been filed was published in the Official Journal this January.

Is it possible for a reference to reach a ruling in just a few short winter months, with no apparent hearing? Can anyone explain what has happened?

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!

Case C-493/12: referring decision now available

Following yesterday's post, The SPC Blog can confirm that the mystery judgment leading to the reference to the Court of Justice of the European Union in Case C-493/12 is that of Mr Justice Warren of 10 October 2012 in Eli Lilly v HGS. The ever-helpful Micaela Modiano has even rooted out a copy for readers' consideration here (thanks, Micaela -- and thanks to our readers for their comments posted on the earlier item).

Novartis mystery case heads for ECJ: can anyone help?

According to the UK's IPO, Case C-442/11 Novartis AG v Actavis UK Limited is the latest SPC dispute to be referred to the Court of Justice for a preliminary ruling. According to the IPO, this case --  another reference from the High Court for England and Wales -- raises the following questions:

"Where a supplementary protection certificate has been granted for a product as defined by Regulation 469/2009 for an active ingredient, are the rights conferred by that certificate pursuant to Article 5 of the Regulation in respect of the subject matter as defined in Article 4 of the Regulation infringed:

i. by a medicinal product that contains that active ingredient (in this case valsartan) in combination with one or more other active ingredients (in this case hydrochlorothiazide); or

ii. only by a medicinal product that contains that active ingredient (in this case valsartan) as the sole active ingredient?"

This seems to be a bit of a mystery. Martijn de Lange (Netherlands Patent Office) has told The SPC Blog:

"I totally missed that reference and I can't find it on BAILII or with Google either. Maybe you could put it on the blog and possibly some reader may supply it". 

This blogger hasn't been able to find any reference to it on the Curia website either. Can anyone help?

nb If you were planning on submitting comments on this reference to the UK IPO so that the government can decide what, if any, position it wishes to take, the IPO's notice does not stipulate a deadline by which submissions must be made. Having said that, you would be well advised to email your comments here, if you have any, as soon as possible.