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.

Bayer CropScience: now you can read the AG's Opinion in English

From our friend Mary Smillie (Rouse Legal) comes the good news that an unofficial English translation of the Advocate General's Opinion in Case C-11/13 Bayer CropScience has been made by one of her colleagues, working from the French version.

You can read it here or download it here.

Thanks so much!

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?

Bayer CropScience: AG's Opinion published

Yesterday the Advocate General's Opinion in Case C-11/12 Bayer CropScience AG was delivered by Niilo Jääskinen. Frustratingly for this blogger, the Opinion was published in almost every official language of the EU, except English --the only one this blogger can truly understand.

There's a short note on this Opinion on the IPKat weblog, by Paul England (Taylor Wessing). If any readers can add to it, The SPC Blog will be really grateful. Although it's "only" a plant protection product for which the SPC is sought, it's about active substances and safeners and should, at least in theory, be of interest to our pharma readers too.

Bayer CropScience: AG Opinion this coming Thursday

Here's a forthcoming attraction!  Next Thursday we expect to see the Opinion of Advocate General Jääskinen in Case C-11/13 Bayer CropScience. The SPC Blog will bring you news of it as soon as it can.

Thursday 13/02/2014 09:30	Opinion C-11/13	Intellectual property Bayer CropScience Court of Justice - Third Chamber	DE	Courtroom I - Level 8
	Request for a preliminary ruling – Bundespatentgericht – Interpretation of the terms ‘product’ and ‘active substance’ contained in Article 1.3 and 1.8 and in Article 3(1) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ 1996 L 198, p. 30) – Whether those terms cover Isoxadifen Advocate General : Jääskinen

Italy: Consiglio di Stato reinstates original Pfizer Xalatan order

While much of the content of this weblog addresses the technical issues relating to securing an SPC, the scope of the blog extends beyond those issues, covering the economic and commercial dimensions of SPCs, how they are deployed strategically by their owners and how they fare when measured against the yardstick of competition law.

In this context The SPC Blog welcomes the following contribution from Gian Paolo Di Santo (Partner NS Head of the I.P./I.T. Department of law firm Pavia e Ansaldo, Milan).  Gian Paolo is not one of our regular contributors, which makes his contribution all the more welcome to us.  This is what he writes:

In this case, somehow breaking a tradition which sees Italian “old school” lawyers (as I am) who are a bit reticent on contributing to blogs actually discussing their cases on a open stage, I write to report the news that the Consiglio di Stato (i.e. the final decisional body of administrative courts in Italy) has annulled the decision issued by the TAR Latium (i.e. the first instance administrative Court which has jurisdiction over antitrust decisions of the Italian Competition Authority, 'ICA') on the matter concerning the abuse of dominant position put in place inter alia through a misuse of patent/SPC rights in Italy by Pfizer in relation to the Xalatan product. Accordingly, the original order of the ICA which fined Pfizer over 10 million Euros is now final and binding. 

For the time being only the ruling-- allowing the ICA and Assogenerici’s appeal -- is available, while the reasoning for the decision will be published within a few months (and – if it is of any interest – I will be keen to provide readers with better information as soon as they are published) [yes, please, says The SPC Blog. Meanwhile, the ruling can be read here or downloaded here]. However I wanted to be the first to provide you with this information, mainly to avoid the impression that such an important decision is rapidly labelled as the decision of an Italian body which “does not understand of IP”, as I have seen that many commentators did in the past when commenting on this matter. 

It is the first time in Italy in which the misuse of patent law in the pharmaceutical field has been carefully scrutinised in order to assess an abuse of dominant position. The only precedent known to me in Europe had so far been the AstraZeneca case (CJEU decision of December 6, 2012 in case C-457/10P), but this Italian Pfizer case potentially appears even more interesting, as it might give some hints on how competition law may help to tackle unfair practices such as the implementation of the so-called “patent thickets” and “evergreening” policies by the originators, which are practices that had been denounced by the European Commission in its inquiry on the pharmaceutical sector which was concluded on July 8, 2009.

Latanoprost

Some commentators asserted that the decision of the TAR Latium, annulling ICA’s decision, was correct because Pfizer had not actually broken any patent rule, since the strategy they implemented, characterized in particular by the indication of a divisional patent as a basic patent to file a request for SPC, was in accordance with the applicable legislation which allows the filing of divisional applications. It is reasonable, however (awaiting the written reasoning of the decision, expected in the coming months), to think that the Council of State has determined that the object of the ICA’s investigation, and the reasons of the consequent sanction, were not founded on the legality of Pfizer’s conduct under a civil or administrative profile, but rather on the complex strategy put in place by Pfizer in relation to the active principle latanoprost, the verification of its legality under the typical profile of competition law (on the merits), and in particular  the  possible breach of the prohibition of abuse of dominant position set out in Article 102 TFEU.

In other words, the central point of the issue appeared to be that, under antitrust law, the subject in a dominant position cannot engage in conduct that could be perfectly legitimate if performed by a subject that is not in a dominant position. The ICA considered that Pfizer’s overall strategy was unjustifiable unless it was interpreted as having solely an exclusionary intent and purpose. This had nothing to do with the competition on the merits that in the patent/pharmaceutical field should be characterized by making innovative products available to the public.

Pfizer’s defence, in a nutshell, was that all the acts put in place by that company (request of – several – divisional patents all covering the same identical product, request of an SPC using as “basic patent” the last possible of those patents, starting of an aggressive enforcement campaign after the grant of the divisional patent and SPC against the genericists which had prepared themselves to launch after the expiry of the parent patent protecting the active principle as such) were lawful under an IP point of view.

In my opinion one of the central aspects of all this issue is that

" ... in 2002 the situation was crystallised with the expiry of the patent protection expected in Italy in September 2009 (by virtue of the lack of a SPC on the main patent in our country). Accordingly, the generic companies legitimately came to expect they could enter the Italian market on that date. This reliance was frustrated by the exclusionary strategy of Pfizer which applied for the divisional patent exclusively to obtain the SPC to align the expiry of patent protection for Xalatan in Italy with the rest of Europe” (ICA decision, § 197). 

And also Pfizer – as it clearly emerged from the inspection – had already in mind that the LOE (loss of exclusivity) would have taken place in Italy before than in the rest of Europe.

The ICA therefore assessed that the divisional patent had been unlawfully exploited, seeking protection for an active ingredient already protected by a granted and fully valid parent patent and whose related medicinal product had already been authorized since many years, with the sole purpose of using such a divisional patent as a vehicle for the request for an SPC in Italy. Such behaviour was aimed at preventing entrance into the market of competitors at the time of parent patent’s expiry, thus remedying the original "oversight" regarding the application for an SPC, filed for in all other European countries. To confirm the exclusionary nature of Pfizer’s behaviour, the ICA deemed particularly suspicious the fact that no new drug had been placed on the market on the basis of the new EP '168 patent, and that no technological development was achieved in this patent. 

Xalatan was in fact realized, from the moment when it was first placed on the market in the late ‘90s, in Italy and in all other countries where the parent patent EP '417 was extended, with characteristics of dosage and amount of active ingredient per drop (which was the key element of EP '168, applied for only in 2002) that remained unchanged over time. In addition, and this was even more significant to confirm suspicion, the divisional EP '168 was curiously filed only in Italy, hence adopting a different strategy with respect to what had been done with EP '417, which had instead been validated in all European countries.

Apart from the obvious professional joy that I feel after a long battle that lasted over four years, my personal and intimate feeling is that the ICA order of January 2012  as well as the decision of the Consiglio di Stato, as soon as it is published, should be read with careful consideration as it is an occasion to somehow rethink a bit the relation between patent law and competition law.