The SPC blog

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

Sunday, 20 April 2014

Portugal adjusts term to match CJEU order

From our friend João Jorge (RCF - Intellectual Property, Lisbon) comes the following information for which we gratefully thank him:
As a consequence of CJEU Decision C-555/13 (that's Merck Canada, noted on The SPC Blog here), the Portuguese PTMO has released on 17 April a Directive from the Board (2/2014), dated 10 April, informing that a verification is to be conducted to ensure that the term for all SPCs complies with the referred decision ensuring that "the 15 years exclusivity defined in that CJEU decision is not exceeded".

In practice this decision will affect about 30 SPCs currently in force, all corresponding to products in the market as SPCs normally do.

This Directive was not unexpected.

However, as PT patent attorneys we are used to seeing in this type of change, the PTMO has already corrected the term in the online database and has sent notifications informing the respective patent attorneys. The effect of the recalculation is that some of the SPCs will have a sudden death, some of them with a new end of validity date that is before the date of entry into force. The others will see a reduction in the duration but still remaining in force.

The Directive has a final note stating that a one month term shall be given to the owners of these affected SPCs that wish to file paediatric extensions but that, due to this recalculation, they would no longer be able to do it. We have to bear in mind that the duration of some of these SPCs was cut by more than two years.

Finally, publication in the Official Journal will be carried out for those SPCs that, with these changes, have already reached the end of their validity. For all the other affected SPCs, no publication is expected to occur.

Just a final note: this publication of end of validity will only happen in 21 April. So, until then what a wonderful grey area for lawyers!"
The SPC Blog also thanks its friends at the Lisbon practice of Baptista, Monteverde & Associados for sending us the link to the same information on the BMA Newsflash, here.

With all this news coming from Portugal, it almost feels as though that lovely country lies right at the heart of Europe and not at its distant Atlantic edge.

Wednesday, 2 April 2014

SPCs and medical devices: disappointment for Cerus

Via this post by Darren Smyth (EIP) on the IPKat weblog comes news of two SPC applications in the name of Cerus Corporation: SPC/GB/07/043 and SPC/GB/07/044.  The outcome of both applications was that authorisation to place a product on the market as a medical device under Directive 93/42 cannot be considered equivalent to authorisation under the medicinal products Directive, Directive 2001/83.  Accordingly, the two applications were held not to comply with Article 3(b) of the SPC Regulation, which requires "a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate".  Darren observes that this appears to be the majority view around Europe, though there are some conflicting cases in the Netherlands and Germany where the assessment processes were held to be equivalent and SPCs were allowed.  

The Cerus Corporation decision, dated 31 March, is summarised on the UK IPO website as follows:

EC Design Examination Certificate No. G7 02 05 16178 063 was filed in support of SPC application SPC/GB/07/043 for “Platelet preparation obtainable by addition, and subsequent photoactivation, of amotosalen or its salt, to a suspension of platelets in plasma”. EC Design Examination Certificate No. G7 06 09 60562 004 was filed in support of SPC application SPC/GB/07/044 for “Platelet preparation obtainable by addition to plasma, and photoactivation, of amotosalen or its salt”. These EC Design Examination Certificates relate to medical devices that meet the criteria of Article 1(4) of Directive 93/42/EEC because they relate to a device that incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which acts upon the body with action ancillary to that of the device. As a consequence, they fall within class III medical devices and the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in the medicinal products legislation (Directive 2001/83/EC). Class III devices have the highest risk potential in terms of the vulnerability of the human body (taking account of the potential risks associated with the technical design and manufacture of the device). Explicit prior authorization with regard to conformity is required for such devices to be placed on the market. As a consequence of the need to assess the substance as part of the assessment of the device overall, the applicant argued that these EC Design Examination Certificates can, as a consequence, be considered to meet the requirements of Art 3(b) of the SPC regulation, i.e. they represent a valid authorization to place, on the market as a medicinal product, the product for which an SPC has been applied for.
The hearing officer reviewed the SPC regulation and the relevant parts of the medical devices and medicinal products directives. He took account of the purpose of both codes, the means by which medicinal products and medical devices deliver their principle mode of action, and the actual performance that is being assessed under both codes. He concluded that the assessment carried out in relation to the substance, i.e. the safety, quality and usefulness of the substance, when considered in light of the means by which the medical device delivers its action and considering the process by which a device is approved, including the roles of notified bodies and competent bodies, means that the conformity assessment procedure for a class III medical device is not the same as or equivalent to the process carried out to authorise a medicinal product for human use.
As a consequence, the SPC applications were found not to meet the requirements of Article 3(b) and were rejected under Article 10(2) of the SPC Regulation. 
As ever, readers' comments are invited and appreciated.

Three SPC seminars coming up -- with discounts for SPC Blog readers

From our old friend Rechtsassessor Jean-Claude Alexandre Ho (IP conference manager at FORUM Institut für Management GmbH) comes news of three SPC-related seminars which he is organising. They are as follows:
1. 'Eli Lilly, Actavis, Georgetown II: Quo vadis, SPC?', the update seminar in which Dr Christopher Brückner, the author of the SPC commentary noted here (participants will receive the new second edition on top of course documentation), will speak on the CJEU's "Super Thursday" and on how to understand the decisions and which practical consequences we may expect for the future. Date: 17 June 2014; venue: Amsterdam. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 880 down from € 980). 2. 'Supplementary Protection Certificates', the fifth edition of FORUM's advanced SPC seminar in English. This is a one and a half day course conducted by Dr Brückner (participants will also receive the new second edition of the SPC commentary on top of course documentation). Date: 25 and 26 September 2014; venue: Amsterdam. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 1,200 instead of € 1,340). 
3. 'SPC for Beginners', the third edition of FORUM'S basic SPC seminar in English, once again with Dr Christopher Brückner and his updated SPC commentary as an add-on. Date: 24 September 2014; Venue: Amsterdam. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 880 down from € 980).
To register and gain the benefit of your reduced fee, just forward this blogpost to Jean-Claude himself at jc.alexandreho@forum-institut.de, or call him, quoting "The SPC Blog" (+49 6211 500-675) and specifying which event(s) you would like to attend.

Tuesday, 25 March 2014

U-turn on the U-turn: more comments on the Italian latanoprost antitrust decision

Recently the new decision issued by the Italian antitrust authorities in the matter of the latanoprost case was discussed on this weblog (see earlier posts here and here).

Micaela Modiano (Modiano & Partners) and Anna Maria Stein (Franzosi Dal Negro Setti) now add more information about this important decision, so as to shed some light on why, after the the Italian antitrust authority (Autorità Garante della Concorrenza e del Mercato) had first found that Pfizer had abused its dominant position, and after a first U-turn of the Italian administrative court (Tribunale Amministrativo Regionale) denying that there had been any abuse by Pfizer, the administrative appeal court (Consiglio di Stato) has now taken a further U-turn and instead held that Pfizer has abused its position.

As those of you who have followed this case already know, Pfizer owned a patent with compound claims to, inter alia, latanoprost on which it had filed SPCs and paediatric extensions in various EU countries, but not in Italy. Pfizer had obtained a divisional on the basis of that patent, had validated the patent in Italy, Portugal and Spain and then obtained an SPC and a paediatric extension in Italy on the basis of the divisional patent. At the end of opposition proceedings, the divisional patent had been maintained with claims to the use of latanoprost for a certain therapeutic indication.

The Italian antitrust authority had held that Pfizer had abused its dominant position. Important factors which had led to such decision were the fact that Pfizer had not clearly informed the Italian Patent and Trade Mark Office that the Italian SPC application was based on the divisional while in other EU countries it was based on the parent patent. This was a clear attempt to draw principles from the AstraZeneca case, where AstraZeneca had been found to have intentionally supplied false information to various Patent Offices in an attempt to obtain IP rights and/or or IP right expiry dates to which it was not entitled. It is worth noting that nothing in the SPC Regulation precludes a company from filing an SPC for a product in one country on the basis of one patent and in another country on the basis of another patent, be it a divisional or a wholly different patent. It is also worth noting that Pfizer never made representations to the Italian Patent and Trade Mark Office about the “nature” of its patent, so that the accuracy of the parallel with AstraZeneca appears to be very limited.

The Italian administrative court had in fact denied that there had been any abuse by Pfizer, noting inter alia that Pfizer's behaviour did not include the “quid pluris” (such as an intentional misrepresentation to the Italian Patent and Trade Mark Office) which is necessary for a finding of abuse.

Contrary to this, the Italian administrative appeal court (Consiglio di Stato) has now held that Pfizer did abuse its dominant position. A few of the points made by the Consiglio di Stato to support this position are quite interesting and will probably spur some debate among the lovers (or haters?) of divisionals.

As a first point, even though during the proceedings relating to this antitrust challenge Pfizer had clearly shown that – as is also inevitably based on the provisions of the SPC Regulation - basing the Italian SPC and paediatric extension on the divisional did not lead to an SPC expiry date different from the one achieved by the other SPCs and paediatric extensions which were based on the parent patent, the Consiglio di Stato does not seem to have appreciated this point, since in the decision the court has emphasized that the divisional patent expired in 2009 whereas thanks to the Italian SPC and paediatric extension the expiry date was postponed to 2012 (evidently not realizing that the comparison had to be made among the various SPCs, or the various paediatric extensions, and not between the patent and the SPC/paediatric extension).

Even more notably, on the point of the actual abuse the Consiglio di Stato held that (our English translation):
“Here, we do not discuss a conduct prohibited by patent law, but the anti competitive implications of a number of acts which, in and of themselves, are legitimate [i.e. obtaining a divisional patent and an SPC]. After all, the abuse of a dominant position, attributed to Pfizer, is nothing but the specification of the broader category of abuse of right, whose precondition is in fact the existence of a right, which then is used in an instrumental manner that is not coherent with the goal for which the law acknowledges it – in this specific case, the exclusion of the competitors from the market.”
At this stage, the question that first springs to mind is what other, legitimate, purpose obtaining a patent and an SPC can serve, for the party that obtains such IP rights, if not that of excluding competitors from the market (after all, patents and SPCs, like all IP rights, are exclusive rights). This answer, at least in the view of the Consiglio di Stato, can probably be found in the following passage of the decision (our English translation):
“In the present case, the behaviour adopted by Pfizer by way of the exploitation of the rights connected with the ownership of the main patent and with the position on the market allowed to defer [the entry into the market] of generics of Xalatan, without entailing any concrete use of the same active pharmaceutical ingredient different from the one already protected. The assessment of the [Italian antitrust] authority, who saw in such behaviour a goal going beyond, and differing from, the one that is specific to the patent protection … is therefore fully justified.”
It will not come as a surprise, after reading this passage, that in at least three other passages of the decision the Consiglio di Stato insists on the fact that the grant of the divisional patent was not followed by the marketing of any new product (Pfizer's Xalatan, comprising latanoprost as the active pharmaceutical ingredient, was already on the market when the divisional patent was granted).

Thus what transpires from the decision is that the Consiglio di Stato considered that, for the divisional patent to be legitimate, it had to be accompanied by the marketing of a new product (falling within the scope of the patent). This is in contrast with the fact that, as said above and by definition, patents are exclusive rights and not a permission, let alone an obligation, for the patent owner to implement the invention in actuality. In addition, this is in contrast with the fact that one and the same product can be validly covered by several patents (Markush formula for the active ingredient, salts, polymorphs, process for making the active ingredient, formulation, process for making the formulation, use for a certain therapeutic indication, etc.), none of which require the marketing of a new product for such patents to be valid and non-abusive.

As far as we know, this decision is one of the few decisions on the interaction between divisional patents and antitrust laws in Europe. In addition, the action was started before the Italian authorities as Pfizer's allegedly abusive behaviour was limited to Italy (given that in most other European countries the SPCs and paediatric extensions were based on the parent patent), but throughout the proceedings the parties relied on the case law of the CJEU in the matter of abuse of dominant position and ruled on the basis of Art. 102 TFEU rather than on the exclusive basis of Italian law. It is thus hoped that, if this decision is cited in the future by other authorities ruling on the same issues, this will be done with a view to clarifying whether the exclusive nature of a patent is, in and of itself, a legitimate reason to own a patent or whether each (divisional) patent must be accompanied by a new product for it to be legitimate also from the point of view of competition law.

Sunday, 9 March 2014

Pfizer Xalatan ruling: Consiglio di Stato ruling now available

Last month, in our blog post "Italy: Consiglio di Stato reinstates original Pfizer Xalatan order", here, we hosted a contribution from Gian Paolo Di Santo (Partner NS Head of the I.P./I.T. Department of law firm Pavia e Ansaldo, Milan) on the question of whether Pfizer was in breach of competition law rules in seeking to maximise its protection for latanaprost.

The decision of the Consiglio di Stato (in Italian) was published in full on 12 February and Gian Paolo has kindly provided us with a copy that you can access here or download here. According to Gian Paolo,
"the decision is rather concise and straightforward, mainly recapping the development of the whole procedure and essentially acknowledging that the Authority decision (which was far more detailed) was not affected by any lack of reasoning and that instead the decision of the TAR Latium (first instance administrative Court) failed to understand the very core of the matter. The problem was that, even if the request for a divisional patent was legitimate, this did not allow Pfizer to use such a divisional patent solely for the purpose of excluding its competitors by means of a SPC + paediatric extension requests. Of course one might have expected some more indications from the Supreme administrative Court, but instead they mainly referred to the decision of the ICA and stated that the investigation that took place could not be considered erroneous".

Thursday, 20 February 2014

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.

Tuesday, 18 February 2014

"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.

Monday, 17 February 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!

Sunday, 16 February 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?

Friday, 14 February 2014

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.