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

Friday, 27 March 2015

Paediatric extensions: is there an official county-by-country list?

One of our readers has asked if there exists a reliable and authentic source that lists all of the countries which support paediatric patent extensions. This blogger clicked around the World Intellectual Property Organization and World Health Organization websites a bit, but couldn't find such a list in either of them -- and he's not sure who else might compile one. Does anyone know?

Thursday, 26 March 2015

What has the CJEU said this time? A review of the latest SPC musings from Luxembourg

Following the Actavis v Boehringer (C-577/13) judgment from earlier this month (on which see the SPC Blog post here), AIPPI is putting on another Rapid Response event to discuss the implications of this decision for existing and future SPCs.  The event will also look at January’s Forsgren (C-631/13) judgment (discussed here), which has profound things to say on the way active ingredients can be protected by SPCs, particularly for complex biologic products.  

Michael Lubienski (UCB), who was closely involved in the Forsgren referral, will be joined by Edward Oates and Daniel Wise from the SPC group at Carpmaels & Ransford LLP to discuss these decisions.  

The event takes place this Monday, 30 March 2015 (5.30 pm for 6 pm start) at Carpmaels & Ransford (1 Southampton Row, London, WC1B 5HA), with drinks afterwards.  

Attendance is free for UK AIPPI members and new applicants for membership, and a mere £25 for non-members.  If you would like to attend the event, please register at https://aippiuk-cjeu-spcs-again.eventbrite.co.uk/

Wednesday, 25 March 2015

SPCs for beginners

Recently The SPC Blog posted this item on the forthcoming SPC for Beginners, run by FORUM-Institut on 6 May in Frankfurt, offering a 10% registration fee reduction to readers of this weblog. It's not the only course of its kind, though. One of our readers has drawn our attention to the fact that there's another one coming up a few weeks later in London. There's no special rate for SPC Blog readers, but there is a 15% early bird reduction if you register before 1 May. Its details are as follows:

"SPCs for beginners", Tuesday 16 June 2015. Venue: The Rembrandt Hotel, London. In the chair is Paul Inman (Wragge Lawrence Graham LLP). Speakers are four Drs: Paul Brady (Abel & Imray), Oliver Kingsbury (Elkington & Fife LLP), Andrew Rudge (Pfizer Ltd) and Mike Snodin (Park Grove IP). For further details and registration, just click here.

This blogger believes that FORUM Institut and Management Forum were once related, but wonders whether it is time for their branding to diverge a little ...


Tuesday, 24 March 2015

Notification dates, (co)exclusivity, similar drugs, orphans and the FDA: a comment

Further to Marc Nevant's observations, posted on The SPC Blog yesterday (here), Mike Snodin -- whose article Marc cited -- has added some further comments of his own. Says Mike:
The EMA’s reliance upon the Notification Date for calculating periods (data exclusivity and orphan market exclusivity) running from the date of a MA is confirmed in the answer to question 12 in “EMA Procedural advice for users of the centralised procedure for generic/hybrid applications” (see this link).

The EMA’s practice on this point was the basis of one of the arguments in my article from October 2011. The legal basis for that practice is Article 297(2) of the Treaty on the Functioning of the EU, which is a point noted in my article from October 2014.

The decision in T-140/12 is fascinating, as it appears to mean that the (co-)exclusivity awarded to one product can effectively extend the period of (co-)exclusivity on the market for another, “similar” product. In this respect, that decision is similar to that in Depomed Inc. v U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592, where orphan exclusivity was awarded to a non-identical drug in circumstances where “clinical superiority” of that drug had not been demonstrated over an already approved, “similar” drug.

The FDA does not appear to be inclined to follow the ruling in Depomed (see this link), and so it will be very interesting to see what Teva does in respect of the ruling in T140/12 – and whether the CJEU will eventually get to rule on this aspect of orphan marketing exclusivities.
Thanks, Mike!

Monday, 23 March 2015

Determination of periods of regulatory exclusivity: grant date v notification again!

From our friend and reader Marc Nevant (French and European Patent Attorney, Cabinet Beau de Loménie, Paris) comes the following note, for which The SPC Blog offers its sincere thanks. Writes Marc:
I have recently come across Case T-140/12, a General Court of the European Union ruling in Teva v European Medicines Agency (EMA). In short, Teva sought an order to annul the EMA’s refusal to grant its application for marketing authorisation (MA) for imatinib Ratiopharm, a generic version of (Novartis's) orphan drug product imatinib (trade name Glivec), in so far as it concerned therapeutic indications for the treatment of chronic myeloid leukaemia (CML).

The matter is essentially about orphan drug exclusivity and the interpretation of Regulation 141/2000 on orphan medicinal products. There is, however, a parapraph in the decision that should be of interest for the readers of this blog. Paragraph 12 mentions that 
“Pursuant to Article 8 of Regulation No 141/2000, the period of market exclusivity enjoyed by the medicinal product imatinib, marketed under the commercial name Glivec, in so far as concerns the CML therapeutic indications — the original marketing authorisation for which took effect on 12 November 2001 — expired on 12 November 2011”.
It turns out that 12 November 2001 is the date of notification of the MA (the grant date being 7 November 2001). This suggests that the determination of periods of Regulatory Exclusivity for centrally approved products could be affected by the “grant date v notification date” debate, and further suggests (if the decision is transposed to SPC cases) that, for centrally approved products, the date of notification of the MA is de facto the date referred to in §1 of Article 13 of SPC Regulation 469/2009, as already argued at length by Mike Snodin (see e.g. the post on this blog of 30 October 2014).

Let’s hope that the judges in Seattle Genetics (on which see earlier posts here and here) will share this view!

Friday, 20 March 2015

SPCs for first-timers and old hands: a couple of forthcoming events

From Rechtsassessor Jean-Claude Alexandre Ho (Conference Manager Intellectual Property, FORUM Institut für Management GmbH) comes news of two more SPC seminars. They are:
The Frankfurt coat of arms
1. 'Supplementary Protection Certificates', the sixth edition of FORUM's English SPC seminar with Dr Christopher Brückner, the author of the SPC commentary (participants will receive the latest edition on top of course documentation). Date: 7 and 8 May 2015; venue: Frankfurt. More information is available here. SPC Blog readers are entitled to a 10% discount against the registration fee (€ 1,200 instead of € 1,340).

2. 'SPC for Beginners', the fourth edition of FORUM'S basic SPC seminar in English, once again with Dr Christopher Brückner. Date: 6 May 2015; Venue: Frankfurt. 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 (valid only for registrations until 8 April 2015), 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.

This blog is always pleased to learn of events for which discounts are available for its readers.

Friday, 13 March 2015

No paediatric extension when conditions are not met before SPC expires

In BL O/098/15 Otsuka Pharmaceuticals Company Limited's application, 4 March 2015, Dr Lawrence Cullen, for the United Kingdom's Intellectual Property Office (UKIPO), held that it was not possible to grant an application for a paediatric extension for patent protection when the conditions for establishing one's entitlement to a paediatric extension -- the completion of investigations relating to paediatric indications and the issue of an updated marketing authorisation  -- had not been fulfilled before the expiry of the SPC.

Otsuka, who had an SPC for ‘aripiprazole or a salt thereof’, used in the treatment of schziphrenia and bipolar affective disorder, was unsuccessful in securing a paediatric extension. In reaching his decision, Dr Cullen distinguished the earlier and authoritative decision of the Court of Appeal for England and Wales in EI du Pont de Nemours & Co v UKIPO [2009] EWCA Civ 966 [on which see The SPC Blog post here and note by Sebastian Moore and Jonathan Turnbull here], on the basis that, in that case, while the requirements for an extension had not been met at the date of application, they had still been met before the date of expiry of the related SPC and it was the case that matters in relation to the extension of an SPC had to be decided before that SPC expired. This was so even if the decision was taken on the last day of the SPC's existence because, once the SPC expired, others were entitled to enter the market and the interest of third parties (i.e. generic pharmaceutical companies) had to be taken into account.

In Dr Cullen's own words:
"55 I accept that the applicant has to carry out the studies in the paediatric population first and get approval from the EMEA. This involves a commitment of time and resources up front. I accept that if the applicant carries out the necessary steps, then they should be entitled to the reward without taking too restrictive a view of how and when the applicant meets the requirements to qualify for an extension to the SPC.

56 However, I do not take this to mean that this should extend beyond the expiry date of the SPC. I think that it is reasonable to expect that matters in relation to an extension to an SPC are decided before the SPC expires, even if this decision is taken on the last day of the SPCs existence! Once the SPC expires, others are entitled to enter the market. Because of this, I think that, after the expiry date of the SPC, one must take account of the interest of third parties. Knowing when the SPC will expire is important for the entry of third parties, such as generic medicine companies, into the market because once the SPC expires; they are free to bring their own versions of the medicines comprising this active ingredient to market. If an application for an extension to a granted SPC was still considered to be capable of rectification after the expiry date of the SPC and the grant of an extension could be back-dated, this would, in my view, introduce uncertainty and, even, the potential for abuse. It would not be clear in such a situation when the paediatric studies would have to be completed by and when the updated MA would be available. There needs to be some clarity as to when matters are complete and others can enter the market. This seems to me to represent an appropriate balance, as referred to in recital 10 of the SPC regulation, to take account of all the interests at stake “in a sector as sensitive and complex as pharmaceuticals” while also making sure that research into paediatric uses of medicines is given the necessary incentive".
An applicant for a paediatric extension has 28 days in which to appeal.

Thursday, 12 March 2015

Telmisartan: no double-dipping says CJEU, as it avoids answering all the questions

This morning the Court of Justice of the European Union (CJEU) delivered its ruling in Case C‑577/13, Actavis Group PTC EHF, Actavis UK Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG, this being a request for a preliminary ruling from the Patents Court, England and Wales.

In short, this is a tale of a European patent application for ‘Benzimidazol derivatives, medicaments containing them and process for their preparation’ which Boehringer filed 23 years ago, in 31 January 1992 and which was granted in May 1998 (the ‘basic patent’). This patent disclosed and claimed numerous molecules, one of which is telmisartan -- an active ingredient for treating high blood pressure and to reduce cardiovascular morbidity (a fancy term for 'heart disease') in adults.  Claims 5 and 8 of the basic patent were for telmisartan alone and for one of its salts.

On the basis of that patent and a marketing authorisation granted on in December 1998 for the medicinal product Micardis, which contained telmisartan as the sole active ingredient, Boehringer obtained in August 1990 a supplementary protection certificate (SPC -- a patent term extention) for it. The product description for this SPC was ‘[t]elmisartan, optionally in the form of a pharmaceutically acceptable salt’. This SPC expired in December 2013.

Meanwhile, in April 2002 a company in the Boehringer group secured a marketing authorisation for a combination of telmisartan and hydrochlorothiazide (a diuretic that acts by inhibiting the kidney’s ability to retain water). The hydrochlorothiazide molecule has been known since 1958 and is in the public domain. Telmisartan and hydrochlorothiazide are the sole active ingredients of the medicinal product sold by Boehringer as MicardisPlus. In September 2002 Boehringer applied to the UK  Intellectual Property Office (UKIPO) for an SPC for the combination of the active ingredients telmisartan and hydrochlorothiazide. Hold on, said the UKIPO, the combination must be clearly claimed in the patent if it is to be regarded as requiring protection as such -- but the basic patent contained only claims which related to telmisartan by itself. So why not apply to amend the basic patent by inserting a claim to the combination of telmisartan and hydrochlorothiazide?

Boehringer, taking the UKIPO up on this suggestion, asked for the application for the combination SPC to be suspended and, in November 2003, applied to the UKIPO to amend the basic patent by inserting a new claim 12, relating to a pharmaceutical combination of telmisartan and hydrochlorothiazide. The UKIPO agreed to all of this, granting the application to amend in November 2004: the patent as amended expired on 30 January 2012.

As soon as the amendment was allowed, Boehringer asked the UK IPO to revive its suspended application for the combination SPC application. Fine, said the UKIPO, and the combination SPC was granted in January 2005. It is due to expire on 30 January 2017.

This all looks so straightforward that it is hard to imagine that anything might go wrong.  But we have not yet reached the end of the story.

Actavis, a generic medicinal products manufacturer, claimed that the combination SPC was invalid since, at the date on which the application was originally made for it back in September 2002, claim 12 did not yet exist and the product in question was not therefore specified anywhere in the claims of Boehringer’s basic patent. But this is no problem, responded Boehringer. After all, is it not allowed under both EU and national legislation to amend patents after they have been granted?  Since the result of an amendment has retrospective effect, the basic patent retrospectively protected the product for which the combination SPC application was originally made before the amendment.

Actavis's action, lodged with the Patents Court, England and Wales, come before Mr Justice Birss who decided to pose the following questions for a preliminary ruling:
‘(1) (a) If a patent does not, upon grant, contain a claim that explicitly identifies two active ingredients in combination, but the patent could be amended so as to include such a claim, could this patent, whether or not such an amendment is made, be relied upon as a “a basic patent in force” for a product comprising those ingredients in combination pursuant to Article 3(a) of Regulation No 469/2009/EC?

(b) Can a patent that has been amended after the grant of the patent and either (i) before and/or (ii) after the grant of the SPC be relied upon as the “basic patent in force” for the purposes of fulfilling the conditions set out in Article 3(a) of Regulation No 469/2009?

(c) Where an applicant applies for an SPC for a product comprised of active ingredients A and B in circumstances where:
(i) after the date of application for the SPC but before the grant of the SPC, the basic patent in force, being a European Patent (UK) is amended so as to include a claim which explicitly identifies A and B;

and

(ii) the amendment is deemed, as a matter of national law, always to have had effect from the grant of the patent;

is the applicant for the SPC entitled to rely upon the patent in its amended form for the purposes of fulfilling the [Regulation No 469/2009] Article 3(a) condition?

(2) For the purposes of determining whether the conditions in Article 3 [of Regulation No 469/2009] are made out at the date of the application for an SPC for a product comprised of the combination of active ingredients A and B, where:

(a) the basic patent in force includes a claim to a product comprising active ingredient A and a further claim to a product comprising the combination of active ingredients A and B, and

(b) there is already an SPC for a product comprising active ingredient A (“Product X”), is it necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone?

(3) Where the basic patent in force “protects” pursuant to Article 3(a) [of Regulation No 469/2009]:

(a) a product comprising active ingredient A (Product X); and

(b) a product comprising a combination of active ingredient A and active ingredient B (“Product Y”);

and where:

(c) an authorisation to place Product X on the market as a medicinal product has been granted;

(d) an SPC has been granted in respect of Product X; and

(e) a separate authorisation to place Product Y on the market as a medicinal product has subsequently been granted,

does … Regulation [No 469/2009], in particular Articles 3(c) and (d) and/or 13(1), preclude the proprietor of the patent being issued with an SPC in respect of Product Y? Alternatively, if an SPC can be granted in respect of Product Y, should its duration be assessed by reference to the grant of the authorisation for Product X or the authorisation for Product Y?

(4) If the answer to Question 1(a) is in the negative and the answer to Question 1(b)(i) is positive and the answer to Question 1(b)(ii) is negative, then in circumstances where:

(a) in accordance with Article 7(1) of … Regulation [No 469/2009], an application for an SPC for a product is lodged within six months of the date on which a valid authorisation to place that product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1)];

(b) following the lodging of the application for the SPC, the competent industrial property office raises a potential objection to the grant of the SPC under Article 3(a) of … Regulation [No 469/2009];

(c) following and in order to meet the aforesaid potential objection by the competent industrial property office, an application to amend the basic patent in force relied upon by the SPC applicant is made and granted;

(d) upon amendment of the basic patent in force, the said amended patent complies with Article 3(a) [of Regulation No 469/2009];

does Regulation [No 469/2009] prevent the competent industrial property office from applying national procedural provisions to enable (a) suspension of the application for the SPC in order to allow the SPC applicant to apply to amend the basic patent, and (b) recommencement of the said application at a later date once the amendment has been granted, the said date of recommencement being
– after six months from the date on which a valid authorisation to place that product on the market as a medicinal product was granted, but

– within six months of the date on which the application to amend the basic patent in force was granted?’
This morning the CJEU cut to the chase and answered all these questions with a brevity which will be commendable if it provides the information that the trial judge actually needs in order to make his decision:
Article 3(a) and (c) of Regulation ... 469/2009 ... must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a supplementary protection certificate, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second supplementary protection certificate for that combination.
Comments on this decision are, as usual, welcomed.

Tuesday, 24 February 2015

Dutch Council of State upholds Syngenta's "wrong date" appeal

Writing on behalf of himself and his Netherlands CMS colleagues Edmon Oude Elferink, Conny Delissen and Willem Hoorneman, Rogier de Vrey brings news of a recent judgment delivered by the Dutch Council of State on 18 February 2015 in what he describes as a very interesting SPC case [so far as this blogger is concerned, all SPC cases are interesting, and he can even find room in his heart for those decisions on the Special Mechanism ...]. The Council of State is the highest general administrative court in the Netherlands, so its pronouncements deserve our attention. Writes Rogier
This case basically concerns the issue whether it is possible to rectify – in this case extend – the term of protection of an SPC, after it has been granted, if the term of protection of the certificate is incorrectly calculated.

In this case, the Netherlands Patent Office ("NPO") granted Syngenta an SPC on 9 December 2005 on the basis of a ('mono') Polish MA. It is now undisputed, after the University of Queensland judgment of the Court of Justice of the European Union (C-630/10), that the SPC was granted on the basis of the wrong MA. The NPO should have used the Finnish "combi-MA" for the calculation of the term of the SPC. As a result, the certificate was valid until 24 March 2014 while, had the Finnish "combi-MA" been used, the term of the certificate would have extended for more than 1½ years. 
On 3 September 2013, about eight years after the grant of the certificate, Syngenta asked the NPO to rectify the duration of the certificate. At the time of this request, the certificate was still in force. This request was denied by the NPO. The NPO also dismissed the notice of objection lodged by Syngenta to the NPO. The Court of The Hague subsequently dismissed the appeal brought by Syngenta against this decision of the NPO. Syngenta appealed this decision with the Administrative Jurisdiction Division of the Council of State, requesting the president to grant an interim injunction. This request for an interim injunction was rejected as well.

Council of State
In the proceedings on the matters before the Council of State, NPO asserted that there is no obligation to reconsider its decision to grant the certificate in 2005. Syngenta could have filed a notice of objection (after 9 December 2005) within the statutory period of 6 weeks, which it had not done. Article 17(2) of Regulation 1610/96 (the Regulation) does not, according to the NPO, lead to another result, as this clause allegedly only refers to the possibility of lodging an objection in accordance with national rules of procedure (the 6 weeks term). There were no new facts or changed circumstances that would require reconsideration of the original decision under administrative law (art. 4:6 of the Dutch Administrative Act). Finally, NPO asserted that rectifying the duration of the certificate could affect the interests of third parties.

Syngenta argued – in brief - that the interpretation of NPO of Article 17(2) of the Regulation does not comply with the mandatory and supranational nature of Regulation 1610/96, the general aim and purpose of this Regulation and the principle of Loyalty in EU Law (Article 4 (3) TEU). The correction mechanism introduced in Article 17(2) would be meaningless if invoking this Article would be subject to a national appeal period of 6 weeks. Article 17(2) was inserted (at a later stage) in the Regulation as an option for appeal, separate from the option provided by Article 17(1). Moreover, Article 17(2) should be interpreted broadly. The fact that in this case the incorrect calculation of the duration of the certificate is not the result of an error in the entry in the application of the date of the first MA, but the result of the use of an incorrect MA, can not preclude application of Article 17 (2).

The Council of State (on the merits) was convinced by the arguments of Syngenta and upheld the appeal lodged by Syngenta. The Council of State ruled that the duration of the certificate granted to Syngenta will be extended in the sense that the expiry date of the certificate will be set at 18 December 2015 and ordered NPO to compensate Syngenta for the costs of the proceedings.

In particular, this broad interpretation of Article 17(2) and the ability to basically at anytime request rectification under Article 17(2), is groundbreaking and has a potential impact on the position of SPC owners. To our knowledge, the judgment is the first of its kind in the European Union. We are very pleased with the spectacular result.
Rogier has helpfully furnished The SPC Blog with an English translation of this decision, which you can read here or download here

Friday, 20 February 2015

CJEU rules in Merck/Sigma Special Mechanism dispute

Last week the Court of Justice of the European Union (CJEU) gave its ruling in Case C‑539/13, Merck Canada Inc., Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals plc, this being a request for a preliminary ruling from the Court of Appeal (England and Wales).

To remind readers of the background, in 2004 a number of new Member States (the 'accession states') joined the European Union. Some of those states had not historically permitted the patenting of pharmaceutical products. By 2004, such patents were permitted, but there remained a number of cases where patents or supplementary protection certificates had been granted in other Member States for pharmaceutical products at a time when no such protection had been available in one or more of the accession states. Accordingly, a special derogation from the normal free movement rules was negotiated as part of the accession arrangements.

This derogation, known as the 'Specific Mechanism', was appended to the Act of Accession. It permitted the owner of a pharma patent or SPC to prevent the parallel importation of the patented product from one of the accession states if, at the time of filing, such protection was unavailable in that accession state. It also anyone who intended to import such a product to demonstrate to the relevant national authority that he had given notice of that intention to the holder or beneficiary of the protection.

Merck Canada, which was incorporated in Canada, was the registered proprietor of apatent and SPC for montelukast sodium, an active ingredient in a product called 'Singulair'. The second claimant, Merck Sharp Dohme, was a UK company and its exclusive licensee. Merck filed for protection when montelukast sodium could not be patented in Poland.

Sigma, a parallel importer of pharma products into the United Kingdom. In June 2009 Pharma XL, an associated company of Sigma that was responsible for applying for parallel import authorisations for the Sigma group of companies, sent a letter to Merck Sharp Dohme which stated that it intended to import Singulair into the UK from Poland. This letter referred to the Specific Mechanism and asked whether there were any objections to importation. Merck Sharp Dohme did not respond. In September 2009 PXL applied to the Medicines and Health Regulatory Agency (MHRA) for parallel importation licences. This application required confirmation that either the Specific Mechanism did not apply or that one months’ prior notification had been given to the patent holder. Pharma XL indicated that one months’ notice had been given. In May 2010 the MHRA granted Pharma XL a licence in respect of the 5mg dose of Singulair. In June and July, Pharma XL wrote to Merck Sharp Dohme, saying it planned to import Singulair from Poland and enclosed copies of the intended representation of the repackaged products. Again Merck Sharp Dohme did not respond, so Sigma began to import 5mg Singulair. In September, Pharma XL was granted a second licence in respect of the 10mg dose. Pharma XL wrote two further notification letters to Merck Sharp Dohme in respect of the 10mg dosage, but again there was no response, so Sigma began to import the 10mg form of Singulair too.

In December, Merck Canada wrote to Pharma XL objecting to the importation of Singulair under the specific mechanism and asserting that its patent had been infringed. Sigma stopped its activity, but Merck Canada nonetheless sued for infringement of both the patent and the SPC.

Sigma's primary defence was that the Specific Mechanism merely conferred upon a patent holder the option of preventing imports: the derogating provisions were inapplicable unless and until the patent holder demonstrated his intention to exercise that option -- which did not happen till December 2010. In any event, having failed to respond to the letters from Pharma XL, Merck Canada was estopped from asserting its rights.

When the case came before the Patents County Court, Judge Birss QC (as he then was) rejected both these defences. In his view, the Specific Mechanism did not require the patent holder to demonstrate his intention to oppose importation before that activity was rendered an infringement -- and he declined to refer any issue concerning the proper interpretation of the Specific Mechanism to the CJEU. Also, he found on the facts that Merck Canada was not estopped from relying on its patent rights. He granted an injunction and ordered Sigma to deliver up its unsold stocks of Singular. Sigma appealed.

The Court of Appeal for England and Wales (Lord Justice Patten, Lady Justice Black and Lord Justice Kitchin) upheld the trial judge's decision relating to estoppel: this was because there was no suggestion that Merck Canada had been, or ought to have been, aware of Sigma's existing state of mind and, in particular, the misunderstanding which Sigma had already formed as to Merck Canada's attitude to the importation of patented pharmaceutical products from Poland. There was no pre-existing relationship, contractual or otherwise, that could have imposed a duty on Merck to respond to Pharma XL's letters and Merck Canada had not acted unconscionably in delaying its decision to bring proceedings within the legal time limit.

The Court of Appeal also agreed that Judge Birss QC was right to make the order for delivery up, on the basis that his finding of infringement had been correct. However, this action raised three groups of questions that concerned the proper interpretation of the specific mechanism. These had to be answered by the CJEU before the Court of Appeal could decide the appeal. As Lord Justice Kitchin, giving judgment for the Court, explained:
Under Article 267 of the TFEU this court may submit a request to the Court of Justice for a ruling on a question concerning the interpretation of a rule of EU law if it considers it necessary to do so in order to resolve a dispute before it. In my judgment this case raises three groups of questions concerning the proper interpretation of the Specific Mechanism which must be answered for this court to decide this appeal.

The first concerns the conditions which must be satisfied before a patent holder may bring infringement proceedings under the Specific Mechanism and, in particular, whether the derogation confers upon the patent holder an option of preventing imports falling in its scope; and whether the derogation is inapplicable unless and until the patent holder demonstrates his intention to exercise that option.

The second concerns the identity of the person who must give the notice under the second paragraph of the Specific Mechanism and, in particular, whether a notification is compliant if it is given by an applicant for regulatory approval in the Member State into which the products are to be imported; and whether it makes any difference if the notification is given and the application for regulatory approval is made by one legal entity within a group of companies which form a single economic unit, and the acts of importation are to be carried out by another legal entity within that group under licence from the first legal entity.

The third concerns the identity of the person to whom the notice must be given under the second paragraph of the Specific Mechanism and, in particular, whether, in a case where a group of companies form a single economic unit comprising a number of legal entities, it is sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group which has legal ownership of or an exclusive licence under the patent. A subsidiary question also arises as to whether a notification which is otherwise compliant is rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs".

I recognise that this court is not obliged to make a reference but I believe it is appropriate to do so for the following reasons. First, these questions are not acte clair. Second, the Specific Mechanism has not yet been considered by the Court of Justice and, although its Iberian predecessor was considered by the Court in Case C-191/90 Generics and Harris Pharmaceuticals, there is uncertainty as to how the decision of the Court in that case should be understood. Finally, the parties helpfully provided to us after the hearing an agreed table which shows that the Specific Mechanism will continue to be relevant until 2019. In all these circumstances I believe it to be desirable that the questions raised in this case are answered authoritatively as soon as possible.

I would therefore make a reference to the Court of Justice for a preliminary ruling on each of the three groups of questions posed at [97], [98] and [99] above. They are currently formulated in general terms on the basis of questions originally proposed by Sigma. We have not had the benefit of any comments from Merck. Accordingly, I would invite the parties to consider them further in the light of this judgment and to propose draft questions and a draft reference for our consideration.
The questions referred to the CJEU thus read as follows:
1 May the holder, or his beneficiary, of a patent or supplementary protection certificate rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so? 2 If the answer to Question 1 is yes:
(a) How must that intention be demonstrated? 
(b) Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights?
3 Who must give the prior notification to the holder or beneficiary of a patent or supplementary protection certificate under the second paragraph of the Specific Mechanism? In particular:
(a) Must the prior notification be given by the person intending to import or market the pharmaceutical product? or 
(b) Where. as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant's regulatory approval?; and
(i) Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product? 
(ii) Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product?
4 To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular:
(a) Is the beneficiary of a patent or supplementary protection certificate limited to persons who have a legal right under national law to bring proceedings to enforce that patent or supplementary protection certification? or 
(b) In a case where a group of companies forms a single economic unit comprising a number of legal entities, is it sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate, on the basis either that such legal entity may be characterised as a beneficiary of the patent or SPC, or that it is to be expected that such notification in the ordinary course of events will to come to the attention of the persons who make decisions on behalf of the patent or SPC holder?
If the answer to Question 4(b) is yes, 
(c) is a notification which is otherwise compliant rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs" of a company when that company is not the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate but is the operating subsidiary or marketing authorisation holder in the Member State of importation and when that Regulatory Affairs department in practice regularly receives notifications from parallel importers regarding the Specific Mechanism and other matters?
The CJEU has now answered these questions as follows:
1. The second paragraph of the Specific Mechanism  ... must be interpreted as not requiring the holder, or beneficiary, of a patent or supplementary protection certificate to give notification of his intention to oppose a proposed importation before invoking his rights under the first paragraph of that mechanism. However, if such a holder or beneficiary does not indicate such an intention during the one-month waiting period laid down in the second paragraph of the mechanism, the person proposing to import the pharmaceutical product in question may legitimately apply to the competent authorities for authorisation to import the product and, where appropriate, import and market it. The Specific Mechanism thus denies that holder or his beneficiary the possibility of relying on his rights under the first paragraph of the mechanism with regard to any importation and marketing of the pharmaceutical product carried out before such an intention was indicated.

2. The second paragraph of the Specific Mechanism must be interpreted as meaning that the notification must be given to the holder, or beneficiary, of the patent or the supplementary protection certificate, the latter term designating any person enjoying the rights conferred by law on the holder of the patent or the supplementary protection certificate.

3. The second paragraph of the Specific Mechanism is to be interpreted as not requiring the person intending to import or market the pharmaceutical product in question to give notification himself, provided that it is possible from the notification to identify that person clearly.