New SPC reference to the CJEU on Article 3(c) – Novartis (C-354/19)

Carpmaels & Ransford and Awa have kindly prepared the following summary on a recent SPC reference to the CJEU:

"The Swedish Patent and Market Appeal Court has made a reference to the CJEU relating to the interpretation of Article 3(c) of the SPC Regulation for Medicinal Products, in light of Article 3(2) of the SPC Regulation for Plant Protection Products. In brief, the court is asking whether, in a case such as the present, an SPC to a new therapeutic indication is available where the applicant has an earlier SPC to the same active ingredient.

Article 3(c) of the Medicinal Products Regulation states that one of the requirements for SPC grant is that “the product has not already been the subject of a certificate” in the same member state and at the date of the SPC application. Article 3(2) of the Plant Protection Regulation provides that “[t]he holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders”, while Recital 17 of the Plant Protection Regulation suggests that Article 3(2) is also valid for the interpretation of Article 3 of the Medicinal Products Regulation.

The Swedish SPC application underlying this reference is based on Novartis’s marketing authorisation for the medicinal product Ilaris®, which contains the anti-IL1beta antibody canakinumab. The marketing authorisation supporting the SPC application is a decision from 2013 which for the first time authorises canakinumab for the treatment of systemic juvenile idiopathic arthritis (SJIA), which is a serious condition responsible for high childhood mortality and severe morbidity. The corresponding basic patent is limited to the use of antibodies such as canakinumab in the treatment of juvenile rheumatoid arthritis.

Novartis has an earlier granted SPC based on a separate patent which protects the canakinumab antibody per se. The SPC is supported by a marketing authorisation for canakinumab in the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), which is a different indication from SJIA and which falls outside of the scope of the patent that supports the later SPC application.

In view of the existence of the earlier SPC, the Swedish court is asking whether Article 3(c) in light of Article 3(2) precludes the grant of the later SPC application, which relates to a new therapeutic indication protected specifically by its own basic patent. The Swedish court has therefore referred the following question to the CJEU (our translation):

Against the background of the basic objective that supplementary protection for medicinal products aims to accommodate and which consists of stimulating pharmaceutical research in the Union, does Article 3(c) of the Regulation concerning Supplementary Protection Certificates for medicinal products, considering Article 3(2) of the Regulation concerning the creation of a Supplementary Protection Certificate for plant protection products, constitute an obstacle against an applicant, that has previously been granted a Supplementary Protection Certificate concerning a product which is protected by a basic patent in force for the product as such, being granted a Supplementary Protection Certificate concerning a new use of the product in a case such as the present where the new use constitutes a new therapeutic indication which is protected specifically by a new basic patent?

Carpmaels & Ransford represents Novartis AG in respect of its Ilaris® product. AWA represented Novartis AG before the Swedish patent office and courts in relation to the Swedish SPC application."

An SPC Hat-trick: a THIRD referral under Article 3(a) heads to the CJEU

Many thanks to Nicholas Fischer and Andrew Hutchinson (Simmons & Simmons) for sharing their article (here) on the latest referral to the CJEU on SPCs from the UK Court, which will be published in Bio-Science Law Review.

In short summary, the UK Court of Appeal referred another question to the CJEU seeking clarity concerning the correct interpretation of Article 3(a) of the SPC Regulation. This makes it a hat-trick of referrals (England 2 – Germany 1) trying to understand what it means for a product to be ‘protected’ by a patent. This referral follows Sandoz’s appeal of Arnold J’s first instance decision, in which the outcome was held to be clear (in favour of SPC grant), even if the legal test was not. The UK Court of Appeal has overturned Arnold J’s decision, stayed the appeal and referred another question to the CJEU.

The question asked by the Court of Appeal is:

“Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?”

Following the CJEU hearing the Teva v Gilead referral on Article 3(a) on 20 February (sitting as a Grand Chamber of 15 Judges) it will be interesting to see whether they deliver an overarching decision on Article 3(a) or approach this step-wise via the subsequent referrals from Germany and now the UK. We have heard that there will be an AG opinion in that case on or around 25 April so watch this space.

A new CJEU referral on claims with functional features

Last week, the 14th Senate of the German Federal Patent Court referred new questions to the CJEU on the criteria for Article 3(a) of Regulation (EC) No. 469/2009 (decision 14 W (pat) 12/17) in an attempt to clarify when a functional definition in a claim refers implicitly, but necessarily and specifically to the product in question, as stipulated by the CJEU in Eli Lilly (C-493/12).

Dirk Bühler (Maiwald), who acted for the patentee Royalty Pharma, has kindly provided a copy of the decision (here), an English translation of the decision (here) and a summary of the case (see below the questions).  For those who just want to read the questions, they are reproduced directly below:

1. Is a product protected by a basic patent in force according to Article 3 (a) of Regulation (EC) No 469/2009 only if it belongs to the protected subject-matter as defined by the claims and is thus provided to the person skilled in the art as a specific embodiment? 

2. Is it therefore not sufficient for the requirements of Article 3 (a) of Regulation (EC) No 469/2009 that the product in question meets the general functional definition of an active substance class as mentioned in the claims, but apart from that is not individualized as a specific embodiment of the teaching protected by the basic patent?

3. Is a product not protected according by Article 3 (a) of Regulation (EC) No 469/2009 by a basic patent in force if it is covered by the functional definition contained in the claims, but was developed only after the filing date of the basic patent based on independent inventive activity?

Summary 

Background 

It seems fair to say that Medeva (C-322/10) and its progenies have rather complicated than clarified as to when a product is protected by a basic patent in accordance with Article 3 (a) of the Regulation (see e.g. latest referral of Judge Arnold ([2017] EWHC 13 (pat)).

Even though it is clear in view of the numerous decisions by the CJEU since Medeva that Article 3(a) precludes SPCs for products which would infringe the patent despite not being referred to in the claims at all, e.g. for the presence of the term “comprising, there has been a debate as to how specifically the product must be disclosed in individualized form in the claims. 

For claims with functional definitions this debate has focused on whether the requirement set by Eli Lilly that such claims must refer implicitly, but necessarily and specifically to the product allows for SPCs in situations where the product is not disclosed as an individualized embodiment. Whilst this position has been endorsed by the UK courts for generic antibody claims ([2014] EWHC 2404 (Pat)) and claims with Markush formulas ([2017] EWHC 987 (Pat)), patent offices in other jurisdictions have taken a more restrictive standpoint and interpret Eli Lilly to require an individualized disclosure of the specific compound at least in the specification or to refer to antibodies only.

The referred case
The claims of the basic patent EP 1 084 705 B1 are concerned with the treatment of Diabetes mellitus by administration of DPIV-inhibitors and are based on the inventors’ recognition that inhibition of the enzyme DPIV generally allows for lowering of blood glucose levels by preserving the endogenous incretin hormones. The patent discloses individual DPIV inhibitors and points out that other DPIV inhibitors may be used as well. The general nature of the invention has been recognized by the German Federal Court of Justice in its decision on the German patent DE 196 16 486  based on the priority filing which belongs to the leading case on enablement in Germany (BGH X ZB 8/12 – Dipeptidyl-Peptidase-Inhibitoren).

DPIV-inhibitors marketed for treatment of Diabetes mellitus include sitagliptin which is not disclosed individually in the basic patent and has been developed by a licensee of the patent. Sitagliptin is also protected by a later filed composition of matter patent. The situation is thus comparable with Eli Lilly where the claims were directed to the genus of Neutrokine-alpha antibodies, but the product in question, tabalumab which is a Neutrokine-alpha antibody, was not individually disclosed in the claims or the specification and had been developed after the filing date of the basic patents.
An SPC application for sitagliptin was rejected by the German Patent and Trademark Office because sitagliptin would not be disclosed individually in the patent. The rejection was appealed.

In its referring decision the Senate acknowledges that sitagliptin is a DPIV-inhibitor as demonstrated by the assessment report of the EMA and would thus be within the extent of protection conferred by Article 69 EPC. However, according to the Senate’s interpretation of Medeva and Eli Lilly it would not be sufficient for the purpose of Article 3 (a) that the product in question, namely sitagliptin, falls within the extent of protection (Schutzbereich )conferred by the claims. It would rather be required that the product is disclosed specifically enough to form the subject matter (Schutzgegenstand) of the claims which in the absence of an individualized disclosure of sitagliptin in the basic patent would not be the case. 

The Senate however acknowledges that a different position has been taken by e.g. UK courts on highly comparable case scenarios (see [2017] EWHC 987 (Pat) in view of Medeva and Eli Lilly. This divergent interpretation of the CJEU’s case law by the national courts and patent offices would not be acceptable to applicants and run counter to the overall objective of the Regulation, namely to provide a uniform solution for the common market. 

The Senate has therefore decided to stay the appeal proceedings and to refer the following questions:

1. Is a product protected by a basic patent in force according to Article 3 (a) of Regulation (EC) No 469/2009 only if it belongs to the protected subject-matter as defined by the claims and is thus provided to the person skilled in the art as a specific embodiment?

2. Is it therefore not sufficient for the requirements of Article 3 (a) of Regulation (EC) No 469/2009 that the product in question meets the general functional definition of an active substance class as mentioned in the claims, but apart from that is not individualized as a specific embodiment of the teaching protected by the basic patent?

3. Is a product not protected according by Article 3 (a) of Regulation (EC) No 469/2009 by a basic patent in force if it is covered by the functional definition contained in the claims, but was developed only after the filing date of the basic patent based on independent inventive activity?

Thanks Dirk!

New CJEU referral - C527/17 - Does Regulation (EC) No. 469/2009 apply to CE-marked drug/device combinations?

The 14th Senate of the German Federal Patent Court has referred the controversial question of whether Regulation (EC) No. 469/2009 applies to CE-marked drug/device combinations to the CJEU for further clarification (decision 14 W (pat) 13/16). A copy of the decision can be found here. The case is now pending before the CJEU with case number C-527/17.  Markus Coehn (Peterreins Schley), who acted for the applicant, has kindly provided the following background and summary of the case:

Background:
There is largely agreement that Regulation (EC) No. 469/2009 does not apply to medical devices. Besides the formal aspect that CE-marked medical devices are not authorized according to Directive 2001/83/EC, the regulatory hurdle for obtaining a CE-mark is generally considered as too low to justify compensation of the patent term. At the same time, there is also agreement that the Regulation (EC) No. 469/2009 should be applicable to all types of pharmaceutical research without discrimination. This legislative goal is expressly stated in the Proposal for a Council Regulation (EEC) concerning the creation of a supplementary protection certificate for medicinal products, COM(90) 101 final-SYN 225, margin number 25. 

These two positions clash in cases of drug/device combinations, in particular drug/device combinations in which the drug is incorporated in the medical device and provides an ancillary (i.e. supporting) effect. Such drug/device combinations can only be authorized by a notified body according to the CE-marking procedure (Directive 93/42/EEC) but not by a regulatory authority for medical products (according to Directive 2001/83/EC). Nevertheless, regulatory authorities are involved in the CE-marking procedure by means of the so-called consultation process: prior to approval, the notified body asks a regulatory authority for medical products to assess the quality, safety and usefulness of the drug component. The regulatory authority then carries out the assessment according to the standards of Directive 2001/83/EC. On basis of this advice, the notified body then issues or denies the CE-mark. Preparing for and conducting the consultation process can be lengthy and time-consuming, in particular since the regulatory authorities often require evidence on basis of clinical trials to demonstrate quality, safety and usefulness of the drug component. Thus, the main reason for granting SPCs – loss of commercially exploitable patent term due to long regulatory approval procedures according to directive 2001/83/EC – equally applies at least to some drug/device combinations. 

 The present situation is best exemplified with the following example: Consider a new and innovative drug that has to be administered as an integral part of a medical device. The EU legislator only allows authorizing of the drug/device combination according to the CE-marking procedure. Since the drug is new, the regulatory authority involved in the consultation process requires the manufacturer to carry out substantial clinical trials to be done in compliance with Directive 2001/83/EC. Is such a manufacturer entitled to a SPC? If not: Is this not a discrimination of a pharmaceutical research to deny a SPC, contrary to the legislator’s intentions?

There is presently no common ground between the courts of the EU member states on how to resolve this issue. The referral to the CJEU will hopefully provide much-needed further clarification.

The referred case:
The referral concerns a German SPC application on basis of European Patent EP 0 681 475 B1 relating to the 2nd medical use of the anti-proliferative paclitaxel for the treatment of restenosis. Restenosis is a common side-effect of angioplasty, a minimally invasive procedure in which blood vessel are dilated to remove a stenosis. Paclitaxel as such was already authorized as a cancer drug by the EMA (EMEA/H/C/000216) on July 19th 1999. For this reason, the SPC request was limited to paclitaxel for the local administration to dilated blood vessels for the prevention or treatment of restenosis, i.e. limited to a different purpose in the sense of the Neurim decision (C-130/11). 

The SPC request was based on a CE-mark authorizing a stent which incorporated paclitaxel as an integral part. The manufacturer indicated in the CE-marking procedure that paclitaxel is incorporated into the stent to prevent and treat restenosis. The regulatory authority advising the notified body in the consultation process required that the usefulness of paclitaxel for treating restenosis is established on basis of a clinical risk/benefit analysis, i.e. on basis of clinical trials establishing therapeutic efficacy for treating restenosis in comparison to placebo (stent only). After a positive advice from the regulatory authority, the notified body issued the CE-mark in 2003.

The SPC application was rejected by the German Patent and Trademark Office on Feb. 19th, 2016. An appeal was lodged against the decision. The appeal is pending before the 14th Senate of the Federal Patent Court and stayed until the CJEU has rendered its decision.

The referring decision:
The English translation of the referred question reads as follows:

 “Is Art. 2 of the Regulation (EC) No. 469/2009 of the European Parliament and the Council dated May 6th, 2009, concerning the supplementary protection certificate for medicinal products to be interpreted such that an authorization according to Directive 93/42/EEC for a drug-device-combination in the sense of Art. 1(4) of Directive 93/42/EEC has to be considered as equivalent to an marketing authorization according to Directive 2001/83/EC, if the drug component, in the course of the approval procedure according to Annex I, Section 7.4, Paragraph 1 of the Directive 93/42/EEC, was scrutinized for quality, safety and usefulness according to Directive 2001/83/EC by an authority for a medicinal product of an EU member state?”

In the Reasons of the decision, the Federal Patent Court discusses two main aspects, namely whether an authorization according to Directive 93/42/EEC can be considered as equivalent to an authorization according to Directive 2001/83/EC and whether an authorization according to Directive 93/42/EEC can be considered as an administrative authorization procedure. 

Turning to the first aspect, the Court notes that an analogy may be seen to the CJEU’s decisions Synthon (C-159/09), Generics (UK) (C-427/09), Hogan Lovells (C-229/09), and Sumitomo Chemical (C-210/12) in which the CJEU considered authorizations not explicitly mentioned in Art. 2 of Regulation (EC) No. 469/2009. In these cases, the question of whether the drug/plant protection product was subject to (equivalent) safety and efficacy testing during the authorization procedure was decisive in determining whether or not such authorizations fall into the ambit of the SPC regulations. The Court concludes that, in the present case, the drug component underwent testing of safety and efficacy/usefulness that was equivalent to the requirements of Directive 2001/83/EC.
 
Turning to the second aspect, the Court considers that notified bodies are not authorities, but notes that notified bodies are vested with public authority. Furthermore, the Court notes that the notified body has to duly consider the advice of the regulatory authority in the consultation process with the effect that the notified body is barred from issuing a CE-mark in case of a negative advice from the regulatory authority. Thus, the CE-marking process has, in this case, the same obligatory character as an administrative procedure.

Taking these two aspects and the legislative aim of Regulation (EC) No. 469/2009 into account, the Court recommends considering an authorization according to Directive 93/42/EEC for a drug-device-combination as being equivalent to a marketing authorization according to Directive 2001/83/EC for the purposes of Art. 2 of Regulation (EC) No. 469/2009.

Many thanks Markus!

A new CJEU referral - C-681/16

In case C-681/16 (Pfizer Ireland Pharmaceuticals, Operations Support Group), the Landgericht Düsseldorf  has referred questions to the CJEU relating to SPCs and the specific mechanism.  According to the UKIPO's website, the questions are:

1.Can the holder of a supplementary protection certificate that was issued to it for the Federal Republic of Germany rely on the specific mechanism to prevent the importation of products into the Federal Republic of Germany from the accession States the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania … and Croatia (Annex IV to the 2003 Act of Accession, OJ 2003 L 236, p. 797, as amended in OJ 2004 L 126, p. 4, for Estonia, Latvia, Lithuania, Poland, Slovenia, Hungary, Slovakia, the Czech Republic; Part I of Annex V to the 2005 Act of Accession, OJ 2005 L 157, p. 268, for Romania and Bulgaria; Annex IV to the 2011 Act of Accession, OJ 2012 L 112, p. 60, for Croatia) if the supplementary protection certificate was applied for in the Federal Republic of Germany at a point in time at which the laws for obtaining such a supplementary protection certificate already existed in the respective accession States but could not be applied for by, or issued to, the holder of the supplementary protection certificate issued for the Federal Republic of Germany because the basic patent required for the issuing of the supplementary protection certificate did not exist in the accession State?

2.Does it make any difference to the answer to Question 1 if it was merely at the time of the filing of the application for the basic patent issued for the Federal Republic of Germany that such protection through a basic patent could not be obtained in the accession State but, by the time of publication of the application on which the basic patent issued for the Federal Republic of Germany was based, it could be so obtained?

3.Can the holder of a supplementary protection certificate that was issued to it for the Federal Republic of Germany rely on the specific mechanism to prevent the importation of products into the Federal Republic of Germany from the accession States the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania… and Croatia if those products are imported after the expiry of the term of the supplementary protection certificate stipulated in the original decision to grant the patent but before the expiry of the six-month extension of the term of the supplementary protection certificate that was granted to it on the basis of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004?

4.Does it make any difference to the answer to Question 3, in the case of Croatia, that, on account of the accession of Croatia in 2013, the specific mechanism did not come into force until after the entry into force of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 on 26 January 2007 – unlike in the other Member States which acceded prior to 26 January 2007, namely the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria [and] Romania …?

New CJEU Reference and Comments for the UKIPO - C-492-16 - Incyte Corporation

Case C-492/16 (Incyte Corporation) appears to be the latest SPC dispute to be referred to the CJEU for a preliminary ruling.  According to the Curia website, the following questions have been referred:

1.  Must Article 17(2) 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 ¹ be interpreted as meaning that ‘the date of the first authorization to place the product on the market in the Community’ is incorrect in an application for a supplementary protection certificate, within the meaning of that regulation and of 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, ² where that date was determined without taking account of the Court of Justice’s interpretation of the law in the judgment in Seattle Genetics (Case C-471/14), with the result that it is appropriate to rectify the date of expiry of the supplementary protection certificate even if the decision to grant that certificate was made prior to that judgment and the time limit for appealing against that decision has already expired?

2.  Is the industrial property authority of a Member State which is entitled to grant a supplementary protection certificate required to rectify, of its own motion, the date of expiry of that certificate in order to ensure that that certificate complies with the interpretation of the law set out in Case C-471/14?
____________¹ OJ 1996, L 198, p. 30.
² OJ 2009, L 152, p. 1.

In addition, the UKIPO is seeking comments on this case.  Comments must be emailed to policy@ipo.gov.uk by 25 January 2017.

New referral to the CJEU

In Merck Sharp & Dohme v Comptroller-General of Patents [2016] EWHC 1896 (an appeal to BL O/117/16), Mr Justice Arnold has referred the following questions to the CJEU for a preliminary ruling:

(1) Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?

(2) If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

This case arose because Merck Sharp & Dohme filed an SPC application one day before patent expiry but only had the "End of Procedure Communication" but not a marketing authorisation.

Date fixed for Seattle ruling

The ruling of the Court of Justice of the European Union in Case C-471/14 Seattle Genetics (on which see earlier SPC Blog post here and JA Kemp post here) is now expected on Tuesday 6 October.

Seattle is a city that is famous for its coffee, always a good way to help wake you up -- but on 6 October the SPC community will need no wake-up call. We'll all be waiting expectantly for the CJEU to make its pronouncement.

Seattle Genetics and the question of dates: the Advocate General opines

Congratulations to JA Kemp for so speedily posting this news item on yesterday's Advocate General's Opinion in the Court of Justice of the European Union (CJEU) SPC reference in Case C-471/14 Seattle Genetics. This was a request for a preliminary ruling from the Oberlandesgericht Wien. According to this note:

Both the term of an SPC and the deadline for applying for an SPC may be set by the date of the first Marketing Authorisation for a product. An issue has arisen since many Marketing Authorisations have two dates associated with them: the date of the Marketing Authorisation itself and the (later) date on which the Marketing Authorisation is notified in the EU’s Official Journal. Practice across Europe has begun to diverge as to which of these dates should be used. The UK Intellectual Property Office, for instance, uses the date of notification, as do the Belgian, Slovenian and Portuguese Patent Offices. In many other EU territories, however, the earlier date of the Marketing Authorisation is used. In practical terms this has resulted in SPCs being granted in EU territories with different terms, albeit only differing by a few days in length.

This issue came before the Oberlandesgericht Wien after Seattle Genetics appealed a decision of the Austrian Patent Office to use the date of Marketing Authorisation to calculate the term of an SPC. Given the divergent practice across the EU territories, and the fact that it was not clear whether Community law or local law should apply, the Oberlandesgericht Wien referred two questions to the CJEU. The questions referred were:

Is the date of the first authorisation to place the product on the market in the Community pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law or does that provision refer to the date on which the authorisation takes effect under the law of the Member State in question? If the Court’s answer is that the date referred to in Question 1 is determined by Community law, which date must be taken into account — the date of authorisation or the date of notification? The Advocate General (AG) has now issued his preliminary Opinion, answering the first question by confirming that it is Community law which applies. The AG has answered the second question by confirming it is the date of notification which should be used. The AG’s Opinion is therefore in conformity with the approach currently adopted by the UK Intellectual Property Office, and Belgian, Slovenian and Portuguese Patent Offices.

The questions referred by the Oberlandesgericht Wien and the AG’s Opinion deal only with Article 13 of the SPC Regulation, which sets the term of an SPC. It is nonetheless slightly disappointing that the AG did not see fit also to comment upon other Articles in the SPC Regulation which are affected by the date of the first Marketing Authorisation. In particular, Articles 3(d) and 7, which concern the requirement for an SPC to be based on the earliest Marketing Authorisation in an EU member state, and the deadline for applying for an SPC, respectively. However, it seems likely that the same reasoning would apply to those Articles.

The AG’s opinion is not binding on the CJEU, but does set out the key points which will be taken into account by the CJEU when coming to their decision. The CJEU’s final decision is not expected for another 12 months or so.

Seattle Genetics: CJEU calls for an AG's Opinion

Our good friend Mike Snodin (Park Grove IP) has spotted that the Court of Justice of the European Union (CJEU) has indicated that the Advocate-General’s opinion in Case C-471/14 Seattle Genetics will be issued on 10 September 2015.  To remind readers, this is a reference for a preliminary ruling from the Oberlandesgericht Wien (Austria) which was made in October of last year, so it's proceeding fairly swiftly through the CJEU. The questions referred are:

Is the date of the first authorisation to place the product on the market in the Community pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law or does that provision refer to the date on which the authorisation takes effect under the law of the Member State in question?

If the Court’s answer is that the date referred to in Question 1 is determined by Community law, which date must be taken into account — the date of authorisation or the date of notification?

Mike hypothesises that the call for an Advocate General's opinion must mean that the CJEU does not believe that the answers to the questions posed are either obvious or clearly deducible from existing case-law.

For further information see The SPC Blog's posts here (announcing the reference) and here (flagging an article by Mike Snodin).

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.

Seattle Genetics and an alternative question -- but will the CJEU answer it?

The SPC Blog has received further news from our friend Mike Snodin (Park Grove IP) that he has published another article in Scrip Regulatory Affairs. This latest article, entitled “Supplementary Protection Certificates: the Court of Justice of the EU will have its day after all” (a copy of which can be obtained here), relates to the questions referred to the Court of Justice of the European Union (CJEU) in Case C-471/14 Seattle Genetics [on which see earlier SPC Blogpost here].

As regular readers of this blog will know, the questions referred by the Oberlandesgericht Wien in Seattle Genetics relate to the issue of whether longer term should be awarded to certain SPCs by relying upon the date of notification of a “centralised” Marketing Authorisation instead of the (earlier) date of the European Commission’s decision to issue the Authorisation.

Mike’s article discusses and analyses the questions referred to the CJEU and highlights potential problems with regard to the framing of those questions. In an attempt to clear away any confusion that could be caused by the manner in which the questions referred have been framed, Mike presents an alternative question that is more precisely adapted to the facts underlying Seattle Genetics. He concludes by expressing the hope that the CJEU decides to answer such an alternative question, and by outlining reasons why, in his view, that alternative question should be answered in favour of using the date of notification for “centralised” MAs.

Seattle "Relevant date" reference: UKIPO seeks comments

Back in October The SPC Blog posted a this item from Daniel J. Wise (Carpmaels & Ransford), "Austria refers Seattle Genetics to CJEU: is "relevant date" for EU or national law?". The UK Intellectual Property Office is now seeking comments on this reference, with a view to advising the UK government as to whether it wishes to make representations in this reference. According to the UKIPO's media release:

CJ case: C-471/14: SEATTLE GENETICS

We have received notification of a new case referred to the Court of Justice of the European Union (CJEU): C-471/14: A request for a preliminary ruling concerning the supplementary protection certificate for medicinal products.

The questions referred to the Court of Justice (CJ) for a preliminary ruling are:

1. Is the date for the first authorisation to place the product on the market, pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law, or does that provision refer to the date on which the authorisation takes effect in the law of the Member State in question?

2. If the Court determines that the answer is that the date is determined by Community law, is this the date of authorisation or the date of notification?

This case and the questions referred to the Court can also be viewed on our website at:

https://www.gov.uk/government/publications/references-to-the-european-court-of-justice/references-to-the-european-court-of-justice-2014

If you would like to comment on this case please e-mail policy@ipo.gov.uk by 01 December 2014.

The UKIPO provides further information about its solicitation of comments:

We understand how difficult it is to provide detailed comments in the time available. The IPO has tight time limits in which to consider and provide advice to ministers on CJ cases. In order to help us provide the right advice, we just need a short email by the deadline stating whether you think the UK should intervene and some general points about how you think we should answer the questions.

You are welcome to follow this email up with more detailed comments after the deadline, which can be taken into consideration if we have chosen to submit observations or if we decide to attend a hearing.

If you are aware of any references to the Court of Justice that are not currently included on our website, you are also welcome to send us your views. If you choose to do this, please include clear information about the case to help us to identify it.

Further information on intellectual property CJ cases can be found on our website https://www.gov.uk/government/publications/references-to-the-european-court-of-justice. 

Austria refers Seattle Genetics to CJEU: is "relevant date" for EU or national law?

From our friend Daniel J. Wise (Partner, Carpmaels & Ransford LLP ) comes the following information about a development from Austria:

On 15 October 2014 the Oberlandesgericht Österreich referred questions to the CJEU on a preliminary ruling regarding the calculation of the SPC term under Article 13 of the SPC regulation.  The case has been assigned the reference number C-471/14 (Seattle Genetics).    The referral not only asks whether under Community law the authorisation’s notification or the decision date should be used to calculate the SPC term, but crucially first asks whether Community law even applies, or whether instead the relevant date should be determined under national law.  The referred questions are (translated from the original German-language decision):  

1.     Is the date of the first authorisation to place the product on the market in the Community under Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products determined under Community law, or does the Regulation refer to the date on which the authorisation takes effect according to the law of the respective member state?      

2.     If the CJEU affirms that the date under question 1 is determined under Community law: which is the relevant date – that of the authorisation or that of the notification?    

The need for a referral in this area has been clear, particularly since the UKIPO’s change of practice a year ago to use the date of notification rather than the date of the decision to calculate the SPC term based on centralised authorisations (BL O/418/13 – GENZYME).  This approach typically results in a few extra days of term, which can be very valuable.  Belgium, Slovenia and most recently Portugal use a similar approach, but other national patent offices have resisted, arguing either that the SPC regulations make it clear that the date of the decision is the relevant date, or that in the absence of a CJEU ruling on the matter there is no need for them to change their practice.   

The referral is based on Austrian SPC application no. SZ 39/2012 (“Brentuximab vedotin or pharmaceutically acceptable salts thereof”).  The applicant (Seattle Genetics) applied for the SPC based on EP 1 545 613 and Takeda’s authorisation EU/1/12/794/001 for Adcetris (Brentuximab vedotin).  The authorisation is dated 25th October 2012, but was notified 5 days later, on 30th October 2012.  In calculating the SPC term, the Austrian patent office used the decision date of the authorisation, but Seattle Genetics argued that the notification date should be used, resulting in 5 additional days of SPC term bringing the SPC’s term to 30th October 2027.  In its reasoning, Seattle Genetics referred to the practice in the UK, Belgium, Slovenia and Portugal, as well as Art. 13 and Recital 9 of the Regulation, and the authorisation itself which states that the authorisation is valid from the date of notification.  The Austrian Oberlandesgericht seems to think that if Community law applies, then the relevant date should be the date of the decision, but if national law applies then in Austria it is likely that the relevant date is the notification date.  

It will be interesting to see what the CJEU says.  It would be short-sighted if the CJEU only answered these questions with reference to Article 13, though.  Whatever the answers, SPC applicants will want to know if the same logic applies to Articles 3(d) and 7 as well ... 

Thanks so much, Daniel, for taking the trouble to share this with us.

"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

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!