The SPC Blog once again thanks Alice de Pastors for sharing her excellent and informative SPC News (no.30) with readers of this weblog.  Unfortunately, it looks like this will be the last issue.  Thanks Alice for all your efforts!

Readers can access the SPC News here.

Nab paclitaxel - the UKIPO decision

Not a direction to steal some drug, but rather the full name of the active in this UKIPO decision, considering inter alia the requirements of Article 3d.

The UKIPO's summary is below and the link to the case here: 

The product for which a Supplementary Protection Certificate (SPC) was sought is defined in the application as “paclitaxel formulated as albumin bound nanoparticles” - referred to as “nab paclitaxel”. Article 3(d) requires that the supporting marketing authorization is the first authorization for the product in the EU. Article 1(b) defines a product as “the active ingredient or combination of active ingredients of a medicinal product”. The examiner considered that paclitaxel, a well-known anti-cancer drug, was the sole active ingredient in the product and therefore the application did not comply with Article 3(d) as it had been previously received marketing authorisations in the EU.

The hearing officer considered that the application was in line with the purpose of the Regulation and had circumstantial and consequential parallels with the SPC held to be valid by the Court of Appeal in Re. Generics UK Ltd v Daiichi Pharmaceutical Co Ltd; Daiichi Sankyo Co Ltd EWCA Civ 646 [2009].

The applicant submitted that nab-paclitaxel represented a new single active ingredient. The hearing officer accepted a range of clinical and in vitro evidence showing that nab-paclitaxel is more effective and safer than paclitaxel, for example in treating breast tumours and in treating non-small cell lung cancer and pancreatic cancer in combination with other drugs. He also accepted that nab-paclitaxel is transported across cell membranes and remains intact inside tumour cells. However, he considered on the basis of the evidence before him that albumin did not play an active role in killing tumour cells but that it functioned as a carrier, which is regarded as a conventional function of albumin. He held that nab-paclitaxel was not a new single active ingredient but a combination of two ingredients and that the albumin component of nab-paclitaxel did not have a therapeutic effect on its own. Consequently, he held that nab-paclitaxel did not qualify as a combination of active ingredients, having regard to the ruling of the Court of Justice of the European Union (CJEU) in Massachusetts Institute of Technology (C-431/04). Several other authorities relating to this subject are also referred to in the decision.

The applicant contended that nab-paclitaxel was a new application of paclitaxel and therefore should be granted an SPC in light of the CJEU ruling in Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (C-130/11). The hearing officer interpreted the judgment in Re. Neurim as requiring that the new application of a product should be limited to a new therapeutic application and held that nab-paclitaxel did not represent a new therapeutic application of paclitaxel. The application was refused as the hearing officer held it did not comply with Article 3(d) of the SPC Regulation having regard to the definition of a product pursuant to Article 1(b). 

C572/15 (Xeloda) - SPC term calculation and EU accession

The facts in this case (link here ) are as follows.

Roche markets a medicinal product called "Xeloda" in Estonia.  The active substance is capecitabine.  Roche has a basic patent granted on 15 April 1998.  Xeloda was registered for the first time in Estonia on 8 June 2001 and was granted an SPC by the Estonian Patent Office.  

Accord obtained an Estonian marketing authorisation (MA) for a generic version of the product. Roche brought an action before the Estonian district court seeking an injunction against Accord to prevent infringement of their rights until SPC expiry, which Roche calculated to be 8 June 2016.   

Accord considered that the SPC was not valid because the first MA for Xeloda had been  granted in Switzerland in 1998, so they said the maximum 15 years of protection actually expired in 2013. 

Roche countered that the SPC duration should be 15 years from the date of the Estonian MA.  They argued that, as the SPC was issued at a time when Estonia was not a member of the European Union, then only Estonian law applied, according to which the duration of validity of the SPC depended not on the grant of the first MA in the European Union, but the grant of that authorisation in Estonia.

The Estonian Supreme Court then referred the following questions to the ECJ:

"(1) Must Article 21(2) of Regulation No 469/2009 … be interpreted as shortening the duration of [an SPC] issued in a Member State which was issued under national law before the accession of the State in question to the European Union and whose duration in relation to an active substance, as stated in the [SPC], would be longer than 15 years from the time when the first [MA] in the Union was granted for a medicinal product consisting of the active substance or containing it?

(2) If the answer to the first question is in the affirmative, is Article 21(2) of Regulation No 469/2009 … compatible with European Union law, in particular the general principles of European Union law on the protection of acquired rights, the principle of the prohibition of retroactive effect of law, and the Charter …?"

The CJEU held that, for the purpose of calculating the duration of the SPC, the relevant marketing authorisation was to be that first granted in the EU or, in the EEA, even though this was granted before Estonian accession.  

This was not considered to be a retrospective application of EU rules because an SPC took effect only at expiry of the patent, which was after the date of accession. 

The court also ruled that it had no jurisdiction to rule on the validity of Article 21(2) of the SPC Regulation.

The CJEU conclusion was as follows:

1.      The Court of Justice of the European Union does not have jurisdiction to rule on the validity of Article 21(2) 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, as amended by the Act concerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community.

2.      Article 21(2) of Regulation No 469/2009, as amended, must be interpreted as meaning that it applies to a supplementary protection certificate, relating to a given medicinal product, granted by a Member State prior to its accession to the European Union. To the extent that that medicinal product was the subject, within the European Economic Area, of a marketing authorisation before that granted in that Member State, and, as the case may be, before its accession to the European Union, only the first marketing authorisation must be taken into account for the purposes of determining the duration of validity of the supplementary protection certificate.

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.

Brexit: what does Boris Johnson have to say about SPCs?

Fortunately nothing at all,  but after the UK's exit from normality we've been asked what impact there will be on SPCs in the UK?

As SPCs are granted in the UK under an EU regulation, which will no longer apply after Brexit, in the future it will be necessary for the UK to enact legislation to create some form of equivalent protection. Presumably this will not be at the top of the list of priorities for our new PM, and possibly we will adopt the current EU legislation into UK law, but without appeal to the CJEU for obvious reasons.  The possibility remains that any new protection could be of a different scope, but this seems an unlikely outcome given that there will apparently be some other things to do as well.  After Brexit the UK courts will not be bound by the existing CJEU decisions, or be able to refer questions on SPCs to the CJEU, and we may have divergent opinions on similar legal issues between the UK and EU as we move forward.  Given the view of some of the UK judges on the opinions of the CJEU, this could be rather interesting.

There will also need to be a new mechanism for extending the SPC term after appropriate paediatric studies, assuming the UK looks to maintain equivalent protection with the rest of the EU.

SPCs already granted by the UKIPO should be unaffected, but could potentially have a different validity if the law that applies to them is interpreted differently by a court free from the constraints of CJEU decisions.

Finally, this will all have to be subject to any new or transitional approval regime, given that the EMA may cease to have any jurisdiction in the UK.

All in all, Brexit has placed the UK in a position that arguably is more complex than SPC case law….and that's saying something.

Rob and Catherine

SPC Seminar coming up soon!

Daniel Wise of Carpmaels & Ransford has written in to the Blog to say that there are a few last places available for Carpmaels’ annual “SPC Summer Review” event taking place next Thursday, 7th July 2016, from 17:30 (for a 18:00 start) at their offices in central London (One Southampton Row, WC1B 5HA).  The seminar will focus on recent CJEU and national guidance for combination product SPCs, including Actavis v Boehringer (C-577/13) and Merck Sharp & Dohme (BL O/117/16), the current approach to Neurim-style SPCs, and will provide a timely opportunity to discuss the implications for SPCs of Brexit and the Unitary Patent & Unified Patent Court.  Drinks and canapés will be served afterwards.  If you would like to join, please send an email to kmm@carpmaels.com, with the subject line “I would like to attend the SPC Summer Review 2016”.  Attendance is free of charge.

Re-launch of the European Commission's tender for a Study on legal aspects of SPCs in the EU

The European Commission's initial tender for a "Study on legal aspects of supplementary protection certificates in the EU" has had to be re-launched due to a very limited number of bids:  the new tender has a closing date of 27 July 2016. 

The study's purpose is stated as follows:

The contracted study shall evaluate whether a new European SPC title, with the current or broader scope within the field of pharmaceutical and plant protection products, with improved provisions, is required to meet the requirements of current and expected innovative market developments in the EU.

With this primary purpose, the study shall evaluate the current SPC framework in terms of its legal efficiency in meeting its stated objectives given the development of directly affected and related product markets.

It shall also suggest whether the existing SPC rules need to be recalibrated given identified limitations.

The results could serve as a basis for an impact assessment for a future proposal by the Commission to recalibrate the existing EU SPC rules.

Details of the tender can be found here.

Update on IL PTE practice: Notification date of MA to be used in calculating PTE duration

Liad Whatstein of Liad Whatstein & Co. brings news of a recent decision of the Israeli Patent Office regarding the calculation of the duration of Israeli patent term extensions (PTEs).  Liad represented Novartis in the IL PTE petition for secukinumab (Cosentyx®).  He writes:

The Israel PTO recently accepted that for the purpose of calculating the duration of IL PTEs the EMA MA notification date shall be taken into account. This development changes the practice of the IL PTO and comes only a few months after the IL Patents Commissioner held that the EMA MA grant date should be used.

The Israeli PTE system is unique and is based on a series of linkages to the expiry dates and extension periods of the US PTE and SPCs granted in any of the EU-5 countries (United Kingdom, Italy, France, Spain and Germany). In addition, the Israeli PTE must end no later than 14 years from the earliest date in which a regulatory approval was obtained in either the Unites States or the EU-5 countries.

In the matter of IL PTE petition for Apixaban (Eliquis®) published on September 16th, 2015, the IL Patents Commissioner held that for the purpose of calculating the duration of IL PTEs the EMA MA grant date rather than the EMA MA notification date will be used. As a consequence, the PTE for Apixaban (Eliquis®) will expire in Israel two days earlier than would have been the case if the EMA MA notification date started the 14 year count. The IL Commissioner justified his decision by referring to the lack of uniformity between different European Patent Offices on this issue (i.e., whether the EMA grant date or the EMA notification date should be used to calculate the duration of SPCs under Article 13 of Regulation No 469/2009). However, the IL Commissioner was not apprised of the opinion of the ECJ advocate general (AG) in Seattle Genetics which was published prior to the decision in the Apixaban case. If the IL Commissioner had been apprised of the opinion of the AG, the Commissioner would have likely reached a different result.

In any event, after the CJEU published its binding decision in Seattle Genetics (case C-471/14) on October 6th, 2015, it was only a matter of time until the IL PTO would be called to reevaluate its position. In the matter of IL PTE petition for secukinumab (Cosentyx®), the IL PTO examiner initially calculated the IL PTE period based on the EMA grant date which was 4 days earlier than the notification date. The patentee argued that once the CJEU issued a final decision, which is applicable in all of the EU-5 Countries (among others), holding that the calculation of the duration of supplementary protection should be based on the EMA MA notification date – the IL PTO is bound to follow the CJEU determination. The IL PTO reevaluated its position and decided to follow the CJEU ruling, effectively canceling the IL Commissioner’ decision in the matter of IL PTE petition for Apixaban (Eliquis®).

Many thanks to Liad for sharing the news with us!

Austrian SPC decision on an SPC application based on a variation type II of an existing MA

Bianca-Lucia Vos and Klemens Stratmann of Hoffmann-Eitle have generously provided a copy of a recent decision of the Higher Regional Court of Vienna (here) regarding an SPC application based on a variation type II of an existing marketing authorisation.  An English translation of the decision can be obtained here.  Bianca-Lucia and Klemens comment:

On January 21, 2016 the Higher Regional Court of Vienna, Austria, issued a decision (34 R 104/15) on the interpretation of Art. 3(b) of Regulation 469/2009 in the light of the Neurim judgment of the CJEU (case C-130/11). In the case underlying the appeal to the Higher Regional Court of Vienna, the Austrian Patent Office had rejected an SPC application that was based on a second medical use patent (EP 0 758 900) and a Type II variation of an existing (national) marketing authorization for Botox due to which the indication protected by the selected basic patent, i.e. treatment of chronic migraine, was added to the already approved indications of Botox. The Examiner had calculated the 6-month time limit for filing the SPC application according to Art. 7(1) of Regulation 469/2009 from the date of the very first marketing authorization for Botox in Austria. In his view, the amendment by a Type II variation of a marketing authorization does not newly trigger the 6-month time limit for applying for an SPC.

However, following the considerations of the European Court of Justice in the Neurim decision C-130/11, the Higher Regional Court of Vienna ruled that a marketing authorization as amended by a Type II variation can be considered as a valid marketing authorization in the sense of Art. 3(b) of Regulation 469/2009. The Court also emphasized that patent protection and marketing authorization must harmonize in terms of content, and that earlier authorizations do not deprive the more recent authorization of a patented use from being the “first authorization” pursuant to Art. 3(d) of Regulation 469/2009, if the earlier authorization refers to areas not protected by the basic patent.

Accordingly, the Court also held that an earlier authorization granted for a use outside the scope of protection of the patent has no negative effect in so far as it does not trigger the 6-month time limit pursuant to Art. 7(1) of Regulation 469/2009.  Therefore, the contested decision had to be reversed, and the Patent Office ordered to render a decision on the merits as to whether the application had been filed in due time.

Applying the principles set forth by the CJEU in Neurim, the Higher Regional Court Vienna hence confirmed that an SPC application may be filed on the basis of a Type II variation of an existing marketing authorization as “valid authorization to place the product on the market” according Art. 3(b) and “first authorization” in the sense of Art. 3(d) of Regulation 469/2009.

Many thanks to Bianca-Lucia and Klemens for sharing this decision!

SPC seminar coming up -- discount for SPC Blog readers

From our old friend Rechtassessor Jean-Claude Alexandre Ho (IP conference manager at FORUM Institut für Management GmbH) comes news of an SPC-related seminar which he is organising.

'Quo vadis, SPC?', the update seminar in which Dr Christopher Brückner, the author of the SPC commentary noted here (participants will receive the second edition on top of course documentation), will speak on the CJEU's referrals from 2011 to 2016 and on how to understand the decisions and which practical consequences we may expect for the future.  Date: 31 May 2016; venue: Basel.

More information is available here.  SPC Blog readers are entitled to a 10% discount against the registration fee (CHF 1,160 down from CHF 1,290).

To register and gain benefit of your reduced fee, just forward this blogpost to Jean-Claude himself at jc.alexandreho@forum-institut.de, or call him, quoting "The SPC Blog" (+49 6211 500-675).

SPCs and Medical Devices - a decision from the German Federal Patent Court

The SPC Blog is grateful to Ulrike Herr and Raphael Bösl at Isenbruck Bösl Hörschler LLP for providing a recently published decision of the German Federal Patent Court regarding SPCs and medical devices, here.  Ulrike and Raphael represented the Leibniz-Institut für Neue Materalien gemeinnützige GmbH in the proceedings and have kindly provided the following summary of the decision:

"The German Federal Patent Court (BPatG) has handed down recently the decision for the SPC case Leibniz-Institut für Neue Materialien gemeinnützige GmbH (14 W (pat) 45/12). This decision of December 8, 2015 concerns the application of Regulation 469/2009 to medical devices.

In Short: The BPatG emphasised that an SPC is not granted for a medicinal product as such (or as in the present case: for a medical device), but only for an active ingredient or for a combination of active ingredients, respectively, of a medicinal product. The term "active ingredient" means that the product exerts a pharmacological, immunological or metabolic action of its own. Moreover, currently, the BPatG does not seem to grant SPCs for medical devices based on Regulation 469/2009 at all.

The Case: The Leibniz-Institut für Neue Materialien gemeinnützige GmbH ("Leibniz") filed an SPC application in Germany for the medical device product "aminosilane-coated iron oxide nanoparticles" based on EC Design Examination Certificate no. 11870GB411100614 granted under the Medical Device Directive (MDD) 93/42/EEC. Aminosilane-coated iron oxide nanoparticles are used for the local treatment of solid brain tumours. The method is based on the principle of introducing the magnetic nanoparticles directly into a tumour and then heating them in an alternating magnetic field. As a result of the treatment, tumour cells are either irreparably damaged or sensitized for additional therapies. The therapeutic effect is achieved by physical means.

The German Patent and Trademark Office (GPTO) rejected the SPC application essentially on the grounds that the product is not a medicinal product but a medical device and that the EC Design Examination Certificate which is governed by MDD 93/42/EEC is allegedly not a valid marketing authorisation under Article 3(b) of Regulation 469/2009. The GPTO excluded also application of Regulation 469/2009 to medical devices by analogy. In the UK, the corresponding SPC application was rejected for similar reasons. The Hearing Officer held that a product, which had not been subject to an administrative authorisation procedure, is excluded by Article 2 of Regulation 469/2009 (see post dated 8 August 2014).

In Germany, Leibniz appealed against the rejection decision and argued inter alia that, on one hand, the product is a medical device according to Article 1(2)(a) of MDD 93/42/EEC owing to its physical effect, on the other hand, the product is a medicinal product according to Article 1(a) of Regulation 469/2009, since the product is administered in view to restoring or improving physiological functions in humans. The appellant pointed out that according to Regulation 469/2009, the term "active ingredient" is not limited to products having a pharmacological, immunological or metabolic action.

Grounds for the BPatG’s Decision: The BPatG did not share Leibniz’s view. It held that it must be assessed first, if the scope of Regulation 469/2009 is opened. The BPatG mentioned that according to Article 2, application of Regulation 469/2009 requires inter alia that the "aminosilane-coated iron oxide nanoparticles" constitute a product in terms of Article 1(b) of Regulation 469/2009. The BPatG admitted that the term "active ingredient" is not defined in the Regulation. Therefore, the Court reviewed relevant CJEU case law including the recent decision Forsgren, C-631/13 of 15 January 2015, concerning the interpretation of Article 1(b) of Regulation 469/2009 with respect to an active ingredient that is covalently bound to other active ingredients forming part of a medicinal product. The BPatG is of the opinion that in Forsgren, the CJEU has finally clarified that only substances producing a pharmacological, immunological or metabolic action of their own are active ingredients in terms of Regulation 469/2009 (cf. CJEU, Forsgren, C-631/13 of 15 January 2015,  paragraph 25).

As outlined above, the therapeutic effect of the product "aminosilane-coated iron oxide nanoparticles" is achieved by physical means. Thus, under consideration of Forsgren, the BPatG concluded that aminosilane-coated iron oxide nanoparticles are not a product according to Article 1(b) of Regulation 469/2009, since said nanoparticles are not substances producing a pharmacological, immunological or metabolic action of their own. As a result, the BPatG decided that in the present case, already for this reason the scope of Regulation 469/2009 is not opened. Consequently, any remaining questions were not assessed and the appeal was rejected.

It is important to note that ground 6 of the decision seems to reflect the current position of the BPatG concerning the grant of SPCs for medical devices based on Regulation 469/2009. The BPatG indicates that, in principal, section 16a paragraph 1 of the German Patent Act includes the option of extending the type of products for which an SPC may be granted by additional regulations. The Court acknowledges that the effective patent protection for medical devices is insufficient for recovering the investment put into research owing to the necessary preclinical and clinical studies and the authorisation procedure. Both aspects led to the introduction of SPCs for medicinal products for human use and for veterinary medicinal products. However, the Court points out that only the legislators are competent to create a similar regulation for medical devices. In contrast, the Courts are barred from extending supplementary protection to medical devices. Thus, at present, at least the 14th division of the BPatG does not seem to be willing to grant SPCs for medical devices based on Regulation 469/2009."

Many thanks to Ulrike and Raphael for sharing this decision! 

Difficult Questions, Important Answers...

The title of this post could be a summary of the issues facing the UK in the referendum on EU membership but, in fact, is a new article by Mike Snodin that he has published discussing the questions posed in the latest case at the CJEU (C-572/15, F. Hoffmann la Roche).  A copy of Mike’s article, entitled “Difficult Questions, Important Answers: The Latest Case on SPCs”, can be viewed here. 

Mike’s article discusses two possible ways in which the CJEU could answer the questions posed without contravening principles relating to legal certainty.  It also explains reasons why the answers that the CJEU provides are likely to attract significant interest, including from outside of the sphere of the law on SPCs.

Time for a review of the SPC regime...

The EU is putting out to tender a project to review the fundamentals of the SPC regime. See here for details. The deadline for reply is the 4th February.  This could get quite interesting.

The EU communication states that:

"The study shall evaluate whether a new European SPC title, in its current scope, or broadened with improved provisions, is required to meet the requirements of current and expected innovative market developments in the EU.

With this primary purpose, the study shall evaluate the current SPC framework in terms of its legal efficiency in meeting its stated objectives given the development of directly affected and related product markets. The study shall also evaluate some economic aspects of the current SPC framework.

It shall also suggest whether the existing SPC rules need to be recalibrated given identified limitations.

The results could serve as a basis for an impact assessment for a future proposal by the Commission to create a European SPC title, and complement the recalibration of the existing EU SPC rules".

New UK IPO Decision - can you rely on an "end of procedure" communication under Art 3(b)?

For those interested in UKIPO decisions, here is a link to a recent decision (BL O/117/16) from the IPO which looks at 2 specific points:

(i) Can the End of Procedure Communication from the RMS as part of the Decentralised Procedure (DCP) for granting MAs act as means to show that a valid authorisation has been granted for the medicinal product – as required by Art 3(b) of the SPC regulation; and

(ii) can an SPC for a combination, based on the same patent but later MA, be granted when the SPC for the monoproduct has already been granted using an Earlier MA but the same basic patent.  Recent CJEU case law was considered  (Sanofi, C-433/12, and Boehringer, C-577/13) to work out if more than one SPC can be granted based on same patent.

Click here for the decision. 

 If you are the type of person who turns to the end of a novel first to find out "whodunnit" then the answers to these questions are:

(i) No; and 

(ii) Yes

This case arose because  - with only one day left to patent expiry - the patentee only had the "End of Procedure Communication", but not the MA.