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.     

Pharmaq v Intervet - an English language version of the decision has arrived

The SPC blog is grateful to the attorneys at Thommessen in Norway for providing an unofficial English language translation here (and also on the blog resources page) of the Oslo District Court’s Judgement of 25 August 2015 in the Pharmaq and Intervet matter.   

A summary of the Judgement, reproduced below,  is authored by the advocates Eirik W. Raanes, Camilla Vislie and Magnus Hauge Greaker at Thommessen who represent Intervet Internatinal B.V. in the proceedings.  Thanks to all of them.

They write:

Pharmaq v Intervet International BV: Oslo District Court’s Judgment 25 August 2015

Oslo District Court has delivered a Judgement in the case between Pharmaq AS and Intervet International BV, where the EFTA Court delivered its Advisory Opinion on 9 April 2015 (Case E 16/13 Pharmaq v Intervet International BV). The case inter alia concerns the validity and scope of protection of Intervet’s Norwegian SPC protecting the active ingredient in Intervet’s vaccine against Pancreas Disease in salmon. 

In Oslo District Court’s Judgment 25 August 2015, Pharmaq’s claims for invalidity and non-infringement of the SPC on the basis of Article 2, 3 and 4 of the SPC Regulation, were rejected.

Pharmaq has appealed the Judgement, and the hearing at Court of Appeal is preliminary scheduled to take place in the late autumn of 2016.

Before Oslo District Court, Pharmaq challenged the validity of Intervet’s SPC on the basis of Article 2, 3 and 4 of the SPC Regulation. Pharmaq also submitted an alternative claim for non-infringement on the basis of Article 4 of the SPC Regulation.

Article 2 of the SPC Regulation:

With respect to the validity challenge under Article 2 Pharmaq submitted that Intervet’s vaccine was placed on the market prior to being granted a market authorisation in accordance with Directive 2001/82/EC. In support of this challenge Pharmaq invoked that Intervet between 2003 and 2011 had delivered its vaccine to fish farmers in Norway and Ireland under Special Approval Exemptions and AR16 licenses.

A provisional MA was granted for the vaccine in the UK in 2005. An ordinary MA was granted for the vaccine in Norway in 2011. Pharmaq submitted that the UK PMA from 2005 could not be considered to be a marketing authorisation within the meaning of Article 2 of the SPC Regulation, which would have the consequence that Intervet’s supply of the vaccine under Special Approval Exemptions and AR16 licenses subsequent to the grant of the UK PMA would be relevant for the assessment under Article 2 of the SPC Regulation.

Oslo District Court started by concluding that the UK PMA was the first MA granted within the EEA area for the purpose of Article 2 of the SPC. This had the consequence that only events that took place prior to 6 May 2005 (the date the UK PMA was granted) was relevant for the assessment of whether the vaccine was placed on the market within the meaning of Article 2 of the SPC Regulation.

Further, Oslo District Court held that it is only authorisations granting full market access that entail that a product has been “placed on the market” within the meaning of Article 2 of the SPC Regulation. According to Oslo District Court, this interpretation of Article 2 was supported by the wording of the SPC Regulation, the purpose of the SPC Regulation and the system which it is a part. The Court referred to that the objective of the SPC Regulation is to compensate the patent holder for the time that has passed between the filing of the patent application and the completion of the regulatory process for obtaining a marketing authorisation, i.e. in other words the SPC Regulation is intended to compensate for lack of full market access. The Court went on pointing out that the term “placed on the market”, or similar, in the SPC Regulation is only used in connection with marketing authorisations pursuant to Directive 2001/82 (Veterinary Medicinal Products Directive) and that under the Veterinary Medicinal Products Directive it is only marketing authorisations that allow for a product to be “placed on the market”.

With respect to the CJEU’s Judgement in the Cases C-195/09 Synthon and C-427/09 Generics, that Pharmaq had relied on, Oslo District Court noted that those cases concerned products that had been granted full market access and consequently were not comparable with the case at hand.

Pharmaq also submitted that the Special Approval Exemptions and AR16 licenses only could be considered as permissions that did not allow for “placing on the market” if they were granted on the basis of national rules that implement Article 8 of the Veterinary Medicinal Products Directive correctly. The Court, however, rejected this argument and held that the relevant question rather was whether the Special Approval Exemptions and AR16 licenses in legal terms conferred a market access that corresponds with the rights a market authorisation affords. Oslo District Court noted that the Advisory Opinion of the EFTA Court must be interpreted in the light of other sources of EU/EEA law and must be understood such that the relationship between the Special Approval Exemptions/AR16 licenses and the Veterinary Medicinal Products Directive was not decisive.

Oslo District Court found that strong policy concerns supported its interpretation of Article 2 of the SPC Regulation. In the Court’s view it would counteract supplies under limited authorisations according to Articles 7 to 11 of the Veterinary Medicinal Products Directive if such authorisations were to disqualify the product from SPC protection. This consideration also indicated that it should not be of significance whether a limited authorisation is granted within the framework of the Veterinary Medicinal Products Directive, because it is not possible for manufacturers to know whether the authorities have complied with the Directive.

Under the concrete assessment of the Special Approval Exemptions and AR16 licenses, Oslo District Court found that there were decisive differences between the market access under a marketing authorisation and the market access on the basis of the Special Approval Exemptions/AR16 licenses. The Court inter alia pointed out that the Special Approval Exemptions/AR16 licenses only could be granted in special situations and at the authorities’ discretion, and that the permissions were limited both with respect to volume and time. In the Court’s view there are thus significant qualitative and quantitative differences between Special Approval Exemptions/AR16 licenses and marketing authorisations, since the latter gives the holder an unlimited right to market and sell the product, subject to the restrictions that apply generally to medicinal products.  

Based on this the Court concluded, noting that it had not been in doubt, that the authorisations prior to 6 May 2005, could not entail that the product had been “placed on the market” within the meaning of Article 2 of the SPC Regulation.

Article 3:

Pharmaq submitted that the Special Approval Exemptions in any event amounted to marketing authorisations within the meaning of Article 3 of the SPC Regulation, and that Intervet’s SPC therefore was granted in breach of Article 3(d) and 7(1) of the SPC Regulation.

Oslo District Court rejected this submission, noting inter alia that a marketing authorisation within the meaning of Article 3 of The SPC Regulation must, as in other provisions of the Regulation, be understood as a marketing authorisation granted in accordance with Veterinary Medicinal Products Directive, and that the Special Approval Exemptions were not such authorisations.

Article 4:

In Intervet’s marketing authorisation the active ingredient in the vaccine was identified as “Inactivated Salmon Pancreatic Disease Virus Strain F93-125”. The product description of Intervet’s SPC comprised: 

“Salmonid pancreatic disease virus that, when injected intraperitoneally at a titre of 103.5 TCID50 into Atlantic salmon post-smolts held in sea water at 14°C causes the fish to develop symptoms of pancreatic disease, wherein

a) said virus is the virus strain as deposited at ECACC under Deposit number V94090731 or closely related strains which share similar genotypic and/or phenotypic characteristics to said deposited virus strain and

b) said virus reacts serologically with convalescent anti-FPDV antiserum or antiserum raised against the deposited virus strain V94090731 and

c) said virus is in an inactive form.”

Pharmaq submitted that the SPC was granted in breach of Article 4 of the SPC Regulation, since this provision required that the SPC should be confined to the strain identified in the marketing authorisation. In the alternative Pharmaq submitted that the SPC did not cover their virus strain (ALV 405).

On this topic Oslo District Court split into a majority, consisting of the legal judge and one expert lay judge, and a minority, consisting of one expert lay judge.

The majority held that the SPC was not granted in breach of Article 4 of the SPC Regulation and that a vaccine based on Pharmaq’s virus strain would infringe the SPC.

The majority referred to the opinion of the Advocate General in case C-392/97 Farmitalia, where the Advocate General emphasized that the meaning of the term “product” in the SPC Regulation could not be determined based only on textual grounds. The majority found it difficult to determine the meaning of the product definition without also considering the purpose of the SPC Regulation, because a literal interpretation based on the marketing authorisation would, for a vaccine that is based on inactivated whole-virus particles, imply that it would be possible for a competitor to make a new vaccine based on a different isolate of an identical or similar virus, without infringing the SPC. In the majority’s view this seemed to give an unreasonable result.

The majority went on by ascertaining that case law provided support for a purpose oriented interpretation. The Court inter alia referred to case C-392/97 Farmitalia and the EFTA Court’s Advisory opinion.

On this backdrop the majority concluded that Article 4 of the SPC Regulation permits that a SPC covers other strains than identified in the marketing authorisation, provided that the other strain can be said to constitute the same active ingredient with a similar prophylactic effect as the strain identified in the marketing authorisation.

On the basis of this criterion the majority continued with a comparison of Intervet’s and Pharmaq’s virus strains. Based on a comprehensive material, inter alia studies, submitted by the Parties, the majority concluded that the differences between the virus strains F93-125 and ALV 405 are insignificant and that they thus must be considered to be the same active ingredient. Further, the majority concluded that both strains may be used in the same prophylactic field. Thus, it was held that the SPC was valid and that Pharmaq’s virus strain was covered by the SPC’s scope of protection.  

The minority interpreted Article 4 of the SPC Regulation such that the product description of the SPC must be confined to the strain that is identified in the marketing authorisation, and thus held that the SPC granted to Intervet is invalid.  

Once again, Alice de Pastors has kindly provided a copy of her annual SPC report, which includes statistics on SPC applications in Europe between 1991 and December 2014.  SPC News 29 – September 2014 is available to read here.

Thanks, Alice!

New CJEU referral - C572/15 - duration of an SPC issued under national law

In the Eurovision contest of CJEU SPC referrals it is maximum points to Estonia for the referral that is C-572/15, on the topic of Article 21 of Regulation 469/2009.   The two referred questions are below, with Q1 on the topic of the transitional provisions and Q2 raising the interesting issue of possible incompatibility with EU law in the event that Q1 is answered in the affirmative.... 

The following questions have been referred for a preliminary ruling:

1. Must Article 21(2) of Regulation 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) be interpreted as shortening the duration of a supplementary protection certificate 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 supplementary protection certificate, would be longer than 15 years from the time when the first marketing authorisation 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 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) 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 of Fundamental Rights of the European Union?

If you have any thoughts, the UKIPO has set a deadline of 22 December 2015 to send them in to policy@ipo.gov.uk.  

Farewell

Little did I realise, when we started The SPC Blog back in June 2008, that I would be saying goodbye to a thriving weblog with an email subscription list of nearly 2,100 – a blog that has also attracted well in excess of 800,000 pageviews and which has supported highly popular annual seminars in which people from all sectors of the pharma and agrochemical patent term extension world have gathered to share their thoughts, their experiences and, all too often, their frustration with the rulings of the Court of Justice of the European Union.

Anyway, it is with a feeling of great happiness that The SPC Blog has been so popular – and so useful – that I take my leave of it and step down as I take the retirement route. 

Do please continue to give the blog your every support and help to keep it as the valuable resource which it has become!

Supreme Court affirms IP High Court's relaxation of the PTE system in Japan

Earlier this month The SPC Blog was delighted to host "Patent term extension in Japan: a guest post", here, by Dr Seigen Tsukuda (Ohno & Partners, Japan).  Here's a sequel, bringing some fresh news.

This is a quick notice that, on 17 November 2015, the Supreme Court rendered a decision rejecting the JPO's appeal against Intellectual Property High Court (IPHC) Grand Panel decision issued in May 2014. As a general principle, the Supreme Court decision can be outlined thuss:

In order to reject an application for a patent term extension (PTE) based on a prior authorization, in view of category and subject of patented invention(s) for which the application is submitted, a prior authorization and a new authorization shall be compared in terms of elements examined for authorization, such elements being relevant to substantial identity as a pharmaceutical product, and it must be established that the prior authorization encompasses the new authorization in terms of an authorization for production and sales of a pharmaceutical product.

The decision applied the above principle to the present facts as follows:

In the context of product patents directed to ingredients of pharmaceutical products, "elements examined for authorization relevant to substantial identicalness as a pharmaceutical product" are components, quantity, administration, dosage amount, effect and efficacy. Administration and dosage amount of the previously authorized pharmaceutical product are 

"... intravenous drip infusion of 5mg/kg (body weight) per dose or 10mg/kg (body weight) per dose ... administration interval is 2-week or longer ...", 

while those of the newly authorized pharmaceutical product are 

"... intravenous drip infusion of 7.5mg/kg (body weight) per dose ... administration interval is 3-week or longer ...". 

Further, production and sales of the subject pharmaceutical product for a combination therapy of XELOX therapy and bevacizumab therapy newly became available by such new authorization. Based on the facts described above, it is not established that the prior authorization encompasses the new authorization in terms of an authorization for production and sales of a pharmaceutical product. Therefore, the decision of appeal board of the JPO is not legitimate, and the IPHC Grand Panel decision is approved.

As can be seen from the above, it seems that the Supreme Court accepted almost the whole framework of the IPHC Grand Panel decision establishing that a PTE may be allowed based on any substantially new authorization, so long as the subject patent covers the newly authorized pharmaceutical product.

Upon the Supreme Court decision, the JPO announced on 18 November 2015 that the JPO starts revising its PTE examination guidelines and stops examinations for PTEs until a publication of the revised guidelines. It is expected that under the revised guidelines, applications for PTE shall be more easily allowed. Further, while the Supreme Court decision is silent, as IPHC Grand Panel decision mentioned in obiter dictum, scope of an extended patent may become narrower than previously expected. It is therefore recommended that, whenever a new pharmaceutical product is authorized in Japan, an application for a PTE shall be considered for any patent covering the new pharmaceutical product

In this respect it should be noted that, when a patentee wishes to obtain a PTE, if an authorization is not delivered by 6 months and one day before the expiration date of a subject patent, a provisional application must be submitted by that day, i.e. 6 months and one day before the expiration date (Patent Act Article 67-2-2, paragraph 1), otherwise a non-provisional application must be submitted within three months from the delivery of an authorization (Patent Act Article 67-2, paragraph 2 and Implementing Regulation of Patent Act Article 3).

Further, in our previous post, it was mentioned that 

"If the patentee may wish to obtain a PTE corresponding to a dependent claim in the future, it is recommended to file a divisional application to establish a patent specifically directed to the invention of the dependent claim, describing the invention as an independent claim". 

Under the new examination guidelines, PTE may become available without filing such divisional applications.