After the Rulings, the Reasoned Orders: a note on Queensland and Daiichi

On my travels and beset by some miserable connectivity, I've not been able to keep the flow of posts going as I would have liked. It is therefore with both thanks and apologies that I bring you this note which The SPC Blog received from Marjan Noor and Andrew Hutchinson (Simmons & Simmons LLP) last week:

"We had not seen much commentary on the above Reasoned Orders so bring them to your attention. Queensland is particularly interesting in relation to process patents:

Queensland, paras 40-41:

40 … just as Article 3(a) of Regulation No 469/2009 precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent (Medeva, paragraph 25), where the basic patent relied on in support of a SPC application relates to the process by which a product is obtained, that provision also precludes a SPC being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from that process. The grant of a SPC is not conditional on whether it is possible to obtain a product directly as a result of the process by which the product is obtained, where that process has been the subject of a patent.

41 The answer to Question 6 is therefore that, in the case of a basic patent relating to a process by which a product is obtained, Article 3(a) of Regulation No 469/2009 precludes a SPC being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from the process in question. Whether it is possible to obtain the product directly as a result of that process is irrelevant in that regard."

Many of the paragraphs in all three reasoned orders are the same and include the same references to the Medeva judgment. The conclusions in Case C-6/11 Daiichi follow Yeda and emphasise the need for an active ingredient to be "identified in the wording of the claims". Queensland takes this principle and applies it to process patents, which are required to identify the product of the process; the process alone seems to be insufficient. Queensland also repeats Medeva's "one SPC per patent rule" in the context of process patents".

After Medeva: what the commentators say ...

With regard to patent extension as in most other areas, we depend on the 
commentators to tell us what they see as happening from their vantage points

Following last week's ruling of the Court of Justice of the European Union in Case C-322/10 Medeva, The SPC Blog has received comments and opinions from so many people -- readers and others -- that it has been difficult to sift through them all.  The blog records below some of the first impressions of those who work in the field:

"The confirmation of the Attorney General’s opinion that a “mis-match” between an SPC and an MA is not fatal to that SPC application is welcome to the research-based pharmaceutical industry. However, every issue relating to the SPC protection of combination products has by no means been resolved. Also, many in the pharmaceutical industry will be disappointed that the CJEU has not adopted the infringement test argued for by Medeva and the UK Government" (Tim Powell: Powell Gilbert LLP)

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"This decision has far-reaching consequences. It means that innovative pharmaceutical companies can benefit from SPCs for their patents also if the relevant MA was granted for a combination product that is only partly disclosed by the patent relied on. For countries where the disclosure test was applied (such as the Netherlands) the possibility to obtain SPCs has been broadened. It also means that SPCs cannot be granted for active ingredients A + B, if the MA is in place for A + B and the wording of the claims of the patent only specify A. This means a limitation of the granting practice in countries where the infringement test was used (where SPCs for A + B were granted). 

Following the CJ decision, this has already led to the Court of Rome ruling (on 25 November) that Novartis cannot invoke its (Italian) SPC granted for a combination product that was not fully disclosed by its patent [noted by The SPC Blog here]. Several issues regarding both the application for SPCs and the protection granted by a valid SPC remain unresolved and are the subject of several other referrals to the CJ regarding the interpretation of the SPC Regulation. Medeva does provide possibilities for the pharmaceutical industry and companies should currently apply for SPCs as long as one of the active ingredients of the relevant MA is specified in the wording of the claims of the patent" (Gertjan Kuipers and Tjibbe Douma: De Brauw Blackstone Westbroek).

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“The CJEU rulings are welcome and have confirmed a relatively broad scope of SPC protection covering all combinations of a particular active ingredient with others, providing that the active ingredient is supported by the underlying patent. 

This is, perhaps, not as narrow a view of SPC protection as it was feared the Court of Justice might support. They have also expressed the legal position succinctly - the circumstances where you cannot obtain an SPC are now clearer. 

In essence, the CJEU has confirmed that it should not be possible to obtain SPC protection claiming active ingredients that owe nothing to the disclosure in the underlying patent. They have also avoided imposing the harsh result predicted by UK judges in previous cases such as Gilead” (Will James: Marks & Clerk Solicitors).

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"Although these decisions bring some much needed clarity to the application of the SPC regulations to combination drugs, we foresee several issues that remain unclear, particularly the meaning of “specified in the wording of the claims” in relation to Article 3(a). A brief review of the French, German and Spanish versions of the current decisions does not seem to remove the ambiguity, although they possibly lean towards a more restrictive approach than that implied by the English-language decisions" (Hugh Goodfellow and Daniel Wise, Carpmaels & Ransford).

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"The Medeva decision makes it clear that SPCs on combination products do not need to mirror the exact combination that is the subject of the marketing authorisation. Instead a patentee must match its SPC product to the active ingredients ‘specified’ in its patent. That SPC can then be enforced, it would seem, against any medicinal product containing (rather than matching) the active(s) the subject of the SPC. 

However, as ever, further questions are raised. What is meant by “specified”: do claims for classes of products and Markush formulae “specify” the individual actives they cover? Where does this leave biologic patents that claim, for example, antibodies to a particular antigen without disclosing the antibody? Is it really the intention that a patent can only ever have one SPC or is the CJEU’s decision limited to the single active A/combination A+B scenario? Has the CJEU stated that a single active SPC can be enforced against a combination? The wording of the CJEU decision is not clear. 

This is sadly another decision that raises as many important questions as it answers" (Marjan Noor and Andrew Hutchinson, Simmons & Simmons LLP).

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"In the quest for minimizing an alleged extension of protection for combination products, the CJEU has now come up with an answer which is primarily economically beneficial to the authorities charging applicants official fees for long specifications, and in reality confers a broader protection than would have been possible if using the infringement test to define the product, which may not be in the public interest.

On a constructive approach to the new legal situation, the best advice looking forward is for patent drafters to develop standard lists of all known active ingredients (approved or in the pipeline) in order to keep all options open for including combinations in the patent claims either in divisional applications, when time allows for that, or by limiting the patent using the central limitation procedure at the EPO" (Sidsel Hauge: Awapatent)

New pharma patent booklet available

Martin Paltnoi (CEO, MPS Business Services Ltd) has emailed The SPC Blog with news that he has produced a booklet, Pharmaceutical Patents - A Practical Guide which, he informs us, is written in a concise and easily digested manner the purpose of which is to give those interested a thumbnail sketch of the relevant issues concerning pharmaceutical intellectual property: They can become a little more informed without having to wade through the detail. This booklet includes a section on SPCs.  Anyone interested should contact MPA here or phone Martin on +44 (0)1707 654850.

Yeda, by Order of the Court

Somehow, with all the excitement of the unified patent court and the unitary patent system for Europe buzzing round his ears, this member of The SPC Blog team quite forgot that Case C‑518/10, Yeda Research and Development Company Ltd, Aventis Holdings Inc v Comptroller General of Patents, Designs and Trade Marks, a reference for a preliminary ruling from the Court of Appeal (England and Wales), was still in the pipeline. This case has sped through the judicial corridors of Luxembourg, arriving in November 2010 and departing -- in the form of an Order -- on 25 November which was handed down this morning.

The following is written in substantial reliance on a very helpful note prepared by Hugh Goodfellow (Carpmaels & Ransford), sent to this weblog by his colleague Edward Oates.

Yeda held a basic patent for a therapeutic composition that includeda monoclonal antibody and an anti-neoplastic agent. The marketing authorisation which Yeda cited in support of its SPC application related to a medicinal product (Erbitux) which contained the antibody alone (cetuximab) but mentioned that the antibody was indicated to be used in combination with the anti-neoplastic agent (irinotecan).

In its SPC filing strategy, Yeda attempted to cover two options, by filing one SPC application that identified the product merely as "cetuximab" and another application for "cetuximab in combination with irinotecan". The UK IPO refused both SPC applications.

• The "cetuximab" SPC application was refused for failing to satisfy the requirements of Article 3(a) of the SPC Regulation because the basic patent did not protect the specified product. 
• The combination SPC application was refused under Article 3(b) of the Regulation because the referenced marketing authorisation related to the active ingredient cetuximab alone. 

Yeda appealed this decision to the High Court for England and Wales, arguing that its patent allowed it to oppose any use by a third party of the active ingredient cetuximab, including use as a single agent treatment, because such use would constitute indirect (or contributory) infringement of its patent for the purpose of Section 60(2) of the UK Patents Act 1977. Yeda therefore said that, for the purposes of the application of Article 3(a), the active ingredient at issue was protected by the patent. While this initial appeal was unsuccessful, the Court of Appeal was persuaded that the law was not clear and referred the matter to the Court of Justice for a preliminary ruling.

The Court of Justice considered that the referred question was, for all essential purposes, answered by the judgment in Medeva (C-322/10) and therefore delivered a Reasoned Order. The Court's language is closely modelled on that used Medeva and concludes that Article 3(a) precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent. The ruling of the Court is therefore as follows:

"Article 3(a) ... must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone".

Observing that this Order will come as no surprise to commentators in the field following Medeva, Hugh adds that we might expect to see further Reasoned Orders, for example in the Queensland and Daiichi referrals. He continues:

"It will be interesting to see whether the Court's reasoning in this case could be avoided in future cases by using different claim language, e.g. by using method features to define the combination therapy. Would such claims still be considered to specify the active ingredient as "forming part of a combination in conjunction with another active ingredient? Another approach, which does not appear to have been pleaded in Yeda, would have been to argue that the patent is for an "application" of the active ingredient in the sense of Article 1(c) (with the "application" being a combination therapy with the other active ingredient). Unfortunately, however, the CJEU's order is couched in terms that will make it difficult to run such an argument in the future".

[Corrected post] That elusive Explanatory Memorandum ...

This is an amended and corrected version of the post that originally went out last night.  The SPC Blog thanks Micaela Modiano (Modiano & Partners) for her help.

The SPC Blog has just received the following request from a reader who is currently doing some research into supplementary protection certificates:

"Do you know how I can find the Explanatory Memorandum to the SPC Regulation? I have searched on the internet and at eur-lex.europa.eu/LexUriServ, but cannot trace it".

Micaela writes:

"I too had difficulties finding it in the past, so I ended up writing to the Eur-Lex Helpdesk Publications Office and they sent it to me via email (at the time, the only available version was in Greek...). It is possible that despite my request they have not yet included it in the same webpage where the Greek version can be found, and this may be why the reader could not find it. I therefore attach it to this email so that the reader (and all SPC blog fans) now have it. What Eur-Lex does not do for us, we do for ourselves...".

The Explanatory Memorandum  to the Proposal for a European Parliament and Council Regulation (EC), of 11 April 1990, concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final - SYN 255) can now be accessed here.

I've also located the Explanatory Memorandum to the Proposal for a European Parliament and Council Regulation (EC), of 9 December 1994, concerning the creation of a supplementary protection certificate for plant protection products (COM(94) 579 final), which can be accessed here.

Negative term SPCs: judgment now available

Further to today's earlier post, here is the judgment of the Court of Justice in Case C-125/10 Merck Sharp & Dohme Corp v Deutsches Patent- und Markenamt.  It is surprisingly short, being just 46 paragraphs in length.  The active part of the decision reads as follows:

Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006, read in conjunction with Article 36 of Regulation No 1901/2006, must be interpreted as meaning that medicinal products can be the object of the grant of a supplementary protection certificate where the period that has elapsed between the date of lodging the basic patent application and the first marketing authorisation in the European Union is less than five years. In such a case, the period of the paediatric extension provided for by the latter regulation starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation.

Court of Justice gives go-ahead to negative term SPCs

The Court of Justice of the European Union gave its ruling this morning in Case C-125/10 Merck Sharp & Dohme Corporation. Infuriatingly, the recently-redesigned Curia website hasn't yet managed to make the ruling accessible -- but The SPC Blog has received the following information from Hogan Lovells LLP, which successfully represented Merck & Co. in these proceedings.  According to the Hogan Lovells media release, the Court of Justice has it ruled that negative term supplementary patent certificates (SPCs) are permissible:

" ... The decision means the SPC protection for the diabetes drug Januvia can be extended by two and a half months until mid-September 2022. This extension would reward Merck’s efforts to research and provide valuable information on the effects of Januvia in the child population. 

The issue came to the fore in 2007 when Merck applied for a negative SPC extension for Januvia in several EU countries. Januvia is Merck's registered trade mark for the active ingredient sitagliptin. 

Bulgaria, the Netherlands, and the United Kingdom granted negative term SPCs; Greece granted a zero term SPC; various other states, including Germany, refused to grant any SPC at all. 

In Germany Merck took its case against the national patent office to the Federal Patent Court, which referred the matter to the CJEU, asking whether it is permissible to grant negative or zero term SPCs. Merck was represented before the CJEU by Dr. Andreas von Falck and Miriam Gundt of Hogan Lovells' Dusseldorf office, and by Dr. Monica Heinemann of patent attorney firm Abitz & Partner. 

... In 2006 a six month extension to the SPC term was introduced to incentivize innovators to investigate and report on whether their products are suitable for use in the pediatric population. Prior to the introduction of this incentive, many products were used to treat the pediatric population without having been studied or authorized for such use ...

A negative term SPC, as the name suggests, offers a negative term of SPC protection after patent expiry because the period between filing the patent and wining marketing authorisation is less than five years. 

The value of a negative term SPC is that it forms the basis for an SPC extension of up to six months to reward studies of the medicine in the pediatric population ...".

The SPC Blog expects the judgment to be accessible here once it materialises online. At present all that is available is the Advocate General's Opinion, discussed on The SPC Blog here and indeed elsewhere.

Court of Rome applies Medeva, suspends provisional relief

From Evelina Marchesoni (Bird & Bird) comes an update to The SPC Blog's recent post on the Italian proceedings on valsartan and hydrochlorotiazide.She writes:

"On 11 November 2011 the Court of Rome granted a preliminary injunction requested by Novartis enforcing its SPC no. C-UB1999P000648, expiring on September 25, 2012 and covering the medicinal product “Cotareg” (valsartan + HCTZ).

In his decision the dudge ordered Mylan to stop manufacturing, commercializing, advertising, distributing, importing, exporting, storing and/or offering in any form (including the request of insertion in the so called “transparency list”) the generic products of Cotareg. 

Mylan appealed against this interim order and, after the issue of the decision of the Court of Justice in Case C-322/10 Medeva and Case C-422/10 Georgetown, sought an application to stay the preliminary injunction pending appeal. 

Mylan pointed out that, also in light of the Court of Justice's ruling, Novartis’s certificate claiming the combination of valsartan and HCTZ was invalid according to Article 3(a) of the Regulation, as it referred to a basic patent, EP 0 443 983, which did not provide such a combination.

By his decision, issued on 25 November 2011, the President of the IP Division of the Court of Rome, considering that on 24 November 2011 the decisions from the ECJ were published and they affirmed that Art.3(a) of the Regulation should be interpreted “as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate”, ordered the provisional suspension of the preliminary injunction decision. 

This short decision of the Court of Rome, which you can access in full here (in Italian) probably constituted the first application in Europe of the interpretation of the Court of Justice decisions in the Medeva and Georgetown cases.

Discussion of the appeal is scheduled for 16 December 2011".

Thank you, Evelina, for this information, which is much appreciated.

AIPPI UK Group holds rapid response seminar on Medeva, Georgetown

The SPC Blog is pleased to announce that the AIPPI UK Group has organised a rapid response seminar which will enable interested parties to get together and discuss the repercussions of last week's rulings in Medeva and Georgetown, briefly noted here and here on this weblog.

Details of the seminar are as follows:

Tuesday 29 November 2011, 5.30pm for 6pm

SPCs for combination products –

Rapid Response to

CJEU Medeva and Georgetown judgment

Hugh Goodfellow

Partner, Carpmaels & Ransford

Venue:

Carpmaels & Ransford

One Southampton Row, London WC1B 5HA

Drinks will be served afterwards

There are a number of combination product cases pending before the Court of Justice of the European Union that, when taken together, probe almost every aspect of the Regulation’s requirements for a valid SPC to be obtained. The CJEU’s judgment in the Medeva and Georgetown cases has been handed down on Thursday 24 November, the first in the series of cases referred to that court.  Following up the AIPPI event on the topic in September, Hugh Goodfellow. Partner at Carpmaels & Ransford, has agreed to host a Rapid Response, to provide the opportunity to discuss and debate the implications of this Judgment.

If you would like to attend this event, whether you are a member or not, please register at:

www.aippi.org.uk/medeva

This course is directed at all levels of practitioners with an interest in intellectual property and will provide them with an understanding of current issues and future potential developments in the law of supplementary protection certificates.  Attendance is free.

SRA and IPReg, and (pending approval) BSB, CPD: 1.5 hours.  AIPPI United Kingdom is accredited under the Solicitors Regulation Authority’s and the Bar Standards Board’s CPD schemes.  

Georgetown ruling also out

Also delivered today is the judgment of the Court of Justice of the European Union in Case C‑422/10, Georgetown University, University of Rochester, Loyola University of Chicago v Comptroller General of Patents, Designs and Trade Marks, this being a reference for a preliminary ruling from the Patents Court, England and Wales.

The Georgetown SPC applications

A pappilomavirus

In June 1993 Georgetown University applied for a European patent entitled ‘Papillomavirus vaccine’, for a human papillomavirus (PV) L1 protein capable of inducing neutralising antibodies against papillomavirus virions. There are many human papillomavirus (HPV) genotypes, which are grouped according to the similarity of their DNA sequences. Types 6 and 11 are responsible for condylomas, whereas types 16 and 18 are responsible for precancerous lesions in the genital region and also cervical cancer. The Georgetown University patent claims included a vaccine for the prevention of papillomavirus infection, comprising at least that protein, or fragment thereof, of, among others, HPV‑16, HPV‑18 or HPV‑16 and HPV‑18 together. That patent, granted on 12 December 2007, is due to expire on 23 June 2013.

In December 2007, relying on a marketing authorisation (MA) granted to Sanofi Pasteur in September 2006 for the medicinal product Gardasil, containing HPV‑6, HPV‑11, HPV‑16 and HPV‑18 purified proteins obtained from yeast cells (Saccharomyces cerevisiae), Georgetown University filed four SPC applications, identifying the product as ‘the recombinant L1 protein’ of HPV‑6, HPV‑11, HPV‑16 and HPV‑18 (SCP/GB07/079, SCP/GB07/073, SCP/GB07/080 and SCP/GB07/078), respectively. Relying on an MA granted to GlaxoSmithKline Biologicals in September 2007 for the medicinal product Cervarix, containing HPV‑16 and HPV‑18 purified proteins obtained from insect cells (Trichoplusia ni), Georgetown University filed two SPC applications identifying the product as ‘the recombinant L1 protein of papillomavirus type 16 as expressed by an insect cell’ (SCP/GB07/071) and ‘the recombinant L1 protein of papillomavirus type 18 as expressed by an insect cell’ (SPC/GB07/70), respectively.

The UK IPO rejected all these applications for failure to comply with the condition laid down in Article 3(b) of Regulation 469/2009, since the medicinal product for which the MA was granted contained more active ingredients than those for which SPC protection was sought.

The Rochester SPC applications

In March 1994 the University of Rochester applied for a patent entitled ‘Production of human papillomavirus capsid protein and virus-like particles’ for ‘a method of expressing the human papillomavirus capsid protein coding sequence of type 6 ([HPV]-6), type 11 ([HPV]-11) …’. The patent claims included a ‘purified recombinant human papilloma virus-like particle or capsomere which comprises human papillomavirus 16 ([HPV]-16) L1 capsid protein expressed from an L1 protein coding sequence …’ and ‘… a multivalent vaccine comprising a virus-like particle from different human papilloma viruses’. That patent was granted on 25 May 2005 and is due to expire on 7 March 2014.

T IPO granted the University of Rochester SPCs based on the MAs for Gardasil and Cervarix, identifying the product as ‘the combination of the virus-like particles of the recombinant Ll protein of human papillomavirus types 6, 11, 16 and 18’ (SCP/GB07/018) and ‘the combination of the virus-like particles of the recombinant Ll protein of human papillomavirus types 16 et 18’ (SCP/GB07/076). However, it refused to grant a SPC based on the MA for Cervarix identifying the product as ‘the virus-like particle of the recombinant L1 protein of human papillomavirus type 16 as expressed in an insect cell’ (SCP/GB07/075), for failure to comply with the condition laid down in Article 3(b).

The Loyola SPC application

In October 1995 Loyola University of Chicago applied for a patent entitled ‘Papilloma virus-like particles, fusion proteins and process for producing same’. The patent claims included ‘recombinant-produced papilloma virus-like particles that are formed after expression of the viral structure proteins Ll or Ll and L2, characterised in that one or more sections of the Ll protein are deleted, wherein the ability to form virus-like particles remains’. That patent was granted on 10 May 2006 and is due to expire on 8 October 2015.

The UK IPO granted a SPC to Loyola University of Chicago identifying the product as ‘the combination of the virus-like particle of the recombinant L1 protein of human papillomavirus types 16 and 18’ based on the MA for Cervarix (SCP/GB07/077). However, it refused to grant a SPC based on the MA for Cervarix identifying the product as ‘the virus-like particle of the recombinant L1 protein of human papillomavirus type 16 as expressed in an insect cell’ (SCP/GB07/069), since the application thus worded, based on the MA for Cervarix, failed to comply with the conditions laid down in Article 3(b).

The appeal and reference

The Patents Court, before which all three SPC applicants appealed, decided to stay the proceedings and refer the following question to the Court for a preliminary ruling, which is worded in the same terms as the sixth question referred by the Court of Appeal (England and Wales) in Case C 322/10 Medeva.

‘Does … Regulation [No 469/2009] and, in particular, Article 3(b), permit the grant of a [SPC] for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of … Regulation [No 469/2009]; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC which is the first [MA] that places the single active ingredient or combination of active ingredients on the market?’

Initially this case was joined with Case C‑322/010 for the purposes of the oral procedure and the judgment. However, in view of the factual differences between the situations at issue in the main proceedings, the cases were disjoined.

This morning the Court ruled as follows:

"Article 3(b) ... must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients".

As with this morning's earlier post on Medeva, comments will follow in due course.

Medeva ruling now out

The Court of Justice of the European Union gave its ruling this morning in Case C‑322/10, Medeva BV v Comptroller General of Patents, Designs and Trade Marks, a reference for a preliminary ruling from the Court of Appeal (England and Wales).

 Bordetella pertussis

In brief, in April 1990 Medeva applied for a European patent for a method for the preparation of an acellular vaccine against Bordetella pertussis (whooping cough agent), also known as ‘Pa’. This preparation consisted of a combination of two antigens as active ingredients -- pertactin and filamentous haemagglutinin (‘filamentous haemagglutinin antigen’). Their ratio was such as to provide a synergistic effect in vaccine potency. The patent was granted by the EPO on 18 February 2009, expiring on 25 April 2010.

Medeva filed five SPC applications with the UK's IPO, seeking supplementary protection for DTPa-IPV/HIB vaccines covering diphtheria (D), tetanus (T), whooping cough (Pa), poliomyelitis (IPV) and/or meningitis (Haemophilus influenzae, also known as ‘HIB’). In support of those applications, Medeva submitted marketing authorisations (MAs) granted by the French, German and UK authorities for a range of medicinal products each of which contained, in addition to the combination of pertactin and filamentous haemagglutinin, between eight and 11 other active ingredients.

In November 2009 the IPO refused to grant the SPCs applied for. In the case of four of the applications, more active components or ingredients were specified in the applications for SPCs covering those components than were identified in the wording of the claims of the basic patent, and they were not therefore protected by the basic patent under Article 3(a) of Regulation 469/2009. As for the fifth application, while the active components or ingredients identified in the patent were the same as those specified in the SPC application (ie combination of pertactin and filamentous haemagglutinin), the MAs submitted in support of that application did not fulfil the conditions laid down in Article 3(b) since they related to medicinal products containing nine active ingredients, that is to say vaccines which did not contain only the active components or ingredients specified in the SPC application and in the patent claims.

Medeva appealed unsuccessfully to the High Court and then again to the Court of Appeal, which stayed the proceedings and referred the following questions for a preliminary ruling:

‘1 Regulation No 469/2009 … recognises, amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8 [in the preamble to that regulation]. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of … Regulation [No 469/2009] by “the product is protected by a basic patent in force” and what are the criteria for deciding this? 

2 In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria? 

3 In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria? 

4 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if one antigen of the vaccine is “protected by the basic patent in force”? 

5 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if all antigens directed against one disease are “protected by the basic patent in force”?
…
6 Does … Regulation [No 469/2009] and, in particular, Article 3(b), permit the grant of a [SPC] for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the SPC Regulation; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC which is the first [MA] that places the single active ingredient or combination of active ingredients on the market?’

The Court has just ruled as follows:

"1. Article 3(a) of Regulation ... 469/2009 ... must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

2. Article 3(b) of Regulation ... 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients".

Comments to follow, as well as a post on this morning's other ruling in Georgetown.

Spain: court orders change in practice in ganirelix ruling

The SPC Blog has learned from its friend Herwig von Morze that it has been the long-established practice of the Spanish Patent Office to refuse the grant of an active ingredient with its salts. Now, however, following an appeal to the Spanish Federal Court, the Spanish Patent Office has been ordered to grant an SPC for ganirelix and its salts based on the rationale of the Farmitalia decision.

We are chasing up further information on this decision and hope to be able to report on it in greater detail soon.

Düsseldorf Novartis/Actavis order now in English too

In "Düsseldorf valsartan/HTC proceedings referred for preliminary ruling" (here) The SPC Blog received an update from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf, acting for the Actavis defendanta) on the proceedings in Novartis/Actavis before the Düsseldorf District Court. The update contained the order of that court in the original German, here.

The SPC Blog has since received two English translations of the order of the Düsseldorf District Court.

The first translation to arrive came from Cordula Tellman and Frank-Erich Hufnagel (Freshfields Bruckhaus Deringer LLP), which you can read as a pdf file here. As Cordula and Fran-Erich kindly explain, the Court reconfirms the position which it expressed in its ruling in the previous preliminary injunction proceedings: that is, a protection certificate granted for a single active ingredient (e.g. valsartan) would be infringed by a medicinal product containing this single active ingredient, even if combined with another active ingredient (e.g. valsartan + hydrochlorothiazide).  The Court discusses in detail the arguments brought forward by the parties and gives extensive reasoning for its opinion that the SPC is infringed (see in particular paragraphs 17, 20, 22, 24, 28 and 30 of the order).

The second translation, which arrived in a welter of emails following the resumption of this blogger's internet connectivity, came from Thomas and Henrik. You can read it as a pdf file here.

The SPC Blog is grateful to the lawyers of both firms for their efforts to make the ruling and the reasoning of the Düsseldorf court both available and accessible to the SPC community and for their enthusiasm for the subject.

Düsseldorf valsartan/HTC proceedings referred for preliminary ruling

Düsseldorf District Court

The SPC Blog has received from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf) an important update on the proceedings between Novartis on the one hand and Actavis Deutschland GmbH and Actavis Malta Ltd on the other before the Düsseldorf District Court (Thomas and Henrik are representing the two Actavis companies in the action on the merits pending before the Düsseldorf District Court).  This is what they have told us:

"The SPC Blog entries of 21 and 24 March 2011 (here and here, respectively) provided the following information:

1. On 8 March 2011, the Düsseldorf District Court held in preliminary injunction proceedings (case nos. 4b O 280/10 and 4b O 287/10) that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCT) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036). 

2. The Düsseldorf District Court ordered Novartis to file actions on the merits.

On 8 April 2011, Novartis filed such action on the merits (jointly) against Actavis Germany and Actavis Malta (case no. 4b O 66/11).

The latest news is that that on 8 November 2011 the Düsseldorf District Court decided to stay the infringement proceedings.

The question of whether the scope of protection of an SPC which has an active ingredient as its subject matter also extends to a combination of this active ingredient with a further active ingredient was regarded as decisive for the outcome of the infringement proceedings. Obviously, this question is precisely what the dispute between the parties is about. The court did not want to decide the question. It was considered necessary that the interpretation of Articles 5, 4 SPC Regulation be clarified by the Court of Justice of the European Union (CJEU). The Düsseldorf District Court referred the following question for a preliminary ruling to the CJEU:

"Must Articles 5, 4 of EC Regulation No. 469/2009 be interpreted to mean that the protection conferred by a certificate granted for a single active ingredient (in this case valsartan) extends to an embodiment that contains this single active ingredient in combination with another active ingredient (in this case valsartan + hydrochlorothiazide)?"

The Düsseldorf District Court also summarised the parties' pleadings, which differ to a certain extent from those in the parallel UK proceedings (where the High Court made a referral which is already pending before the CJEU as Case C-442/11)".

Thomas and Henrik have kindly sent us the order of the Düsseldorf District Court that the proceedings are stayed and referred to the CJEU, which readers can access here.

Valsartan and hydrochlorothiazide combination: Rome rules

From Daniela Ampollini (Trevisan & Cuonzo Avvocati, Parma, Italy) comes information concerning a recent decision of the Court of Rome concerning a Novartis combination SPC, which this weblog reproduces here with grateful thanks:

"On 11 November 2011 the IP Chamber of the Court of Rome granted the motion for preliminary injunction requested by Novartis AG and Novartis Farma S.p.A. against Mylan S.p.A. on the basis of Novartis’ Italian valsartan and hydrochlorothiazide SPC, the active ingredients in Novartis’ Co-Diovan medicinal product (which is marketed in Italy as Co-Tareg). 

The motion had been filed within the context of a nullity action initiated last September by Mylan, aiming at the revocation of Novartis’ SPC for alleged violation the provisions of the SPC Regulation, in which action Novartis had cross-claimed for infringement of its rights. 

The grounds of invalidity raised by Mylan were substantially based on the assumption that: (i) the SPC would be invalid as the medicinal product Co-Diovan would not be “protected by a basic patent in force” considering that the basic patent EP 443983 did not claim the combination of valsartan and hydrochlrorothiazyde as such and that the “infringement test” (according to which a product is protected by a patent if it “infringes” the patent) would not be the correct test to use in interpreting Art. 3(a) of the SPC Regulation; and (ii) Art. 3(c) of the SPC Regulaton would have also been breached by the valsaran and hydrochlorothiazide SPC as another SPC on valsartan had already been granted based on the same EP ‘983 patent. 

The Court of Rome first noted that the urgency requirement had been met sinceNovartis had produced pre-orders, indicating that Mylan had pre-marketed the drug, as well as the fact that Mylan had officially communicated to the association of Italian wholesalers that its generic version of Co-Diovan would be in the market as of 15 November 2011 (i.e. after the expiry of the valartan SPC-- but not after the expiry of the valsartan and hydrochlorothiazide SPC). It then endorsed the application of the infringement test as to Art. 3(a) of the SPC Regulation and clarified that Art. 3(c) was not breached if the products in question (in this case the product valsartan and the combination product valsartan and hydrochlorothiazide) are different, and therefore found that there had been infringement of a valid SPC. 

The injunction is also noteworthy as it includes a prohibition that Mylan make pre-marketing activity (such as the collection of orders and pre-orders) before the expiry of the SPC, an order of recall of the products that have already been delivered to Mylan’s customers, and an order to notify the Italian Drugs Regulatory Authority with a view to preventing the inclusion of the generic in the substitution list of equivalent drugs. 

The preliminary injunction is now subject to appeal and, in any event, to confirmation at the outcome of the merits proceedings".

You can read the court's order in the original Italian here, and in English translation here

JIPLP note on Medeva, Georgetown Opinion available online

"Supplementary Protection Certificates for combination products" is the title of a Current Intelligence note by Tim Powell and Rebecca Lawrence (Powell Gilbert LLP) on the Advocate General's Opinion of 13 July 2011 in Joined Cases C322/10 Medeva and C422/10 Georgetown University.

The Fourth Chamber of the Court of Justice of the European Union will -- as regular readers of this weblog know -- be giving judgment on Thursday 24 November.  It may be a few weeks till the printed version of Tim and Rebecca's note is published in the Journal of Intellectual Property Law & Practice (JIPLP). Meanwhile, you can read it in full on the jiplp weblog here.

Valsartan: French court upholds ex parte preliminary injunction

The SPC Blog has received further information on the French Valsartan litigation from Laëtitia Benard (Allen & Overy, Paris). This relates to the very recent decision of the Paris First Instance Court on 31 October 2011, ruling on an attempt by Sanofi to remove the preliminary injunction which had previously been granted ex parte  Laëtitia (whose firm acted for Novartis in these proceedings) takes up the story from here:

Further to a preliminary injunction rendered on an ex-parte basis against Sanofi on 27 October 2011, which ruled that Sanofi's generic medicines containing a combination of Valsartan and HCTZ infringed the SPC of Novartis for Valsartan and ordered the prohibition of the manufacturing, the importation, the offer for sale, the holding, the storing and the marketing of the infringing medicines as well as the recall of these medicines from all the distribution channels, Sanofi sought the withdrawal of this ex-parte order on the ground that the infringement was challengeable.  

Ruling on Sanofi's recourse, the President of the Paris First Instance Court rendered an inter-partes decision on 31 October 2011, confirming the ex-parte preliminary injunction previously issued as well as the measures ordered. This ruling is in accordance with the previous decisions of the Paris First Instance Court and of the Losartan decision from the Paris Court of Appeals.   

The main findings of the President of the Paris First Instance Court are as follows: 

"Article 5 of EC Regulation No. 469/2009 provides that subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. 

Thus, since the basic patent covering the active ingredient at stake, Valsartan, protects the owner of the patent against any non-allowed manufacture or marketing of pharmaceutical products containing this active ingredient, an SPC protects its owner against any non-allowed manufacture or marketing of any further pharmaceutical products containing this active ingredient and whose marketing would have been allowed before the expiry of the certificate.

Infringement is characterised when the claims of the patent are reproduced in the litigious product. 

The protection conferred by SPC No. 97C0050 covers the active ingredient that is the subject-matter of EP No. 0 443 983, i.e. Valsartan, which has been the subject-matter of an MA for the treatment of hypertension, cardiac insufficiency and myocardial post-infarction. 

In the present case, it is not challenged that the Valsartan Hydrochlorothiazide Zentiva product is a generic product of Valsartan and that it reproduces the claims of the patent relating to the Valsartan active ingredient. It does not matter that another active ingredient is present in the pharmaceutical product, because this is a mere addition that does not change the features of the claimed active ingredient. Therefore, since the claims of the patent are reproduced, the infringement is sufficiently likely for the measures of Article L. 615-3 to be implemented.

The preliminary injunction measures as well as the measures of recall of the products already marketed must therefore be maintained". 

You can read the French decision here and the English translation here.
An appeal can still be lodged against this decision. 

Brückner & von Czettritz now on sale

Five weeks ago, The SPC Blog announced the impending publication of a major work on SPCs: Ergänzende Schutzzertifikate mit pädiatrischer Laufzeitverlängerung / Supplementary Protection Certificates with Paediatric Extension of Duration -- a commentary on the law relating to SPCs by Dr Christopher Brückner (Patentanwalt, Apotheker, Bardehle Pagenberg, Munich) and Peter von Czettritz (Rechtsanwalt, Preu Bohlig & Partner, Munich).  An introduction to this work's content and methodology can be found here.

The SPC Blog has learned today that this commentary is now available for purchase. You can buy it from the publisher's website here for the very reasonable price of EUR 298.  Enjoy!

Medeva and Georgetown rulings: save the date!

Some readers may not have seen the news, but the Curia diary shows that the Court of Justice will be giving its rulings in Case C-322/10 Medeva and C-422/10 Georgetown University and others in less than a month from now:

Thursday 24/11/2011 09:30

Judgment C-322/10

Approximation of laws Medeva Court of Justice - Fourth Chamber

Thursday 24/11/2011 09:30

Judgment C-422/10

Approximation of laws Georgetown University and Others Court of Justice - Fourth Chamber

The SPC Blog will do its best to bring speedy coverage.

Medeva and the role of the Advocate General: a call for more communication

Regular reader and occasional commentator Paul Inman (Wragge & Co. LLP) has been giving some further thought to the role of the Advocate General in shaping and applying legal policy where issues have been referred to the Court of Justice of the European Union for a preliminary ruling. He writes:

"One (of many) of the causes of consternation arising from Advocate-General Trstenjak’s Opinion in the Medeva reference (discussed many times  in earlier posts on this weblog) was her contention (in para 102) that:

“according to the Court’s case-law, only one supplementary protection certificate may be granted for each basic patent”.

This has caused more than a few squawks of concern by commentators across the continent (and indeed beyond), not least on this blog.

A-G Trstenjak attributes this “case-law” to paragraph 28 of the ECJ Judgment in the Biogen case, from which she has taken a literal quote of the final words of that paragraph. As the world and his wife have since pointed out, however, this is not consistent with past and current practice around Europe (and many examples of multiple SPCs based on single patents have been brought forward).

Of course, the ECJ judgment in Biogen was founded on, and came to very much the same conclusion as that reached by Advocate-General Fennelly in that case. I was struck, therefore, while perusing A-G Fennelly’s opinion in Biogen (as one does on a Friday evening) with paragraph 53 of his opinion, which closes with the words:

“It is nowhere stated that a patent can be the subject of only one certificate, or of a certificate only in respect of one medicinal product, as the same patent may be used for widely differing medicinal products.”

Hurrumph! Don’t these Advocates-General talk to each other? Perhaps Angela Merkel is right – perhaps peace in Europe should not be taken for granted".

Shoot the phoenix, count the cost!

Gently chiding The SPC Blog for the symbolism of its phoenix logo, our good friend Sophie Miller (Legal Adviser, Association of the British Pharmaceutical Industry, ABPI) kindly reminds us that an SPC is not a resurrection of an expired patent, but rather an agreed continuation of a patent term for an inventive pharmaceutical medicine, in accordance with EU Regulation.  She continues:

"Even with an SPC extension, a recent study by the ABPI IPEN with data supplied by UK IPO has found that the actual years of valuable patent life that a pharmaceutical patent that a company can actually use with a product on the market tends to last no longer than a total of between 10 and 12 years (even with the maximum 5 year SPC granted on top of the 20 years from the date of the patent application).

Even once a marketing authorisation has been granted by MHRA or EMA (National or European routes), companies need then to persuade governments (who are the sole purchasers of medicines through their national health services) to purchase new medicines for which companies need to prove increased efficiency over the existing drugs on the market through the Health Technology Appraisal (run in England through the lovely acronymed NICE, the National Institute for Healthcare and Clinical Excellence) , even before you can start to educate the doctors about the innovative new medicine and how it can help patients who are not responding to current treatments on the market. We’ve all heard of postcode prescribing. Well, the NHS is pretty reluctant to allow doctors to prescribe innovative new medicines that may have cost up to about £1.3bn to produce… unless all other avenues have failed with a particular patient first, and even then the local NHS PCT has to agree that the doctor is allowed to spend the money on the patient before treatment can start.

This makes pharmaceutical patents rather unique in that they become more valuable the closer to the end of the patent term you reach – so much so that pharmaceutical companies can find it worth while spending millions on patent litigation to protect weeks worth of SPC (see the Merck negative–term SPC cases in which in order to gain a handful of weeks of a 6 month SPC for paediatric study, Merck spent a lot of money trying to persuade the IPO and other patent offices around Europe to grant a negative term SPC (ie less than zero term) so that they could obtain the promised extra few months of the maximum 6 month extension allowed by the paediatric regulation.)

Compare this with the patents granted in the world say of mobile phones, where you have product almost immediately available on the market as soon as the invention is made to keep up with your cutting edge. They manage to squeeze the most of the full 20 years of market control available from the patent term …

I’d say the pharmaceutical industry as a result gets a pretty rough deal! (Noting also that any profits reported on the share market actually get ploughed back into the process of inventing the next new drug… and they don’t go into the pockets of the share holders at all.) And with the science getting more difficult and personalised (smaller sections of society benefiting from resulting innovation, now that genetically related “lock and key” mechanisms are being investigated) there is less and less money to pay for the next “big thing” through sales of resulting medicines before the generic market gets a look in (who can also use the same clinical data submitted by the innovator patentee to prove their significantly cheaper to produce generic manufacture-only costs medicine is safe to go on the market..). Since none of the profits of the generic industry gets ploughed back into the reimbursement of costs of development of the new medicines by innovator companies, we need all the protection we can get!

So less of the phoenix rising, and more on funding the costs of getting innovation from bench to bedside please!

I attach a handy graphic of information (reproduced below) on the R&D lifecycle we publish in our “Did you Know” booklet about the pharmaceutical industry. 

© Association of the British Pharmaceutical Industry from “Did you know?” Jan 2011 www.apbi.org.uk

This shows the process timeline and average cost of bringing a new medicine to market – even once the basic scientific invention costs are done. It also shows how and why pharmaceutical companies need SPCs".

Knowing how broadly this weblog's readership is spread between the proprietary and generic manufacturers, private practitioners, administrators, investors and academics, I suspect that there may be some interesting responses to Sophie's position. All opinions are welcome on The SPC Blog's moderated comment service.

Quetiapine and Bulgaria's transitional ruling

From our colleague Dimitar Batakliev comes news of a decision of the Bulgarian Supreme Court which interprets the transitional provisions of the SPC Regulation, in particular Art.19a(k) of Regulation 1768/92. The case is AstraZeneca Pharmaceuticals LP v Bulgarian Patent Office, in an action which followed the refusal of the Office to issue an SPC for Quetiapine. The main question is whether the Supreme Court has correctly applied the principle of supremacy of the EU law in national legislation. Dimitar explains as follows:

"In 1997 a patent, BG 61365 for Thiazepine compounds, was granted to AstraZeneca Pharmaceuticals LP as a pipeline patent on the basis of EP 240228. The national legislation at that time allowed granting of such patents for medicinal and other compounds, applied for or protected by patents abroad before entry into force of the Bulgarian Patent Act. The law required that, at the time of applying for the patent, the product must not have been marketed on the territory of Bulgaria, that no certificate of authorship had been issued for the same subject-matter, and that the applicant or the patentee had a serious commercial enterprise in the country of origin of the invention.

The national legislation further provided that the term of protection of such patents should expire with the expiration of the foreign parent patent. Consequently, due to an SPC issued in UK for Quetiapine based on EP 240228, the protection of BG 61365 was extended beyond the regular 20-year period until 24.03.2012.

In 2007, the accession of Bulgaria to the European Union was also accompanied by a reform in the patent legislation. A new provision stated that the pipeline patents with extended term of protection should be deemed to have expired at the 20th year following the filing date of the parent patent. Instead, the patent holders were entitled to file an SPC application under Regulation 1768/92, which had just entered into force for Bulgaria. The SPC applications had to be filed within a transitional 6-month period from the accession of Bulgaria to the EU.

The patentee applied for an SPC and furnished a marketing authorisation for Quetiapine, issued in 1999 in UK, which was the first marketing authorisation for the product in the Community. The Bulgarian Patent Office rejected the application for failure to comply with the requirements of Art. 19a(k) of Regulation 1768/92. That provision stated that an SPC should be granted only if the first marketing authorisation for the product was issued after 01.01.2000.

On the appeal against the decision of the Patent Office, the Administrative Court revoked it and held that the requirement for the date of issue of the first marketing authorisation did not apply to the case. According to the court, there was not such requirement in the national provisions that entitle the former holders of pipeline patents to apply for SPCs.

The Bulgarian Patent Office appealed the decision before the Supreme Administrative Court. It also requested a reference for preliminary ruling, asking whether Art. 19a(k) of Regulation 1768/92 allowed for derogation in the national legislation from the requirement for the date of issue of the first marketing authorisation after 01.01.2000 in favour of SPC applications, based on the former pipeline patents. The Supreme Court confirmed the decision of the court of first instance and upheld all of that court's arguments. It refused to refer the case for a preliminary ruling, stating that Art. 19a(k) of Regulation 1768/92 did not have any significance for the correct decision of the case".

The full text of the decision in Bulgarian can be read here.

Thank you, Dimitar, for this information.

Every day counts -- but how do we count them?

“Every day counts: why pharmaceutical companies in the EU need to make sure they get the right SPC term” is the title of an article by Mike Snodin (Potter Clarkson) which has just been published in the October 2011 edition of Scrip Regulatory Affairs. Mike's article addresses the calculation of SPC term (and the deadline for applying for an SPC) in circumstances where the relevant marketing authorisation has been issued by the European Commission (under the centralised procedure).

Mike notes that, when the first marketing authorisation in the EEA for a medicinal product is obtained via the centralised procedure, the standard practice of many patent offices in Europe (including the offices of Germany, France, the UK, Italy, Ireland, Sweden, the Czech Republic and the Netherlands) has been to set the SPC term based on the date that the European Commission decided to issue the centralised authorisation.

In his new article, Mike argues that the standard practice of many patent offices is incorrect, and that the term of SPCs should (where relevant) instead be calculated using the date of notification to the applicant of the European Commission decision to authorise the medicinal product.

The date of notification is typically two to four days later than the date of the Commission's decision. For this reason, Mike argues that a correspondingly longer SPC term should be available where:

(i) a medicinal product is first authorised in the EEA by way of the centralised procedure;(ii) that authorisation represents the first authorisation in the EEA for a "product" that represents the (combination of) active ingredient(s) present in the medicinal product; and(iii) less than 10 years has elapsed between the date of filing of a patent that protects the "product" and the date that the European Commission decided to issue the centralised authorisation.

If Mike's theory is correct, then in these circumstances the duration of the SPC may be a few days (e.g. 2 to 4 days) longer than has previously been thought to be the case. Of course, for successful medicines, even a few extra days' protection will be valuable.

Moreover, Mike points out that Article 17(2) and Recital 17 of Regulation 1610/96 together make it possible for an SPC holder to file an appeal aimed at correcting the term of a granted SPC.  This means that, provided the SPC in question has not expired, it may not be too late for a proprietor to take action to correct the official registers of those patent offices that have incorrectly calculated the term of the SPC.

You can read Mike's article in full here.

Rivastigmine ruling: judgment now available

Last Monday, in "Rivastigmine patent, SPC held invalid" (here), The SPC Blog reported on a 30 September 2011 decision of Mr Justice Floyd in the Patents Court, England and Wales. The decision had not yet been posted on BAILII and the blog's news item was based on a LexisNexis note.

A check today revealed that the decision had still not been posted on BAILII, but Alison Hall, the very helpful Clerk to Mr Justice Floyd, has circulated an approved copy of the judgment, which you can read in full here.

Daiichi: SPC validity not an issue

The SPC Blog reported a few days ago that Case C-414/11 Daiichi Sankyo Co. Ltd, currently before the Court of Justice of the European Union, concerned among other things a supplementary protection certificate, this being the Greek SPC for levofloxacin hemihydrate, and its infringement by the Greek generics company Demo AEVE.

We have since heard from Constantinos Kilimiris (Patrinos & Kilimiris, Athens) that the litigation in question does not involve any objections to the validity of the SPC. He explains

"As the patent on which the SPC was based was granted in 1986, Demo had argued that the product claims contained in the patent cannot be enforced because of the prohibition of patenting pharmaceutical products per se, which was in force in Greece at the time of filing. 

We had argued, on behalf of Daiichi, that the provisions of Articles 27 and 70.2 of TRIPS prevail over the relevant legislation and that full protection should be available based on the product claims. 

The court found that there is a matter of interpretation of Articles 27 and 70 of TRIPS, which constitute an integral part of community law and decided to refer three questions to the Court of Justice of the European Union.

I would be happy to provide more information if anyone is interested".

Many thanks, Constantinos, for your clarification.