IPO refuses SPC for Circadin

In the recent UK Intellectual Property Office decision of Neurim Pharmaceuticals (1991) Ltd's application, BL O/384/09, hearing officer Dr C Davies rejected an application to an SPC because it did not comply with Article 3(d) of Regulation (EC) 469/2009.

The facts of the case are as follows: Neurim Pharmaceuticals filed an application for the product melatonin (Ciracadin) based on EP 0518468 (concerning the use of melatonin to correct a distortion or deficiency in the plasma melatonin profile of a human subject) and authorisation EU/1/07/392/001 as the first authorisation to place the product on the market.

The examiner observed that the cited marketing authorisation was not the first authorisation to place melatonin on the market as a medicinal product because there was an earlier authorisation to another company for a composition comprising melatonin for use in sheep to initiate an early breeding season.

The applicants disagreed arguing that the Regulation should be interpreted teleologically and on such an interpretation the SPC should be granted and that the application does meet the requirements of Article 3(d).

The hearing officer held that, although the applicant was correct in arguing that the SPC Regulation had to be given a teleological interpretation, the case could not be distinguished from the ECJ decision in Pharmacia and the case law was clear that the intended use of the medicinal product could not be taken into account when considering the relevance of an earlier marketing authorisation.

Paediatric extensions: a major article

"Fostering paediatric research and the right to extend supplementary protection certificates" is the title of a ten-age article in the Journal of Intellectual Property Law & Practice (JIPLP). The authors are Montserrat López-Bellosta and Ana Benetó Santa Cruz (both of Clifford Chance). The online version of this article has been available to JIPLP subscribers since 10 December and the paper version will soon be available too.

According to the article's abstract,

"Legal context: This article analyses Article 36 of EC Regulation 1901/2006 on medicinal products for paediatric use. Among the incentives for promoting paediatric research set out by this Regulation is the possibility of obtaining a 6-month extension to the Supplementary Protection Certificates, given that the conditions set out in Article 36 are met. Granting SPC extensions is reserved to the competent authorities of the EC Member States, this has led to various interpretations of Article 36.

Key points: The article discusses the interpretations of the requirements established by Article 36 for obtaining an SPC extension, concluding that the means of proving compliance with an agreed paediatric investigation plan are not limited to the statement set forth in Article 28.3 of Regulation 1901/2006, and that the required authorizations in all Member States must not necessarily have been granted on the basis of studies carried out according to an agreed paediatric investigation plan. Finally, the article analyses the moment at which an applicant should meet the requirements of Article 36.

Practical significance: The authors argue in favour of an interpretation of Article 36 that avoids introducing factors beyond applicants' control when considering whether the requirements for an SPC extension are met, and which is in line with the underlying objectives of the incentives established by Regulation 1901/2006. The compensation (obtaining an SPC extension) is for performing studies carried out according to an agreed paediatric investigation plan, not for obtaining marketing authorizations".

Generics v Synaptech: on Curia at last

The questions for reference to the European Court of Justice by the Court of Appeal, England and Wales, in Case C-427/09 Generics (UK) Ltd v Synaptech Inc on 23 October (see SPC Blog here) were lodged with the ECJ on 28 October 2009. However, it was not until today that they were posted on the Curia website.

To remind readers, the questions referred are as follows:

"For the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, is the "first authorisation to place the product on the market in the Community" the first authorisation to place the product on the market in the Community which was issued in accordance with Council Directive 65/65/EEC (now replaced with Directive 2001/83/EC) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?

If, for the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, an "authorisation to place the product on the market in the Community" must have been issued in accordance with Directive 65/65/EEC (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?"

This writer assumes that the reason why it takes so long for the Curia website to post questions is that they have to be translated into all of the EU's official languages. If this is so, it seems anomalous that this should be the case for the questions referred but not for Advocate Generals' Opinions or court decisions, which are frequently posted initially in a minority of languages.

Escilatopram - English translation of German decision available

Yesterday, we posted a piece on the German Federal Supreme Court decision on Escilatopram.

Non-German speakers will be delighted to know that the English translation of the decision can be obtained here. It was kindly provided to the Blog by Klemens Stratmann (Hoffmann-Eitle, Munich)

Escilatopram in Germany - the BGH decides

The German Federal Supreme Court (FSC) recently reversed the German Patent and Trademark Court decision on the validity of Escilatopram patent EP 0347 066 and its related SPC (SPC No. 103 99 030 to Escitalopram and non-toxic acid addition salts thereof) - Read the decision in original - here (unfortunately, no English language version available). The IPKat (Thanks!) provides a short summary of the facts of the case here.

On SPCs, the FSC held that a marketing authorisation for a racemic product does not prevent the grant of a supplementary protection certificate to an enantiomer form of the product based on a later marketing authorisation to the enantiomer of the product and a patent on that enantiomer.

You might recall that this case has also been heard and decided in the Netherlands (here in Dutch, and here for an English translation) and the UK (here).

Munich conference to include SPCs, Paedodata

"Biotech & Pharmaceutical Patenting" is the title of a forthcoming conference, to be held at the Hilton Munich Park, Germany, on 7 and 18 February next year. The programme contains a session under the heading 'Patent Term Extensions and Paediatric Data Exclusivity', a 45-minute slot on the first day in which the speakers are Dr Frank Burkert (Bayer Healthcare) and Bert Oosting (Lovells, The Netherlands). The seven bullet-pointed topics include the ever-popular negative-term issue, post-Losartan paediatric data esclusivity and the impact of the ECJ's ruling in Case C-482/07 AHP (noted by the SPC Blog here).

Further information concerning the conference programme, as well as bookings, can be obtained from the conference website here.

SPCs, competition and refusal to supply

SPCs are frequently viewed from the mechanical perspective of the apparently endless sequence of arbitrary steps that have to be taken to secure the formalities that are a necessary condition for extending a patent's life, if not a sufficient one. For this reason it is easy to overlook their interest to competition lawyers.

Two SPC-related items were found on the website of the International Competition Network (ICN) in the context of the Italian Competition Authority's responses last month to a questionnaire on "refusal to deal" -- something that competition lawyers dislike because of its damage to their beliefs in how markets should operate and the philosophy of "everything has its price", but which IP owners regard as part of their patrimony.

The questionnaire sought information on ICN members’ analysis and treatment under their antitrust laws of the refusal of a company to deal with a rival, to give an overview of law and practice in the responding jurisdictions regarding refusals to deal and the circumstances in which they may be considered anticompetitive. "Refusal to deal” is defined as

"the unconditional refusal by a dominant firm (or a firm with substantial market power) to deal with a rival. This typically occurs when a firm refuses to sell an input to a company with which it competes (or potentially competes) in a downstream market. For the purposes of this questionnaire, a refusal to deal also covers actual and outright refusal on the part of the dominant firm to license intellectual property (IP) rights, or to grant access to an essential facility".

"Constructive” refusals to deal, characterized here by a dominant firm’s offering to supply its rival on unreasonable terms (e.g., extremely high prices, degraded service, or reduced technical interoperability) fall within this definition, as does the "margin-squeeze,” which occurs when a dominant firm charges a price for an input in an upstream market, which, compared to the price it charges for the final good using the input in the downstream market, does not allow a rival on the downstream market to compete.

The first SPC reference is to Glaxo - Active ingredients (Italian Competition Authority case A363 Glaxo-Principi attivi, decision n. 15175 of 8 February 2006), published in Bulletin no. 6/2006:

"In February 2006 an investigation into the pharmaceutical group Glaxo concluded with the finding of abusive practices in violation of Article 82 of the EC Treaty. Glaxo refused to grant Fabbrica Sintetici Italiana (FIS), a chemical-pharmaceutical undertaking, a licence to produce an active drug ingredient known as Sumatriptan Succinato, covered in Italy by a supplementary protection certificate, for use in other Member States (in which Glaxo no longer held any patent-rights) in the production of generic drugs known as triptans for the treatment of migraines. The Authority found that Glaxo, in additipn to holding a quasimonopoly on the production of Sumatriptan Succinato worldwide, occupied a dominant position in the Spanish and Italian markets for the production and marketing of triptans sold through hospitals. In these markets Glaxo held a particularly high market-share, equal to about 96% in Italy and 58% in Spain. As for the possibility of access for potential competitors, all the products sold in the markets concerned were found to be covered by industrial patent-rights, which were due to lapse between 2008 and 2012, with the exception of Sumatriptan Succinato which was not covered by any patent in the Spanish market. Based on the investigation’s findings, the Authority deemed that Glaxo’s refusal to grant the requested licence constituted an abuse of dominant position in violation of Article 82 of the EC Treaty, since its refusal hindered the production of an active ingredient needed by producers of generic drugs, potential competitors of Glaxo, to access national markets where Glaxo did not have any exclusive rights. The Authority considered this conduct had no objective justification".

The second SPC reference is Italian Competition Authority case A364 - MERCK-PRINCIPI ATTIVI, decision no. 16597 of 21 March, 2007, published in Bulletin n. 11/2007:

"In A364 Merck the Authority, with a view to ensuring that, pending the outcome of the investigation, Merck’s behaviour would not continue to cause serious and irreparable harm in the markets concerned, adopted interim measures obliging the company to issue without delay – and at least for stockpiling purposes – licences authorising the production in Italy of Imipenem Cilastatina. In accordance with this ruling, in August 2005 Merck issued a license to the chemical firm Dobfar to manufacture this active ingredient, whose Supplementary Protection Certificate expired in January 2006. In November 2006 Merck presented a commitment under Article 14-ter of Law no. 287/1990, offering free licenses to manufacture and sell the active ingredient Finasteride and related generic drugs, even though the Supplementary Protection Certificate does not expire until 2009. The Authority deemed that this commitment was likely to result in the permanent removal of any anticompetitive effects flowing from Merck’s former refusal to grant licences".

Generics v Daiichi note available

The Current Intelligence note by Bratin Roy ((McDermott Will & Emery UK LLP) on the Court of Appeal (England and Wales) decision in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd & Another [2009] EWCA Civ 646 (2 July 2009), Court of Appeal, England and Wales (noted here on The SPC Blog), published in this month's Journal of Intellectual Property Law & Practice, is available in full at no charge from that journal's weblog here.

SPC practice in Germany - changes due to the PatModG

Klemens Stratmann (Hoffman-Eitle, Munich) has kindly informed us of some recent developments on SPCs practice in Germany due to the Patentrechtsmodernisierungsgesetz (shortened - PatModG; English translation - The Act to simplify and modernise the Patent Act), which entered into force on 1 October 2009:

"One change concerns requests for the correction of the duration of granted SPCs. Prior to 1 October 2009, the terms of granted SPCs could only be corrected by lodging a request for partial nullification at the Federal Patent Court. The SPC proprietor was barred from filing such request. Although there is no explicit legal basis for requests of this type to be found in Regulation 1768/92, that this can be allowed may be derived from Art. 17(2) and Recital 17 of Regulation 1610/96 (Federal Patent Court decision "Finasterid", 15 March 2007, 3 Ni 2/06).

New Sec. 49a (4) of the German Patent Act allows for the first time the filing of requests for the correction of an SPC at the German Patent and Trademark Office. Further, such requests can be filed by the owner of the SPC, for instance if he was in error regarding the first authorization to place the product on the market in the Community when filing the SPC request.

New Sec. 49a(3) of the German Patent Act implements the provisions of Regulation 1901/2006 on medicinal products for paediatric use.

The German legislators also took the opportunity with this change to introduce fees for extensions of paediatric SPCs. Should an SPC application already be pending, the request to extend the SPC costs 100 € as of October 1, 2009. If the request for SPC extension is lodged after the SPC application, the fee is 200 €."

The SPC Blog would be interested in knowing how corrections are handled in other European countries. Please post your comments below.

Medeva pertussis vaccines fail the Art 3 test as question of appeal remains unresolved

On Monday, in Medeva BV's application, BL O/357/09, Dr Lawrence Cullen was faced with five applications for supplementary protection certificates (SPCs), each of which was based on the same patent, EP (UK) 1 666 057 B1, which was filed on 20 April 1990 with a priority date of 8 May 1989, then granted on 18 February 2009.

The SPCs covered pertussis vaccines, each of which contained the two active ingredients expressly covered by the basic patent, in combination with several other active ingredients [there's a neat tabular representation of the combinations at p.2 of the decision]. Dr Cullen upheld the examiner's view that the basic patent could not be construed as protecting any combination of this type and that an application for an SPC covering only the two claimed active ingredients could not succeed because there was no marketing authorisation for such a product; all the authorisations were for combined products [these are neatly tabulated on p.3]. Since the defects in the application had not been remedied by Medeva within the four-month window for rectifying them, the applications were doomed.

At paragraphs 12 to 13 Dr Cullen mentions a preliminary issue, which remains outstanding since his decision dealt only with the substantive question of whether the applications fulfilled the requirements of Article 3 of Regulation 469/2009:

"12. In correspondence with the examiner, the applicant gave notice that they
considered his report dated 31 July 2009 to be a ‘final decision’ on these
applications and, as a consequence, that they would bring this ‘final decision’ to
refuse these SPC applications as an appeal before the Patent Court. The
examiner wrote back on 1 September 2009 indicating that this examination report
did not constitute a final decision, that a response to the examination report was
awaited and that, if the applicant did not have further arguments or observations
on these applications, they could request a final decision on these applications
from the Office, either at an oral hearing, or if they wished to expedite matters, on
the basis of the papers currently on file. The applicant replied on 9 September
2009 waiving their right to be heard and indicating that they would like a decision
based on the papers currently on file so that the status of these applications
could be resolved before expiry of the basic patent in April 2010.

13. However, this request was made without prejudice to the ongoing question over
whether or not it is appropriate to launch an appeal based on an examination
report. While the Office agreed to the applicant's request for a decision from the
papers, it also indicated that it would reserve its right to seek an order to have
this appeal application struck out on the ground that there was no decision of the
Office to appeal from at that date".

Chewing the fat? Chewy Lipitor goes for paediatric extension

According to Trading Markets, Pfizer Inc said today that it has submitted paediatric data for Lipitor (atorvastatin) to the European Medicines Agency (EMEA), after the EMEA concluded that Pfizer's programme studying the use of Lipitor in children with high cholesterol complied with its criteria. This submission includes a new chewable form of Lipitor, including a paediatric-appropriate 5 mg dose (see also Welt Online, RTT News ).

Just over a week ago, Dr Reddy's filed an application to manufacture a generic version of the drug (see here and here).

No further UK appeal over levofloxacin

According to a news item this morning on the UKSCblog, which focuses on the activities of the new Supreme Court for the United Kingdom which took over the appellate functions of the House of Lords this autumn, the Supreme Court has refused permission to appeal in Generics (UK) Ltd v Daiichi Pharmaceuticals [2009] EWCA Civ 646 (noted here on The SPC Blog). Generics (now known as Mylan) wanted to appeal against the decision of the Court of Appeal that that Daiichi's by then expired patent antibacterial levofloxacin and the supplementary protection certificate based upon it were valid.

This news item has been picked up by Zenopa here. It does not however appear on the Supreme Court's own website or on any of the usual internet news channels.

Ask the IPO ... at the SPC Seminar 2010

The SPC Blog is pleased to announce that Lawrence Cullen, Deputy Director of the UK Intellectual Property Office, will be joining the panel for the Hot Topics and Questions discussion at the SPC Law and Practice 2010 Seminar.

The SPC Blog's 2010 seminar: you're all invited!

The SPC Blog is delighted to announce SPC Law and Practice 2010, the weblog's second annual seminar. Once again we are fortunate that Olswang LLP has agreed to host the event, which is free, at its London office.

The seminar takes place on Wednesday 13 January 2010. It will run from 1.30pm, when registration commences, till the last drop of wine is sipped and the last peanut ceremonially crunched at 6pm. Last year's seminar was very well attended and, judging by the growth of interest in SPCs, paediatric extensions and patent term prolongation in general over the past year, we expect a capacity crowd of 90 participants or thereabouts.

Highlights of the afternoon include presentations on the current state of SPCs in Spain (Javier Huarte, Grau and Angelo) and the Netherlands (Martijn de Lange, Netherlands Patent Office) as well as patent term extension in the USA (Jeffrey Boone, Covidien). SPC Blog team member Rob Stephen (Olswang) takes the chair. There will also be a celebrity line-up for the Hot Topics and Questions session, which will be full of surprises.

For further details click the invitation here. To tell the SPC Blog that you'll be coming, email Verity here

IPO issues new SPC guide

The Intellectual Property Office in the United Kingdom has recently prepared, and now issued, a handsome new guide to SPCs, Supplementary Protection Certificates: Guide for Applicants, though for some souls who are unfamiliar with the subject a more welcome title might have been A Guide for the Perplexed, given the level of detail and conceptual complexity which accompanies almost every step of this topic in practice. Weighing in at 34 pages and attractively illustrated, this booklet, which is current to September 2009, aims

"to give a short introduction to the procedures for applying for a Supplementary Protection Certificate or an extension to a certificate in the United Kingdom. It is intended to serve as a guide only and is not an authoritative statement of the law on Supplementary Protection Certificates. It is therefore advisable to seek independent professional advice about any matters covered by this booklet and not to rely on the booklet alone".

The SPC Blog agrees that professional advice is a good idea; it would never do for a private individual who holds a pharmaceutical patent to go wandering off into the arcane area of patent term extension without at least having a quiet word or two with his friendy local lawyer ...

Seriously, this is a useful, well-structured, well-referenced guide which, when read by a client before meeting a lawyer, can save time, focus minds and dispel misapprehensions. The IPO should be congratulated for putting it together.

Synaptech for ECJ reference: to join with Synthon v Merz?

In Generics (UK) Ltd v Synaptech Inc [2009] EWHC 659 (Ch), Roger Wyand QC, sitting as a Deputy Judge in the Patents Court (England and Wales), held that the term "the first authorisation to place the product on the market" should be interpreted wherever it occurs in the European supplementary protection certificate (SPC) Regulation as referring to the first authorisation compliant with Directive 65/65/EEC. On this basis the Intellectual Property Office had correctly granted an SPC with a term calculated on the basis of a first Directive 65/65/EEC authorisation in 2000, rather than earlier non-compliant authorisations (see The SPC Blog here for comments on that decision).

Today the Courts Service has released this order of the Court of Appeal (Lords Justices Jacob and Rimer and Mr Justice Kitchin):

"UPON APPEAL from the order of Mr Roger Wyand QC, Deputy High Court Judge dated 9 June 2009

AND UPON HEARING Counsel for the Appellant and Counsel for the Respondent

IT IS ORDERED that

1) the questions set out in the Schedule to this Order concerning the interpretation of Regulation (EEC) 1768/92 be referred to the Court of Justice of the European Communities for a preliminary ruling in accordance with Article 234 of the Treaty establishing the European Community
2) this Court will request that the Court of Justice of the European Communities join this reference with the reference in pending Case C-195/09 Synthon v Merz, referred by Floyd J on 29 May 2009 [on which, see The SPC Blog here]
3) all further proceedings in this appeal be stayed until the Court of Justice of the European Communities has given its ruling on the said questions or until further order
4) the Senior Master shall forthwith, and without waiting for time to appeal against this Order to expire, transmit to the Registrar of the ECJ, pursuant to CPR Pt 68, this Order and the Schedule thereto
5) costs be reserved
6) there be liberty to apply".

The Schedule to this order can be read in full here. In short, the questions referred -- which overlap with those in Synthon v Merz, are as follows:

"(1) For the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, is the “first authorisation to place the product on the market in the Community” the first authorisation to place the product on the market in the Community which was issued in accordance with Council Directive 65/65/EEC (now replaced with Directive 2001/83/EC) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?

(2) If, for the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, an “authorisation to place the product on the market in the Community” must have been issued in accordance with Directive 65/65/EEC (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?"

Losartan and Caspofungin in Denmark

As you may recall, the Blog reported that an application was made for the paediatric extension of Caspofungin in Denmark in February this year. Andreas Schmitt of A.S. Dataservices writes:

"Denmark has recently granted pediatric extensions for Losartan and Caspofungin (see here for page of Patent Journal).

The expiry date given for Caspofungin doesn't take the extension into account, but after contacting the Danish Patent Office, they informed me that the date will be corrected in one of the next issues of the journal."

Paediatric extensions: "more disharmony"

The cover story of the October 2009 issue of Informa's ten-times-a-year Patent World is a review by Ewan Nettleton (Bristows) entitled "Paediatric Extensions -- more SPC disharmony?" According to the appetiser on the journal's website,

"There has been a flurry of cases concerning supplementary protection certificates (SPCs) in recent months, several of which concern the so-called ‘paediatric extension’. These extensions to the term of an SPC were introduced into European legislation a couple of years ago as part of a package of measures to incentivise the pharmaceutical industry to conduct the necessary tests and trials to assess whether medicines are appropriate to administer to children".

The article, which sets out the basic legal propositions underpinning paediatric extensions, went to print before the Court of Appeal belatedly handed down its decision to reverse the decision of the High Court in E I du Pont Nemours & Co v United Kingdom Intellectual Property Office [2009] EWCA Civ 966 (see The SPC Blog here). In endorsing the Dutch approach which Ewan Nettleton summarises in his article, the Court of Appeal has done its bit to reduce the disharmony -- but there is still scope for discord ...

Grounds for Irish Losartan Decision Available

We follow up on our previous posting that the paediatric extension for Losartan was recently granted in Ireland - Dolores Cassidy of the Irish Patent Office has pointed out that the the grounds of the decision are now available here, on the Irish Patent Office website.

Court of Appeal for England and Wales rules on Losartan paediatric extension

The final version of the Court of Appeal's "mystery decision" in E I du Pont Nemours & Co v United Kingdom Intellectual Property Office [2009] EWCA Civ 966 , which was handed down in draft form on 19 September, has at last been made generally available today. This decision reverses that of John Baldwin QC, sitting as a High Court judge (see The SPC Blog here) in which he upheld the Intellectual Property Office's decision to refuse to grant a paedriatric extension to the term of an SPC for Losartan.

At para 59 Lord Justice Jacob (with whom the other appellate judges agreed) explains:

"We indicated at the conclusion of the oral hearing that the appeal would be allowed. This was necessary in order that the Patent Office could extend the SPC before it expired. These are my reasons for that decision. They are largely the same (though I fear expressed at much greater length) as those of the Dutch Patent office [noted here on the SPC Blog] which, by its letter of 2nd June, extended the corresponding Dutch SPC".

The SPC Blog welcomes further comment on this very full decision, and may provide some additional comments of its own in due course.

Losartan and third party oppositions in the Netherlands

As most seasoned SPC Blog readers will recall, third party Actavis lodged an objection with the Netherlands Patent Office against the decision by the Netherlands Patent Office to grant the extension of the term of the supplementary protection certificate to Dupont (reported here http://thespcblog.blogspot.com/2009/06/losartan-decision-in-netherlands.html).
The Netherlands Patent Office declared the petition inadmissible in view of article 19.2 of Reg. 469/2009 which rules out an opposition procedure against the granting of a certificate.

Actavis appealed at the Administrative chamber of the Court of the Hague, arguing in particular that article 19.2 only applies to the granting of certificates, not to the awarding of term extensions.

The Court has rejected this appeal (a copy of the decision is available here): There is nothing in the documentation concerning the Paediatric Regulation to suggest that the legislator found an opposition procedure against the granting of term extensions desirable, but an opposition procedure against the granting of certificates not. Furthermore article 16.2 of Reg. 469/2009 stipulates that any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent. That body under Dutch patent law is the Court of The Hague, section Civil, department Intellectual Property.

Unlike in the Netherlands, in some countries not only the courts but also the national patent offices have the power under their national patent law to revoke patents. This leads to a bit of a contradiction between article 16.2 and 19.2 (and also 15.2 and 19.2). We invite the Blog readers to comment on how these countries deal with such third party oppositions.

Losartan: now it's Latvia's turn

SPC enthusiast and expert Alice de Pastors has just told the SPC Blog that, in August of this year, the Latvian Patent Office published a notice regarding the issue of paediatric extension for Losartan. Alice also sent us an extract of page 1135 of Latvian Patent Gazette of 20 August 2009, adding: "The August Latvian Patent Gazette is available here". Thanks so much, Alice!

And if you're wondering what might cause hypertension in laid-back Latvia, here's a selection of tasty recipes, some of which are quite likely to clog up those arteries.

Ball and Barnett note now available online

Last week this weblog noted the publication, in issue 2 of volume 10 of the Bio-Science Law Review (published six times a year by Lawtext), of a note by Jonathan Ball and Elizabeth Barnett (Norton Rose), "High Court Upholds UK's Strict Approach on Paediatric Extension to SPCs". This note on E I Du Pont Nemours & Co [2009] EWHC 1112 (Ch), now somewhat overtaken by events (see the comments posted on last week's note) but still of interest, can now be read in full here.

The SPC Blog thanks Nicholas Gingell of Lawtext for making this pdf available.

Losartan in Italy

The SPC Blog has recently heard from Micaela Modiano of Modiano and Partners that the Italian PTO also granted the pediatric extension for losartan in Italy, see excerpt here from the Italian PTO online IP rights database.

Micaela comments -

"It is also interesting that in Italy the regulatory agency (AIFA) issued an official communication, here, published in the Italian OJ, indicating not only that it had accepted the variation determined by the addition of the pediatric indication, but also that "Therefore, the patent owner or SPC owner has the right to a 6-month extension of the period provided for." (see highlighted sentence in the official communication)

As far as we know, this is the first time that the Italian regulatory agency has officially commented on something that would then be taken up by the Italian PTO (usually, it's the other way round, i.e. the Italian regulatory agency uses the Italian PTO sources for determining when SPCs expire and in turn determining when a generic MA request can be submitted, according to a certain interpretation of the Italian IP code made by the Italian regulatory agency the correctness of which is currently unclear).

We were told by the Italian PTO that they welcomed the Italian regulatory agency communication as the PTO examiners feel that they are unable to determine when the studies made by the SPC owner justify the pediatric extension and when they don't. It remains to be seen whether an official communication by the Italian regulatory agency as made in the losartan case will thus become the standard practice in case of pediatric studies."

More on Losartan - this time from Ireland

We are pleased to have heard from Yvonne McKeown from MacLachlan & Donaldson in Ireland that the Irish Patent Office has granted a paediatric extension for Losartan (see Irish Patent Office Official Journal extract here).

Losartan paed-ex in the UK: a new case note

The newly-minted issue 2 of volume 10 of the excellent Bio-Science Law Review (published six times a year by Lawtext) carries a note by Jonathan Ball and Elizabeth Barnett, both of London law firm Norton Rose, on paediatric extensions. Entitled "High Court Upholds UK's Strict Approach on Paediatric Extension to SPCs", this is an analysis of the Patents Court for England and Wales in E I Du Pont Nemours & Co [2009] EWHC 1112 (Ch), the Losartan application (noted here on The SPC Blog).

Since the publisher of the Bio-SLR is an old friend, I'll see if I can persuade him to let blog readers have sight of this four-page note in pdf format.

CORRECTION Human drug extensions in the US: article now available online

Correction: the wrong link to the article was added to the earlier version of this post.

Further to our previous post, Oxford University Press has very kindly agreed to allow readers of The SPC Blog to gain free access to Jeffrey S. Boone's article, "Patent term extensions for human drugs under the US Hatch–Waxman Act". You can read his excellent piece in full here. The SPC Blog thanks OUP for its kindness.

Patent extension for human drugs in the US: a fresh critique

Patent term extension is not a solely European preoccupation, though readers of this weblog might sometimes wonder whether Europe ("the home of the SPC") was the only theatre of war between those who seek to extend their chance of enjoying their hard-earned patent protection and those who, in the name of competition, fight them tooth and nail. There's plenty going on in the United States too. That this is so is evident from an article published this month: "Patent term extensions for human drugs under the US Hatch–Waxman Act". It's written by Jeffrey S. Boone (Vice President, Intellectual Property, Covidien, based in Hazelwood, MO) and you can find it in the Oxford University IP flagship publication, the peer-reviewed Journal of Intellectual Property Law & Practice 2009 4(9):658-664. The abstract reads as follows:

"Legal context: The US Drug Price Competition and patent Term Restoration Act of 1984 was a major revision to US pharmaceutical law. A significant provision of that law was the ability, under specific circumstances, to obtain an extension of the term of a patent that claims a new drug. The determination of eligibility for a patent extension is a complex matter that has been subject to differing interpretations by the courts and regulatory agencies.

Key points: This article reviews the circumstances under which a patent can be extended, how an application for extension is submitted, and how the term of extension is calculated. A case study is presented to further illustrate the procedures.

Practical significance: By limiting when a generic product can be launched, the determination of whether a patent is eligible for a patent term extension can have a major economic impact on both the innovator company and generic competitors. An understanding of patent term extension eligibility is a critical part of the life-cycle analysis of pharmaceuticals".

ECJ Ruling on AHP Manufacturing v BIE

The judgement is out on ECJ case C-482/07 AHP Manufacturing BV v Bureau voor de Industriële Eigendom, also operating under the name Octrooicentrum Nederland, available here in French, German, Dutch and other languages, but unfortunately, not yet in English.

Here are the essentials questions and (distilled) answers:

1. Does Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as subsequently amended, and more specifically Article 3(1)(c) thereof, preclude the grant of a certificate to the holder of a basic patent for a product for which, at the time of the submission of the application for a certificate, one or more certificates have already been granted to one or more holders of one or more other basic patents? - No

2. Does Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, as subsequently amended, and more specifically recital 17 and the second sentence of Article 3(2) thereof, give rise to a different answer to Question 1? - No

Art. 3(1)(c) of Council Regulation 1768/92, in consideration of Art. 3(2) second sentence of Regulation 1610/96, should be interpreted such that it does not preclude the grant of a certificate to the holder of a basic patent for a product for which at the time of submission of the application, one or more certificates have already been granted to one or more holders of one or more basic patents. (see paragraph 43 of the decision)

3. When answering the previous questions, is it relevant whether the last application submitted, like the previous application or applications, is submitted within the period prescribed by Article 7(1) of Regulation (EEC) No 1768/92 or that prescribed by Article 7(2) of Regulation (EEC) No 1768/92? - No

4. When answering the previous questions, is it relevant whether the period of protection afforded by the grant of a certificate pursuant to Article 13 of Regulation (EEC) No 1768/92 expires at the same time as, or at a later time than, under one or more certificates already granted for the product concerned? - No

5. When answering the previous questions, is it relevant that Regulation (EEC) No 1768/92 does not specify the period within which the competent authority, as referred to in Article 9(1) of that Regulation, must process the application for a certificate and ultimately grant a certificate, as a result of which a difference in the speed with which the authorities concerned in the Member States process applications may lead to differences between them as to the possibility of a certificate being granted? - No

We'll provide more specifics on the reasoning in a later posting.

Synthon v Merz: questions for the ECJ

The questions referred to the Court of Justice of the European Communities for a preliminary ruling in Synthon v Merz by Mr Justice Floyd (Patents Court, England and Wales) -- reported by the SPC Blog here -- have just been posted on the Curia website for all to see. The case is now Case C-195/09 Synthon BV v Merz Pharma Gmbh & Co KG. The questions referred read as follows:

"1. For the purposes of Articles 13 and 19 of Council Regulation ... 1768/92, is an authorisation a "first authorization to place ... on the market in the Community", if it is granted in pursuance of a national law which is compliant with Council Directive 65/65/EEC, or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that Directive?

2. For the purposes of Articles 13 and 19 of Council Regulation ... 1768/92, does the expression "first authorization to place ... on the market in the Community", include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with Council Directive 65/65/EEC?

3. Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in Council Directive 65/65/EEC within the scope of Council Regulation ... 1768/92 as defined by Article 2?

4. If not, is an SPC granted in respect of such a product invalid?"

We await the answers with excitement and trepidation ...

"An uncertain equation"

Howrey's IP Intelligence Newsletter Europe, Summer 2009, carries an article, "Calculating an SPC Term: An Uncertain Equation", by Marjan Noor and Claudia Zeri. It sets out the relevant recent case law and its context in a most effective fashion.

Right: when calculating the term of an SPC, be prepared for the occasional surprising result.

Some of the cases discussed can be found in the earlier postings of on the SPC Blog here and here

A Recent Review of the Scene

Alice de Pastors of Cabinet Alice de Pastors has kindly provided a shortened version of her firm's SPC News, which we're posting below:

What is the situation in July 2009?
Supplementary Protection Certificates in Europe are governed
– in the 27 EU countries, Norway and Iceland by recently codified Regulation EC Regulation No. 469/2009, replacing Regulation 1768/92, amended by Regulation (EC) No 1901/2006 of 12 December 2006 relating to medicinal products for paediatric use
– in Switzerland by National law of 3 February 1995.

Paediatric SPC extensions in Europe
- EC Regulation No. 1901/2006 on medicinal products for paediatric use entered into force, with direct effect in member states, on 26 January 2007.
As far as intellectual property is concerned, the main paediatric reward is a six-month extension of the SPC.

- Situation on 31 July 2009
We noticed applications for paediatric extension for 2 active substances.
§ Caspofungin
The corresponding applications were filed in August 2008.
For the time being the status of these applications is as follows
- Paediatric extension granted in Denmark and The Netherlands
- Paediatric extension application published in Belgium, Finland, France, The United Kingdom, Ireland, and Sweden. It is important to note that the UK Patent Office refused the paediatric extension because the application does not include an authorisation containing a statement of compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of EC Regulation 1901/2006.
§ Losartan
The corresponding applications were filed in February 2009.
For the time being the status of these applications is as follows
- Paediatric extension granted in Denmark, Finland, France, The Netherlands and Sweden
- Paediatric extension application published in Austria, Belgium, Germany, The United Kingdom and Ireland. It is important to note that the UK Patent Office refused the paediatric extension because a statement on compliance with agreed PIP was not included in the marketing authorisation and authorisation in all the EU member states must be confirmed before the six-month extension to the SPC can be granted.

- Potential paediatric extensions for the next years
We reviewed EMEA decisions agreeing on PIP or granting waivers and noted data for medicinal active substances that are protected by a supplementary protection certificate due to expire in the next three years.
In addition to losartan (see above), we identified 10 products which could benefit from paediatric SPC extensions:
- anastrozole, docetaxel and pramipexole, protected by SPCs expiring in 2010,
- atorvastatin, latanoprost and valsartan, protected by SPCs expiring in 2011,
- zoledronic acid, rabeprazole, montelukast and candesartan, protected by SPCs expiring in 2012.

Medicinal Product SPCs in Europe from 1991 to 2008

About 11900 SPC applications for medicinal products regulated by EEC Regulation 1768/92 or National laws have been filed in European countries from January 1991 to December 2008, and published until the end of June 2009.
In the graph below, is shown, for each country the number of SPCs filed from 1991 to 2008, dispatched according to their status.

1991-2008 SPCs

The situation differs from one country to another due to the importance of the markets and/or to the applicable laws and/or to the date of entry in force of the EU Regulation.
So for SPCs in force in June 2009 we noted:
- in the twelve new EU countries (SPC EU Regulation since 2004 or later) there are few SPCs in force : 0 to 14 SPCs per country
- in Spain, Greece, Portugal and Iceland (SPC EU Regulation since 1998) there are 67, 53, 44, 3 SPCs in force, respectively
- in Denmark, Finland, Ireland and Norway (SPC EU Regulation since 1993 or 1994) there are 83, 67, 75, 52 SPCs in force, respectively
- in Austria, Belgium, Switzerland, Germany, France, United-Kingdom, Italy Luxembourg, The Netherlands, Sweden (SPC EU Regulation since 1993 or 1994 or Swiss Law) there are 108 to 134 EU or CH SPCs in force.
There are no more national SPCs in force in France and Sweden and only 19 in Italy.

Medicinal Product SPCs in Europe in 2008
How many SPCs?
868 SPCs filed in 2008 were published at the end of June 2009.
In the graph below, is shown the number of SPCs for each country.
Medicinal Product SPCs filed in 2008

Which medicinal products?
The 868 SPCs filed in 2008 and published at the end of June 2009 cover about 100 different products (active ingredients, combinations of active ingredients, or formulations).
- Among these 868 SPCs, about 18,3% relate to antineoplastic agents, 15,7% to influenza or papillomavirus vaccines, 14,6% to antiviral agents, and 10% to glucose lowering agents.
- We noted products, for which were lodged at least 20 SPCs. These products can be roughly sorted according to their therapeutic category:
· Glucose lowering agents: metformin and vildagliptin combination (30), metformin and sitagliptin combination (27)
· Direct thrombin inhibitors: dabigatran etexilate (26)
· Antivirals: efavirenz+emtricitabine+tenofovir disoproxil fumarate combination (45; 23 referring to Merck, 16 to Gilead Sciences, 3 to Emory University and 3 to Shire patents), raltegravir (25), fosamprenavir (20), maraviroc (23)
· Vaccines: H5N1 influenza vaccine (96; 29 referring to GlaxoSmithkline Biologicals, 21 to Medimmune Vaccines, 18 to Mount Sinai School of Medicine and 28 to Wisconsin Alumni Research Foundation patents), Papillomavirus vaccine (27; Cervarix® 17, Gardasil® 10)
· Antineoplastic agents: panitumumab (62; 20 referring to Amgen Fremont, 42 to Aventis Holdings and Yeda Research and Development patents), lapatinib (25), sunitinib (22), temsirolimus (21), trabectedin (20)
· Drugs used in nicotine dependence: varenicline (20).

French decisions affecting SPCs
As usual, there are very few French decisions relating to patents. We mention however a few decisions relating to SPCs.

- Decisions affecting Zinnat® drugs
Two decisions of TGI Paris relate to French SPC 92C0212 referring to French patent FR2531087:
TGI Paris (20/02/2009) Glaxo Group Ltd and Laboratoire GlaxoSmithKline / Qualimed and Merck Génériques,
TGI Paris (20/02/2009) Glaxo Group Ltd and Laboratoire GlaxoSmithKline / Sandoz
French SPC 92C0212 expired on 8 August 2008. This SPC was referring to FR2531087 patent relating to amorphous cefuroxime axetil.
According to these decisions the Court revoked French SPC 92C0212, for lack of novelty of claims 1 2 and 3 and for lack of inventive step of claims 4, 5, 7, 8, 11 and 13 of French patent FR2531087 over GB1571683 patent relating to cefuroxime axetil.

- Other decisions
We noted 3 decisions relating to French SPCs
- Cour d'appel de Paris rejected on 14/01/2009 Medimmune Vaccines appeal against the decision of the French Patent Office granting a SPC for A/Vietnam/1194/2004 (H5N1) whole virus inactivated antigen and not for Daronrix® drug: new plea in law, no substantive decision.
- The French Patent Office rejected on 26/09/2008 a SPC application for lipid complex of amphotericin B, a phosphatidyl choline and a phosphatidyl glycerol on the grounds that the 2 phospholipids were mere excipients and the SPC application did not refer to the first marketing authorisation for amphotericin B.
- Cour d'appel de Paris rejected on 11/04/2008 Novo Nordisk appeal against the refusal by French Patent Office of a SPC application for somatropin because the MA referred to was not the first MA for somatropin.

BIA Forum 2009 to tackle SPCs again

Celebrating its 20th anniversary, the BioIndustry Association has designed an attractive and colourful logo for its 2009 Forum. This event takes place on Thursday 1 October, which sadly clashes with the first full day of the CIPA Congress (both events are being held in Central London).

The Intellectual Property Hot Tops once again include SPCs, the full list being:

* Innovative Medicines Initiative (IMI) Policy and Guidance
* European Patent Office (EPO) procedural changes
* Patent litigation update
* EPO referral on dosage regimes
* US legislation – an update following the introduction of the Obama administration
Court costs updates
* Supplementary Protection Certificates (SPCs)
* European Litigation and Legislation updates)

The Hot Topics speakers and panelists are

* Michael Burdon, Partner, Olswang
* Kristina Cornish, Partner, Kilburn & Strode
* Fiona Crawley, Counsel, Bryan Cave
* Sue Foster, Attorney, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo
* Tim Powell, Partner, Powell Gilbert
* Sarah Roques, Partner, JA Kemp & Co
* Olivér Várhelyi, Head of Unit Industrial Property, DG Internal Market & Services, European Commission

The 2009 Forum web page, with lots 0f details and registration form, can be accessed here. The SPC Blog recalls that last year's BIA Forum was greatly appreciated by those who attended, and is sure that the special attention again devoted to SPCs will help keep this topic high on the agenda of priority issues in the bio-sector.

SPCS: good for Europe, bad for India?

From the Institute of International Trade (the Centre for WTO Studies affiliated to the West Bengal University of Technology) comes a report that India is currently engaged in bilateral negotiations with the European Union over a Free Trade Agreement which contains a chapter on the Intellectual Property. The article quotes IP commentator and author Carlos M. Correa as warning that higher IP standards sought by the EU can create disaster for the supply the FTA resulting in the future extension of patents as well as the possibility of preventing generic competition.

Left: The Taj Mahal: steps were famously taken here to prevent the manufacture of copies ...

The article continues:

"Not only ‘data exclusivity’ provision, FTA also contains the idea of ‘supplementary protection certificate’ that requires for the extension of patent term for an additional 5 years so that it can compensate the minimum time required for the marketing approval of a medicinal product".

The article concludes that the FTA would be bad news for India -- a conclusion that is presumably coloured by the assumption that the only sector of the Indian pharma industry that needs the protection of law is the generic sector, and this will remain the case.

A brisk search of the usual European news sources has not thrown any light on these negotiations. Can any reader of this weblog enlighten us?

IPI initiative on paediatric inconsistencies links patent offices

For what may well be the first time in its history, the lead article in the August Newsletter of the Intellectual Property Institute (IPI), London is about SPCs -- and indeed about the particularly live issue of paediatric extensions. The text runs as follows:

"Paediatric Extensions to Supplementary Protection Certificates

The Institute has been in discussion with a number of stakeholders about present legal uncertainties surrounding applications for the 6-month paediatric extension to a supplementary protection certificate. In order to express concerns that have been expressed about the implementation of the scheme for the examination of applications for paediatric extensions, the Institute convened a meeting at the European Patent Office in The Hague. Delegates included representatives from patent offices all over Europe, officials from the regulatory agencies, and industry (the users).

Genevieve Michaux, a regulatory expert from Covington and Burling LLP, set the scene by outlining the current, rather complex provisions, and there followed an extensive round table discussion among the delegates under the Chatham House rule.

A full report of the meeting will be issued at a later date, but one key issue arising from the meeting was the fact that there were differing views among the national patent offices concerning the documents to be submitted upon filing an application for an extension. It was argued that the end of procedure notification should sufficiently demonstrate the approval of a paediatric product in all Member States. However, the notification is not currently set out in a standard form and it may not include some of the information needed by the national patent offices: it was clear that it would be very useful to develop a common format for this document. This was just one of a number of issues discussed at the meeting which we will be following up in due course".

The IPI should be commended for taking this initiative. It is a small organisation with few resources, yet it selflessly takes on tasks for the benefit of the wider community. Readers whose companies would like to participate in or otherwise support the work of the IPI, which has charitable status, should email its Director, Dr Paul Leonard, here or telephone him on +44 20 7436 3040.

Questions about the codified Regulation No. 469/2009

The SPC Blog has received a few interesting questions about the new codified Medicinal Product Regulation (EC Regulation No. 469/2009) from John Miles of Potter Clarkson:

"The codified Medicinal Products SPC Regulation (Regulation No 469/2009) does not include within its text any of the apparent amendments made to its predecessor (Regulation No 1768/92) by virtue of Recital 17 of the Plant Protection Products Regulation (Regulation No 1610/96). In particular, Article 3(2) of the Plant Protection Products Regulation is not included in the codified Medicinal Products Regulation.

Article 3(2) of Reg. 1610/96 states:

"The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders. "

This point was addressed to an extent in the following extract from the Record of the third meeting of national SPC experts held at the EMEA on 26 September 2008 (the bit in bold is the question, and the bit in plain text thereafter is the answer recorded).

The Commission has reccently proposed a codified version of Regulation1768/92 including the amendments introducted by Regulation (EC) No 1901/2006, see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52008PC0369:EN:HTMLWhy does this version not include amendments that were introduced by Regulation 1610/96 (see in particular recital 17)?

Some enquiries have been received in this regard and transmitted to the Commission services competent on the codification legislation. They considered that Regulation 1610/96 did not introduce any amendment into Regulation 1768/92. Therefore, no provision originating from Regulation 1610/96 is present in the consolidated version of Regulation 1768/92.

Recital 17 of Regulation 1610/96 does no more than state that certain provisions of Regulation 1768/92 must be interpreted in accordance with certain "detailed rules" contained in Regulation 1610/96.

Regulation No 1768/92 was repealed by Regulation No 469/2009 (see Article 22). The second paragraph of Article 22 states that

References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II.

Does this mean that Recital 17 of the Plant Protection Products Regulation applies to the codified Regulation No 469/2009 in the same way it applied to Regulation No 1768/92 (now repealed)?

If so, is it certain the codified Medicinal Products Regulation has to be interpreted to include Article 3(2) of the Plant Protection Products Regulation?

If Article 3(2) does not apply to the codified Medicinal Products Regulation, is there anything in that Regulation to prevent the holder of more than one patent for the same product obtaining more than one certificate for that product?

Below is an extract from the Record of the first meeting of national SPC experts held on 3 February 1995 (ie before the 1610/96 Regulation came into force) which seems to indicate that the original 1768/92 Regulation should be interpreted to allow for more than one certificate in that circumstance.

First Question
After an application for an SPC has been lodged for a particular product but before the certificate is granted, may a second party lodge a separate application for an SPC in respect of the same product and obtain a certificate like the first applicant?

Answer:
The Commission representative indicated that severall applications could be lodged for a particular product, either by the same company or different companies. With regard to the admissibility of these application, the only condition to be met was that, at the date of the application, the product had not already been the subject of a certificate (Article 3(c)). Accordingly, if on the date of lodging the application a certificate had already been granted for the product on the basis of the Regulation, the new application was inadmissible under Article 3(c). On teh other hand, if no certificate had been granted, the second application was admissible.

No delegation expressed a dissenting view. "

If someone can clarify some of these points, please do so in the Comments section below.

Losartan paediatric extension: news from France

The SPC Blog is pleased to have heard from Michèle Lavé (Cabinet Alice de Pastors, Le Chesnay, France) that on Friday the French Patent Office published in the BOPI the grant of the paediatric extension of French SPC for Losartan (95C0018). The extension was granted on 6 July 2009, giving a new expiry date of 2 March 2010.

Losartan extension: not granted in the United Kingdom, but granted in The Netherlands

Astellas appeal dismissed, with no reference to ECJ

Mr Justice Arnold has just given his ruling this morning in Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat), an appeal against the decision of the Intellectual Property Office, United Kingdom. At the time of writing this post, the decision has not yet been added to the decisions freely available on the BAILII website, but you can read it in full here.

Arnold J dismissed the appeal, considering the hearing officer's decision to be correct. He did not feel that this was a matter that was appropriate to refer to the Court of Justice of the European Communities for a preliminary ruling:

31. ... Astellas contends that Takeda was wrongly decided and that the correct test to apply under Article 3(a) of the Regulation is the infringement test.

32. Counsel for Astellas supported the five reasons given by Kitchin J in Gilead [see SPC Blog here] for questioning the correctness of Takeda. In particular, he submitted that Takeda is inconsistent with the ECJ’s ruling on the second question in Farmitalia that to determine whether a product is protected by a basic patent reference must be made to the national law governing the patent. He argued that this must mean determining whether the product falls within the scope of protection of the patent in accordance with section 125 of the Patents Act 1977 and Article 69, and the Protocol on the Interpretation of Article 69, of the European Patents Convention. He also submitted that, in the light of Kitchin J’s judgment, it could not be said that it was acte clair that the infringement test was wrong and that this question should be referred to the ECJ.

33. Counsel for the Comptroller submitted that none of the five points identified by Kitchin J justified the conclusion that the infringement test was the right test. In particular, she submitted that there is a distinction between the scope of protection of a patent and infringement: the scope of protection is limited to that specified in the relevant claim properly construed, whereas infringement is not so limited. A product which includes all the elements of the claim infringes, but so does a product which also includes additional elements which are not specified in the claim at all. Accordingly, she argued, it is the scope of protection which matters, not whether a product infringes. She also submitted that consideration of the Opinion of Advocate General Fennelly in Farmitalia leads to the conclusion that the ECJ rejected the infringement test in that case. Finally, she submitted that the matter remained acte clair. She acknowledged, however, that it is the Comptroller’s understanding that at least one Member State of the Community, namely Norway, applies the infringement test.

34. I am not convinced that Takeda is wrong. To my mind, Jacob J’s reasoning remains persuasive. Furthermore, I agree that there is a distinction between the scope of protection and the question of infringement. As to Farmitalia, it is not clear to me that the ECJ either endorsed or rejected the infringement test in that case. Nevertheless, I agree with Kitchin J that there are arguments in favour of the infringement test which do not appear to have been considered in Takeda and which merit consideration by a higher court and perhaps the ECJ.

35. I have considered whether it is appropriate to refer this question to the ECJ. If I were confident that the Court of Appeal would refer it, I would avoid delay by making a reference now. I am not confident that the Court of Appeal will refer it, however. I conclude that the decision whether to refer should be left to that Court.

On the same basis, Arnold J decided not to to refer a question about the correct treatment of applications for SPCs for combination products to the ECJ.

The SPC Blog's note on the original decision can be read here.