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".