On 10 May 2009, the High Court handed down its judgment in Generics (UK) Limited v Synaptech Inc holding that the “first authorisation to place the product on the market in the Community” in Article 13 of the EC Council Regulation 1768/92 (the “Regulation”) referred only to marketing authorisations granted in accordance with Directive 65/65/EEC. The case was heard before Roger Wyand QC, sitting as a Deputy High Court Judge.

Legislative Framework

The Regulation sets out a regime for the granting of Supplementary Protection Certificates (“SPCs”) which provide for up to five years additional protection beyond patent expiry for medicinal products. SPCs are granted in order to compensate the patentee for the lost period of effective monopoly caused by the time taken to complete the necessary safety and efficacy testing to obtain a marketing authorisation so that the product can be placed on the market. The requirements for safety and efficacy tests were first sought to be harmonised by Directive 65/65/EEC and are now set out in Directive 2001/83 (as amended).

Article 13 deals with the duration of the SPC to be granted and provides that an SPC shall be granted for the period of time that elapses between the date of the application for the basic patent covering the product and “the first authorisation to place the product on the market in the Community” , reduced by 5 years, and subject to a maximum of 5 years.

Background

Galantamine had been on the market in Europe for more than 40 years. In particular, galantamine, under the trade mark Nivalin, was authorised for the treatment of polio in Austria in the 1960s and remained on the market in Austria even after Austria’s accession to the EEA in 1994. Galantamine was also authorised in West Germany in 1978 under the AMG 1976 (the national German Medicines Act). The AMG 1976 included a provision that products then already on the market and which remained on the market on 1 January 1978 (the date on which the AMG came into force) were automatically granted a deemed market authorisation (for up to 12 years) without further enquiry or safety and efficacy testing, provided the German authority was notified of the product within 6 months of 1 January 1978. Galantamine met these requirements and was accordingly granted a ‘fictitious’ approval to be placed on the market in Germany without going through the safety and efficacy investigation required by Directive 65/65. In 2000 however, a Swedish marketing authorisation was granted for the product which was in accordance with Directive 65/65 (apparently the same one considered by the ECJ in Case C-527/07 Generics (UK) Limited, Regina v Licensing Authority (acting through the Medicines and Healthcare products Regulatory Agency), as reported later in this Update).

Synaptech obtained European Patent EP (UK) 0 236 684 protecting galantamine for the treatment of Alzheimer’s disease, which expired on 16 January 2007. Synaptech applied for, and was granted, an SPC for this product in the UK to expire on 15 January 2012. In its application for this SPC, Synaptech cited the Swedish marketing authorisation granted in 2000 (and not the earlier Austrian or German authorisations) as the first authorisation to place the product on the market in the Community within the meaning of Article 13 of the Regulation. Accordingly, the SPC was granted with the maximum term of 5 years.

Whilst accepting for the purposes of the proceedings that the earlier Austrian and German authorisations were not 65/65 compliant, Generics claimed that they were nonetheless relevant authorisations for the purposes of calculating SPC term under Article 13 and so the term of the SPC should be reduced such that it in fact expired on 31 December 2008. The issue that had to be decided by the Court therefore was whether “the first authorisation to place the product on the market in the Community” referred to in Article 13 needed to be a Directive 65/65 compliant authorisation or whether any prior marketing authorisation would suffice.

ECJ case law

Mr Wyand QC first considered the ECJ’s decision in Hassle AB v Ratiopharm GmbH 1 which also considered the interpretation of this wording but in the context of the transitional provisions of the Regulation set out in Article 19. In this case, Hassle argued that although they had received 65/65 compliant marketing authorisations in France and Luxembourg, as these authorisations did not in fact enable them to place the product on the market (for which a national pricing authorisation was additionally required), the first authorisation in the Community referred to in Article 19 should be taken to be the later national pricing authorisation and not the earlier 65/65 compliant marketing authorisations. The ECJ disagreed however and held that there was “nothing to justify the words ‘authorisation to place…on the market’ being interpreted differently depending on which provision of [the Regulation] they appear in….It follows therefore that the first authorisation to place the products on the market in the Community must… be a marketing authorisation issued in accordance with Directive 65/65”.

Synaptech submitted that this judgment supported their case. Generics however submitted that what the ECJ were really considering here was whether the marketing authorisation is “of the nature” of an authorisation in accordance with 65/65 and they were not considering a distinction between authorisations which were strictly 65/65 compliant and other authorisations which, whilst not as rigorous as 65/65 compliant authorisation, performed the same function. Thus Generics argued, although the ECJ said the words “authorisation to place the product on the market” must be given the same meaning wherever they appeared in the Regulation and that they required a marketing authorisation in accordance with 65/65, this was being said in contradistinction to some other authorisation of a completely different nature such as a national pricing authorisation.

Mr Wyand QC then went on to consider the ECJ’s decision in Novartis v Comptroller- General 2 in which a Swiss marketing authorisation was held to be the relevant marketing authorisation for the purposes of calculating SPC duration under Article 13 even though it was not 65/65 compliant as Switzerland is not a Member State of the EU but rather an EFTA State. Whilst this decision prima facie seemed to suggest that a marketing authorisation need not be 65/65 compliant to be relevant for Article 13 (and so supported Generics’ case), Mr Wyand QC noted however that the ECJ’s decision was based on a provision of the Regulation introduced by the EEA Agreement which provided that authorisations granted in accordance with the national legislation of an EFTA State shall be treated as an authorisation granted in accordance with 65/65. As such the Swiss authorisation was to be treated as 65/65 compliant. Synaptech submitted that the ECJ judgment did not therefore in fact open up Article 13 to authorisations which were not 65/65 compliant.

Judgment

Having considered these ECJ judgments (and three conflicting German and Belgian national decisions based upon them), Mr Wyand QC took the view that the ECJ judgment in Novartis did not open Article 13 up to marketing authorisations which were not 65/65 compliant. He therefore considered the decision in Hassle as being the only ECJ authority on the point he had to decide and furthermore that this decision was binding upon him. Accordingly, he held Synaptech’s interpretation of Article 13 of the Regulation to be correct.

Judgment was handed down notwithstanding that the High Court (Mr Justice Floyd) had recently referred a number of questions to the ECJ in a different case (Synthon v Merz Pharma reviewed in last edition (May) of Life Sciences Update), and in particular the following question:

For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92, does the expression "first authorisation 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?

It is understood that the judgment is now under appeal.