EC Council Regulation 1768/92 (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).
Key provisions of the Regulation
Article 2 sets out the scope of the Regulation and provides that:
“Any product [i.e. the active ingredient or combination of active ingredients of a medicinal product] protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorization procedure as laid down in Council Directive 65/65/EEC...may, under the terms and conditions provided for in this Regulation be the subject of a certificate.”
Article 3 of the Regulation sets out the following conditions for obtaining an SPC in a given Member State (with each condition being satisfied in that Member State in which the application is submitted and being applicable on the date of application):
(a) the product must be protected by a basic patent in force;
(b) a valid authorisation to place the product on the market in accordance with Directive 65/65/EEC...must have been granted;
(c) the product must not have already been the subject of an SPC; and
(d) the authorization referred to in (b) must be the first authorization to place the product on the market as a medicinal product.
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 marketing authorisation to place that product on the market in the Community, less 5 years, but subject to a maximum of 5 years. As such, a maximum of 15 years exclusivity from first marketing authorisation in the Community can be obtained, thereby reflecting Recital 8 of the Regulation.
Article 19 sets out the transitional provisions and essentially provides an additional condition that must be met in order to obtain an SPC. It provides that:
Any product which on the date of accession is protected by a valid patent and for which the first authorisation to place it on the market as a medicinal product in the Community or within the territories of Austria, Finland or Sweden was obtained after 1 January 1985 may be granted a certificate.
Article 19 therefore excludes from the scope of the Regulation products which were first authorised before 1 January 1985.
Background to the dispute Synthon BV v Merz Pharma
From before 1976, Merz had placed on the market in Germany a medicinal product, the active ingredient of which was memantine hydrochloride. Under the German domestic Act on Restructuring of Medicinal Product Law of 1976, products then already on the market and which remained on the market on 1 January 1978 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. Memantine met these requirements and was accordingly authorised to be placed on the market in Germany without going through the safety and efficacy investigation required by Directive 65/65.
In Luxembourg, the Luxembourg Medicines Act of 1983 implemented the provisions of Directive 65/65 into Luxembourg national law and came into full force on 30 June 1983. Despite this implementation, on 19 September 2003, the Luxembourg authority granted a marketing authorisation for memantine without undertaking an independent assessment of its safety and efficacy as required by Directive 65/65 but instead relied on the earlier deemed authorisation in Germany.
Both the German and the Luxembourg marketing authorisations were withdrawn in 2002 and on 15 May 2002, were replaced by centralised marketing authorisations granted for memantine by the EMEA. These EU marketing authorisations were granted following an assessment of safety and efficacy data as required by Directive 65/65 and were therefore the first authorisations within the Community to do so.
On 14 April 1989, Merz applied for European Patent 0 392 059 (the basic patent), which was granted in 1993. The basic patent was for a second medical use of memantine rather than for the product memantine itself.
On 13 November 2002, Merz applied to the UK Patent Office for an SPC, which was granted as SPC No GB 02/046 on 14 August 2003. In its application, Merz identified the 2002 authorisation as the first authorisation to place the product on the market in the Community, not the earlier German or Luxembourg authorisations.
The Patent Office accordingly granted Merz an SPC for the maximum term of 5 years (and therefore expiring in April 2014), notwithstanding that memantine had in fact been on the market in the EU long before the application for the basic patent was even made.
The dispute in this case was whether Merz should have been granted this SPC. Synthon contended that the SPC should either be found invalid or have a zero year term.
ECJ decisions considered by Floyd J
Article 13 of the Regulation was considered in joined cases C-207/03 and C-252/03 Novartis v. Comptroller and Ministre de L’Économie v. Millennium Pharmaceuticals Inc (the Liechtenstein case). In his Opinion, the Advocate General makes it clear that the purpose of Article 13 is to set up a single system of extended protection and, to ensure that this extended period of exclusive use lasts for the same time throughout the Community, and by virtue of the EEA Agreement, the EEA. The decisive factor he considered was the date on which that use commences, namely the date from which the drug can be lawfully marketed in a part of the EEA, regardless of where, and regardless of the enabling document which could indeed be something other than a national authorisation issued by a Member State under 65/65 provided the document allowed the lawful marketing of the product in part of the EEA.
What constituted a first marketing authorisation in the Community was also considered by the ECJ in the context of the transitional provisions in Article 19 in Case C-127/00 Hässle v Ratiopharm. In Germany, the relevant date for the Article 19 transitional provision was 1 January 1988. Authorisations in accordance with 65/65 had been granted in France and Luxembourg before that date but Hässle wished to reference a later German authorisation granted after 1 January 1988 arguing that something more than a 65/65 authorisation was required for Article 19, in this case a subsequent authorisation under the national pricing authorisation. The Court rejected this argument holding that to do otherwise would be to put a different meaning to the words ‘authorisation to place... on the market’ in Article 3 and Article 19. The Court rejected the contention that for the purposes of Article 19 something more than an authorisation under 65/65 was required.
Floyd J was of the opinion that the issue in the Hassle case was however distinguishable from the issue in the current case, which is whether something less than a 65/65 authorisation should also be taken into account.
National decisions considered by Floyd J
Floyd J then considered the relevant national decisions, the first of which was the decision of the German Bundespatentgericht (German Federal Patent Court) in Neuraxpharm Arzneimittel and others v. Merz where the court considered the validity of the corresponding German memantine patent and SPC.
The Bundespatentgericht held the underlying patent invalid on conventional patent law grounds, which is itself a ground of invalidity of the SPC. It was therefore not necessary for the court to go on to consider arguments relating specifically to the validity of the SPC, but it did so nonetheless. The court first rejected an argument that the SPC was invalid under Article 3(d) because the 2002 authorisation was not the first authorisation. They found that the earlier German authorisation was not granted in compliance with 65/65 and so should not be taken into account. The Court nevertheless held that the SPC was invalid under Article 2 as the product was one which had not undergone a 65/65 compliant authorisation procedure in Germany before being placed on the market and so Merz’s application for an SPC was outside the scope of the Regulation altogether.
In a separate decision in Merck v Almirall on 18 July 2006, the Bundespatentgericht held (following the ECJ in Hässle) that the first authorisation to place a product on the market was construed for the purposes of Article 19 as referring only to a 65/65 compliant one and Article 13 had to be construed in the same way. As such two earlier marketing authorisations in Portugal and Spain, which were not 65/65 compliant as neither country had implemented 65/65 into its national law at that time, were not to be counted for the purposes of Article 13.
In contrast, the Court of First Instance of Brussels, when considering the validity of the corresponding Belgian SPC for the same drug, held that the earlier Portuguese marketing authorisation should be taken into account, instead following the Advocate General’s Opinion in Novartis that national marketing authorisations could be taken into account.
Considerations in the current case
Having considered the relevant case law, Floyd J concluded that three issues (as set out below) were relevant.
In each case, whilst expressing his own views as to the correct answers, he considered that a reference to the ECJ was necessary.
Issue (i) - Was the Luxembourg authorisation an authorisation in accordance with 65/65? If so, the SPC should not have been granted and is invalid.
Synthon argued that because the Luxembourg authorisation was granted at a time when 65/65 had been implemented into national law, it was not for the Court to look behind that authorisation to enquire whether the Luxembourg authorities had in fact carried out an investigation into the safety and efficacy of the product as required by 65/65. Merz disagreed.
Floyd J preferred Synthon’s argument, and as such, took the view that the Luxembourg authorisation, having been granted under Luxembourg law which had already implemented 65/65, was the first authorisation to place the product on the market in the Community for the purposes of Article 13. The SPC should therefore be zero term but in any event invalid as this date of the Luxembourg authorisation would cause Merz’s SPC to fall foul of Article 19.
Issue (ii) - Even if the German and Luxembourg authorisations were not in accordance with 65/65, can they nevertheless be taken into account when applying Article 19 and Article 13?
Synthon argued that the German and Luxembourg authorisations, even if not compliant with 65/65, should be taken into account for the purposes of Articles 13 and 19 as they were permitted by national law and equivalent to 65/65 compliant authorisations.
Synthon argued that where the Regulation meant to refer to a specific kind of authorisation it did so expressly, but where it did not, then authorisations, including national authorisations which were not 65/65 compliant, were intended to be included. This was the case for Articles 13 and 19.
Merz disagreed, relying on the ECJ’s decision in Hässle in which it held that the marketing authorisation referred to in Article 19 was a 65/65 authorisation and there was no basis to justify the words “authorisation to place. .on the market” being interpreted differently depending on which provision of the Regulation they appeared in.
Floyd J noted that the Advocate General’s decision in Novartis provided some basis for a retreat from Hassle and that there were also the conflicting national German and Belgian decisions. In light of these uncertainties, Floyd J considered that a reference to the ECJ would be necessary.
Issue (iii) - Are products, which have been authorised to come on to the market for the first time without needing to go through a 65/65 administrative procedure, within the scope of the Regulation at all as a result of Article 2?
Merz’s argument was consistently that the German and Luxembourg authorisations were not authorisations compliant with 65/65. Synthon argued that even if Merz were correct in this, then as memantine had first been placed on the market in Germany and Luxembourg without needing to go through the safety and efficacy testing procedure laid down by 65/65 (as was common ground), then Merz’s application for an SPC was outside the scope of Article 2 altogether.
Floyd J considered that to construe the Regulation so as to benefit products which had not first to undergo an authorisation procedure as laid down by 65/65 would be to extend the scope of the Regulation beyond its intended purpose.
Floyd J noted that care had not been taken in Article 2 to make clear whether it referred to a first authorisation in the Community or simply the first authorisation in the Member State where the application was made. One would need to look at the context and purpose of Article 2 to decide which was intended. Article 2 constrains the operation of the Regulation to cases where in order to obtain a first marketing authorisation in the Community the need to go through the administrative authorisation procedure under 65/65 arose. If it did not arise, there would be no compensation needed for lost time.
It is clear from the Regulation that where there is an earlier 65/65 compliant authorisation in another Member State that this can reduce or extinguish altogether the SPC protection afforded to a product which otherwise meets the national SPC requirements set out in Article 3. If an earlier 65/65 compliant authorisation can have such an effect, then it is even more compelling that a product placed on the market in the Community without even the need for such an authorisation should also extinguish the available SPC protection.
Questions referred to the ECJ
The questions referred by Floyd J are:
1) For the purposes of Articles 13 and 19 of Council Regulation (EC) No 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 (EC) No 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 (EC) 1768/92 as defined by Article 2?
4) If not, is an SPC granted in respect of such a product invalid?
Is a further reference from the English Courts likely?
Generics (UK) Limited made a claim against Synaptech Inc in the English Patent Court with regard to the validity of a SPC for galantamine (Generics (UK) Limited v. Synaptech Inc  EWJC 659). The basic patent for galantamine, EP 0 236 684 entitled “Galantamine or analogues thereof for treating alzheimer’s disease” expired on 16 January 2007. The SPC No. SPC/GB00/033 for a product described as “Galantamine or acid addition salts thereof” is due to expire on 15 January 2012. The Marketing Authorisation on which the SPC was based was authorised by the Swedish Agency (the MPA) on 1 March 2000, this was a MA granted to Janssen-Cilag under the brand-name of Reminyl.
Generics (UK) Limited claimed that the SPC was invalid because MAs were granted in Germany and Austria for medicinal products containing the active ingredient, galantamine, before the Swedish Authority granted the MA for Reminyl. These were for a product called Nivalin, which was used to treat polio. Nivalin was authorised in Germany on 1 January 1978 (in the same way that memantine had been authorised) as an existing product on the market, without being tested for safety and efficacy in accordance with Directive 65/65. Nivalin had been authorised in Austria in the early 1960s and continued to be marketed there when in 1994, Austria joined the EEA. Nivalin was still on the market in Germany and Austria up until 1999.
On 20 May 2009, Mr R Wyand QC handed down his judgment in Generics UK Ltd v Synaptech. This case was heard in December 2009, and raised an issue similar to issue (ii) in the Synthon case regarding whether a Marketing Authorisation has to be granted in accordance with Directive 65/65 to be a valid Marketing Authorisation for the purposes of the SPC regulation. Despite the judgment of Floyd J in the Synthon case (and his referral of a question to the ECJ in relation to issue (2)) the judge in this case (Mr R Wyand QC) decided that the case should be decided in Synaptech’s favour, and judgment was handed down on this basis. In particular, Mr R Wyand QC considered that the wording in Hässle was clear and binding on him. At the hearing on 20 May 2009, the judge did however grant leave to Generics (UK) Ltd to appeal to the Court of Appeal to refer the matter to the ECJ.
The granting of SPCs is a matter for national patent offices, and this has led to differences of interpretation of the law across Europe, leading to numerous references to the ECJ to date, of which the Synthon one is just the latest. It remains to be seen whether a reference will follow in the Generics v. Synaptech case on appeal.