Generics UK Ltd v Synaptech Inc

This reference is made in the context of proceedings to determine the correct expiry date of Supplementary Protection Certificate No. SPC/GB00/033 for the product “Galantamine or acid addition salts thereof” (“the galantamine SPC”).The galantamine SPC belongs to Synaptech, Inc (“Synaptech”) and is currently due to expire on 15 January 2012. Synaptech contends that this is the correct date. Generics [UK] Limited (“Generics”) disagrees. It submits that on a proper reading of Council Regulation (EEC) 1768/92 (Footnote: ²) the correct expiry date should have been either 16 January 2007 or 31 December 2008.

Generics therefore brought a claim in the UK Patents Court seeking rectification of the register of patents under section 34 of the Patents Act 1977, so as to amend the expiry date for the galantamine SPC to one of the two dates given above. The claim was rejected by the Patents Court in a judgment dated 20 May 2009. Generics appealed that judgment to the Court of Appeal. The Court of Appeal has decided to make this reference without hearing oral argument from the parties.

The dispute turns on the question of how the expiry date of the galantamine SPC, calculated according to Article 13(1) of Regulation 1768/92, should be determined. Generics contends that the “first authorisation” referred to in Article 13(1) is simply the first authorisation that enabled the product to be placed on the market in the Community or the EEA, whether or not that authorisation complied with the requirements of Directive 65/65/EEC (or its successor Directive 2001/83/EC). Synaptech contends that the relevant first authorisation under Article 13(1) must be an authorisation that complied with Directive 65/65/EEC (or its successor Directive 2001/83/EC).

The galantamine SPC at issue in this case was granted pursuant to Regulation 1768/92. (Footnote: ³) The dispute turns specifically on the interpretation of Article 13 of that Regulation, which sets out the methodology for calculating the expiry date of an SPC granted pursuant to the Regulation. It reads as follows:

“(1)

The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community reduced by a period of five years.

(2)

Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.”

In interpreting this provision, the submissions of the parties also refer in part to Articles 3(b) and 19(1) of Regulation 1768/92, and in particular the various amendments to those Articles.

Article 3 of Regulation 1768/92 sets out the conditions under which an SPC may be granted by an individual Member State. Those conditions include, in Article 3(b), the stipulation that in the Member State in which the SPC application is submitted,

“a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate”.

By Decision 7/94 of the EEA Joint Committee, which came into effect on 1 July 1994, Point 6 of Annex XVII was added to the EEA Agreement. This introduced amendments to inter alia Articles 3(b) and 19(1) of Regulation 1768/92, which took effect for the purposes of the EEA Agreement. These amendments are referred to hereinafter as the “EEA deeming provisions” and provided as follows:

On 24 June 1994 the Treaty of Accession of Austria, Sweden and Finland was signed which resulted in a different deeming provision being inserted into Article 3(b). Article 19(1) was also amended. These amendments took effect from 1 January 1995 and are referred to hereinafter as the “EU deeming provisions”. They provided as follows:

Galantamine has been on sale in parts of Europe as a medicine for more than 40 years. The compound has been known since the 1950s and was used in Eastern Europe to treat neuromuscular conditions. There was a marketing authorisation for galantamine as a treatment for polio in Austria in 1963 under the trade mark “Nivalin”. This took place prior to Austria’s accession to either the EEA or the EC, under the Austrian national medicines regulation law then in force in Austria, namely the Spezialitätenordnung of 1947. It is accepted that this law did not comply with the requirements of Directive 65/65/EEC.

By some point in the 1960s, Nivalin was also on the market in Germany, on the basis of Germany’s domestic medicines legislation. It was also indicated for polio. In 1976 Germany enacted a law (the Arzneimittelgesetz or AMG 1976) that was intended to implement the Community rules on the grant of marketing authorisations, then contained in Directive 65/65/EEC. The AMG 1976 came into force on 1 January 1978. The effect of the provisions of the AMG 1976 was that, as an existing product, Nivalin could remain on the market in Germany from 1978 until it was assessed in accordance with the new rules under a special a posteriori assessment procedure (the Nachzulassungsverfahren). During that time, the product was deemed to be authorised, and this status was referred to as a “fictitious” authorisation. The “fictitious” authorisation was withdrawn between July 2000 and January 2001 and there was no assessment under the Nachzulassungsverfahren.

What subsequently occurred may be summarised as follows:

There has never been a factual determination of whether either the German or the Austrian authorisations of Nivalin did in fact comply with the requirements of Directive 65/65/EEC as it stood at the relevant times. But for the purposes of these proceedings it is accepted by Generics that those authorisations did not at any time comply with Directive 65/65/EEC, and that the first Directive 65/65/EEC compliant authorisation of galantamine was therefore the Swedish authorisation in March 2000.

The basic galantamine patent expired on 16 January 2007. However on 7 December 2000 Synaptech made an application to the UK Patent Office (Footnote: ⁴) for a UK SPC, listing the Swedish authorisation in March 2000 as the first authorisation to place the product on the market in the Community. Based on that authorisation, the galantamine SPC was granted with a maximum term of 5 years, expiring in January 2012.

The dispute between the parties is as to whether the Patent Office was correct to calculate the term of the galantamine SPC on the basis of the Swedish authorisation in March 2000. Synaptech’s case is that this was correct. Generics’ case is that the SPC term should have been calculated by reference either to the German authorisation, or the Austrian authorisation.

Generics’ primary case is that Article 13(1) of Regulation 1768/92 does not require “the first authorisation to place the product on the market in the Community” to be an authorisation granted in accordance with Directive 65/65/EEC. This, it contends, is demonstrated by the plain and natural wording of the Regulation, and was confirmed by the judgment of the ECJ in Novartis. (Footnote: ⁵) In that case, the ECJ ruled that the “first authorisation” under Article 13(1) included a marketing authorisation granted in Switzerland and recognised in Liechtenstein, notwithstanding that the Swiss authorisation did not comply with Directive 65/65/EEC. Generics rejects the contention of Synaptech that Novartis was decided by reading Article 13(1) as if it contained the EEAdeeming provisions set out at paragraph 7 above.

As its secondary case, Generics submits that if (contrary to its primary submission) Novartis was decided on the basis of the EEA deeming provisions, then it follows that either:

In respect of Generics’ primary case, Synaptech relies on the judgment of the ECJ in Hässle. (Footnote: ⁶) In Synaptech’s submission, the effect of that judgment is that the “first authorisation” in Article 13(1) must be a marketing authorisation that is issued in accordance with Directive 65/65/EEC. Further, Synaptech contends that Novartis was decided on the basis of the EEA deeming provisions, and that it was on this basis alone that the Swiss marketing authorisation was held to be the relevant “first authorisation” for the purposes of Article 13(1). This submission was accepted by the trial Judge and the Court of Appeal heard no oral argument on the primary case before making this reference.

In relation to Generics’ secondary case set out in paragraph 16(b) above, Synaptech contends that on a proper reading of Articles 3(b), 13 and 19(1) of the Regulation as enacted to include the EU deeming provisions any relevant Austrian authorisation had to be dated subsequent to 1 January 1982.

Synaptech contends that the alternative case set out in paragraph 16(a) above requires Generics to argue that the matter is to be decided on the basis of the Regulation as enacted to include the EEA rather than the EU deeming provisions. Synaptech contends that this is wrong. Even if (contrary to its primary position) the EEA deeming provisions do apply to this case, Synaptech contends that on a proper reading of Articles 3(b), 13 and 19(1) of the Regulation as enacted to include the EEA deeming provisions, the law remains that any relevant Austrian authorisation had to be dated subsequent to 1 January 1982.

The Court of Appeal is aware of the pending reference from the Patents Court in Case C-195/09 Synthon v Merz, which raises (in its question 2) similar issues to those that arise in question 1 in the present case. The Court of Appeal has also been referred to a number of decisions in similar cases brought before the courts of Germany and Belgium, as well as the Netherlands Patent Office, which have reached conflicting conclusions on whether the “first authorisation” in Article 13(1) of Regulation 1768/92 must be an authorisation that complies with Directive 65/65/EEC.

In view of the need for a consistent and certain approach to questions of interpretation of Regulation 1768/92 (and by implication its successor Regulation 469/2009), the Court of Appeal, pursuant to Article 234 EC, requests the Court of Justice of the European Communities to make a preliminary ruling on the following questions of Community law:

In the light of the overlap between the legal issues raised by this reference and those raised in Case C-195/09 Synthon v Merz, the Court of Appeal also respectfully requests that this case be joined with Case C-195/09 for the purposes of the oral hearing and final judgment, pursuant to Article 43 of the Rules of Procedure of the Court of Justice.