Generics UK Ltd v Synaptech Inc [2009] EWCA Civ 1119

[2009] EWCA Civ 1119Case No HC2008/C00231Case No 013982
IN THE COURT OF APPEAL
Date Friday 16th October 2009
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Before
LORD JUSTICE JACOBLORD JUSTICE RIMERMR JUSTICE KITCHIN
Between
GENERICS UK LIMITEDAPPELLANTSYNAPTECH INCRESPONDENT
UPON APPEAL from the order of Mr Roger Wyand QC, Deputy High Court Judge dated 9 June 2009AND UPON HEARING Counsel for Appellant and Counsel for the Respondent
OrderIT IS ORDERED that1) 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 Community2) 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 20093) 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 order4) 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 thereto5) costs be reserved6) there be liberty to applyNote This order was drawn by Mr A Lee (Associate) to whom all enquiries regarding this order should be made. When communicating with the Court please address correspondence to Mr A Lee, Civil Appeals Office, Room E307, Royal Courts of Justice, Strand, London WC2A 2LL (DX 44450 Strand) and quote the Court of Appeal reference number. The Associate’s telephone number is 020 7073 4828SCHEDULEREQUEST FOR PRELIMINARY RULING OF THECOURT OF JUSTICE OF THE EUROPEAN COMMUNITIES

Introduction

[1]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 Council Regulation (EEC) No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products [1992] OJ L182/1. the correct expiry date should have been either 16 January 2007 or 31 December 2008.[2]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.[3]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).

Relevant Community legislation

[4]The galantamine SPC at issue in this case was granted pursuant to Regulation 1768/92. Now replaced by Council Regulation (EC) No 469/2009; but the old Regulation 1768/92 continues to be the relevant Regulation for the purposes of this case. 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.”
[5]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.[6]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”.[7]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: (a) in Article 3(b) the following shall be added:
“; for the purpose of this subparagraph and the Articles which refer to it, an authorisation to place the product on the market granted in accordance with the national legislation of the EFTA State shall be treated as an authorisation granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate.” (b) Article 19(1) shall be replaced by the following: “1. Any product which on 2 January 1993 is protected by a valid patent and for which the first authorization to place it on the market as a medicinal product within the territories of the Contracting Parties was obtained after 1 January 1985 may be granted a certificate. In case of certificates to be granted in Denmark, in Germany, in Finland and in Norway, the date of 1 January 1985 shall be replaced by that of 1 January 1988. In the case of certificates to be granted in Belgium, in Italy and in Austria, the date of 1 January 1985 shall be replaced by that of 1 January 1982.”
[8]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”.

(a) In Article 3(b) the following is added:

“For the purpose of Article 19(1), an authorisation to place the product on the market granted in accordance with the national legislation of Austria, Finland or Sweden is treated as an authorisation granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate.” (b) Article 19(1) is replaced by the following: “1. Any product which on the date of accession is protected by a valid patent and for which the first authorization to place it on the market as a medicinal product in the Community or within the territories of Austria, Finland, Norway or Sweden was obtained after 1 January 1985 may be granted a certificate. In the case of certificates to be granted in Denmark, in Germany, in Finland and in Norway, the date of 1 January 1985 shall be replaced by that of 1 January 1988. In the case of certificates to be granted in Belgium, in Italy and in Austria, the date of 1 January 1985 shall be replaced by that of 1 January 1982.”

Factual background

[9]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.[10]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.[11]What subsequently occurred may be summarised as follows:(a) In 1987 the application for the basic galantamine patent was filed by Synaptech in the European Patent Office, claiming the use of galantamine for the treatment of Alzheimer’s disease.(b) On 1 January 1994 the EEA agreement (to which Austria was a party) entered into force. A year later, on 1 January 1995, Austria became a member of the EC and ceased to be a member of EFTA.(c) In 1997 Janssen-Cilag took over distribution of Nivalin in Austria.(d) In 1999, Janssen-Cilag filed a new application in Sweden for a marketing authorisation for galantamine for Alzheimer’s under the brand name “Reminyl”. The Swedish Medical Products Agency assessed the application according to the criteria then laid down in Directive 65/65/EEC, and authorised Reminyl on that basis on 1 March 2000.(e) The Austrian Nivalin authorisation was subsequently withdrawn in 2001, and the German Nivalin authorisation was withdrawn between July 2000 and January 2001.(f) Under the mutual recognition procedure, UK authorisation for Reminyl was granted in September 2000, based on the earlier Swedish authorisation.[12]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.[13]The basic galantamine patent expired on 16 January 2007. However on 7 December 2000 Synaptech made an application to the UK Patent Office As it was then. It has subsequently been renamed the UK Intellectual Property Office. 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.[14]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. Summary of submissions of the parties Generics’ submissions

Summary of submissions of the parties

[15]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. Joined Cases C-207/03 and C-252/03 Novartis v Comptroller-General [2005] ECR I-3209. 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.[16]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:(a) Generics is entitled to rely on the same provision in this case in relation to the Austrian authorisation of Nivalin as from 1994. Accordingly, pursuant to the EEA deeming provisions, that Austrian authorisation is to be treated as having been granted in accordance with Directive 65/65/EEC for the purposes of Article 13(1); or(b) Generics is entitled to rely on the EU deeming provisions set out at paragraph 8 above, which in Generics’ submission has the same effect as the EEA deeming provisions on the interpretation of Article 13(1).

Synaptech’s submissions

[17]In respect of Generics’ primary case, Synaptech relies on the judgment of the ECJ in Hässle. Case C-127/00 Hässle v Ratiopharm [2003] ECR I-14781. 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.[18]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.[19]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.

Decisions of other courts

[20]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.

Questions referred under Article 234 EC

[21]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:(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?[22]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.