In an interesting and well written decision, Court of Justice of the European Communities (including Court of First Instance Decisions) on reference for a preliminary ruling from the High Court of Justice of England and Wales (United Kingdom) in a dispute between Genericks UK V.s Licensing Authority of UK (MHRA) on Marketing authorization refusal to generic player for Galantamine (Reminy).
Background
Galantamine was first marketed in Austria In 1963, under the brand name 'Nivalin'for the treatment of Polio. Later in 1995, the authorisation of Nivalin was amended to include 'symptomatic treatment' of Alzheimer's disease, the original Nivalin dossier per se was never brought up-to-date in accordance with the requirements of Directive 65/65 and Directive 75/319, which had been applicable in Austria since 1 January 1994 by virtue of the EEA Agreement.Later on, innovator Waldheim withdrew Nivalin from the market in 2001.
Meanwhile, as a result of cooperation agreements with Waldheim, in 1999 Janssen-Cilag AB submitted a full application to the competent Swedish authority (the Swedish Medicinal Products Agency, 'the Swedish MPA'), pursuant to Article 4 of Directive 65/65 (now Article 8 of Directive 2001/83), for marketing authorisation for Galantamine under the brand name 'Reminyl', for the treatment of Alzheimer's disease (in particular, an Alzheimer-type dementia).
The application was submitted on the basis of the generic product exception in Article 10(1) of Directive 2001/83. Nivalin, which was the subject of an authorisation from Austria, was specified as the reference medicinal product authorised for a period of not less than 10 years in the EEA. The application also mentioned the British authorisation of Reminyl as the reference medicinal product in the United Kingdom, and as the product used for the bioavailability study necessary to show that the Generics's product was, in fact, a generic of Nivalin/Reminyl.
The Licensing Authority rejected Generics's application. It considered that Nivalin, covered by the Austrian authorisation, could not be used as the reference medicinal product for an application for marketing authorisation for a generic medicinal product within the meaning of Article 10(1) of Directive 2001/83, since its dossier had not been updated since 1 January 1994 to comply with the requirements of Community legislation, applicable in Austria following the entry into force of the EEA Agreement. As regards Reminyl, the 10-year period of protection referred to in Article 10 of Directive 2001/83 in its original version had not yet expired and, therefore, the authorisation could not be granted on that basis.
First, as regards the argument according to which Generics is relying on Nivalin's two variations of 1995, introduced after Austria acceded to the EU, Shire and Janssen-Cilag, the United Kingdom Government and the Commission correctly point out that such variations in and of themselves do not demonstrate that the entire package of data in the dossier for Nivalin conformed with the Community provisions in force. This is because the dossier relating to Nivalin for its original use (treatment of polio) was never updated and brought into compliance with the Community legislation.
in order to be able to grant a marketing authorisation for a generic medicinal product on the basis of the abridged procedure ... what matters is that all the particulars and documents relating to the reference medicinal product remain available to the competent authority for the Member State where the application for the marketing authorisation is made and not that the reference medicinal product has in fact been placed on the market
Decision of Court
Where a medicinal product falling outside of the scope of the Annex to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products has been placed on the market in a Member State (Austria) under its national authorisation procedure prior to the accession of that Member State to the European Economic Area (EEA) or the Community and the dossier of the product in question was not updated in accordance with Directive 65/65/EEC (now Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use) after that Member State's accession to the EEA and the Community, that product is not to be considered to be 'a reference medicinal product which is or has been authorised under Article 6 ... in a Member State' within the meaning of Article 10(1) of Directive 2001/83.
However, where a product containing the same active ingredient has subsequently been authorised under Article 6 of Directive 2001/83 and placed on the market in the Community, that product may constitute a reference medicinal product for the purposes of Article 10 of Directive 2001/83, provided that the period of protection has expired and the bioequivalence of the generic product with this product has been demonstrated.
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Update on July 10, 2009
IN THE HIGH COURT OF JUSTICE CHANCERY DIVISION MR ROGER WYAND QC (sitting as a Deputy High Court Judge)
Innovator Synaptech Inc. obtained European patent EP (UK) 0 236 684 which protected Galantamine or analogues thereof for treating Alzheimer's disease. That patent expired on 16th January 2007. However, Synaptech obtained a Supplementary Protection Certificate No. SPC/GB00/033. The SPC is due to expire on 15th January 2012. Generics (UK) Limited contends that this is wrong. They say that the SPC ought to have expired, at the latest, on 31st December 2008. Generics brought this action asking the court to determine the correct term for the SPC and to make an order for rectification of the register of patents under section 34 of the Patents Act 1977
Highlights of Court’s decision: It was argued on behalf of Generics that the Austrian marketing authorisation in this case should also be deemed to be Directive 65/65 compliant. However, it would appear from Article 19(1) of the SPC Regulation, as amended, that this would apply only to marketing authorisations issued after 1st January 1985. In the present case the Austrian marketing authorisation was granted long before that date and so is not deemed to be Directive 65/65 compliant. Accordingly, the Defendant's construction of the wording of the SPC Regulation is correct and I dismiss the Claimant's action.Deatiled decision of court: http://www.bailii.org/ew/cases/EWHC/Ch/2009/659.html
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