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Thursday 28 July 2011

Synthon ruling rejects pre-65/65 authorisations

This morning the Court of Justice of the European Union handed down its ruling in Case C‑195/09 Synthon BV v Merz Pharma GmbH & Co. KGaA, this being a reference for a preliminary ruling from the Patents Court, England and Wales.

To summarise, even before 1 September 1976 Merz was offering memantine for sale in Germany as a medicinal product for human use under the brand name Akatinol. That product, used in the treatment of Parkinson’s Disease and for other indications, was covered by an authorisation issued in accordance with German legislation from 1961 which did not requiere medicinal products to be tested for safety or efficacy. Under the German Law of 1976 memantine was granted a marketing authorisation in Germany without going through the procedures required under Directive 65/65, the first-ever European pharma Directive.

In June 1983 Merz applied to the competent Luxembourg authorities for a marketing authorisation for that medicinal product.  This was was issued in September 1983 under a Luxembourg Law of 1983. However, the Luxembourg authorities relied on the German marketing authorisation issued previously and did not test the safety and efficacy of memantine. In April 1989 Merz applied for a European patent for memantine hydrochloride which was granted even though memantine was already available commercially, on the ground that the patent was for a second medical use of memantine: for the preparation of a medicinal product to treat Alzheimer’s Disease. This patent expired on 13 April 2009.

Both the German and Luxembourg marketing authorisations were withdrawn when, in May 2002, a series of marketing authorisations valid within the European Community (‘the 2002 marketing authorisations’) were issued to Lundbeck as a licensee of Merz under Council Regulation 2309/93. This authorisation of 2002 was for the medicinal product Ebixa, the brand name adopted in order to market memantine's second medical use. Before this authorisation was issued, the safety and efficacy of Ebixa had been tested by the European Agency for the Evaluation of Medicinal Products, in accordance with Directive 65/65.

In November 2002 Merz applied to the United Kingdom Patent Office for an SPC for memantine. In its application, Merz referred to the basic patent valid in the UK and also to the 2002 marketing authorisation, but not to the prehistoric German or Luxembourg marketing authorisations. The SPC was granted in August 2003 for a term of five years.

Generics manufacturer Synthon then challenged the validity of Merz's SPC and maintained that, if valid, its term of protection should be fixed at zero. The Patents Court had some doubt both as to the scope of the SPC regulation, Regulation 1768/92, and the definition of ‘first authorisation to place … on the market in the Community’, within the meaning of Articles 13 and 19 of that regulation, it decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(1) For the purposes of Articles 13 and 19 of [Regulation No 1768/92], is an authorisation a “first authorisation to place … on the market in the Community” if it is granted in pursuance of a national law which is compliant with [Directive 65/65], 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 [Regulation 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 [Directive 65/65]? 
(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 [Directive 65/65] within the scope of [Regulation No 1768/92] as defined by Article 2? 
(4) If not, is an SPC granted in respect of such a product invalid?’
Today's ruling runs as follows:
"1. Article 2 of Council Regulation ...1768/92 ... must be interpreted as meaning that a product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65 ... and, in particular, without undergoing safety and efficacy testing, is not within the scope of Regulation ...1768/92, as amended, and may not, therefore, be the subject of a supplementary protection certificate.

2. A supplementary protection certificate granted for a product outside the scope of Regulation No 1768/92, as amended, as that scope is defined in Article 2 of that regulation, is invalid".
The Court's ruling is, by ECJ standards, unusually short and to-the-point for an intellectual property ruling.  The SPC Blog's post on the Advocate General's Opinion, on which the Court's ruling was based, can be read here.


Anonymous said...

does anyone know if the two cited marketing authorisations from Luxembourg and Germany are available? and if so how to get a copy?

Anonymous said...

does anyone know if the two earlier marketing authorisations for Germany and Luxembourg available anywhere?

Anonymous said...

Difficult to find, but if you take a look at the papers filed at the Patents Court in the UK invalidation action which led to the ECJ referral, you may be able to get copies of them.