Advocate General Mengozzi has given his opinion on the questions referred to the European Court of Justice by the UK courts in April 2009 in relation to Synthon BV v Merz Pharma GmbH. Please see our previous article on the referral from Floyd, J here.

Referred questions

The referred questions related to interpretation of the Supplementary Protection Certificate (SPC) Regulation (European Community Council Regulation No. 1768/92), in particular, whether it is possible to obtain an SPC in circumstances where a medical product has been (legally) placed on the market without carrying out the safety testing required by Directive 65/65EEC and also the meaning of the phrase "first authorisation to place the product on the market".

Directive 65/65EEC, along with Directive 81/85/EEC, harmonises, at European Community level, the requirements of safety and efficacy testing to obtain a marketing authorisation for a medical product.


Merz Pharma GmbH (Merz) is the holder of an SPC granted on 14 August 2003, relating to a patent for the second medical use of a known product, Metamine, which had been on the market since 1976. Although the SPC related to marketing authorisations for Metamine granted in 2002, the original 1976 marketing authorisation had been obtained in Germany, where the law in force at that time did not require safety testing.

Findings of the Advocate General

Advocate General Mengozzi has found that the SPC Regulation:

"must be interpreted, pursuant to Article 2 thereof, as meaning that products placed on the market as medicinal products in Community territory before obtaining a marketing authorisation in accordance with Directive 65/65/EEC or with Directive 81/851/EEC do not fall within the scope of the regulation"

and that SPCs for such products "must be deemed to be invalid". This opinion addresses the third and fourth of the four questions referred to the ECJ by Floyd, J.

In case the ECJ does not concur with his initial findings that the SPC for Metamine must be deemed to be invalid, Advocate General Mengozzi has also proposed answers to the first two of the four questions referred from the UK court, namely whether for the purposes of the SPC Regulations:

  1. a marketing authorisation obtained without the safety tests required by Directive 65/65/EEC could constitute a first marketing authorisation in the Community; and
  2. a marketing authorisation which was obtained under the national law transposing the Directive 65/65/EEC, to co-exist with the system of authorisation contained in that directive could be a first marketing authorisation in the Community.

The Advocate General answered both of these questions in the affirmative, the effect of which would mean that the term of the SPC granted to Merz should be calculated using the original 1976 authorisation rather than the 2002 authorisation and would therefore have a term of zero.

If the ECJ follows either set of reasoning provided by the Advocate General, this would represent a victory for Synthon, who were challenging the validity of Merz's SPC and would provide some comfort to the generics industry as a whole.

The opinion represents a purposive interpretation of the SPC Regulation, seeking to apply the rationale behind the SPC Regulation rather than a strict interpretation of its wording as adopting a strict interpretation would potentially give patent owners a longer period of protection than was originally foreseen by the SPC Regulation.

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