The AG has opined on two references from the UK (Synthon BV v Merz Pharma GmbH & Co KG (Case C-195/09) and Generics (UK) Ltd v Synaptech Inc (Case C-427/09)) in relation to the SPC Regulations (Regulation 1768/92, but now consolidated in Regulation 469/2009).
- The AG provides useful guidance on the approach to the interpretation of the SPC Regulations.
- The AG opined that Article 2 of the SPC Regulations provides a precondition for the SPC Regulations to apply, namely that the 'product' has to be subject to an authorisation procedure as laid down in the relevant Community legislation before being put on the market in the Community. Consequently, non-compliance with Article 2 is a further ground of invalidity.
- The AG also considered the meaning of the 'first authorisation to place the product on the market in the Community' in the context of the transitional provisions of the SPC Regulations and for calculating an SPC's duration. The AG opined that this term would include:
- authorisations which were issued for a use of a 'product' (ie, active ingredient or combination of active ingredients) which is different to those claimed by the patent on which the SPC is based; and
- authorisations which were: (i) issued pursuant to national provisions transposing the relevant Community legislation (even if incorrectly implemented); or (ii) permitted to co-exist with such authorisations by either the transitional provisions of the relevant Community legislation or the terms of the EEA Agreement.
- The AG's opinions appear to be most relevant for SPCs based on second medical use patents where the 'product' had already been marketed for a long period of time for its original use. The AG's opinion applies a more stringent test when determining the validity / duration of such SPCs.
- The AG's opinions are not binding, and may therefore not be followed by the ECJ when it gives its judgment in these cases.
Interpretation of the SPC Regulations
The AG acknowledges apparent contradictions in the SPC Regulations arising out of its literal interpretation, which could result in conflicting outcomes. The AG opined that such conflict should be resolved by analysing the objectives of the SPC Regulations as set out in the preamble. In adopting this approach, the AG placed significant weight on:
- the balance of the conflicting interests of originators (by compensating for the loss of market exclusivity caused by the authorisation procedure) and those of generics (by ensuring that market exclusivity is not unduly extended);
- ensuring a uniform solution throughout the Community and preventing heterogeneous development of national law;
- reducing any arbitrary distinctions and outcomes resulting from a literal interpretation of the SPC Regulations; and ensuring the rules for SPCs are uniform and simple for the relevant national authorities to apply.
Article 2 of the SPC Regulations: a precondition for grant and a ground of invalidity
Using the approach above, the AG opined that Article 2 of the SPC Regulations "must be interpreted as meaning that products placed on the market as medicinal products in Community territory before a marketing authorisation in accordance with the relevant Community legislation has been obtained do not fall within the scope of the regulation". Any SPC which does not satisfy this precondition is invalid, irrespective of the fact that the content of Article 2 does not appear in the specified grounds of invalidity of the SPC Regulations (under Article 15).
This precondition or ground of invalidity appears to be most relevant when considering SPCs based on second medical use patents where the 'product' had already been marketed for a long period of time for its original use.
The first authorisation to place the product on the market
In case the AG was incorrect in this opinion (and the SPC was valid and its duration needed to be calculated), the AG also considered the meaning of the 'first authorisation to place the product on the market in the Community' as relevant to the transitional provisions of the SPC Regulations relevant to these cases (Article 19(1) of Regulation 1768/92) and for calculating an SPC's duration (Article 13).
The AG considered that both the ECJ decisions in Hässle1 and Novartis2 provided useful interpretative guidance. In addressing the meaning of this phrase, the AG stated that "it is necessary to clarify whether a marketing authorisation… can be regarded as having been ‘issued in accordance with Directive 65/65’ within the meaning of the judgment in Hässle and can, therefore constitute a first authorisation to place on the market in the Community..". (emphasis added)
In light of this, the AG opined that the requirement of an authorisation being ‘issued in accordance with Directive 65/65’ was met, such that the 'first authorisation to place the product on the market in the Community' would include:
- any authorisation issued pursuant to national provisions transposing the relevant Community legislation. It is irrelevant if the national procedures have not properly implemented Community legislation or do not require toxicological or pharmacological testing or, clinical trials. This avoids national SPC granting authorities having to verify whether the national procedure is compatible with the Community legislation;
- any authorisations which were allowed to co-exist with such authorisations by virtue of the transitional provisions of the relevant Community legislation. For these authorisations it is irrelevant whether the Member State implemented the transitional provisions by: (i) extending the validity of the original authorisation (as in Luxembourg and the relevant authorisation in the Synthon case); or (ii) by the grant of a new authorisation under the terms of the transitional provisions (as in Germany, by 'fictitious' or 'post-marketing authorisations' as relevant to both the Synthon and Synaptech cases); and
- any authorisations which were issued under national law in EFTA States and allowed to co-exist with such authorisations by virtue of the terms of the EEA Agreement (as for the Austrian authorisations in the Synaptech case). This view is supported by the ECJ's decision in Novartis and results in a consistent interpretation to those provisions which where expressly amended by the EEA Agreement (Article 3(b) and 19(1) of the SPC Regulations). This remains the case even if such national authorisation does not satisfy the requirements of the relevant Community legislation.
In summary, when calculating an SPC's duration (under Article 13) or considering the relevant transitional provisions of the SPC Regulations, the relevant date:
- is the date of grant of an authorisation pursuant to national provisions transposing the relevant Community legislation;
- is the date of grant of the 'fictitious' or 'post-marketing authorisations' granted by a Member State implementing the transitional provisions of the relevant Community legislation;
- is the date on which the extension to the original authorisation takes effect (if, like Luxembourg, the Member State has implemented the transitional provisions of the relevant Community legislation in this way); or
- appears to be the date of grant of the national authorisation in EFTA States which were subject to the provisions of the EEA Agreement. However, the AG's opinion in the Synaptech case is less clear on this point.
The period for which a 'product' is available on the market before grant of the 'fictitious' or 'post-marketing authorisations' or extension to the original authorisation is irrelevant. The AG supports his opinion by stating that this results in a simple and uniform rule which avoids the need of a relevant authority in a Member State to verify the date of first marketing prior to harmonisation.
Further, for the purposes of calculating an SPC's duration or considering the transitional provisions of the SPC Regulations, the AG opined that "the first marketing authorisation for the product as a medicinal product must be regarded as the first marketing authorisation in the Community, regardless of the kind of medical use which constitutes the subject-matter of that authorisation and regardless of whether that use may possibly be the same as the use protected by the basic patent". The AG states that this interpretation is consistent with the concept of 'product' under the regulation and consistent with ECJ case law (citing MIT3, Pharmcia Italia4, Yissum5and Biogen6 ).