SPCs remain in a state of flux

The Honourable Mr Justice Arnold of the UK High Court recently asked the European Court of Justice (ECJ) to clarify what is meant by the “first authorisation” for the purposes of calculating the duration of an supplementary protection certificate (SPC) (AstraZeneca AB v Comptroller General [2012] EWHC 2840 (Pat)). This decision will be of interest to pharmaceutical companies because it could impact on the term of protection conferred by their SPCs.

Background
In order for an SPC to be granted for a medicinal product, a valid authorisation to place the product on the market as a medicinal product must have been granted in accordance with EU Directive 2001/83/EC or EU Directive 2001/82/EC, as appropriate (Article 3(a) of the SPC Regulation (469/2009)). The SPC Regulation also requires the marketing authorisation to be the “first authorisation” to place the product on the market as a medicinal product (Article 3(d) of the SPC Regulation).

How is the term of an SPC calculated?
An SPC takes effect at the end of the term of a basic patent. The term of the SPC is equal to the period which elapsed between the filing date of the basic patent and the filing date of the “first authorisation” in the European Community, which is reduced by a period of five years. The term of the SPC cannot exceed five years, but the term might be extended to five and a half years in all if an extension of the certificate has been granted (Article 13 of the SPC Regulation).

What is the “first authorisation”?
The “first authorisation” in the European Community includes a first authorisation in Norway, Iceland and Liechtenstein, as well as in the present EU member states, even though Liechtenstein does not grant SPCs.

A marketing authorisation granted in Switzerland may count as a “first authorisation” in the European Community if it is effective in Liechtenstein (part of the European Economic Area (EEA)), even though Switzerland is not part of the European Union or the EEA and is not bound by the SPC Regulation. This is because a customs agreement between Switzerland and Liechtenstein means that Swiss marketing authorisations can be automatically recognised in Liechtenstein.

In Novartis (C 207/03 and C 252/03) the ECJ previously ruled that a marketing authorisation granted in Switzerland is to be counted as a “first authorisation” in the European Community for the purposes of calculating the term of an SPC. In response to the Novartis decision, a “negative list” was introduced in Liechtenstein in 2006 to prevent the automatic recognition of Swiss marketing authorisations in Liechtenstein.

It is therefore important for the pharmaceutical industry to ascertain exactly where the “first authorisation” was obtained in the European Community in order to determine accurately the term of protection conferred by its portfolio of SPCs.

Facts
AstraZeneca was granted European Patent (EP) 0 832 900, with claims that provide protection for an active ingredient known as gefitinib, which treats non-small cell lung cancer. AstraZeneca markets gefitinib as IressaTM.

AstraZeneca applied for an SPC in the United Kingdom on 11th December 2009 for the product gefitinib. EP(UK) 0 832 900 is due to expire on 22nd April 2016. The UK Intellectual Property Office (IPO) granted an SPC based on EP(UK) 0 832 900, and it calculated the expiry date of the SPC to be 1st March 2019.

The term of AstraZeneca’s SPC was calculated by the UK IPO by referring to a marketing authorisation granted by the Swiss regulatory authority on 2nd March 2004. This significantly shortened the SPC term. AstraZeneca lodged an appeal against this decision because it took the view that the term of the SPC should be calculated by reference to a later marketing authorisation granted by the European Medicines Agency (EMEA). If AstraZeneca is correct, the term of protection conferred by its SPC would be five years, such that the expiry date of the SPC would be 22nd April 2021.

AstraZeneca’s marketing authorisations
AstraZeneca’s Swiss marketing authorisation was obtained in 2004 (ie, before the introduction of the negative list in Liechtenstein in 2006). The Swiss marketing authorisation was limited in duration and applied less stringent criteria than those imposed by the EU regulatory authorities under the relevant directives. In order to extend the term of the marketing authorisation in Switzerland, AstraZeneca was requested to submit additional data within a time limit. AstraZeneca submitted no such additional data and so the Swiss marketing authorisation was withdrawn; this also had the effect of withdrawing the corresponding marketing authorisation in Liechtenstein.

AstraZeneca was subsequently granted a new marketing authorisation by the EMEA in 2009, after obtaining more data. A new marketing authorisation was also granted in Switzerland in 2010.

“First authorisation”
The UK IPO followed the ECJ’s earlier decision in Novartis in ruling that the 2004 marketing authorisation granted in Switzerland, which was also effective in Liechtenstein (and hence part of the EEA), was the “first authorisation” in the European Community. Consequently, the UK IPO was of the view that the term of AstraZeneca’s SPC should be less than three years.

AstraZeneca, on the other hand, argued that the 2004 Swiss marketing authorisation was not the “first authorisation” in the European Community in view of two decisions handed down by the ECJ (Hässle (C-127/00) and Synthon (C-195/09)).

In Hässle the ECJ stated that the relevant marketing authorisation for SPC purposes is that which complies with the requirements of the relevant EU directives. AstraZeneca argued that the data used to obtain the limited duration Swiss marketing authorisation in 2004 was not sufficient to obtain a marketing authorisation from the EMEA because it did not comply with the requirements of the relevant EU directives.

In Synthon the ECJ stated that when a product is placed on the market without first having received an EU compliant marketing authorisation, the product is outside the SPC system. Again, AstraZeneca argued that the 2004 limited duration Swiss marketing authorisation was not an EU compliant marketing authorisation.

In the case at hand, on the basis of the rulings handed down in Hässle and Synthon, AstraZeneca argues that the 2004 Swiss marketing authorisation should not be used to calculate the term of its SPCs. It also argues that Novartis is not relevant to its case because that decision either was confined to specific facts or was wrongly decided.

In view of the differing interpretations of the existing ECJ case law, the following questions have been referred to the ECJ:

• Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in EU Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the “first authorisation to place a product on the market” for the purposes of Article 12(1) of the SPC Regulation? 
• Does it make a difference to the answer to the first question if: 
  • the set of clinical data on which the Swiss authority granted the marketing authorisation was considered by the EMEA as not satisfying the conditions for the grant of a marketing authorisation pursuant to EU Regulation 726/2004; and/or 
  • the Swiss marketing authorisation was suspended after grant and was reinstated only following submission of additional data? 
• If Article 13(1) of the SPC Regulation refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in EU Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of the SPC Regulation?

The judge has suggested that the answer to the above questions should be:

• Yes, the 2004 Swiss marketing authorisation was the “first authorisation”.
• No, the circumstances make no difference.
• Yes, the product is ineligible for any SPC protection at all in line with the ECJ’s decisions in Hässle and Generics (C-427/09), but contrary to that in Neurim (C-130/11).

Comment
The innovative pharmaceutical industry will surely hope that the “first authorisation” will not be considered to be a marketing authorisation that fails to comply with EU directives, whereas generics companies will seek the opposite result.

The ECJ’s answers to the questions posed by the UK High Court could impact on future filing strategies of pharmaceutical companies – for example, it might discourage pharmaceutical companies from seeking their first marketing authorisation in Switzerland.

Most commentators assumed that we had all seen the back of this issue, following the ECJ’s decision in Novartis, but it seems not. We can only hope that the ECJ’s decision in this case will lend ultimate clarity to this strange lacuna in the law. However, as we have seen following the ECJ’s decision in Medeva (C-322/10), this may be a false hope.