In another attempt to clarify the basic criteria for SPC eligibility, Mr. Justice Arnold has referred AstraZeneca AB v Comptroller-General [2012] EWHC 2840 concerning the duration of an SPC when the marketing authorisation has been suspended, to the Court of Justice of the European Union.

The Facts

In March 2004, AstraZeneca, a British-Swedish multinational pharmaceutical company, obtained a marketing authorisation (MA) for their drug, Iressa, in Switzerland. Under the customs and patent union between Switzerland and Liechtenstein, the Swiss MA was automatically recognised in Liechtenstein and therefore the European Economic Area (EEA).

In 2003, AstraZeneca had submitted an application to the European Medicines Agency (EMA) for a European MA but the Committee for Proprietary Medicinal Products (CHMP) was not willing to grant one, citing insufficient data as having been provided. The data apparently failing to answer questions which had been raised by the CHMP. Having failed to provide sufficient data within the required time period, the MA was suspended in October 2005, terminating its effect in Liechtenstein.

The Swiss MA in operation from 2004-2005 was limited in duration and loosely applied the criteria the European Union (EU) authorities required under the relevant Directives. During this period, it was therefore legal to market Iressa in Liechtenstein, but nowhere else in the EEA or EU.

In 2008, AstraZeneca re-submitted its application to the EMA supported by further clinical trials and sufficient data addressing the CHMP’s concerns with the original application. AstraZeneca was ultimately granted a European MA in 2009 and a new Swiss MA the following year, after which it was permissible for AstraZeneca to put Iressa back on the market in Switzerland and Liechtenstein. Between 2005–2009 it was illegal to market Iressa anywhere in the EU or EEA. 

The question therefore arose as to which MA applied as the first authorisation on the market for an SPC application.

Which was the first MA?

Under the SPC regime, the date of the first MA authorises the drug to be placed on the market in the EEA. An SPC cannot be granted for more than 5 years and the duration of the protection of the patent cannot exceed 10 years for the holder’s first MA.

The Comptroller of Patents in the UK regarded the 2004 Swiss MA as the first MA. The reason for this was because of the decision in Novartis AG and others v Comptroller-General of Patents, Designs and Trade Marks for the United Kingdom (Case C-207/03) where it was held that a Swiss MA could trigger the SPC provisions due to its effect in Liechtenstein and therefore the EEA.

However, AstraZeneca argued that the Swiss MA could not have triggered the SPC provision due to the Hassle AB v Ratiopharm GmbH (Case C-127/00) decision where it was held that the only MA which would trigger an SPC is one granted in accordance with the relevant EU Directives, which the Swiss MA was not. In addition, the principle which arose from Synthon BV v Merz Pharma GmbH & Co KgaA [2009] EWHC 656 (Pat) ("Synthon") was that when a product is placed on the market without first having received an EU-compliant MA, the product is outside the SPC system. 

Mr. Justice Arnold took into consideration three points when considering which was the first MA. First, the objective of the Regulation is to ensure sufficient protection to encourage pharmaceutical research which is important in the continuing improvement in public health. Second, the Regulation aims to prevent the development of different national laws leading to further discrepancies which are likely to create barriers to the free movement of medicinal products within the Community. Finally, the pharmaceutical sector is complex and it is important to take into consideration all the interests at stake, including those of public health.

He concluded that the Swiss MA was the first authorisation. Iressa was authorised to be placed on the market in Liechtenstein during the period from March 2004 to October 2005.

Is the drug now disqualified entirely from SPC protection?

In Synthon and Generics (UK) Ltd v Synaptech Inc C-427/09 ("Generics"), the Court held that where a product is placed on the Community market without first having undergone the testing and regulatory approval required under EU Directives, then not only will the SPC Regulation not apply, but any SPC that has already been granted will be invalid. 

The Comptroller argued that this implied the compound in Iressa could now never be granted a valid SPC having already been marketed in the EEA without first receiving an EU-compliant MA.

Mr. Justice Arnold agreed with the reasoning in Synthon and Generics which was more consistent with previous cases and viewed the product to be ineligible for any SPC protection. Although Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (Case C-130/11) was considered, which suggests the contrary; it placed an unbalanced emphasis on the objectives of the SPC Regulation. 

Analysis

The decision means pharmaceutical companies should be alert that as soon as they are granted an MA in the EU or EEA the time to seek an SPC is running. It does not matter if the MA is suspended or disrupted in the future, the fact is that the medicinal product would have been authorised to be on the market from that initial date.

Although, Mr. Justice Arnold has given his views on the matter, the case has been referred to the Court of Justice of the European Union (CJEU). This type of situation was not easily predicted and the referral arises due to alleged inconsistencies between a number of earlier rulings on SPCs.

So many SPC scenarios were not foreseen, it is difficult to know if we will ever have clarity. We await the CJEU’s decision and hope clarity may yet be achieved.