Can special approvals also be marketing authorisations? – when does the SPC clock actually start ticking?

It is not always clear, when applying for a Supplemental Protection Certificate (SPC), which authorisation is the relevant first authorisation. For veterinary medicinal products there are several possible routes to authorisation to market. The EFTA Court recently clarified community law as regards the first marketing authorisation according to the SPC regulation. This judgment may be important for future applications for SPC protection and in invalidity proceedings against SPCs.

Supplemental Protection Certificates, or SPCs, can provide a prolonged period of protection for medicinal products of up to five years following the expiration of a patent. The reason for granting this additional protection period is to compensate for the delay to the commercial exploitation of the invention, which is commonly caused by the clinical trials and processes required for establishing the medicinal product’s safety and efficacy – in the end this is needed to obtain the mandatory marketing authorisations required to put the product on the market.

Similarly to patent rights, SPCs can be declared invalid by national courts if the application granted did not in fact meet the conditions required for granting an SPC. One argument used in such invalidity proceedings is that the SPC application was based on a marketing authorisation that was not the first authorisation to put the product on the market (with the consequence that the SPC protection period was prolonged unlawfully) and that the SPC in question must thus be declared invalid.

However, in the context of an SPC it is not always clear which authorisation should be considered the first marketing authorisation. For veterinary medicinal products, there are various authorisations and means of obtaining permission to put a product on the market. There are a number of authorisations or permissions besides the regular marketing authorisation – for example, for special or extraordinary situations where different requirements might apply.

Should all of these sometimes temporary or conditional authorisations be seen as the relevant first “SPC-qualifying” marketing authorisation? This is a pertinent question, both for rights holders and competitors, which up until recently has remained in the dark.

In early April this year the EFTA Court shed some light on the uncertainty in a judgment in its case No E-16/14 (Pharmaq AS vs. Intervet International BV). The proceedings in the referring national (Norwegian) court concerned a Norwegian SPC for a vaccine against viral pancreatic disease in salmonid fish. The claimant had previously lost a patent dispute against the SPC-holder, in which the court found that the claimant’s medicinal product (also a vaccine against pancreatic disease in fish) fell under the scope of the patent that was the basis for the SPC in question. After having lost the patent infringement case, the claimant sought a court declaration that the SPC was invalid, inter alia due to the SPC not having been based on the first marketing authorisation – the SPC-holder had been supplying its product under a “special approval exemption” and under an “exceptional authorisation” prior to the marketing authorisation referred to in the SPC. The claimant thus argued that the SPC marketing authorisation was not the first authorisation to place the product on the market.

In these national proceedings, the District Court of Oslo referred questions regarding the interpretation of the EC regulation No 1768/92 (the SPC regulation) to the EFTA Court. One of the central issues was which permissions or authorisations were to be considered as the relevant marketing authorisations under the SPC regulation.

The EFTA Court initially found that administrative authorisation procedures, as set out under Title III in directive 2001/82/EC, are the relevant marketing authorisation in relation to an SPC. Such administrative procedures include testing of the safety and efficacy of the medicinal product, the result of which must accompany the application for marketing authorisation – which is the reason for granting the additional protection period in the first place.

The EFTA Court then considered in particular two kinds of special authorisation forms and whether these constituted marketing authorisations as regards an SPC. These were 1) a special and conditional approval based on article 26(3) of directive 2001/82/EC granted under specific circumstances and where the approval is conditional upon specific procedures concerning inter alia safety and incident reporting, and 2) a special provisional permission based on article 8(1) of directive 2001/82/EC granted in the event of serious epizootic diseases.

As regards the first authorisation form – the special and conditional approval – the EFTA Court noted that such authorisations require specific procedures, particularly concerning the safety of the medicinal product, notification to authorities of any incidents and actions to be taken upon any incidents. The EFTA Court thus found that approvals according to article 26(3) of the directive constitute relevant marketing authorisations and can be considered “first” marketing authorisations in the context of SPCs.

In contrast, the EFTA Court noted that the second authorisation form – the permission to supply medicinal products under article 8(1) of directive 2001/82/EC – rather constitute an exemption to the authorisation scheme set out in that directive. Such a provisional permission, the EFTA Court noted, does not require safety and efficacy testing as for marketing authorisations and it does not entitle the producer to market the product, but only to supply it to the extent necessary to combat the disease in question. Therefore, the second form of special permission does not as such constitute a relevant marketing authorisation in the context of SPCs. Thus, only certain kinds of the permissions or authorisations available – which include testing for safety and efficacy according to Title III of directive 2001/82/EC – may form a basis for an SPC. Which of all available national permissions and authorisations should be considered as such marketing authorisations is, however, up to the national courts to decide, based on the merits in each case.

Consequently, according to the judgment of the EFTA Court, the “SPC clock” does not necessarily start ticking at the first permitted use on the market – but rather at the first authorisation which has been subject to safety and efficacy measures, in accordance with Title III of directive 2001/82/ EC. Upon several different uses and authorisations for a product, it is thus just as important to choose the right marketing authorisation when applying for an SPC as it is to base your argument on the relevant authorisation in any invalidity proceedings.

Court decisions from the EFTA Court are of course not binding within the EU and it remains to be seen whether the judgment from the EFTA Court will be followed by the European Court of Justice. Nevertheless, the EFTA Court judgment provides relevant and useful arguments for any
future SPC proceedings.