The Higher Regional court of Vienna (Oberlandesgericht Wien) has asked the CJEU to answer what many in the pharma industry have been asking: is the duration of a Supplementary Protection Certificate (SPC) to be determined by the date of the decision which first authorises a medicinal product to be placed on the market in the Community, or by the date of the notification of the first authorisation?
The referral has been assigned the case no. C- 471/14 (Seattle Genetics), and has implications for both pending SPC applications and granted SPCs. It has been estimated that a positive ruling would provide a longer exclusivity period for over 200 human or veterinary medicinal products, with the potential additional term ranging from 1 to 12 days. For the pharmaceutical industry, even a small number of additional days of exclusivity is very valuable, and for a blockbuster drug may equate to several millions of US$, €s or £s in sales.
SPCs provide a means of obtaining additional protection for pharmaceutical and plant protection products in Europe following patent expiry, to compensate for delays in placing products on the market due to the need to fulfil regulatory requirements. The duration of the SPC is set out by Article 13(1) of the Council Regulation (EC) 469/2009 ("the SPC Regulation") which provides that the duration shall be equal to the period which elapsed between the filing date of the patent and the date of first authorisation to place the product on the market in the Community, less a period of 5 years. The duration of the SPC may not exceed 5 years.
Each EU Member State has its own procedures for the authorisation of medicines. In addition, it is possible to submit a single application to the European Medicines Agency (EMA) for a marketing authorisation that is valid throughout the EU. This is known as the 'centralised procedure', and it is such 'centralised' marketing authorisations that have led to the current uncertainty, in particular, because there are two dates associated with centralised authorisations: i) the date of the European Commission's decision to grant the marketing authorisation, and ii) the date on which the applicant for the marketing authorisation is notified of that decision. The date of notification is often several days later than the date of grant of the marketing authorisation.
Prior to 2013, all national Patent Offices in the EU, except Belgium, used the date of decision to calculate the duration of the SPC. Then, in October 2013, in decision BL O/418/13 (Genzyme) the UK Intellectual Property Office held that the correct date to use was actually the date of notification. The UK hearing officer decided that, under EU law, the granted authorisation takes effect only upon notification to the applicant. Therefore, it was the date of notification that was to be used as the "date of first authorisation" when calculating the SPC duration under Article 13(1) of the SPC Regulation. Since the UK decision, Patent Offices in Portugal, Slovenia and Estonia have also changed their practice and now use the date of notification. In contrast, the Dutch and Danish Patent Offices have resisted any practice change and had continued to base the duration of an SPC on the date of grant of the marketing authorisation.
The Austrian court's referral to the CJEU for a ruling in this matter will be binding on all EU Member States, and seeks to clarify what date should be used to calculate the SPC duration.
The questions referred are:
1. Is the date for the first authorisation to place the product on the market, pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law, or does that provision refer to the date on which the authorisation takes effect in the law of the Member
State in question?
2. If the Court determines that the answer is that the date is determined by Community law, is this the date of authorisation or the date of notification?
Before dealing with the question of which date to use when calculating the SPC duration, the Austrian court felt that it was first necessary to address the question as to whether the date of the first authorisation was governed by Community law or by the national law of the EU Member States. The court then gave its view that if Community law applies, then the relevant date should be the date of the decision, but if national law applies then in Austria it is likely that the relevant date is the notification date. We now await the CJEU's view.
Based on the timeframes of recent preliminary rulings on SPC cases, we expect the CJEU decision to issue in late 2015 or early 2016.
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