Advocate General gives his opinion on “negative term” SPCs

15 July 2011

Mary Smillie

In the July 2010 edition of Life Sciences update, we reviewed the pending references before the Court of Justice of the European Union concerning Supplementary Protection Certificates (SPCs).  These included Case C-125/10 between Merck Sharp & Dohme Corp and the German Patent and Trade Mark Office.  The opinion of Advocate General Bot was issued on 9 June 2011 and we wait to see whether the Court will follow it. 

Background

Regulation (EEC) No. 1901/2006 (“the Paediatric Regulation”) has caused some uncertainty.  Its aim is to increase the number of clinical trials carried out in children, and gives an incentive or reward to a patent holder to increase the period of their SPC by 6 months.  The SPC itself is applied for by the patent holder to obtain up to an extra 5 years protection in patent life to make up for the time lost in development of the medicinal product.   However, the situation which has faced Merck in the different national patent offices in Europe is whether or not it is entitled to a SPC where it has obtained the Marketing Authorisation relatively quickly - and does not qualify for any additional time under Regulation (EC) No 1768/92 (“the SPC Regulation”).   In the past, prior to the Paediatric Regulation, this question has not arisen because it would have been pointless to apply for and obtain a SPC which did not extend the period of patent protection.  However, Merck has made the applications post-implementation of the Paediatric Regulation because it wants to extend the SPC (if granted) in the future by six months allowed.
 
The national patent offices in Europe do not agree whether the application should be refused or whether to grant a SPC with a zero term or grant a SPC with a negative term.  The question referred by the German Bundespatentgericht was:

“Can a supplementary protection certificate for medicinal products [1] be granted if the period of time between the filing of the application for the basic patent and the date of first authorisation for marketing in the Community is shorter than five years?”

Advocate General Bot’s Opinion

The Advocate General’s opinion is that this question is not answered precisely by the texts of the SPC Regulation and the Paediatric Regulation and so has to be deduced from the aims of these two regulations.  The aim of the SPC Regulation is to grant the holder of a patent a maximum of 15 years of exclusivity from the date of the first marketing authorisation to place the medicinal product onto the market in the EU or the rest of the EEA.  The aim of the Paediatric Regulation is to extend the SPC granted for this purpose by six months.  Therefore the Advocate General’s view is that the practical effect of these regulations taken together is to guarantee the patent holder a possible maximum period of exclusivity of 15 years and 6 months from the date of the first marketing authorisation to place the medicinal product onto the market in the EU or the rest of the EEA. 

On this basis Advocate General Bot’s Opinion is in favour of the national patent offices being able to grant an SPC if the period of time between the filing of the application for the basic patent and the date of first authorisation for marketing in the EU or rest of the EEA is less than five years. 

The Advocate General also considered whether this SPC should be a zero-term or a negative term SPC.  Although this was not specifically asked in the question from the Bundespatentgericht, its answer is important because the different national patent offices in Europe have so far reached different conclusions.  Negative term SPCs have been granted in the UK, the Netherlands and Bulgaria and a zero-term SPC in Greece.  

The Advocate General considered that the duration of the certificate cannot be “rounded up to zero” in order to allow the six-month term start from the date of patent expiry.   This is because the aim of the SPC and Paediatric Regulations together is to give a maximum of 15 years 6 months exclusivity from the date of the first marketing authorisation in the EU or rest of the EEA, and not to extend the date of expiry of all SPCs by six months.  The Advocate-General cited policy reasons for not supporting such a systematic extension, as it would risk the fair balance which currently exists between the interests of the consumers and national social security systems and the costs of necessary research. 

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[1] Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version).  This codifying Regulation came into effect after the decision by the German Patent office, so the decisive regulation is Regulation No. 1768/92