16 June 2011

SPCs provide additional protection, beyond patent  expiry, for products (medicinal or plant protection) that  require a marketing authorisation.
Extension  of SPC  Duration
The  duration of an SPC is calculated using the following formula:
Duration = {[Date of 1st relevant Marketing Authorisation)  -  (Patent Filing Date)] - 5}, subject to a maximum of 5 years.
However, since early 2007, a 6-month  extension to an existing SPC has been available in respect of products for which clinical trials have taken place in the paediatric population in accordance with an investigation plan approved by the European Medicines Agency.
The additional 6 months creates the possibility of obtaining a positive SPC term even if the equation would have previously led to a zero or negative figure (i.e. when less than 5 years has elapsed between patent filing and marketing authorisation issuance).
The question then arises of whether the SPC legislation allows the granting of SPCs that, in the absence of extension, would have a zero or a negative term.
In the article, "Making the Most of Paediatric SPC Extensions", published on 7 July 2007 in RAJ Pharma, Mike Snodin and John Miles of our firm argued that zero or negative term SPCs should be granted, in order to enable those conducting clinical trials in the paediatric population to benefit from the 6-month extension of SPC term provided by Regulation No.1901/2006 as a reward for conducting those trials.
Mike and John's hypothesis was tested when Merck & Co. applied for SPCs across Europe in respect of sitagliptin, a product which obtained a relevant marketing  authorisation 4 years, 8 months and 16 days after  the filing date of  the patent upon which the SPC applications were based.
Several patent offices granted SPCs for sitagliptin with either a zero term (Greece) or a negative term (the UK and the Netherlands), but applications were refused in other territories including Germany.
Merck  appealed  the  refusal  of the German SPC application to the German Federal Court of Justice (Bundesgerichtshof). On hearing the arguments, the Bundesgerichtshof referred the following question to the CJEU (as case C-125/10).
"Can  a supplementary protection certificate for medicinal products be granted if the period of time between  the filing of the application for the basic patent and the date of the first authorisation for marketing in the Community is shorter than five years?"
Advocate-General's   opinion
Encouragingly, the Advocate-General Yves Bot's opinion is that the answer to the question should be "yes".  Although the opinion is not yet available in  English, Mr Bot's reasoning appears to be in line with the arguments set out in the above-mentioned 2007 article.
Of the two possible alternatives presented by Mike and John for calculating the term of an  extended  SPC, Mr Bot has proposed adopting the one  that is less generous to SPC owners ("Model A" in the 2007 article). This  appears to  be on the ground that, according to  Mr Bot, the original SPC legislation and Regulation No.1901/2006 have the combined objective of ensuring a maximum total of 15 and a half years   of post-marketing exclusivity for products benefiting from both patent and SPC protection.
Action points
Please contact us for advice if you have a medicinal product for which:
(a)   a marketing authorisation  could be (or has been) issued in Europe before 5 years have expired from the date of filing of a patent protecting the product; and
(b)  the results from clinical trials in the paediatric population have been
(or  will  be) submitted to one or more regulatory bodies in Europe.
If these conditions are met, you may be entitled to more Supplementary Protection than is conventionally  available.
If you require any further information, please contact our SPC & Regulatory group.

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