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Tuesday 28 January 2014

A mystery reference from Portugal: can anyone help?

Our friend and long-time reader and contributor John Miles (Potter Clarkson) has written to ask whether any readers of The SPC Blog might be able to shed any light on another reference to the Court of Justice of the European Union for a preliminary ruling, Case C-555/13.  As John mentions,
The question has now been published but no background to it. It is a reference from the Tribunal Arbitral (Portugal).  I am updating the European Patents Handbook chapter on SPCs and would like to be able to include some more details of it.
The information about this case, as it appears on Curia, looks like this:
Request for a preliminary ruling from the Tribunal Arbitral (Portugal) lodged on 28 October 2013 – Merck Canada Inc. v Accord Healthcare Limited and Others 
(Case C-555/13) 
Language of the case: Portuguese 
Referring court 
Tribunal Arbitral 
Parties to the main proceedings 
Applicant: Merck Canada Inc. 
Defendants: Accord Healthcare Limited, Alter SA, Labochem Ltd, Synthon BV, Ranbaxy Portugal – Comércio e Desenvolvimento de Produtos Farmacêuticos, Unipessoal Lda 
Question referred 
May Article 13 of Regulation No 469/2009 1 be interpreted as permitting, by means of a supplementary protection certificate for medicinal products, the period for exclusive exploitation of the patented invention to be more than fifteen years from the date of the first authorisation to place the medicinal product in question on the market within the Community (not including the extension provided for in Article 13(3) of that regulation)?
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) (OJ 2009 L 152, p. 1).
If anyone can help, that would be great!


Luis Ferreira said...

I think this is about a case with a curious situation involving the interplay of two different patent acts, in which older patents had a term of 15y from grant. In some situations this could mean the SPC provides a granted+authorized protection of more than 15y. I suspect the referred question does not fully reflect this.
Drop me a line if you need more info.
Luis H Ferreira

Andreas Schmitt said...

I believe the case is related to the Montelukast SPC expiring 17/08/2014. The SPC has been calculated following the transitional provision article 6 - Decreto de Lei 36/2003 for patents granted according to the former Portuguese patent law and is based on PT99213, which has been filed on 11/10/1991 and has a patent term until 02/10/2013 (15 years after the date of grant). The EU authorization has been on 25/08/1997, so one would expect an SPC expiry of 25/8/2012 (not accounting pediatric extensions). The formula used according to Decreto de Lei 36/2003 allows SPC terms exceeding the 15 years after market authorization and there are a few other examples for this case in Portugal.
Hope this can help,

Andreas Schmitt
A.S. Dataservices

Gondavcar said...


I do not know the exact case but it certainly has to do with what both Luis and Andreas have written.
Anyhow, the problem with the calculation of the extension of SPCs does not come from the old portuguese IP Code granting a duration of 15 years from grant (as long has it results a final duration of at least 20 years from apllication date), but it is due to Regulation (EC) No 469/2009 itself as it was drafted taking in account that a duration of a patent was always 20 years (from application date). Some portuguese patents have more than 22, 23 and even 24 years of duration (from application) as they took 7, 8 and even 9 years to be granted...!
The interesting thing here will be to see the importance CJEU will give to the recitals of the Regulation.

João Jorge
RCF - Intelectual Property

Anonymous said...

Looks like we have a decision 13.02.2014 - can anyone confirm / post a copy of the decision?