Javier Huarte and his colleague Sara Pelaz (Grau & Angulo, Barcelona) have kindly sent The SPC Blog the following information to share with our readers:
"By means of a judgment dated 20 June 2012 (here), the Commercial Court No. 1 of Pamplona has upheld a revocation action by Cinfa and Actavis against the Spanish SPC for telmisartan + hctz, on the grounds of article 15.1(a), in relation to article 3(a), of the SPC Regulation.
The active ingredient ‘hctz’ was not specified in the wording of the claims of the basic (mono) patent. Accordingly, since it couldn’t do otherwise, the court has relied on the ECJ Medeva decision to conclude that the SPC must be deemed invalid and revoked.
As far as we are aware, this is the first post-Medeva decision in Spain to decide on an SPC for combination products.
The SPC holder (Boehringer) can appeal the judgment.
Javier and Sara
hope to be able to forward an English translation of the decision within a few days. On behalf of all our readers, we thank you both very much!
5 comments:
Thanks for Javier and Sara for sharing the information and the judgment. Please, note that the text of the same has two mistakes (pages 2 and 3): telmisartan SPC will expire on 2013, not 2011 or 2012.
Thanks for the post. What was the patent number of the basic patent? I am wondering if HCTZ was mentioned in the description and, if so, what the Court had to say about that.
(I think that, although the Spanish can confirm for us...) The Patent was EP (ES) 0 502 314. The EP was granted in German. In the English translation that I have there is no mention of HCTZ in the claims, but HCTZ does appear in the decription.
Thanks -- that's very interesting. Was there any attempt to make an amendment to refer to HCTZ (assuming that's even possible in Spain)? Did BI's lawyers make arguments based on the disclosure of HCTZ in the description?
Please enlight regarding Boehringer appeal on this judgement.
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