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Thursday, 14 July 2011

SPCs and Escitalopram in Austria: a correction

From our friend Rainer Schultes (ENWC Rechtsanwälte, Vienna) comes some helpfully corrective information regarding the SPC Blog's earlier post on June 28. This post referred to an item published by International Law Office (ILO) about the recent Austrian Supreme Court’s ruling on an SPC for Escitalopram (17 Ob 5/11a). Rainer explains that the facts were incorrectly represented:
"The law suit did not arise between the holder of an earlier SPC and the holder of a later SPC (and not between licensor and licensee) but between the holder of both, the earlier SPC for the racemate Citalopram and the later SPC for Escitalopram on the one side and a generic Escitalopram on the other side.

With reference to ECJ Case C-431/04 – MIT the Supreme Court confirmed that substances which do not have an effect of their own on the organism, cannot be considered “active ingredients” in the sense of EC Regulation 469/2009.

The decision was rendered in summary proceedings. On a prima facie basis, the defendant could not demonstrate that the R-enantiomer contained in the racemate Citalopram did not have an effect of its own on the human. Thus it remains to be verified in the main action whether the R-enantiomer has a clinical effect or not".
Rainer (who meanwhile points out that the illustration on the 28 June post was the Austrian Constitutional Court, not the Supreme Court -- this being an error induced by a Google Image search) has also kindly supplied this weblog with the anonymised full text of the decision in German. Rainer, thanks so much!

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