Escitalopram in Austria -- Supreme Court ruling now in English too

The recent posts concerning the recent Austrian Supreme Court’s ruling concerning an SPC for Escitalopram (17 Ob 5/11a) continue to generate interest. Following Rainer Schultes's kind provision of the original German-language text of the Austrian Supreme Court's decision (here), The SPC Blog has now received via Chris Hayes (Lundbeck) an English translation of that decision (here).  Many thanks!

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!

SPC is presumed valid in proceedings for injunctive relief, says top Austrian court

This weblog does not often receive news from Austria, but International Law Office has recently posted a note on a ruling of the Austrian Supreme Court on 16 February (17 Ob 5/11a). The ruling arose from an unusual set of facts in which the holder of an SPC challenged the grant of a later SPC which, it alleged, was based on the same active ingredient as its own earlier SPC.  In patent infringement proceedings the holder of the later SPC had secured interim injunctive relief against the holder of the earlier one but, once the patent on which the later SPC was based had expired, the holder of the earlier one sought a discharge of that injunction on the basis that, on the expiry of the admittedly valid patent, the injunction was now based only on the SPC which should not have been granted.

The Supreme Court considered that, for the purposes of interim relief -- where the degree of investigation open to the court is limited -- granted rights such as SPCs must be presumed to be valid unless there was sufficient evidence to the contrary. Interim injunctions are governed by the Austrian Enforcement Act (not the Patent Act) and, while this law provide for the possibility of a stay of enforcement if sufficient monetary security is offered, this option is not available in patent and SPC litigation since the consequences of continuation of an infringement cannot be foreseen with sufficient certainty.

Source: "Court clarifies legal aspects of supplementary protection certificates", by Ferdinand Graf and Tanja Melber, Graf & Pitkowitz Rechtsanwälte GmbH, Austria, International Law Office, 27 June 2011