German Escitalopram ruling in English: now we know why there's no ECJ reference

The deckchair is empty:
we're all at work!

Last Wednesday The SPC Blog posted here a note on the recent Escitalopram SPC decision from Germany. The text of this decision was kindly supplied by Chris Hayes (Lundbeck), who offered us sight of an English translation once it became available. This afternoon, some ten minutes ago in fact, this member of the blogging team found the English translation sitting in his in-box. He has lost no time in uploading it here for the benefit of anyone who finds the original German text too difficult. As mentioned in last week's post, the German Patent Court declined to make a further reference to the Court of Justice for a preliminary ruling. Said the Court:

"The present legal dispute does not raise any questions not yet clarified as to the interpretation of Regulation (EC) 469/2009, and this is why the Board has not followed the suggestion of Plaintiff to stay the proceedings in accordance with Art. 267 Treaty on the Functioning of the European Union (TFEU) and to refer the questions Plaintiff has formulated to the European Court of Justice as part of proceedings for a request for preliminary ruling. Such a referral is only possible if questions need to be decided regarding Community law, which cannot be answered either on the basis of legal sources nor have been sufficiently clarified in the case law of the European Court of Justice. Plaintiff was not able to formulate such a question of the law nor is such a question otherwise apparent. In the present nullity proceedings, the question is, on the contrary, decisively the subsumtion of the specific facts under the legal rules pertinent in this regard. The question that is of major significance in this case is whether escitalopram has its own medicinal effect and thus must be considered to be a different active ingredient than is citalopram. However, the Board cannot present the European Court of Justice with this factual question. The viewpoint in connection with this of whether the authorization for a medicinal product that contains as active ingredient a chemical compound as racemate that bars the grant of an SPC for a medicinal product that contains as active ingredient an enantiomer of the racemic compound and is the subject matter of a later marketing authorization as well as its own substance patent, also does not raise any legal questions requiring clarification. The purpose of Art. 3 (d) Regulation (EC) 469/2009 as a regulation lies in the objective to not prolong the overall term of protection granted by an SPC for a product in that several subsequent certificates can be granted for one and the same product (cf. German Federal Court of Justice decision “Escitalopram” in GRUR 1010, at 123, no. 76). Since, however, it must be assumed – as presented – for lack of any convincing, contradictory reference points that escitalopram is, within the terms of Art. 1(b) Regulation (EC) 469/2009, a different product than is citalopram, this viewpoint does not bar the grant of the SPC. That no other conclusion could be derived from the decision of the German Federal Court of Justice of 14 October 2008 (“Doxorubici-Sulfat”, X ZB 4/08, in GRUR 2009, at 41) was already specifically clarified by the Federal Court of Justice in its “Escitalopram” decision (see Federal Court of Justice “Escitalopram” decision in GRUR 2010, at 123, no. 77).

None of the other disputed questions decisive for the present nullity proceedings reveals an abstract, not-clarified legal question which would require an interpretation by the European Court of Justice. For these reasons, the Board did not order a stay of the proceedings pursuant to Art. 267 TFEU nor did it refer the case, in accordance with the suggestion made by Plaintiff as an auxiliary motion, to the European Court of Justice. The Board believes that its opinion is confirmed by the evaluation voiced by the Federal Court of Justice in its “Escitalopram” decision which insofar was also based on an “acte claire” (see Federal Court of Justice “Escitalopram” decision in GRUR 2010, at 123, no. 78)".