The messy case law from the Court of Justice of the European Union (“CJEU”) on supplementary protection certificates (“SPC”) that protect “combinations” of pharmaceutical products has left many patentees that relied in good faith on the criteria laid down by the CJEU in the judgment of 16 September 1999, Case C-392/97 (“Farmitalia”) with patents whose claims are not totally aligned with the new criteria laid down in the judgment of 24 November 2011, Case C-322/10 (“Medeva”), and the ensuing saga. Readers will remember that in Farmitalia the CJEU responded that it was not for the CJEU but for national courts to determine whether or not a product is protected by the basic patent. This was cohe [...]
In the last instance, the Consiglio di Stato (the Italian supreme administrative court) established that Pfizer did commit abuse of a dominant position while it obtained and enforced in Italy its SPC protection over latanoprost. While the news was spread a few weeks ago already (the decision is dated 14 January 2014), the reasons of the decision have just been made available (they bear the date of 12 February 2014).
It is sufficient to recall that in September 2012, the Regional Administrative Court – in reversing t [...]
As my colleague Rik Lambers, from Brinkhof, reported in the blog he posted last Thursday (12 December 2013), that day was a big day for Supplementary Protection Certificate (“SPC“) aficionados, since the European Court of Justice (“ECJ“) published three new judgments that will further feed the long-running saga of SPC decisions. Readers will no doubt have heard that for the good of legal certainty, the ECJ clarified what it meant when in the judgment of 24 November 2011 (Case C-322/10, Medeva BV v. Comptroller General of Patents, Designs and Trade Marks, “Medeva“) it wrote that “article 3(a) of Regulation (EC) No. 469/2009 of the European Parliament and the Council of 6 May 2009 concerning t [...]
SPC judgments galore in Luxembourg this morning. The Court of Justice of the European Union (CJEU) provided its judgments in the Eli Lilly case (C‑493/12), in the Actavis case (C‑443/12), and in the Georgetown case (C‑484/12). The CJEU’s Medeva judgment (case C-322/10), and AG Trstenjak’s opinion in that case, raised burning questions on the interpretation of Article 3 (a) SPC Regulation (what does “specified in the wording of the claims” mean?), and Article 3 (c) SPC Regulation (is more than one SPC per basic patent possible?). For your initial thoughts the CJEU’s answers in quotes:
The CJEU reformulates the questions:
24 By its three questions, which it is appropriate [...]
It is hard to think of a recent SPC case before the UK courts where the judge has not had to refer questions to the CJEU in order to either clarify the terms of the SPC Regulation or the CJEU’s earlier interpretations. This necessity has arisen at an early stage in an action between Actavis and Boehringer Ingelheim before the High Court of England & Wales ( EWHC 2927 (Pat)) concerning the validity of an SPC for a combination product.
Boehringer Ingelheim were the proprietors of EP (UK) 0,502,314 which expired on 30 January 2012. Claim 5 of this patent was said to protect the active ingredient Telmisartan (used for the treatment of hypertension). This is the active ingredient in Bo [...]
In Medeva (C-322/10 of 24 November 2011) the Court of Justice of the European Union (CJEU) had ruled that a Supplementary Protection Certificate relating to a combination of active ingredients can only be granted in view of Art. 3(a) of the Regulation (EC) No. 469/2009, if the active ingredients are “specified” in the wording of the claims of the basic patent relied on. Otherwise, in the view of the CJEU, the necessary protection in the sense of Art. 3(a) of the Regulation does not exist. Since it remains fully unclear what the CJEU means with “specified”, a term alien to patent law, this question meanwhile has become the subject matter of two new referrals to the CJEU, i.e. C-443/12 [...]