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15 years are enough! ECJ decided on the maximum period of exclusivity of a patent and SPC

by Miriam Büttner

In a recent decision the European Court of Justice (ECJ) ruled on the maximum period of exclusivity of a patent and a supplementary protection certificate (SPC) (Order of the Court dated 13 February 2014 – case no C-555/13, Merck Canada Inc. vs. Accord Healthcare Ltd and others).


Merck Canada Inc. (Merck) lodged an application for a patent for the active ingredient “montelukast sodium” in Portugal on 11 October 1991, which was granted on 2 Octo-ber 1998. The first marketing authorization (MA) for a medicinal product containing that active ingredient within the European Union was obtained in Finland on 25 Au-gust 1997. Merck applied for a SPC with the Port [...]

Eli Lilly v HGS – Declaration Denied

It is perhaps a poor reflection on the CJEU that it regularly issues rulings that, when the case is restored before the referring court, lead both parties to an action to claim victory. However this happened yet again when Warren J was given the unenviable task of implementing one of the trio of references decided by the CJEU last December in the world of SPCs.

Most readers will already be familiar with the facts of the Eli Lilly v HGS case. HGS has a patent directed to Neutrokine-alpha which includes a claim to antibodies which bind to this protein. This claim is drawn at a fairly broad level – anything that binds specifically to the full length Neutrokine-alpha polypeptide or the extrace [...]

Can a basic patent be amended under Art. 138.3 EPC to overcome a nullity action brought against its SPC?

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 [...]

Pfizer found guilty in the final round of the latanoprost saga

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).

The story, which commenced in 2010, is already a rather famous one, so I will not dwell again on the facts here. Details can be found in my previous posts here, here and here.

It is sufficient to recall that in September 2012, the Regional Administrative Court – in reversing t [...]

SPCS: ECJ leaves Medeva behind after correcting its own clumsy transcription of Commission’s 1990 explanatory memorandum

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 Flood in Luxembourg: CJEU’s Eli Lilly, Actavis and Georgetown Judgments

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:

Eli Lilly

The CJEU reformulates the questions:

24    By its three questions, which it is appropriate [...]

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