In the aftermath of the CJEU decisions Eli Lilly/Medeva and Actavis/Georgetown II, the Swiss Federal Institute of Intellectual Property proposes changes in its SPC granting practice.
One hot topic in connection with the granting of SPCs concerns the question on how to define whether a product is protected by a basic patent (Art. 3 (a) SPC Regulation (EC) No. 469/2009). This discussion became particularly relevant with respect to combination products with multiple active ingredients. The national courts in the EU member states basically have applied two different approaches: the so called “infringement test” and the “disclosure test”.
In Switzerland SPCs for combination products have [...]
The Supplementary Protection Certificate (“SPC”) seas have been relatively calm after the turmoil caused by “Super Thursday” (i.e. 12 December 2013), when shortly before packing for Christmas the Court of Justice of the European Union (“CJEU”) published three judgments on SPCs in a row. However, over the last few months there have been recent developments, some of which we would like to pick-up on in this blog.
The first development relates to what the relevant date is for calculating the term of the SPC: the date when the marketing authorization was “granted” or the date when the applicant was notified of the decision granting the authorization. So far, patent offices in the United Kingdom [...]
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 [...]
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 [...]
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 [...]