Preliminary injunction based on a combination product SPC is denied by Athens court

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Preliminary injunction based on a combination product SPC is denied by Athens court

Sponsored by

patrinos-logo.png
monument-2011140.jpg

Constantinos Kilimiris of Patrinos & Kilimiris calls for clarity on how to apply the SPC Regulation with regard to combination products after a Greek case appeared to overturn national case law on the matter

A recent decision by the Athens First Instance Single Member Court, hearing a request for a preliminary injunction (PI) based on a supplementary protection certificate (SPC) for a pharmaceutical product combining two active ingredients, seems to overturn national case law on the interpretation of Article 3 (c) of the SPC Regulation.

Case background and ruling

The PI application was filed by an originator company alleging infringement of its combination SPC by a generic company attempting to launch its product at risk.

The defence of the generic company was to challenge the validity of the combination SPC. The generic company alleged that:

  • The SPC was granted in violation of Article 3 (c) of the SPC Regulation as another SPC had already been granted for the first active ingredient of the marketed combination; and

  • The basic patent could not be interpreted as disclosing the active ingredients’ combination as a separate, independent invention.

While the reasoning of the decision is not very clear, it seems that the Athens court based its decision on Court of Justice of the European Union (CJEU) case law, C-443/12 and C-577/13, looking into whether the combination of active ingredients could be regarded as an independent invention of the basic patent. It ruled that this is not the case and, accordingly, that an SPC had already been granted for the same invention. Thus, the combination SPC was granted in violation of Article 3 (c) of the SPC Regulation and was invalid.

Analysis of the decision

This decision is contrary to previous case law from the same court, which, in hearing a PI application based on a combination SPC, had found that the grant of a combination SPC had not violated Article 3 (c) of the SPC Regulation as it was sufficient that the combination be expressly mentioned in the claims, without examining whether the combination could be regarded as an independent invention.

While it is true that the national case law on this issue is divergent among EU member states, it also seems that the Greek case law on this matter is far from settled. Given that referrals are pending on the same issue before the CJEU, one should hope for some clarity on how to apply the SPC Regulation in practice as regards combination products.

more from across site and SHARED ros bottom lb

More from across our site

Tim Gilman, who joined Kasowitz alongside three other partners, says he is excited to be part of the firm’s ‘elite’ litigation team
A backlash against a White House video promoting deportation and Casalonga opening a new office in Düsseldorf were also among the top talking points
The firm has brought on board two counsel and an associate to complement two previously revealed partner hires
Bradford Newman, who has joined the firm’s new Silicon Valley office as head of complex technology disputes, discusses plans to build the practice group and attract local talent
Managing IP summarises the highlights from the IP STARS rankings for copyright and IP transactions work, the final firm rankings release of the year
Developments included the first judgment from the Nordic Baltic division, an injunction covering the UK, and a new code of conduct
Alston & Bird acted for InterDigital, while Samsung was represented by Fish & Richardson, during the arbitration process
Powell Gilbert lawyers reveal how they navigated parallel EPO proceedings and collaborated with European peers to come out on top in the Nordic-Baltic Division’s first judgment
The firms posted increases in revenue and profit per equity partner, with both giving a nod to their IP expertise
EasyGroup, the owner of the easyJet airline, said in a press release that UK-based first-instance judges are “less experienced”, bringing a long-running debate back to the fore
Gift this article