In November last year, I was interviewed about the European Commission’s €462.6 million fine against pharmaceutical giant Teva and what it could mean for European patent practices.
In short, the European Commission fined Teva for artificially extending patent protection by pursuing divisionals and spreading misleading information about a competing product to hinder its market entry and uptake.
The Commission relied on documents from Teva’s in-house lawyers who were “involved in the design of its abusive strategy to protect Copaxone” because in-house lawyer communications are not privileged under EU law.
Teva published a statement at the time noting “Teva disagrees with the Commission’s legal theories which are legally untested and, Teva believes, not supported by the facts. The company will vigorously defend its position on appeal and is well prepared financially to mount a defense.”
At the time of writing, it is unknown if Teva has filed an appeal.
Latest Reports
On January 20, 2025, the Commission published the Final Report of the Hearing Officer and the Summary of Commission Decision.
These documents show that the Commission treated the two claims (pursuing divisionals and spreading misleading information) as individual violations. However, the infringement period and fine were calculated based on the timeframe during which at least one abuse was ongoing.
Extract from the Summary of Commission Decision:
“Since these two abuses are complementary and pursue an identical objective, namely to protect or strengthen Teva’s dominant position on the GA markets, they constitute a single and continuous infringement which started in all Relevant Member States on 3 February 2015 and ended (i) on 31 December 2018 in the Netherlands, (ii) on 31 December 2021 in Italy, (iii) on 31 December 2022 in Poland, and (iv) on 7 February 2024 in Belgium, Czechia, Germany and Spain.”
Analysis
Most noteworthy to users of the European patent system are the documents now published by the Commission, which make it clear that misuse of European divisionals can in itself violate EU law and be subject to fines.
It is apparent that the Commission is focusing on the pharmaceutical sector, and as such, big pharma companies in dominant positions should be careful and consider the decision when devising European divisionals tactics.
Also, the decisions emphasise that, unless you want the European Commission looking over your shoulder when devising patent tactics, it is generally advisable to involve external counsel subject to legal privilege.
