04
Aug
The Tecfidera case and provisional pharma reform agreement put regulatory exclusivity and patent protection in focus
At a glance
The EU General Court annulled a Commission decision granting Biogen extra market protection for Tecfidera, confirming that regulatory deadlines allow for no discretion.
The decision echoes the "Pharma Package" reform reshaping the regulatory exclusivity framework and broadening the Bolar exemptions.
Three years on, the UPC leads on life science preliminary injunction disputes, with evolving case law on "imminent infringement".
The European lifecycle...